CRISPR Cures Inherited Disorder in Mice, Paving Way for Genetic Therapy Before Birth
UC Loses Appeal on CRISPR Patents
Potential DNA Damage From CRISPR ‘Seriously Underestimated,’ Study Finds
Report For Defense Department Ranks Top Threats From 'Synthetic Biology'
UC Berkeley Granted Two CRISPR-Related Patents
Major CRISPR Hurdle: Edited Cells Might Cause Cancer, Find Studies
The Take From Courtside: UC Berkeley Probably Not Going to Win CRISPR Patent Dispute
New CRISPR Method Targeting Blindness In Mice Could Treat Hundreds Of Inherited Diseases
Trying to Slow Lou Gehrig's Disease With CRISPR-Cas9
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Prior to joining KQED, Amel worked at Al Jazeera America, Al Jazeera English, Democracy Now! and Punched Productions. She also helped produce \u003cem>Changing Face of Harlem\u003c/em>, a documentary that tracked gentrification in Harlem over a period of ten years. 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But while CRISPRing human fetuses is years away, at best, the success in mice bolsters what Dr. William Peranteau, who co-led the study, calls his dream of curing genetic diseases before birth.\u003c/p>\n\u003cp class=\"danger-zone\">“A lot more animal work needs to be done before we can even think about applying this [fetal genome editing] clinically,” said Peranteau, a pediatric and fetal surgeon at CHOP. “But I think fetal genome editing may be where fetal surgery [which is now routine] once was, and that one day we’ll use it to treat diseases that cause significant morbidity and mortality.”\u003c/p>\n\u003cp>Simon Waddington of University College London, a leader in research to develop fetal gene therapy who was not involved in the new study, called the CRISPR approach “an elegant refinement of the brute-force technology” that’s been the focus of \u003ca href=\"https://www.nature.com/articles/s41591-018-0106-7\" target=\"_blank\" rel=\"noopener\">animal studies\u003c/a> of fetal genetic therapy.\u003c/p>\n\u003cp>The success in mouse fetuses raises the possibility that, even before \u003ca href=\"https://www.statnews.com/2018/07/25/can-gene-therapy-halt-diseases-in-babies-before-theyre-even-born/\">traditional gene therapy\u003c/a> is ready to treat inherited disorders in utero, genome editing might emerge as a safer, more effective approach. In traditional gene therapy, an entire healthy gene is ferried, typically by a virus, into cells containing a disease-causing gene. With CRISPR, only the mutated bit of a defective gene is changed. It’s the difference between retyping a whole 5,000 word document and using Word’s “find and replace” to correct a typo.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>“We think this represents a safer and more precise way to make changes in the genome,” said Dr. Kiran Musunuru of Penn and a co-leader of the study. “It’s is the better way forward if you want to take CRISPR into the clinic.”[contextly_sidebar id=\"WspKwnRfkmuJ8Ui6Pu5mBgKtCSqZqfJ5\"]\u003c/p>\n\u003cp>The rationale for fetal genetic therapy is simple: it could halt a disease before it causes irreversible and even fatal damage. In people, the inherited liver disease that the scientists targeted in mice, called hereditary tyrosinemia type 1, starts damaging the liver months before birth. Another rationale: because a fetus’s immune system is immature, it is less likely than even a newborn’s to attack the alien CRISPR molecules.\u003c/p>\n\u003cp>For their study, \u003ca href=\"https://www.nature.com/articles/s41591-018-0184-6\" target=\"_blank\" rel=\"noopener\">published in Nature Medicine\u003c/a>, Musunuru and his colleagues gently opened the uterus of a pregnant mouse, removed the fetus from the amniotic sac, and injected CRISPR into the vitelline vein, which is near the surface of the sac and connects to the liver. “We wanted to make sure we got the genome editor into the liver rather than everywhere else,” Musunuru said. The fetus was then replaced in the uterus and was born normally.\u003c/p>\n\u003cp>Instead of using the original form of CRISPR, which cuts DNA where a gene is mutated and inserts a replacement string of A’s, T’s, C’s, and G’s, the scientists used the form of CRISPR called base editing. \u003ca href=\"https://www.statnews.com/2016/04/20/clever-crispr-advance-unveiled/%5D\">Invented\u003c/a> just two years ago, base editing changes an incorrect DNA letter, or base, to the correct one, such as a C to a T or a G to an A. Its advantage is that it doesn’t need to cut DNA to do this, as CRISPR 1.0 does; those cuts can wreak \u003ca href=\"https://www.statnews.com/2018/07/16/crispr-potential-dna-damage-underestimated/\">genetic havoc\u003c/a>, with unknown consequences for CRISPR’d cells.\u003c/p>\n\u003cp>For a dry run, the scientists first made a CRISPR base editor that changes a \u003ca href=\"https://ghr.nlm.nih.gov/gene/PCSK9\" target=\"_blank\" rel=\"noopener\">gene called PCSK9\u003c/a>, which makes a protein that helps regulate the amount of cholesterol in the bloodstream, into a super-cholesterol-lowering form. When injected into mouse fetuses, the base editor changed liver cells as intended and left other organs alone. Crucially, the mouse mother showed no effects of the CRISPR treatment. After birth, the baby mice had ultra-low cholesterol levels, showing that the CRISPR base editor had worked. Only about 15 percent of the liver cells of the baby mice had been edited, but that fraction remained stable through the animals’ adulthood.[contextly_sidebar id=\"7RKromVt2cYnSDdz2L7SJg04iooF89dn\"]\u003c/p>\n\u003cp>The amount of genetic havoc from the base editing was low: about 2 percent, compared to 40 percent for many uses of traditional CRISPR. And none of the likely spots for “off target” effects — DNA sites that resemble the target and so might be inadvertently edited — showed any sign of being altered.\u003c/p>\n\u003cp>The Philadelphia scientists then tried their technique on hereditary tyrosinemia type 1. HT1, which strikes 1 in 100,000 newborns worldwide, is \u003ca href=\"https://rarediseases.info.nih.gov/diseases/2658/tyrosinemia-type-1\" target=\"_blank\" rel=\"noopener\">caused by\u003c/a> any of several mutations in a \u003ca href=\"https://ghr.nlm.nih.gov/gene/FAH\" target=\"_blank\" rel=\"noopener\">gene called FAH\u003c/a>. All the mutations cause the build-up of toxic breakdown products of the amino acid tyrosine, a component of protein, and ultimately destroy the liver. Treatment with the drug nitisinone and a strict tyrosine-free diet is not always effective, with the result that children sometimes develop fatal liver failure or liver cancer.\u003c/p>\n\u003cp>The scientists used their base editor on a gene related to the disease-causing one. If this gene, \u003ca href=\"https://ghr.nlm.nih.gov/gene/HPD\" target=\"_blank\" rel=\"noopener\">called HPD\u003c/a>, is disabled, then no toxic metabolites of tyrosine ever get to where FAH is unable to handle them.\u003c/p>\n\u003cp>Changing a C to a T in the HPD gene disabled it. No toxic molecules built up in the livers of the fetal mice. No other organs showed signs of editing, no off-target effects were detected, and having only 15 percent of their liver cells edited was enough to cure the mice and keep them cured into adulthood. “We weren’t expecting it, but the genome-edited mice did much better” than mice treated with nitisinone, Musunuru said. “They survived longer and gained more weight.”\u003c/p>\n\u003cp>The scientists hope to study fetal base editing for other severe congenital diseases. It remains to be seen whether this technique or conventional gene therapy, which provides an entire replacement gene, will work better.\u003c/p>\n\u003cp>“I’d consider that CRISPR isn’t a replacement” for the latter, Waddington said, “but will be an additional tool” for curing genetic diseases in the womb.\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\u003ci>\u003cspan style=\"font-weight: 400\">This \u003c/span>\u003c/i>\u003ca href=\"https://www.statnews.com/2018/10/08/crispr-cures-inherited-disorder-in-mice-paving-way-for-genetic-therapy-before-birth/\" target=\"_blank\" rel=\"noopener\">\u003ci>\u003cspan style=\"font-weight: 400\">story\u003c/span>\u003c/i>\u003c/a>\u003ci>\u003cspan style=\"font-weight: 400\"> was originally published by STAT, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery.\u003c/span>\u003c/i>\u003cspan style=\"font-weight: 400\">\u003cbr>\n\u003c/span>\u003c/p>\n\n","blocks":[],"excerpt":"In mice with a fatal genetic disease, toxic proteins begin accumulating in the liver before birth. CRISPR performed in utero reversed the condition.","status":"publish","parent":0,"modified":1539042769,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":16,"wordCount":1141},"headData":{"title":"CRISPR Cures Inherited Disorder in Mice, Paving Way for Genetic Therapy Before Birth | KQED","description":"In mice with a fatal genetic disease, toxic proteins begin accumulating in the liver before birth. CRISPR performed in utero reversed the condition.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"CRISPR Cures Inherited Disorder in Mice, Paving Way for Genetic Therapy Before Birth","datePublished":"2018-10-09T21:00:49.000Z","dateModified":"2018-10-08T23:52:49.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"disqusIdentifier":"444942 https://ww2.kqed.org/futureofyou/?p=444942","disqusUrl":"https://ww2.kqed.org/futureofyou/2018/10/09/crispr-cures-inherited-disorder-in-mice-paving-way-for-genetic-therapy-before-birth/","disqusTitle":"CRISPR Cures Inherited Disorder in Mice, Paving Way for Genetic Therapy Before Birth","source":"Hope/Hype","nprByline":"Sharon Begley\u003cbr />STAT","path":"/futureofyou/444942/crispr-cures-inherited-disorder-in-mice-paving-way-for-genetic-therapy-before-birth","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp class=\"danger-zone\">Nearly 40 years after surgeons first \u003ca href=\"https://www.ucsf.edu/news/2011/02/9366/ucsf-surgeon-reflects-performing-worlds-first-fetal-surgery-30-years-ago\" target=\"_blank\" rel=\"noopener\">operated on fetuses\u003c/a> to cure devastating abnormalities, researchers have taken the first step toward curing genetic disease before birth via genome editing: scientists reported on Monday that they used the genome editing technique CRISPR to alter the DNA of laboratory mice in the womb, eliminating an often-fatal liver disease before the animals had even been born.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp class=\"danger-zone\">The research, by a team at the University of Pennsylvania and the Children’s Hospital of Philadelphia (CHOP), is a very early proof of concept. But while CRISPRing human fetuses is years away, at best, the success in mice bolsters what Dr. William Peranteau, who co-led the study, calls his dream of curing genetic diseases before birth.\u003c/p>\n\u003cp class=\"danger-zone\">“A lot more animal work needs to be done before we can even think about applying this [fetal genome editing] clinically,” said Peranteau, a pediatric and fetal surgeon at CHOP. “But I think fetal genome editing may be where fetal surgery [which is now routine] once was, and that one day we’ll use it to treat diseases that cause significant morbidity and mortality.”\u003c/p>\n\u003cp>Simon Waddington of University College London, a leader in research to develop fetal gene therapy who was not involved in the new study, called the CRISPR approach “an elegant refinement of the brute-force technology” that’s been the focus of \u003ca href=\"https://www.nature.com/articles/s41591-018-0106-7\" target=\"_blank\" rel=\"noopener\">animal studies\u003c/a> of fetal genetic therapy.\u003c/p>\n\u003cp>The success in mouse fetuses raises the possibility that, even before \u003ca href=\"https://www.statnews.com/2018/07/25/can-gene-therapy-halt-diseases-in-babies-before-theyre-even-born/\">traditional gene therapy\u003c/a> is ready to treat inherited disorders in utero, genome editing might emerge as a safer, more effective approach. In traditional gene therapy, an entire healthy gene is ferried, typically by a virus, into cells containing a disease-causing gene. With CRISPR, only the mutated bit of a defective gene is changed. It’s the difference between retyping a whole 5,000 word document and using Word’s “find and replace” to correct a typo.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>“We think this represents a safer and more precise way to make changes in the genome,” said Dr. Kiran Musunuru of Penn and a co-leader of the study. “It’s is the better way forward if you want to take CRISPR into the clinic.”\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>The rationale for fetal genetic therapy is simple: it could halt a disease before it causes irreversible and even fatal damage. In people, the inherited liver disease that the scientists targeted in mice, called hereditary tyrosinemia type 1, starts damaging the liver months before birth. Another rationale: because a fetus’s immune system is immature, it is less likely than even a newborn’s to attack the alien CRISPR molecules.\u003c/p>\n\u003cp>For their study, \u003ca href=\"https://www.nature.com/articles/s41591-018-0184-6\" target=\"_blank\" rel=\"noopener\">published in Nature Medicine\u003c/a>, Musunuru and his colleagues gently opened the uterus of a pregnant mouse, removed the fetus from the amniotic sac, and injected CRISPR into the vitelline vein, which is near the surface of the sac and connects to the liver. “We wanted to make sure we got the genome editor into the liver rather than everywhere else,” Musunuru said. The fetus was then replaced in the uterus and was born normally.\u003c/p>\n\u003cp>Instead of using the original form of CRISPR, which cuts DNA where a gene is mutated and inserts a replacement string of A’s, T’s, C’s, and G’s, the scientists used the form of CRISPR called base editing. \u003ca href=\"https://www.statnews.com/2016/04/20/clever-crispr-advance-unveiled/%5D\">Invented\u003c/a> just two years ago, base editing changes an incorrect DNA letter, or base, to the correct one, such as a C to a T or a G to an A. Its advantage is that it doesn’t need to cut DNA to do this, as CRISPR 1.0 does; those cuts can wreak \u003ca href=\"https://www.statnews.com/2018/07/16/crispr-potential-dna-damage-underestimated/\">genetic havoc\u003c/a>, with unknown consequences for CRISPR’d cells.\u003c/p>\n\u003cp>For a dry run, the scientists first made a CRISPR base editor that changes a \u003ca href=\"https://ghr.nlm.nih.gov/gene/PCSK9\" target=\"_blank\" rel=\"noopener\">gene called PCSK9\u003c/a>, which makes a protein that helps regulate the amount of cholesterol in the bloodstream, into a super-cholesterol-lowering form. When injected into mouse fetuses, the base editor changed liver cells as intended and left other organs alone. Crucially, the mouse mother showed no effects of the CRISPR treatment. After birth, the baby mice had ultra-low cholesterol levels, showing that the CRISPR base editor had worked. Only about 15 percent of the liver cells of the baby mice had been edited, but that fraction remained stable through the animals’ adulthood.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>The amount of genetic havoc from the base editing was low: about 2 percent, compared to 40 percent for many uses of traditional CRISPR. And none of the likely spots for “off target” effects — DNA sites that resemble the target and so might be inadvertently edited — showed any sign of being altered.\u003c/p>\n\u003cp>The Philadelphia scientists then tried their technique on hereditary tyrosinemia type 1. HT1, which strikes 1 in 100,000 newborns worldwide, is \u003ca href=\"https://rarediseases.info.nih.gov/diseases/2658/tyrosinemia-type-1\" target=\"_blank\" rel=\"noopener\">caused by\u003c/a> any of several mutations in a \u003ca href=\"https://ghr.nlm.nih.gov/gene/FAH\" target=\"_blank\" rel=\"noopener\">gene called FAH\u003c/a>. All the mutations cause the build-up of toxic breakdown products of the amino acid tyrosine, a component of protein, and ultimately destroy the liver. Treatment with the drug nitisinone and a strict tyrosine-free diet is not always effective, with the result that children sometimes develop fatal liver failure or liver cancer.\u003c/p>\n\u003cp>The scientists used their base editor on a gene related to the disease-causing one. If this gene, \u003ca href=\"https://ghr.nlm.nih.gov/gene/HPD\" target=\"_blank\" rel=\"noopener\">called HPD\u003c/a>, is disabled, then no toxic metabolites of tyrosine ever get to where FAH is unable to handle them.\u003c/p>\n\u003cp>Changing a C to a T in the HPD gene disabled it. No toxic molecules built up in the livers of the fetal mice. No other organs showed signs of editing, no off-target effects were detected, and having only 15 percent of their liver cells edited was enough to cure the mice and keep them cured into adulthood. “We weren’t expecting it, but the genome-edited mice did much better” than mice treated with nitisinone, Musunuru said. “They survived longer and gained more weight.”\u003c/p>\n\u003cp>The scientists hope to study fetal base editing for other severe congenital diseases. It remains to be seen whether this technique or conventional gene therapy, which provides an entire replacement gene, will work better.\u003c/p>\n\u003cp>“I’d consider that CRISPR isn’t a replacement” for the latter, Waddington said, “but will be an additional tool” for curing genetic diseases in the womb.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"floatright"},"numeric":["floatright"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\u003ci>\u003cspan style=\"font-weight: 400\">This \u003c/span>\u003c/i>\u003ca href=\"https://www.statnews.com/2018/10/08/crispr-cures-inherited-disorder-in-mice-paving-way-for-genetic-therapy-before-birth/\" target=\"_blank\" rel=\"noopener\">\u003ci>\u003cspan style=\"font-weight: 400\">story\u003c/span>\u003c/i>\u003c/a>\u003ci>\u003cspan style=\"font-weight: 400\"> was originally published by STAT, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery.\u003c/span>\u003c/i>\u003cspan style=\"font-weight: 400\">\u003cbr>\n\u003c/span>\u003c/p>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/futureofyou/444942/crispr-cures-inherited-disorder-in-mice-paving-way-for-genetic-therapy-before-birth","authors":["byline_futureofyou_444942"],"programs":["futureofyou_54"],"categories":["futureofyou_1062","futureofyou_1","futureofyou_73"],"tags":["futureofyou_94","futureofyou_927","futureofyou_324"],"collections":["futureofyou_1097","futureofyou_1094"],"featImg":"futureofyou_1194","label":"source_futureofyou_444942"},"futureofyou_444391":{"type":"posts","id":"futureofyou_444391","meta":{"index":"posts_1591205157","site":"futureofyou","id":"444391","score":null,"sort":[1536599553000]},"guestAuthors":[],"slug":"uc-loses-appeal-on-crispr-patent","title":"UC Loses Appeal on CRISPR Patents","publishDate":1536599553,"format":"standard","headTitle":"KQED Future of You | KQED Science","labelTerm":{"site":"futureofyou"},"content":"\u003cp class=\"danger-zone\">A federal appeals court on Monday struck another blow against the \u003ca href=\"https://www.statnews.com/2018/06/13/university-of-california-granted-a-key-crispr-patent/\">University of California’s\u003c/a> hopes of invalidating key CRISPR patents \u003ca href=\"https://www.statnews.com/2017/02/15/crispr-patent-ruling/\">held by the Broad Institute of MIT and Harvard\u003c/a>, ruling unanimously that a U.S. patent board correctly concluded that the Broad’s patents did not “interfere” with those that UC had applied for.\u003c/p>\n\u003cp class=\"danger-zone\">Barring an appeal to the U.S. Supreme Court, which is highly unlikely to accept the case, or a request for the full U.S. Court of Appeals for the Federal Circuit to consider the case, the \u003ca href=\"https://www.statnews.com/2017/04/13/crispr-patent-uc-appeal/\">long and bitter legal saga\u003c/a> is largely over, at least in the U.S. (The \u003ca href=\"https://www.statnews.com/2017/03/28/crispr-university-of-california-patent/\">fight over CRISPR patents in Europe\u003c/a> continues.)\u003c/p>\n\u003cp class=\"danger-zone\">The Court of Appeals \u003ca href=\"http://www.cafc.uscourts.gov/opinions-orders\" target=\"_blank\" rel=\"noopener\">decision\u003c/a> held that there was “no interference in fact” between CRISPR patents awarded to the Broad and CRISPR patents that UC had applied for. That is what three judges on the Patent Trial and Appeal Board, part of the U.S. patent office, had ruled unanimously in 2017.\u003c/p>\n\u003cp class=\"danger-zone\">The decision turned on two key and related points: whether the work that Broad scientist \u003ca href=\"https://www.statnews.com/2015/11/06/hollywood-inspired-scientist-rewrite-code-life/\">Feng Zhang\u003c/a> did to make CRISPR edit the genome of mammalian cells was “obvious” in light of what Jennifer Doudna, of the University of California, Berkeley, and her colleagues accomplished in editing free floating DNA in test tubes, and whether Zhang and other scientists trying to do that had a “reasonable expectation of success.”\u003c/p>\n\u003cp class=\"danger-zone\">There was “conflicting evidence,” patent expert Jacob Sherkow of New York Law School said in an interview, on whether any sufficiently skilled scientist could have taken Doudna’s breakthrough (done with her key collaborator, Emmanuelle Charpentier) using CRISPR in test tubes and turned it into a system that worked in human and other mammalian cells, as Zhang (and other scientists) did.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>But in her sweeping opinion, Judge Kimberly Moore wrote that “substantial evidence supports [PTAB’s] finding that there was not a reasonable expectation of success, and we affirm…. [PTAB] did not err in its analysis.” The decision, said Sherkow, “is absolutely 100 percent correct on the law,” leaving UC essentially no path to a re-hearing by the full court, let alone by the Supreme Court.\u003c/p>\n\u003cp>PTAB had ruled that Zhang’s success was by no means assured, citing Doudna’s own comments about how techniques that work in bacteria or test tubes often fail in higher-order cells, and that what Zhang did to turn CRISPR, a bacterial immune system, into a human-genome-editing tool was far from obvious. In an analysis that could well make scientists think twice about discussing the challenges of building on very basic discoveries, Moore cited Doudna’s acknowledgement of a “huge bottleneck” in modifying the genomes of humans and other animals, after Doudna and\u003c/p>\n\u003cp>Charpentier \u003ca href=\"https://www.ncbi.nlm.nih.gov/pubmed/22745249\" target=\"_blank\" rel=\"noopener\">reported\u003c/a> doing so in their test tube DNA in 2012. Doudna had also said that “2012 paper was a big success, but there was a problem. We weren’t sure if CRISPR/Cas9 would work in eukaryotes,” and conceded having “many frustrations” in getting CRISPR-Cas9 to work in human cells.” Those words came back to haunt her and sink UC’s hopes for a foundational CRISPR patent.\u003c/p>\n\u003cp>The central issue before the appeals court was whether the patent board had based its pro-Broad decision on “substantial evidence.” That, Sherkow \u003ca href=\"https://twitter.com/jsherkow/status/1039159547049504769\" target=\"_blank\" rel=\"noopener\">tweeted,\u003c/a>was “an extremely high bar.” The appeals court ruled that the board did have substantial evidence for its decision that the Broad’s CRISPR patents did not overlap with UC’s, nor were they obvious from UC’s. That leaves UC extremely little ground on which to base any appeal.\u003c/p>\n\u003cp>In a statement, the Broad called the court’s decision “correct,” upholding a PTAB ruling that “was clearly supported by sufficient evidence and followed applicable legal standards.’ As for what happens now, the Broad said, “It is time for all institutions to move beyond litigation. We should work together to ensure wide, open access to this transformative technology.”\u003c/p>\n\u003cp>The appeals court decision, in the case \u003ca href=\"https://www.statnews.com/2018/04/30/crispr-patent-appeal-hearing/\">argued\u003c/a> on April 30, clarifies the commercial landscape only partly, however. It allows the Broad to keep its patents, the first of which was awarded in 2014, on the foundational CRISPR-Cas9 genome editing technology for eukaryotic cells invented by Zhang. And it lets the Broad’s many licensees (notably Editas Medicine, which paid the Broad’s eight-figure legal costs) breathe easier. Since CRISPR Therapeutics licensed Charpentier’s invention (which is covered by the UC patent) and Intellia Therapeutics licensed Doudna’s, they now face a tougher but not impossible IP landscape.\u003c/p>\n\u003cp>Wall Street reacted calmly to the news, which analysts and investors had largely expected. Stocks of the major CRISPR companies were largely unchanged in midday trading, with Editas and Intellia slightly up and CRISPR Therapeutics down just under 3 percent. Gena Wang, a biotech analyst at Barclays, said any additional appeals by UC are unlikely to succeed, meaning the Broad should retain its U.S. patents. “We believe cross-licensing likely could occur and do not expect these proceedings to have direct impact on the clinical development of each company,” she said.\u003c/p>\n\u003cp>\u003cem>With additional reporting by Adam Feuerstein\u003c/em>\u003c/p>\n\u003cp>\u003cem>This story has been updated with additional analysis and expert comment. It\u003c/em> \u003cspan style=\"font-weight: 400\">was \u003cem>originally published by STAT, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery. \u003c/em>\u003c/span>\u003c/p>\n\u003cp>\u003c/p>\n\u003cp> \u003c/p>\n\n","blocks":[],"excerpt":"A federal appeals court struck another blow against the University of California’s hopes of invalidating key CRISPR patents held by the Broad Institute of MIT and Harvard.","status":"publish","parent":0,"modified":1538528769,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":11,"wordCount":965},"headData":{"title":"UC Loses Appeal on CRISPR Patents | KQED","description":"A federal appeals court struck another blow against the University of California’s hopes of invalidating key CRISPR patents held by the Broad Institute of MIT and Harvard.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"UC Loses Appeal on CRISPR Patents","datePublished":"2018-09-10T17:12:33.000Z","dateModified":"2018-10-03T01:06:09.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"disqusIdentifier":"444391 https://ww2.kqed.org/futureofyou/?p=444391","disqusUrl":"https://ww2.kqed.org/futureofyou/2018/09/10/uc-loses-appeal-on-crispr-patent/","disqusTitle":"UC Loses Appeal on CRISPR Patents","nprByline":"Sharon Begley\u003cbr />\u003ca href=\"https://www.statnews.com/\">STAT\u003c/a>","path":"/futureofyou/444391/uc-loses-appeal-on-crispr-patent","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp class=\"danger-zone\">A federal appeals court on Monday struck another blow against the \u003ca href=\"https://www.statnews.com/2018/06/13/university-of-california-granted-a-key-crispr-patent/\">University of California’s\u003c/a> hopes of invalidating key CRISPR patents \u003ca href=\"https://www.statnews.com/2017/02/15/crispr-patent-ruling/\">held by the Broad Institute of MIT and Harvard\u003c/a>, ruling unanimously that a U.S. patent board correctly concluded that the Broad’s patents did not “interfere” with those that UC had applied for.\u003c/p>\n\u003cp class=\"danger-zone\">Barring an appeal to the U.S. Supreme Court, which is highly unlikely to accept the case, or a request for the full U.S. Court of Appeals for the Federal Circuit to consider the case, the \u003ca href=\"https://www.statnews.com/2017/04/13/crispr-patent-uc-appeal/\">long and bitter legal saga\u003c/a> is largely over, at least in the U.S. (The \u003ca href=\"https://www.statnews.com/2017/03/28/crispr-university-of-california-patent/\">fight over CRISPR patents in Europe\u003c/a> continues.)\u003c/p>\n\u003cp class=\"danger-zone\">The Court of Appeals \u003ca href=\"http://www.cafc.uscourts.gov/opinions-orders\" target=\"_blank\" rel=\"noopener\">decision\u003c/a> held that there was “no interference in fact” between CRISPR patents awarded to the Broad and CRISPR patents that UC had applied for. That is what three judges on the Patent Trial and Appeal Board, part of the U.S. patent office, had ruled unanimously in 2017.\u003c/p>\n\u003cp class=\"danger-zone\">The decision turned on two key and related points: whether the work that Broad scientist \u003ca href=\"https://www.statnews.com/2015/11/06/hollywood-inspired-scientist-rewrite-code-life/\">Feng Zhang\u003c/a> did to make CRISPR edit the genome of mammalian cells was “obvious” in light of what Jennifer Doudna, of the University of California, Berkeley, and her colleagues accomplished in editing free floating DNA in test tubes, and whether Zhang and other scientists trying to do that had a “reasonable expectation of success.”\u003c/p>\n\u003cp class=\"danger-zone\">There was “conflicting evidence,” patent expert Jacob Sherkow of New York Law School said in an interview, on whether any sufficiently skilled scientist could have taken Doudna’s breakthrough (done with her key collaborator, Emmanuelle Charpentier) using CRISPR in test tubes and turned it into a system that worked in human and other mammalian cells, as Zhang (and other scientists) did.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>But in her sweeping opinion, Judge Kimberly Moore wrote that “substantial evidence supports [PTAB’s] finding that there was not a reasonable expectation of success, and we affirm…. [PTAB] did not err in its analysis.” The decision, said Sherkow, “is absolutely 100 percent correct on the law,” leaving UC essentially no path to a re-hearing by the full court, let alone by the Supreme Court.\u003c/p>\n\u003cp>PTAB had ruled that Zhang’s success was by no means assured, citing Doudna’s own comments about how techniques that work in bacteria or test tubes often fail in higher-order cells, and that what Zhang did to turn CRISPR, a bacterial immune system, into a human-genome-editing tool was far from obvious. In an analysis that could well make scientists think twice about discussing the challenges of building on very basic discoveries, Moore cited Doudna’s acknowledgement of a “huge bottleneck” in modifying the genomes of humans and other animals, after Doudna and\u003c/p>\n\u003cp>Charpentier \u003ca href=\"https://www.ncbi.nlm.nih.gov/pubmed/22745249\" target=\"_blank\" rel=\"noopener\">reported\u003c/a> doing so in their test tube DNA in 2012. Doudna had also said that “2012 paper was a big success, but there was a problem. We weren’t sure if CRISPR/Cas9 would work in eukaryotes,” and conceded having “many frustrations” in getting CRISPR-Cas9 to work in human cells.” Those words came back to haunt her and sink UC’s hopes for a foundational CRISPR patent.\u003c/p>\n\u003cp>The central issue before the appeals court was whether the patent board had based its pro-Broad decision on “substantial evidence.” That, Sherkow \u003ca href=\"https://twitter.com/jsherkow/status/1039159547049504769\" target=\"_blank\" rel=\"noopener\">tweeted,\u003c/a>was “an extremely high bar.” The appeals court ruled that the board did have substantial evidence for its decision that the Broad’s CRISPR patents did not overlap with UC’s, nor were they obvious from UC’s. That leaves UC extremely little ground on which to base any appeal.\u003c/p>\n\u003cp>In a statement, the Broad called the court’s decision “correct,” upholding a PTAB ruling that “was clearly supported by sufficient evidence and followed applicable legal standards.’ As for what happens now, the Broad said, “It is time for all institutions to move beyond litigation. We should work together to ensure wide, open access to this transformative technology.”\u003c/p>\n\u003cp>The appeals court decision, in the case \u003ca href=\"https://www.statnews.com/2018/04/30/crispr-patent-appeal-hearing/\">argued\u003c/a> on April 30, clarifies the commercial landscape only partly, however. It allows the Broad to keep its patents, the first of which was awarded in 2014, on the foundational CRISPR-Cas9 genome editing technology for eukaryotic cells invented by Zhang. And it lets the Broad’s many licensees (notably Editas Medicine, which paid the Broad’s eight-figure legal costs) breathe easier. Since CRISPR Therapeutics licensed Charpentier’s invention (which is covered by the UC patent) and Intellia Therapeutics licensed Doudna’s, they now face a tougher but not impossible IP landscape.\u003c/p>\n\u003cp>Wall Street reacted calmly to the news, which analysts and investors had largely expected. Stocks of the major CRISPR companies were largely unchanged in midday trading, with Editas and Intellia slightly up and CRISPR Therapeutics down just under 3 percent. Gena Wang, a biotech analyst at Barclays, said any additional appeals by UC are unlikely to succeed, meaning the Broad should retain its U.S. patents. “We believe cross-licensing likely could occur and do not expect these proceedings to have direct impact on the clinical development of each company,” she said.\u003c/p>\n\u003cp>\u003cem>With additional reporting by Adam Feuerstein\u003c/em>\u003c/p>\n\u003cp>\u003cem>This story has been updated with additional analysis and expert comment. It\u003c/em> \u003cspan style=\"font-weight: 400\">was \u003cem>originally published by STAT, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery. \u003c/em>\u003c/span>\u003c/p>\n\u003cp>\u003c/p>\n\u003cp> \u003c/p>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/futureofyou/444391/uc-loses-appeal-on-crispr-patent","authors":["byline_futureofyou_444391"],"categories":["futureofyou_1062","futureofyou_1","futureofyou_73"],"tags":["futureofyou_94","futureofyou_80"],"featImg":"futureofyou_341963","label":"futureofyou"},"futureofyou_443403":{"type":"posts","id":"futureofyou_443403","meta":{"index":"posts_1591205157","site":"futureofyou","id":"443403","score":null,"sort":[1531854049000]},"guestAuthors":[],"slug":"potential-dna-damage-from-crispr-seriously-underestimated-study-finds","title":"Potential DNA Damage From CRISPR ‘Seriously Underestimated,’ Study Finds","publishDate":1531854049,"format":"standard","headTitle":"KQED Future of You | KQED Science","labelTerm":{},"content":"\u003cp>From the earliest days of the CRISPR-Cas9 era, scientists have known that the first step in how it \u003ca href=\"https://www.statnews.com/2018/04/04/how-crispr-works-visualized/\">edits genomes\u003c/a> — snipping DNA — creates an unholy mess: Cellular repairmen frantically try to fix the cuts by throwing random chunks of DNA into the breach and deleting other random bits. \u003ca href=\"https://www.nature.com/articles/Nbt.4192\" target=\"_blank\" rel=\"noopener\">Research\u003c/a> published on Monday suggests that’s only the tip of a Titanic-sized iceberg: CRISPR-Cas9 can cause significantly greater genetic havoc than experts thought, the study concludes, perhaps enough to threaten the health of patients who would one day receive \u003ca href=\"https://www.statnews.com/2018/02/21/crispr-sickle-cell-clinical-trials/\">CRISPR-based therapy\u003c/a>.[contextly_sidebar id=\"y9TqAZzR84fJHw52DmhRAZZb04jkzjxD\"]\u003c/p>\n\u003cp>The results come hard on the heels of two \u003ca href=\"https://www.statnews.com/2018/06/11/crispr-hurdle-edited-cells-might-cause-cancer/\">studies\u003c/a> that identified a related issue: Some CRISPR’d cells might be missing a key anti-cancer mechanism and therefore be able to initiate tumors.\u003c/p>\n\u003cp>The DNA damage found in the new study included deletions of thousands of DNA bases, including at spots far from the edit. Some of the deletions can silence genes that should be active and activate genes that should be silent, including cancer-causing genes.\u003c/p>\n\u003cp>The DNA chaos that CRISPR unleashes has been “seriously underestimated,” said geneticist Allan Bradley of England’s Wellcome Sanger Institute, who led the study. “This should be a wake-up call.”\u003c/p>\n\u003cp>Leading CRISPR companies scrambled to play down the latest threat to what they hope will be a multibillion-dollar business \u003cstrong>— \u003c/strong>and to their stock prices, but investors reacted with alarm. Within the first 20 minutes of when the study was released, the three publicly traded CRISPR companies lost more than $300 million in value, and it was downhill from there: CRISPR Therapeutics ended down 8.6 percent, Editas Medicine fell 7 percent, and Intellia Therapeutics lost nearly 10 percent.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>The companies questioned whether the CRISPR-caused DNA damage reported in the new study applied to the kind of cells they’re planning to CRISPR. They emphasized that if genomic scrambling is at all common then it should also be seen in earlier forms of genome-editing such as \u003ca href=\"https://www.statnews.com/2017/11/30/crispr-talens-gene-editing/\">zinc fingers and TALENs\u003c/a> (but apparently isn’t). And they insisted they’re on the case.\u003c/p>\n\u003cp>“We’re not Pollyannaish about this,” said geneticist Tom Barnes, chief innovation officer at Intellia. For its mouse experiments, Intellia analyzes edited genomes for collateral damage both near the editing target and tens of thousands of DNA letters away, he said, but “we have not seen any [cancer-causing] transformation of these cells, even with all the edits we’ve introduced.”[contextly_sidebar id=\"X3REPdHlQY5Hjsf4rQxCF5iuUbyNXJ8K\"]\u003c/p>\n\u003cp>In a statement, Editas spokeswoman Cristi Barnett said the possibility of genetic chaos from CRISPR is “an interesting topic” that the company “actively examine[s].” The reported DNA havoc, she said, is not “specifically problematic in our work to make CRISPR-based medicines.” CRISPR Therapeutics did not respond to requests for comment.\u003c/p>\n\u003cp>Academic scientists were less dismissive of the new study, in Nature Biotechnology. One leading CRISPR developer called it “well-done and credible,” “a cautionary note to the [genome-editing] community,” and consistent with other research showing that the DNA cuts that CRISPR makes, called double-stranded breaks, “can induce the types of genomic DNA rearrangements and deletions they report.” He asked not to be identified so as not to jeopardize business relationships with genome-editing companies.\u003c/p>\n\u003cp>But just as critics of last month’s studies asked why, if CRISPR’d cells can initiate cancer, no CRISPR’d mice had turned up with tumors, so scientists raised similar questions about the new genomic havoc finding: Why don’t scientists see it when they analyze the DNA of CRISPR’d cells?\u003c/p>\n\u003cp>“You find what you look for,” said Bradley. “No one is looking at the impact [of these DNA changes] on downstream genes.”\u003c/p>\n\u003cp>And few studies conduct full-out genome sequencing of CRISPR’d cells. Moreover, scientists typically search for one form of the collateral damage the Sanger study found — deletions of thousands of DNA bases (the double helix’s famous A’s, T’s, C’s, and G’s) — using a standard technique called PCR, which makes millions of DNA copies. But to work, PCR must attach to a “binding site” on DNA; CRISPR sometimes deletes that binding site, said Bradley, whose team used a different technique to analyze the double helix for collateral damage from CRISPR.\u003c/p>\n\u003cp>The Sanger scientists didn’t set out to find collateral DNA damage from CRISPR. As they investigated how CRISPR might change gene expression, a “weird thing” showed up, Bradley said: The target DNA was accurately changed, but that set off a chain reaction that engulfed genes far from the target. The scientists therefore changed course.[contextly_sidebar id=\"dkt97iGOrAQULIvrxP1t89Dkl2rYRsky\"]\u003c/p>\n\u003cp>When they aimed CRISPR at different targets in mouse embryonic stem cells, mouse blood-making cells, and human retinal cells, “extensive on-target genomic damage [was] a common outcome,” they wrote in their paper. In one case, genomes in about two-thirds of the CRISPR’d cells showed the expected small-scale inadvertent havoc, but 21 percent had DNA deletions of more than 250 bases and up to 6,000 bases long.\u003c/p>\n\u003cp>Since therapeutic uses of CRISPR would edit the genomes of billions of cells in, say, a patient’s liver, even rare DNA damage “makes it likely that one or more edited cells … would be endowed with an important [disease-causing] lesion,” the scientists wrote.\u003c/p>\n\u003cp>Nature Biotechnology took a year to publish the paper, after asking Bradley numerous variations of “are you sure?” and “did you consider this?” and asking him to run additional experiments, Bradley said. The results all held up.\u003c/p>\n\u003cp>The one U.S. \u003ca href=\"https://clinicaltrials.gov/ct2/show/NCT03399448\" target=\"_blank\" rel=\"noopener\">clinical trial\u003c/a> using CRISPR’d cells began recruiting patients this year. It will use CRISPR to make immune cells, removed from patients with any of four types of cancer, attack telltale molecules on the tumor cells’ surface. Asked what genome analysis he plans to do, lead investigator Dr. Edward Stadtmauer of the University of Pennsylvania said, “We are doing extensive testing of the final cellular product as well as the cells within the patient.”\u003c/p>\n\u003cp>The possibility of adverse consequences from CRISPR’d cells has caused some company officials to argue that if, say, their therapy cures a child of a devastating disease, but increases her risk of cancer, that might be an acceptable trade-off.\u003c/p>\n\u003cp>That argument may well prevail. In 2003, however, when a boy in a gene therapy trial in France \u003ca href=\"https://www.nejm.org/doi/full/10.1056/NEJM200301163480314\" target=\"_blank\" rel=\"noopener\">developed leukemia\u003c/a> because the repair gene landed in the wrong place in his genome and activated a cancer-causing gene, it shut down gene therapy development on both sides of the Atlantic for years.\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\u003cem>This\u003ca href=\"https://www.statnews.com/2018/07/16/crispr-potential-dna-damage-underestimated/\" target=\"_blank\" rel=\"noopener\"> story\u003c/a> was originally published by STAT, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery.\u003c/em>\u003c/p>\n\n","blocks":[],"excerpt":"Leading CRISPR companies scrambled to play down the latest threat to what they hope will be a multibillion-dollar business.","status":"publish","parent":0,"modified":1531933835,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":22,"wordCount":1198},"headData":{"title":"Potential DNA Damage From CRISPR ‘Seriously Underestimated,’ Study Finds | KQED","description":"Leading CRISPR companies scrambled to play down the latest threat to what they hope will be a multibillion-dollar business.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"Potential DNA Damage From CRISPR ‘Seriously Underestimated,’ Study Finds","datePublished":"2018-07-17T19:00:49.000Z","dateModified":"2018-07-18T17:10:35.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"disqusIdentifier":"443403 https://ww2.kqed.org/futureofyou/?p=443403","disqusUrl":"https://ww2.kqed.org/futureofyou/2018/07/17/potential-dna-damage-from-crispr-seriously-underestimated-study-finds/","disqusTitle":"Potential DNA Damage From CRISPR ‘Seriously Underestimated,’ Study Finds","source":"Hope/Hype","nprByline":"Sharon Begley\u003cbr />STAT","path":"/futureofyou/443403/potential-dna-damage-from-crispr-seriously-underestimated-study-finds","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>From the earliest days of the CRISPR-Cas9 era, scientists have known that the first step in how it \u003ca href=\"https://www.statnews.com/2018/04/04/how-crispr-works-visualized/\">edits genomes\u003c/a> — snipping DNA — creates an unholy mess: Cellular repairmen frantically try to fix the cuts by throwing random chunks of DNA into the breach and deleting other random bits. \u003ca href=\"https://www.nature.com/articles/Nbt.4192\" target=\"_blank\" rel=\"noopener\">Research\u003c/a> published on Monday suggests that’s only the tip of a Titanic-sized iceberg: CRISPR-Cas9 can cause significantly greater genetic havoc than experts thought, the study concludes, perhaps enough to threaten the health of patients who would one day receive \u003ca href=\"https://www.statnews.com/2018/02/21/crispr-sickle-cell-clinical-trials/\">CRISPR-based therapy\u003c/a>.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>The results come hard on the heels of two \u003ca href=\"https://www.statnews.com/2018/06/11/crispr-hurdle-edited-cells-might-cause-cancer/\">studies\u003c/a> that identified a related issue: Some CRISPR’d cells might be missing a key anti-cancer mechanism and therefore be able to initiate tumors.\u003c/p>\n\u003cp>The DNA damage found in the new study included deletions of thousands of DNA bases, including at spots far from the edit. Some of the deletions can silence genes that should be active and activate genes that should be silent, including cancer-causing genes.\u003c/p>\n\u003cp>The DNA chaos that CRISPR unleashes has been “seriously underestimated,” said geneticist Allan Bradley of England’s Wellcome Sanger Institute, who led the study. “This should be a wake-up call.”\u003c/p>\n\u003cp>Leading CRISPR companies scrambled to play down the latest threat to what they hope will be a multibillion-dollar business \u003cstrong>— \u003c/strong>and to their stock prices, but investors reacted with alarm. Within the first 20 minutes of when the study was released, the three publicly traded CRISPR companies lost more than $300 million in value, and it was downhill from there: CRISPR Therapeutics ended down 8.6 percent, Editas Medicine fell 7 percent, and Intellia Therapeutics lost nearly 10 percent.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>The companies questioned whether the CRISPR-caused DNA damage reported in the new study applied to the kind of cells they’re planning to CRISPR. They emphasized that if genomic scrambling is at all common then it should also be seen in earlier forms of genome-editing such as \u003ca href=\"https://www.statnews.com/2017/11/30/crispr-talens-gene-editing/\">zinc fingers and TALENs\u003c/a> (but apparently isn’t). And they insisted they’re on the case.\u003c/p>\n\u003cp>“We’re not Pollyannaish about this,” said geneticist Tom Barnes, chief innovation officer at Intellia. For its mouse experiments, Intellia analyzes edited genomes for collateral damage both near the editing target and tens of thousands of DNA letters away, he said, but “we have not seen any [cancer-causing] transformation of these cells, even with all the edits we’ve introduced.”\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>In a statement, Editas spokeswoman Cristi Barnett said the possibility of genetic chaos from CRISPR is “an interesting topic” that the company “actively examine[s].” The reported DNA havoc, she said, is not “specifically problematic in our work to make CRISPR-based medicines.” CRISPR Therapeutics did not respond to requests for comment.\u003c/p>\n\u003cp>Academic scientists were less dismissive of the new study, in Nature Biotechnology. One leading CRISPR developer called it “well-done and credible,” “a cautionary note to the [genome-editing] community,” and consistent with other research showing that the DNA cuts that CRISPR makes, called double-stranded breaks, “can induce the types of genomic DNA rearrangements and deletions they report.” He asked not to be identified so as not to jeopardize business relationships with genome-editing companies.\u003c/p>\n\u003cp>But just as critics of last month’s studies asked why, if CRISPR’d cells can initiate cancer, no CRISPR’d mice had turned up with tumors, so scientists raised similar questions about the new genomic havoc finding: Why don’t scientists see it when they analyze the DNA of CRISPR’d cells?\u003c/p>\n\u003cp>“You find what you look for,” said Bradley. “No one is looking at the impact [of these DNA changes] on downstream genes.”\u003c/p>\n\u003cp>And few studies conduct full-out genome sequencing of CRISPR’d cells. Moreover, scientists typically search for one form of the collateral damage the Sanger study found — deletions of thousands of DNA bases (the double helix’s famous A’s, T’s, C’s, and G’s) — using a standard technique called PCR, which makes millions of DNA copies. But to work, PCR must attach to a “binding site” on DNA; CRISPR sometimes deletes that binding site, said Bradley, whose team used a different technique to analyze the double helix for collateral damage from CRISPR.\u003c/p>\n\u003cp>The Sanger scientists didn’t set out to find collateral DNA damage from CRISPR. As they investigated how CRISPR might change gene expression, a “weird thing” showed up, Bradley said: The target DNA was accurately changed, but that set off a chain reaction that engulfed genes far from the target. The scientists therefore changed course.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>When they aimed CRISPR at different targets in mouse embryonic stem cells, mouse blood-making cells, and human retinal cells, “extensive on-target genomic damage [was] a common outcome,” they wrote in their paper. In one case, genomes in about two-thirds of the CRISPR’d cells showed the expected small-scale inadvertent havoc, but 21 percent had DNA deletions of more than 250 bases and up to 6,000 bases long.\u003c/p>\n\u003cp>Since therapeutic uses of CRISPR would edit the genomes of billions of cells in, say, a patient’s liver, even rare DNA damage “makes it likely that one or more edited cells … would be endowed with an important [disease-causing] lesion,” the scientists wrote.\u003c/p>\n\u003cp>Nature Biotechnology took a year to publish the paper, after asking Bradley numerous variations of “are you sure?” and “did you consider this?” and asking him to run additional experiments, Bradley said. The results all held up.\u003c/p>\n\u003cp>The one U.S. \u003ca href=\"https://clinicaltrials.gov/ct2/show/NCT03399448\" target=\"_blank\" rel=\"noopener\">clinical trial\u003c/a> using CRISPR’d cells began recruiting patients this year. It will use CRISPR to make immune cells, removed from patients with any of four types of cancer, attack telltale molecules on the tumor cells’ surface. Asked what genome analysis he plans to do, lead investigator Dr. Edward Stadtmauer of the University of Pennsylvania said, “We are doing extensive testing of the final cellular product as well as the cells within the patient.”\u003c/p>\n\u003cp>The possibility of adverse consequences from CRISPR’d cells has caused some company officials to argue that if, say, their therapy cures a child of a devastating disease, but increases her risk of cancer, that might be an acceptable trade-off.\u003c/p>\n\u003cp>That argument may well prevail. In 2003, however, when a boy in a gene therapy trial in France \u003ca href=\"https://www.nejm.org/doi/full/10.1056/NEJM200301163480314\" target=\"_blank\" rel=\"noopener\">developed leukemia\u003c/a> because the repair gene landed in the wrong place in his genome and activated a cancer-causing gene, it shut down gene therapy development on both sides of the Atlantic for years.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"floatright"},"numeric":["floatright"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\u003cem>This\u003ca href=\"https://www.statnews.com/2018/07/16/crispr-potential-dna-damage-underestimated/\" target=\"_blank\" rel=\"noopener\"> story\u003c/a> was originally published by STAT, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery.\u003c/em>\u003c/p>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/futureofyou/443403/potential-dna-damage-from-crispr-seriously-underestimated-study-finds","authors":["byline_futureofyou_443403"],"categories":["futureofyou_1062","futureofyou_73"],"tags":["futureofyou_103","futureofyou_94","futureofyou_17","futureofyou_1275","futureofyou_830","futureofyou_61"],"collections":["futureofyou_1097","futureofyou_1094"],"featImg":"futureofyou_443405","label":"source_futureofyou_443403"},"futureofyou_442882":{"type":"posts","id":"futureofyou_442882","meta":{"index":"posts_1591205157","site":"futureofyou","id":"442882","score":null,"sort":[1529535610000]},"guestAuthors":[],"slug":"report-for-defense-department-ranks-top-threats-from-synthetic-biology","title":"Report For Defense Department Ranks Top Threats From 'Synthetic Biology'","publishDate":1529535610,"format":"standard","headTitle":"KQED Future of You | KQED Science","labelTerm":{},"content":"\u003cp>New genetic tools are making it easier and cheaper to engineer viruses and bacteria, and a report commissioned by the Department of Defense has now ranked the top threats posed by the rapidly advancing field of \"synthetic biology.\"[contextly_sidebar id=\"gb9g2YDw6S8Tv2v2EUI0TWtfXV5po4Qp\"]\u003c/p>\n\u003cp>One of the biggest concerns is the ability to recreate known viruses from scratch in the lab. That means a lab could make a deadly virus that is normally kept under lock and key, such as \u003ca href=\"http://www.who.int/csr/disease/smallpox/en/\">smallpox\u003c/a>.\u003c/p>\n\u003cp>\"Right now, recreating pretty much any virus can be done relatively easily. It requires a certain amount of expertise and resources and knowledge,\" says \u003ca href=\"https://medicine.umich.edu/dept/microbiology-immunology/michael-j-imperiale-phd\" target=\"_blank\" rel=\"noopener\">Michael Imperiale\u003c/a>, a microbiologist at the University of Michigan who chaired the committee convened by the \u003ca href=\"http://www.nationalacademies.org/\" target=\"_blank\" rel=\"noopener\">National Academies of Sciences, Engineering, and Medicine\u003c/a> to assess the state of synthetic biology and offer advice to defense officials.\u003c/p>\n\u003cp>As an example of what's possible, Imperiale pointed to the recent and controversial creation of \u003ca href=\"https://www.npr.org/sections/health-shots/2018/02/17/585385308/did-pox-virus-research-put-potential-profits-ahead-of-public-safety\" target=\"_blank\" rel=\"noopener\">horsepox,\u003c/a> a cousin of smallpox, in a Canadian laboratory. \"These things can now be done,\" he said.\u003c/p>\n\u003cp>Another top danger listed in the report, which was released Tuesday, is making existing bacteria or viruses more dangerous. That could happen, by, say, giving them antibiotic resistance or altering them so that they produce toxins or evade vaccines.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>And one scenario pondered by the experts is the creation of microbes that would produce harmful biochemicals in humans while living on the skin or in the gut. This possibility, the report notes, \"is of high concern because its novelty challenges potential mitigation options.\" Public health officials might not even recognize that they were witnessing a biological attack if the dangerous material was delivered to victims in such an unusual way.\u003c/p>\n\u003cp>All in all, the committee examined about a dozen different synthetic biology technologies that could be potentially misused. For each, they considered how likely it was to be usable as a weapon, how much expertise or resources would be needed, and how well governments would be able to recognize and manage an attack.\u003c/p>\n\u003cp>\"There are certain capabilities that may not be possible now, but in those cases we tried to identify what the bottlenecks or barriers might be that, if overcome, would enable those to be more possible,\" Imperiale says.[contextly_sidebar id=\"hU2ywe0bo5FhMcFg3CwThXSqo89g4izl\"]\u003c/p>\n\u003cp>One of the least concerning possibilities, because of the knowledge and technical barriers, was inventing a brand new pathogen by taking a \"mix and match\" approach to combining genetic parts from multiple organisms, according to the report. It notes that making even simple changes to viruses can produce \"drastic deficiencies\" in key viral properties, \"making any such effort especially difficult,\" and that \"the difficulty increases as the distance from natural pathogens increases.\"\u003c/p>\n\u003cp>But that was exactly the scenario that recently unfolded in a table-top exercise conducted last month by the Johns Hopkins Center for Health Security. During the event, experts in pandemic response and national security grappled with a fictional virus called \"\u003ca href=\"http://www.centerforhealthsecurity.org/about-the-center/pressroom/press_releases/2018-05-15_clade-x-policy-recommendations.html\">Clade X\u003c/a>\" that was created by a terrorist group that inserted genetic elements of deadly \u003ca href=\"https://www.npr.org/2018/05/29/615079779/why-it-s-difficult-for-viruses-to-turn-in-to-deadly-pandemics\" target=\"_blank\" rel=\"noopener\">Nipah\u003c/a> virus into a normally-mild \u003ca href=\"https://www.cdc.gov/parainfluenza/index.html\" target=\"_blank\" rel=\"noopener\">human parainfluenza virus\u003c/a>.\u003c/p>\n\u003cp>The terrorist group in this scenario wanted to depopulate the Earth, and deliberately released the contagious virus at multiple spots around the globe. The resulting pandemic killed 150 million people within a year as officials struggled to contain the social and economic chaos until a vaccine could be made.\u003c/p>\n\u003cp>\"What people don't think about very often is the potential for an engineered organism to become an epidemic or even a pandemic. One of the goals of this exercise was to show that an engineered organism could be the cause of something that we are not really preparing for,\" says \u003ca href=\"http://www.centerforhealthsecurity.org/our-staff/profiles/inglesby/index.html\" target=\"_blank\" rel=\"noopener\">Dr. Tom Inglesby\u003c/a>, director of the Johns Hopkins center. \"What we wanted to show in the exercise was that there are different ways of getting to a pandemic. And we need to be prepared for all of them.\"\u003c/p>\n\u003cp>Much of the public health response to an engineered outbreak would be the same as to a natural outbreak, the exercise showed. That means a possible line of defense is beefing up public health infrastructure such as disease surveillance.\u003c/p>\n\u003cp>And, as the new report notes, the same synthetic biology tools that could be used to harm could also be used to fight this threat, by allowing the rapid creation of better medicines, vaccines, and diagnostics.[contextly_sidebar id=\"9JS7pw28z71O9Hau5X1qfcsxIFZNY5TF\"]\u003c/p>\n\u003cp>\u003ca href=\"https://silver.med.harvard.edu/\">Pamela Silver\u003c/a>, a synthetic biologist at Harvard who was not on the committee but reviewed its report, said that the assessment is \"timely, given that there's a lot of attention being paid to genetic engineering because of \u003ca href=\"https://www.npr.org/sections/health-shots/2015/12/28/460705645/gene-editing-tool-hailed-as-a-breakthrough-and-it-really-is-one\" target=\"_blank\" rel=\"noopener\">CRISPR\u003c/a>,\" the new tool that has made it much easier to edit genes.\u003c/p>\n\u003cp>She does worry, though, that because this report ranked potential threats, \"somebody might say 'oh, here are the three things we have to worry about the most,' and then ignore the others.\"\u003c/p>\n\u003cp>And this assessment was made based on today's technology, she says, but it's clear that biology changes rapidly and is full of surprises. \"So what's the next CRISPR? What's the next big thing?\" Silver asks. \"We need to anticipate, as well. Biology is a rapidly moving field and we need to stay on top of that.\"\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>She says she just recently was looking at a preprint of a scientific paper about engineering bacteria, \"and I noticed that it was from high school students. That's just amazing to me.\"\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2018 NPR. To see more, visit http://www.npr.org/.\u003cimg src=\"https://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=Report+For+Defense+Department+Ranks+Top+Threats+From+%27Synthetic+Biology%27+&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n","blocks":[],"excerpt":"A committee of experts examined about a dozen different synthetic biology technologies that could be potentially misused. For each, they considered how likely it was to be usable as a weapon.","status":"publish","parent":0,"modified":1529517676,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":20,"wordCount":916},"headData":{"title":"Report For Defense Department Ranks Top Threats From 'Synthetic Biology' | KQED","description":"A committee of experts examined about a dozen different synthetic biology technologies that could be potentially misused. For each, they considered how likely it was to be usable as a weapon.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"Report For Defense Department Ranks Top Threats From 'Synthetic Biology'","datePublished":"2018-06-20T23:00:10.000Z","dateModified":"2018-06-20T18:01:16.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"disqusIdentifier":"442882 https://ww2.kqed.org/futureofyou/?p=442882","disqusUrl":"https://ww2.kqed.org/futureofyou/2018/06/20/report-for-defense-department-ranks-top-threats-from-synthetic-biology/","disqusTitle":"Report For Defense Department Ranks Top Threats From 'Synthetic Biology'","source":"Technology","nprImageCredit":"Dr. Hans Gelderblom","nprByline":"Nell Greenfieldboyce\u003cbr />NPR","nprImageAgency":"Visuals Unlimited/Getty Images","nprStoryId":"621350272","nprApiLink":"http://api.npr.org/query?id=621350272&apiKey=MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004","nprHtmlLink":"https://www.npr.org/sections/health-shots/2018/06/19/621350272/report-for-defense-department-ranks-top-threats-from-synthetic-biology?ft=nprml&f=621350272","nprRetrievedStory":"1","nprPubDate":"Tue, 19 Jun 2018 21:37:00 -0400","nprStoryDate":"Tue, 19 Jun 2018 11:05:00 -0400","nprLastModifiedDate":"Tue, 19 Jun 2018 16:53:41 -0400","nprAudio":"https://ondemand.npr.org/anon.npr-mp3/npr/atc/2018/06/20180619_atc_report_for_defense_department_ranks_top_threats_from_synthetic_biology_.mp3?orgId=1&topicId=1128&d=235&p=2&story=621350272&ft=nprml&f=621350272","nprAudioM3u":"http://api.npr.org/m3u/1621579108-a7215c.m3u?orgId=1&topicId=1128&d=235&p=2&story=621350272&ft=nprml&f=621350272","path":"/futureofyou/442882/report-for-defense-department-ranks-top-threats-from-synthetic-biology","audioUrl":"https://ondemand.npr.org/anon.npr-mp3/npr/atc/2018/06/20180619_atc_report_for_defense_department_ranks_top_threats_from_synthetic_biology_.mp3?orgId=1&topicId=1128&d=235&p=2&story=621350272&ft=nprml&f=621350272","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>New genetic tools are making it easier and cheaper to engineer viruses and bacteria, and a report commissioned by the Department of Defense has now ranked the top threats posed by the rapidly advancing field of \"synthetic biology.\"\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>One of the biggest concerns is the ability to recreate known viruses from scratch in the lab. That means a lab could make a deadly virus that is normally kept under lock and key, such as \u003ca href=\"http://www.who.int/csr/disease/smallpox/en/\">smallpox\u003c/a>.\u003c/p>\n\u003cp>\"Right now, recreating pretty much any virus can be done relatively easily. It requires a certain amount of expertise and resources and knowledge,\" says \u003ca href=\"https://medicine.umich.edu/dept/microbiology-immunology/michael-j-imperiale-phd\" target=\"_blank\" rel=\"noopener\">Michael Imperiale\u003c/a>, a microbiologist at the University of Michigan who chaired the committee convened by the \u003ca href=\"http://www.nationalacademies.org/\" target=\"_blank\" rel=\"noopener\">National Academies of Sciences, Engineering, and Medicine\u003c/a> to assess the state of synthetic biology and offer advice to defense officials.\u003c/p>\n\u003cp>As an example of what's possible, Imperiale pointed to the recent and controversial creation of \u003ca href=\"https://www.npr.org/sections/health-shots/2018/02/17/585385308/did-pox-virus-research-put-potential-profits-ahead-of-public-safety\" target=\"_blank\" rel=\"noopener\">horsepox,\u003c/a> a cousin of smallpox, in a Canadian laboratory. \"These things can now be done,\" he said.\u003c/p>\n\u003cp>Another top danger listed in the report, which was released Tuesday, is making existing bacteria or viruses more dangerous. That could happen, by, say, giving them antibiotic resistance or altering them so that they produce toxins or evade vaccines.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>And one scenario pondered by the experts is the creation of microbes that would produce harmful biochemicals in humans while living on the skin or in the gut. This possibility, the report notes, \"is of high concern because its novelty challenges potential mitigation options.\" Public health officials might not even recognize that they were witnessing a biological attack if the dangerous material was delivered to victims in such an unusual way.\u003c/p>\n\u003cp>All in all, the committee examined about a dozen different synthetic biology technologies that could be potentially misused. For each, they considered how likely it was to be usable as a weapon, how much expertise or resources would be needed, and how well governments would be able to recognize and manage an attack.\u003c/p>\n\u003cp>\"There are certain capabilities that may not be possible now, but in those cases we tried to identify what the bottlenecks or barriers might be that, if overcome, would enable those to be more possible,\" Imperiale says.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>One of the least concerning possibilities, because of the knowledge and technical barriers, was inventing a brand new pathogen by taking a \"mix and match\" approach to combining genetic parts from multiple organisms, according to the report. It notes that making even simple changes to viruses can produce \"drastic deficiencies\" in key viral properties, \"making any such effort especially difficult,\" and that \"the difficulty increases as the distance from natural pathogens increases.\"\u003c/p>\n\u003cp>But that was exactly the scenario that recently unfolded in a table-top exercise conducted last month by the Johns Hopkins Center for Health Security. During the event, experts in pandemic response and national security grappled with a fictional virus called \"\u003ca href=\"http://www.centerforhealthsecurity.org/about-the-center/pressroom/press_releases/2018-05-15_clade-x-policy-recommendations.html\">Clade X\u003c/a>\" that was created by a terrorist group that inserted genetic elements of deadly \u003ca href=\"https://www.npr.org/2018/05/29/615079779/why-it-s-difficult-for-viruses-to-turn-in-to-deadly-pandemics\" target=\"_blank\" rel=\"noopener\">Nipah\u003c/a> virus into a normally-mild \u003ca href=\"https://www.cdc.gov/parainfluenza/index.html\" target=\"_blank\" rel=\"noopener\">human parainfluenza virus\u003c/a>.\u003c/p>\n\u003cp>The terrorist group in this scenario wanted to depopulate the Earth, and deliberately released the contagious virus at multiple spots around the globe. The resulting pandemic killed 150 million people within a year as officials struggled to contain the social and economic chaos until a vaccine could be made.\u003c/p>\n\u003cp>\"What people don't think about very often is the potential for an engineered organism to become an epidemic or even a pandemic. One of the goals of this exercise was to show that an engineered organism could be the cause of something that we are not really preparing for,\" says \u003ca href=\"http://www.centerforhealthsecurity.org/our-staff/profiles/inglesby/index.html\" target=\"_blank\" rel=\"noopener\">Dr. Tom Inglesby\u003c/a>, director of the Johns Hopkins center. \"What we wanted to show in the exercise was that there are different ways of getting to a pandemic. And we need to be prepared for all of them.\"\u003c/p>\n\u003cp>Much of the public health response to an engineered outbreak would be the same as to a natural outbreak, the exercise showed. That means a possible line of defense is beefing up public health infrastructure such as disease surveillance.\u003c/p>\n\u003cp>And, as the new report notes, the same synthetic biology tools that could be used to harm could also be used to fight this threat, by allowing the rapid creation of better medicines, vaccines, and diagnostics.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>\u003ca href=\"https://silver.med.harvard.edu/\">Pamela Silver\u003c/a>, a synthetic biologist at Harvard who was not on the committee but reviewed its report, said that the assessment is \"timely, given that there's a lot of attention being paid to genetic engineering because of \u003ca href=\"https://www.npr.org/sections/health-shots/2015/12/28/460705645/gene-editing-tool-hailed-as-a-breakthrough-and-it-really-is-one\" target=\"_blank\" rel=\"noopener\">CRISPR\u003c/a>,\" the new tool that has made it much easier to edit genes.\u003c/p>\n\u003cp>She does worry, though, that because this report ranked potential threats, \"somebody might say 'oh, here are the three things we have to worry about the most,' and then ignore the others.\"\u003c/p>\n\u003cp>And this assessment was made based on today's technology, she says, but it's clear that biology changes rapidly and is full of surprises. \"So what's the next CRISPR? What's the next big thing?\" Silver asks. \"We need to anticipate, as well. Biology is a rapidly moving field and we need to stay on top of that.\"\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>She says she just recently was looking at a preprint of a scientific paper about engineering bacteria, \"and I noticed that it was from high school students. That's just amazing to me.\"\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2018 NPR. To see more, visit http://www.npr.org/.\u003cimg src=\"https://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=Report+For+Defense+Department+Ranks+Top+Threats+From+%27Synthetic+Biology%27+&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/futureofyou/442882/report-for-defense-department-ranks-top-threats-from-synthetic-biology","authors":["byline_futureofyou_442882"],"categories":["futureofyou_1060","futureofyou_1","futureofyou_73","futureofyou_1064"],"tags":["futureofyou_1525","futureofyou_1521","futureofyou_94","futureofyou_17","futureofyou_155","futureofyou_1526","futureofyou_1527"],"collections":["futureofyou_1093","futureofyou_1094"],"featImg":"futureofyou_442883","label":"source_futureofyou_442882"},"futureofyou_442727":{"type":"posts","id":"futureofyou_442727","meta":{"index":"posts_1591205157","site":"futureofyou","id":"442727","score":null,"sort":[1529100213000]},"guestAuthors":[],"slug":"uc-berkeley-granted-two-crispr-related-patents","title":"UC Berkeley Granted Two CRISPR-Related Patents","publishDate":1529100213,"format":"standard","headTitle":"KQED Future of You | KQED Science","labelTerm":{},"content":"\u003cp>The University of California will be receiving two CRISPR-related \u003ca href=\"http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=9,994,831.PN.&OS=PN/9,994,831&RS=PN/9,994,831\" target=\"_blank\" rel=\"noopener\">patents\u003c/a>, marking another step forward in the university's long battle to assert its claims to the revolutionary technology.[contextly_sidebar id=\"HobWula6BihfuZ4zJKYzmOCLk2EeUohl\"]\u003c/p>\n\u003cp>UC Berkeley \u003ca href=\"https://nature1.berkeley.edu/breakthroughs/sp18/genes-to-global-solutions\" target=\"_blank\" rel=\"noopener\">pioneered the technology\u003c/a> in 2012, when a team led by biochemist \u003ca href=\"http://doudnalab.org/\" target=\"_blank\" rel=\"noopener\">Jennifer Doudna\u003c/a> reported that they had successfully developed a “programmable” genome-editing tool that makes highly targeted alterations to the genome of a plant or animal. A team at the \u003ca href=\"https://www.broadinstitute.org/\" target=\"_blank\" rel=\"noopener\">Broad Institute\u003c/a>, owned jointly by Harvard University and the Massachusetts Institute, was also researching the technology during the same period.\u003c/p>\n\u003cp>Commonly known as CRISPR—an acronym for Clustered Regularly Interspaced Short Palindromic Repeats, the groundbreaking technology offers a method to fix genes in living things. It could be used to develop everything from drought-resistant crops, to new treatments for genetic disorders and cancers.\u003c/p>\n\u003cp>UC Berkeley is in a \u003ca href=\"https://www.kqed.org/futureofyou/372137/uc-berkeley-renews-legal-fight-over-crispr-cas9-patent-rights\" target=\"_blank\" rel=\"noopener\">legal fight\u003c/a> with the Broad Institute over the patent rights to CRISPR. UC Berkeley filed its patent application before Broad did, but Broad fast-tracked its application.\u003c/p>\n\u003cp>The United States Patent and Trademark Office in February 2017 \u003ca href=\"https://www.kqed.org/futureofyou/338066/broad-institute-wins-decision-over-uc-berkeley-in-crispr-patent-battle\" target=\"_blank\" rel=\"noopener\">awarded a patent\u003c/a> to Broad for CRISPR's use in plant and animal cells, and a pending patent to UC Berkeley for CRISPR's use in bacterial cells. The UC appealed in April 2017, arguing its scientists were the first inventors of the technology.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>[contextly_sidebar id=\"dldVTmrihr5ckptkstBunRusJqL7Q1kF\"]The patent granted to UC Berkeley on Tuesday focuses on using the tool to edit single-stranded RNA, according to \u003ca href=\"https://www.statnews.com/2018/06/13/university-of-california-granted-a-key-crispr-patent/\" target=\"_blank\" rel=\"noopener\">a \u003cem>STAT News \u003c/em>report\u003c/a>. The federal agency will reportedly award a second patent next week. That patent, reports STAT, will focus on using the tool to edit regions specifically 10 to 15 base pairs long.\u003c/p>\n\u003cp>Some experts are downplaying the patents' significance.\u003c/p>\n\u003cp>According to New York Law School associate professor Jacob Sherkow, who spoke with\u003ca href=\"https://www.statnews.com/2018/06/13/university-of-california-granted-a-key-crispr-patent/\" target=\"_blank\" rel=\"noopener\">\u003cem> STAT\u003c/em>\u003c/a>, the second patent will likely have “pretty minimal” commercial value.[contextly_sidebar id=\"r1GPWMK2Ali0LLhAqlMmjHyUin6pJWDz\"]\u003c/p>\n\u003cp>The USPTO has so far granted more than \u003ca href=\"https://www.broadinstitute.org/crispr/journalists-statement-and-background-crispr-patent-process\" target=\"_blank\" rel=\"noopener\">60 CRISPR-related patents\u003c/a> to inventors from 18 organizations, according to the Broad Institute.\u003c/p>\n\u003cp>Meanwhile, news of the university's patent awards come as two new \u003ca href=\"https://www.nature.com/articles/s41591-018-0050-6.epdf\" target=\"_blank\" rel=\"noopener\">studies\u003c/a> published on Monday caution that gene cells edited with CRISPR-Cas9 \u003ca href=\"https://www.kqed.org/futureofyou/442526/major-hurdle-for-crispr-edited-cells-might-cause-cancer-find-two-studies\" target=\"_blank\" rel=\"noopener\">may be linked\u003c/a> to cancer.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp> \u003c/p>\n\n","blocks":[],"excerpt":"The university is fighting to assert its rights to the revolutionary gene-editing tool known as CRISPR. But some experts are downplaying the patents' significance. ","status":"publish","parent":0,"modified":1529110647,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":12,"wordCount":395},"headData":{"title":"UC Berkeley Granted Two CRISPR-Related Patents | KQED","description":"The university is fighting to assert its rights to the revolutionary gene-editing tool known as CRISPR. But some experts are downplaying the patents' significance. ","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"UC Berkeley Granted Two CRISPR-Related Patents","datePublished":"2018-06-15T22:03:33.000Z","dateModified":"2018-06-16T00:57:27.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"disqusIdentifier":"442727 https://ww2.kqed.org/futureofyou/?p=442727","disqusUrl":"https://ww2.kqed.org/futureofyou/2018/06/15/uc-berkeley-granted-two-crispr-related-patents/","disqusTitle":"UC Berkeley Granted Two CRISPR-Related Patents","source":"Your Genes","path":"/futureofyou/442727/uc-berkeley-granted-two-crispr-related-patents","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>The University of California will be receiving two CRISPR-related \u003ca href=\"http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=9,994,831.PN.&OS=PN/9,994,831&RS=PN/9,994,831\" target=\"_blank\" rel=\"noopener\">patents\u003c/a>, marking another step forward in the university's long battle to assert its claims to the revolutionary technology.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>UC Berkeley \u003ca href=\"https://nature1.berkeley.edu/breakthroughs/sp18/genes-to-global-solutions\" target=\"_blank\" rel=\"noopener\">pioneered the technology\u003c/a> in 2012, when a team led by biochemist \u003ca href=\"http://doudnalab.org/\" target=\"_blank\" rel=\"noopener\">Jennifer Doudna\u003c/a> reported that they had successfully developed a “programmable” genome-editing tool that makes highly targeted alterations to the genome of a plant or animal. A team at the \u003ca href=\"https://www.broadinstitute.org/\" target=\"_blank\" rel=\"noopener\">Broad Institute\u003c/a>, owned jointly by Harvard University and the Massachusetts Institute, was also researching the technology during the same period.\u003c/p>\n\u003cp>Commonly known as CRISPR—an acronym for Clustered Regularly Interspaced Short Palindromic Repeats, the groundbreaking technology offers a method to fix genes in living things. It could be used to develop everything from drought-resistant crops, to new treatments for genetic disorders and cancers.\u003c/p>\n\u003cp>UC Berkeley is in a \u003ca href=\"https://www.kqed.org/futureofyou/372137/uc-berkeley-renews-legal-fight-over-crispr-cas9-patent-rights\" target=\"_blank\" rel=\"noopener\">legal fight\u003c/a> with the Broad Institute over the patent rights to CRISPR. UC Berkeley filed its patent application before Broad did, but Broad fast-tracked its application.\u003c/p>\n\u003cp>The United States Patent and Trademark Office in February 2017 \u003ca href=\"https://www.kqed.org/futureofyou/338066/broad-institute-wins-decision-over-uc-berkeley-in-crispr-patent-battle\" target=\"_blank\" rel=\"noopener\">awarded a patent\u003c/a> to Broad for CRISPR's use in plant and animal cells, and a pending patent to UC Berkeley for CRISPR's use in bacterial cells. The UC appealed in April 2017, arguing its scientists were the first inventors of the technology.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\u003c/p>\u003cp>\u003c/p>\u003cp>The patent granted to UC Berkeley on Tuesday focuses on using the tool to edit single-stranded RNA, according to \u003ca href=\"https://www.statnews.com/2018/06/13/university-of-california-granted-a-key-crispr-patent/\" target=\"_blank\" rel=\"noopener\">a \u003cem>STAT News \u003c/em>report\u003c/a>. The federal agency will reportedly award a second patent next week. That patent, reports STAT, will focus on using the tool to edit regions specifically 10 to 15 base pairs long.\u003c/p>\n\u003cp>Some experts are downplaying the patents' significance.\u003c/p>\n\u003cp>According to New York Law School associate professor Jacob Sherkow, who spoke with\u003ca href=\"https://www.statnews.com/2018/06/13/university-of-california-granted-a-key-crispr-patent/\" target=\"_blank\" rel=\"noopener\">\u003cem> STAT\u003c/em>\u003c/a>, the second patent will likely have “pretty minimal” commercial value.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>The USPTO has so far granted more than \u003ca href=\"https://www.broadinstitute.org/crispr/journalists-statement-and-background-crispr-patent-process\" target=\"_blank\" rel=\"noopener\">60 CRISPR-related patents\u003c/a> to inventors from 18 organizations, according to the Broad Institute.\u003c/p>\n\u003cp>Meanwhile, news of the university's patent awards come as two new \u003ca href=\"https://www.nature.com/articles/s41591-018-0050-6.epdf\" target=\"_blank\" rel=\"noopener\">studies\u003c/a> published on Monday caution that gene cells edited with CRISPR-Cas9 \u003ca href=\"https://www.kqed.org/futureofyou/442526/major-hurdle-for-crispr-edited-cells-might-cause-cancer-find-two-studies\" target=\"_blank\" rel=\"noopener\">may be linked\u003c/a> to cancer.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp> \u003c/p>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/futureofyou/442727/uc-berkeley-granted-two-crispr-related-patents","authors":["11428"],"categories":["futureofyou_1","futureofyou_73","futureofyou_1064"],"tags":["futureofyou_103","futureofyou_94","futureofyou_80"],"collections":["futureofyou_1097","futureofyou_1094"],"featImg":"futureofyou_1194","label":"source_futureofyou_442727"},"futureofyou_442526":{"type":"posts","id":"futureofyou_442526","meta":{"index":"posts_1591205157","site":"futureofyou","id":"442526","score":null,"sort":[1528743626000]},"guestAuthors":[],"slug":"major-hurdle-for-crispr-edited-cells-might-cause-cancer-find-two-studies","title":"Major CRISPR Hurdle: Edited Cells Might Cause Cancer, Find Studies","publishDate":1528743626,"format":"standard","headTitle":"KQED Future of You | KQED Science","labelTerm":{},"content":"\u003cp>Editing cells’ genomes with CRISPR-Cas9 might increase the risk that the altered cells, intended to treat disease, will trigger cancer, two studies published on Monday warn — a potential game-changer for the companies developing CRISPR-based therapies.[contextly_sidebar id=\"Pbm72hAOjQOHNUgNeQaKv0l2d5rX0APO\"]\u003c/p>\n\u003cp>In the studies, published in Nature Medicine, scientists found that cells whose genomes are successfully edited by CRISPR-Cas9 have the potential to seed tumors inside a patient. That could make some CRISPR’d cells ticking time bombs, according to researchers from Sweden’s Karolinska Institute and, separately, Novartis.\u003c/p>\n\u003cp class=\"danger-zone\">\u003ca href=\"https://www.statnews.com/feature/crispr/tracker/\">CRISPR\u003c/a> has already dodged two potentially fatal bullets — a 2017 \u003ca href=\"https://www.nature.com/articles/nmeth.4293.epdf\" target=\"_blank\" rel=\"noopener\">claim\u003c/a> that it causes sky-high numbers of off-target effects was \u003ca href=\"https://www.nature.com/articles/nmeth.4664\" target=\"_blank\" rel=\"noopener\">retracted\u003c/a> in March, and a \u003ca href=\"https://www.biorxiv.org/content/early/2018/01/05/243345\" target=\"_blank\" rel=\"noopener\">report \u003c/a>of human immunity to Cas9 was largely shrugged off as \u003ca href=\"https://www.statnews.com/2018/01/08/immunity-crispr-cas9/\">solvable\u003c/a>. But experts are taking the cancer-risk finding seriously.\u003c/p>\n\u003cp class=\"danger-zone\">The CEO of CRISPR Therapeutics, Sam Kulkarni, told STAT the results are “plausible.” Although they likely apply to one of the main ways that CRISPR edits genomes (replacing disease-causing DNA with healthy versions) more than another (just excising DNA), he said, “it’s something we need to pay attention to, especially as CRISPR expands to more diseases. We need to do the work and make sure edited cells returned to patients don’t become cancerous.”\u003c/p>\n\u003cp class=\"\">Another leading CRISPR scientist, who asked not to be named because of involvement with genome-editing companies, called the new data “pretty striking,” and raised concerns that a potential fatal flaw in some uses of CRISPR had “been missed.”\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>On the other hand, the Novartis paper has been \u003ca href=\"https://www.biorxiv.org/content/early/2017/07/26/168443\" target=\"_blank\" rel=\"noopener\">available\u003c/a> in preliminary form since last summer, and CRISPR experts “haven’t freaked out,” said Erik Sontheimer of the University of Massachusetts Medical School, whose CRISPR research \u003ca href=\"https://www.statnews.com/2018/03/05/crispr-off-target-editing/\">centers\u003c/a> on novel enzymes and off-target effects. “This is something that bears paying attention to, but I don’t think it’s a deal-breaker” for CRISPR therapies.\u003c/p>\n\u003cp>The Karolinska and Novartis groups tested CRISPR on different kinds of human cells — retinal cells and pluripotent stem cells, respectively. But they found essentially the same phenomenon. Standard CRISPR-Cas9 works by cutting both strands of the DNA double helix. That injury causes a cell to activate a biochemical first-aid kit orchestrated by a gene called \u003ca href=\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4235614/\" target=\"_blank\" rel=\"noopener\">p53,\u003c/a> which either mends the DNA break or makes the cell self-destruct.[contextly_sidebar id=\"X1qu0ifjesXey9YHHpOinoS4KNdNuyur\"]\u003c/p>\n\u003cp>Whichever action p53 takes, the consequence is the same: CRISPR doesn’t work, either because the genome edit is stitched up or the cell is dead. (The Novartis team calculated that p53 reduces CRISPR efficiency in pluripotent stem cells seventeenfold.) That might explain something found over and over: CRISPR is woefully inefficient, with only a small minority of cells into which CRISPR is introduced, usually by a virus, actually having their genomes edited as intended.\u003c/p>\n\u003cp>“We found that cutting the genome with CRISPR-Cas9 induced the activation of … p53,” said Emma Haapaniemi, the lead author of the \u003ca href=\"https://www.nature.com/articles/s41591-018-0049-z\" target=\"_blank\" rel=\"noopener\">Karolinska study\u003c/a>. That “makes editing much more difficult.”\u003c/p>\n\u003cp>The flip side of p53 repairing CRISPR edits, or killing cells that accept the edits, is that cells that survive with the edits do so precisely because they have a dysfunctional p53 and therefore lack this fix-it-or-kill-it mechanism.\u003c/p>\n\u003cp>The reason why that could be a problem is that p53 dysfunction can cause cancer. And not just occasionally. P53 mutations are \u003ca href=\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2827900/figure/A001008F1/\" target=\"_blank\" rel=\"noopener\">responsible for\u003c/a> nearly half of ovarian cancers; 43 percent of colorectal cancers; 38 percent of lung cancers; nearly one-third of pancreatic, stomach, and liver cancers; and one-quarter of breast cancers, among others.\u003c/p>\n\u003cp>The Novartis team was trying to see how it could increase the efficiency of CRISPR editing of pluripotent stem cells. Because this kind of stem cell can morph into virtually any kind of cell, it might be able to treat a variety of diseases. Neuroscientist Ajamete Kaykas of the company’s Institutes for BioMedical Research in Cambridge, Mass., got CRISPR’s efficiency at inserting or deleting chunks of DNA up to 80 percent. Unfortunately, when CRISPR worked, it was because p53 didn’t, which raises cancer concerns.\u003c/p>\n\u003cp>As a result, the Novartis \u003ca href=\"https://www.nature.com/articles/s41591-018-0050-6\" target=\"_blank\" rel=\"noopener\">paper\u003c/a> concludes that “it will be critical to ensure that [genome-edited cells] have a functional p53 before and after [genome] engineering.” The Karolinska team warns that p53 and related genes “should be monitored when developing cell-based therapies utilizing CRISPR-Cas9.”[contextly_sidebar id=\"f80ZxqMXgIrsBguckwJZNJRkL6wI6fMd\"]\u003c/p>\n\u003cp>The p53 finding doesn’t mean CRISPR is toast. For one thing, “the two papers present preliminary results,” biochemist Bernhard Schmierer of the Karolinska, co-leader of its study, told STAT. “It is unclear if the findings translate into cells actually used in current clinical studies.”\u003c/p>\n\u003cp>For another, the p53 problem might be worse with Cas9 than with other DNA-cutting enzymes used in CRISPR. And, crucially, it probably affects only one avenue of genome-editing.\u003c/p>\n\u003cp>CRISPR edits genomes in either of two ways. It slices out a chunk of disease-causing DNA, in a process called non-homologous end joining (NHEJ), or gene disruption. That’s how CRISPR Therapeutics is going after sickle cell disease. Alternatively, CRISPR both cuts out a disease-causing stretch of DNA and replaces it with healthy nucleotides, in homology-directed repair (HDR), or gene correction. Several university labs are investigating HDR to treat Duchenne \u003ca href=\"https://www.nature.com/articles/s41551-017-0137-2\" target=\"_blank\" rel=\"noopener\">muscular dystrophy,\u003c/a> among many other diseases.\u003c/p>\n\u003cp>In the normal, mature cells she and her team studied, Haapaniemi said, gene disruption “can happen even when p53 is activated.”\u003c/p>\n\u003cp>That’s good news for CRISPR Therapeutics’ sickle-cell and thalassemia \u003ca href=\"http://www.crisprtx.com/our-programs/our-pipeline.php\" target=\"_blank\" rel=\"noopener\">programs \u003c/a>as well as for Editas Medicine’s lead product, targeting a form of blindness, and others in its \u003ca href=\"http://www.editasmedicine.com/pipeline\" target=\"_blank\" rel=\"noopener\">pipeline\u003c/a>, all of which use NHEJ gene disruption. It also should not affect the gene-disruption approach that Intellia Therapeutics and Regeneron are \u003ca href=\"https://www.intelliatx.com/pipeline/\" target=\"_blank\" rel=\"noopener\">taking\u003c/a> to \u003ca href=\"https://ghr.nlm.nih.gov/condition/transthyretin-amyloidosis\" target=\"_blank\" rel=\"noopener\">transthyretin amyloidosis\u003c/a>.\u003c/p>\n\u003cp>CRISPR-based editing of T cells to treat cancer, as scientists at the University of Pennsylvania are studying in a \u003ca href=\"https://www.statnews.com/2016/06/21/crispr-human-trials/\">clinical trial,\u003c/a> should also not have a p53 problem. Nor should any therapy developed with CRISPR base editing, which does not make the double-stranded breaks that trigger p53. Developed by Harvard’s David Liu, base editing replaces a wrong DNA “letter” with the right one, without cutting, and is the basis for startup \u003ca href=\"https://www.statnews.com/2018/05/14/crispr-editas-beam-base-editing/\" target=\"_blank\" rel=\"noopener\">Beam Therapeutics\u003c/a>.\u003c/p>\n\u003cp>The p53 problem, however, might affect other products that companies hope to develop via gene correction, including glycogen storage disease, cystic fibrosis, and severe combined immunodeficiency.\u003c/p>\n\u003cp>It’s also a potential problem for stem cells. There, the Novartis team showed, p53 inactivation seems to be necessary for both NHEJ disruption and HDR correction. (Novartis’ Kaykas said he could not speak to a reporter without clearance from the company’s communications office.) That could be an issue for therapies using CRISPR’d stem cells: The same dysfunctional p53 that allows CRISPR to work its magic also makes cells likely to become cancerous.\u003c/p>\n\u003cp>Which raises an obvious question — if successfully CRISPR’d cells can seed cancers, why hasn’t this been seen before, and why haven’t the many CRISPR’d mice developed tumors?\u003c/p>\n\u003cp>Karolinska’s Haapaniemi said the effect shows up in large-scale experiments like hers and Novartis’ “but can be missed in small-scale studies where people only focus on editing one gene in one cell type.” In speaking to other scientists, she said, “it seems that other teams have noticed the effect of p53 on editing,” but have not highlighted it.\u003c/p>\n\u003cp>Jacob Corn of the University of California, Berkeley, said that although his lab has seen evidence of p53 activation in a few cases, they have “looked hard for growth effects after editing in [human stem cells] and found nothing.”\u003c/p>\n\u003cp>As for why no one has reported CRISPR’d mice getting cancer, Haapaniemi said, “This is a good question.” One reason might be that “laboratory mice are killed early,” perhaps leaving too little time for them to develop cancer.\u003c/p>\n\u003cp>But Corn said he and others “have all been looking for the possibility of cancer. So far, no one has seen evidence of [it] based on p53 status or induced by editing.”\u003c/p>\n\u003cp>Nevertheless, he called the two papers “important, since they remind everyone that genome editing isn’t magic.”\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\u003cem>This\u003ca href=\"https://www.statnews.com/2018/06/11/crispr-hurdle-edited-cells-might-cause-cancer/\" target=\"_blank\" rel=\"noopener\"> story\u003c/a> was originally published by STAT, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery.\u003c/em>\u003c/p>\n\n","blocks":[],"excerpt":null,"status":"publish","parent":0,"modified":1528739244,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":27,"wordCount":1502},"headData":{"title":"Major CRISPR Hurdle: Edited Cells Might Cause Cancer, Find Studies | KQED","description":"Editing cells’ genomes with CRISPR-Cas9 might increase the risk that the altered cells, intended to treat disease, will trigger cancer, two studies published on Monday warn — a potential game-changer for the companies developing CRISPR-based therapies. In the studies, published in Nature Medicine, scientists found that cells whose genomes are successfully edited by CRISPR-Cas9 have the","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"Major CRISPR Hurdle: Edited Cells Might Cause Cancer, Find Studies","datePublished":"2018-06-11T19:00:26.000Z","dateModified":"2018-06-11T17:47:24.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"disqusIdentifier":"442526 https://ww2.kqed.org/futureofyou/?p=442526","disqusUrl":"https://ww2.kqed.org/futureofyou/2018/06/11/major-hurdle-for-crispr-edited-cells-might-cause-cancer-find-two-studies/","disqusTitle":"Major CRISPR Hurdle: Edited Cells Might Cause Cancer, Find Studies","source":"Health","nprByline":"Sharon Begley\u003cbr />STAT","path":"/futureofyou/442526/major-hurdle-for-crispr-edited-cells-might-cause-cancer-find-two-studies","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>Editing cells’ genomes with CRISPR-Cas9 might increase the risk that the altered cells, intended to treat disease, will trigger cancer, two studies published on Monday warn — a potential game-changer for the companies developing CRISPR-based therapies.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>In the studies, published in Nature Medicine, scientists found that cells whose genomes are successfully edited by CRISPR-Cas9 have the potential to seed tumors inside a patient. That could make some CRISPR’d cells ticking time bombs, according to researchers from Sweden’s Karolinska Institute and, separately, Novartis.\u003c/p>\n\u003cp class=\"danger-zone\">\u003ca href=\"https://www.statnews.com/feature/crispr/tracker/\">CRISPR\u003c/a> has already dodged two potentially fatal bullets — a 2017 \u003ca href=\"https://www.nature.com/articles/nmeth.4293.epdf\" target=\"_blank\" rel=\"noopener\">claim\u003c/a> that it causes sky-high numbers of off-target effects was \u003ca href=\"https://www.nature.com/articles/nmeth.4664\" target=\"_blank\" rel=\"noopener\">retracted\u003c/a> in March, and a \u003ca href=\"https://www.biorxiv.org/content/early/2018/01/05/243345\" target=\"_blank\" rel=\"noopener\">report \u003c/a>of human immunity to Cas9 was largely shrugged off as \u003ca href=\"https://www.statnews.com/2018/01/08/immunity-crispr-cas9/\">solvable\u003c/a>. But experts are taking the cancer-risk finding seriously.\u003c/p>\n\u003cp class=\"danger-zone\">The CEO of CRISPR Therapeutics, Sam Kulkarni, told STAT the results are “plausible.” Although they likely apply to one of the main ways that CRISPR edits genomes (replacing disease-causing DNA with healthy versions) more than another (just excising DNA), he said, “it’s something we need to pay attention to, especially as CRISPR expands to more diseases. We need to do the work and make sure edited cells returned to patients don’t become cancerous.”\u003c/p>\n\u003cp class=\"\">Another leading CRISPR scientist, who asked not to be named because of involvement with genome-editing companies, called the new data “pretty striking,” and raised concerns that a potential fatal flaw in some uses of CRISPR had “been missed.”\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>On the other hand, the Novartis paper has been \u003ca href=\"https://www.biorxiv.org/content/early/2017/07/26/168443\" target=\"_blank\" rel=\"noopener\">available\u003c/a> in preliminary form since last summer, and CRISPR experts “haven’t freaked out,” said Erik Sontheimer of the University of Massachusetts Medical School, whose CRISPR research \u003ca href=\"https://www.statnews.com/2018/03/05/crispr-off-target-editing/\">centers\u003c/a> on novel enzymes and off-target effects. “This is something that bears paying attention to, but I don’t think it’s a deal-breaker” for CRISPR therapies.\u003c/p>\n\u003cp>The Karolinska and Novartis groups tested CRISPR on different kinds of human cells — retinal cells and pluripotent stem cells, respectively. But they found essentially the same phenomenon. Standard CRISPR-Cas9 works by cutting both strands of the DNA double helix. That injury causes a cell to activate a biochemical first-aid kit orchestrated by a gene called \u003ca href=\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4235614/\" target=\"_blank\" rel=\"noopener\">p53,\u003c/a> which either mends the DNA break or makes the cell self-destruct.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>Whichever action p53 takes, the consequence is the same: CRISPR doesn’t work, either because the genome edit is stitched up or the cell is dead. (The Novartis team calculated that p53 reduces CRISPR efficiency in pluripotent stem cells seventeenfold.) That might explain something found over and over: CRISPR is woefully inefficient, with only a small minority of cells into which CRISPR is introduced, usually by a virus, actually having their genomes edited as intended.\u003c/p>\n\u003cp>“We found that cutting the genome with CRISPR-Cas9 induced the activation of … p53,” said Emma Haapaniemi, the lead author of the \u003ca href=\"https://www.nature.com/articles/s41591-018-0049-z\" target=\"_blank\" rel=\"noopener\">Karolinska study\u003c/a>. That “makes editing much more difficult.”\u003c/p>\n\u003cp>The flip side of p53 repairing CRISPR edits, or killing cells that accept the edits, is that cells that survive with the edits do so precisely because they have a dysfunctional p53 and therefore lack this fix-it-or-kill-it mechanism.\u003c/p>\n\u003cp>The reason why that could be a problem is that p53 dysfunction can cause cancer. And not just occasionally. P53 mutations are \u003ca href=\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2827900/figure/A001008F1/\" target=\"_blank\" rel=\"noopener\">responsible for\u003c/a> nearly half of ovarian cancers; 43 percent of colorectal cancers; 38 percent of lung cancers; nearly one-third of pancreatic, stomach, and liver cancers; and one-quarter of breast cancers, among others.\u003c/p>\n\u003cp>The Novartis team was trying to see how it could increase the efficiency of CRISPR editing of pluripotent stem cells. Because this kind of stem cell can morph into virtually any kind of cell, it might be able to treat a variety of diseases. Neuroscientist Ajamete Kaykas of the company’s Institutes for BioMedical Research in Cambridge, Mass., got CRISPR’s efficiency at inserting or deleting chunks of DNA up to 80 percent. Unfortunately, when CRISPR worked, it was because p53 didn’t, which raises cancer concerns.\u003c/p>\n\u003cp>As a result, the Novartis \u003ca href=\"https://www.nature.com/articles/s41591-018-0050-6\" target=\"_blank\" rel=\"noopener\">paper\u003c/a> concludes that “it will be critical to ensure that [genome-edited cells] have a functional p53 before and after [genome] engineering.” The Karolinska team warns that p53 and related genes “should be monitored when developing cell-based therapies utilizing CRISPR-Cas9.”\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>The p53 finding doesn’t mean CRISPR is toast. For one thing, “the two papers present preliminary results,” biochemist Bernhard Schmierer of the Karolinska, co-leader of its study, told STAT. “It is unclear if the findings translate into cells actually used in current clinical studies.”\u003c/p>\n\u003cp>For another, the p53 problem might be worse with Cas9 than with other DNA-cutting enzymes used in CRISPR. And, crucially, it probably affects only one avenue of genome-editing.\u003c/p>\n\u003cp>CRISPR edits genomes in either of two ways. It slices out a chunk of disease-causing DNA, in a process called non-homologous end joining (NHEJ), or gene disruption. That’s how CRISPR Therapeutics is going after sickle cell disease. Alternatively, CRISPR both cuts out a disease-causing stretch of DNA and replaces it with healthy nucleotides, in homology-directed repair (HDR), or gene correction. Several university labs are investigating HDR to treat Duchenne \u003ca href=\"https://www.nature.com/articles/s41551-017-0137-2\" target=\"_blank\" rel=\"noopener\">muscular dystrophy,\u003c/a> among many other diseases.\u003c/p>\n\u003cp>In the normal, mature cells she and her team studied, Haapaniemi said, gene disruption “can happen even when p53 is activated.”\u003c/p>\n\u003cp>That’s good news for CRISPR Therapeutics’ sickle-cell and thalassemia \u003ca href=\"http://www.crisprtx.com/our-programs/our-pipeline.php\" target=\"_blank\" rel=\"noopener\">programs \u003c/a>as well as for Editas Medicine’s lead product, targeting a form of blindness, and others in its \u003ca href=\"http://www.editasmedicine.com/pipeline\" target=\"_blank\" rel=\"noopener\">pipeline\u003c/a>, all of which use NHEJ gene disruption. It also should not affect the gene-disruption approach that Intellia Therapeutics and Regeneron are \u003ca href=\"https://www.intelliatx.com/pipeline/\" target=\"_blank\" rel=\"noopener\">taking\u003c/a> to \u003ca href=\"https://ghr.nlm.nih.gov/condition/transthyretin-amyloidosis\" target=\"_blank\" rel=\"noopener\">transthyretin amyloidosis\u003c/a>.\u003c/p>\n\u003cp>CRISPR-based editing of T cells to treat cancer, as scientists at the University of Pennsylvania are studying in a \u003ca href=\"https://www.statnews.com/2016/06/21/crispr-human-trials/\">clinical trial,\u003c/a> should also not have a p53 problem. Nor should any therapy developed with CRISPR base editing, which does not make the double-stranded breaks that trigger p53. Developed by Harvard’s David Liu, base editing replaces a wrong DNA “letter” with the right one, without cutting, and is the basis for startup \u003ca href=\"https://www.statnews.com/2018/05/14/crispr-editas-beam-base-editing/\" target=\"_blank\" rel=\"noopener\">Beam Therapeutics\u003c/a>.\u003c/p>\n\u003cp>The p53 problem, however, might affect other products that companies hope to develop via gene correction, including glycogen storage disease, cystic fibrosis, and severe combined immunodeficiency.\u003c/p>\n\u003cp>It’s also a potential problem for stem cells. There, the Novartis team showed, p53 inactivation seems to be necessary for both NHEJ disruption and HDR correction. (Novartis’ Kaykas said he could not speak to a reporter without clearance from the company’s communications office.) That could be an issue for therapies using CRISPR’d stem cells: The same dysfunctional p53 that allows CRISPR to work its magic also makes cells likely to become cancerous.\u003c/p>\n\u003cp>Which raises an obvious question — if successfully CRISPR’d cells can seed cancers, why hasn’t this been seen before, and why haven’t the many CRISPR’d mice developed tumors?\u003c/p>\n\u003cp>Karolinska’s Haapaniemi said the effect shows up in large-scale experiments like hers and Novartis’ “but can be missed in small-scale studies where people only focus on editing one gene in one cell type.” In speaking to other scientists, she said, “it seems that other teams have noticed the effect of p53 on editing,” but have not highlighted it.\u003c/p>\n\u003cp>Jacob Corn of the University of California, Berkeley, said that although his lab has seen evidence of p53 activation in a few cases, they have “looked hard for growth effects after editing in [human stem cells] and found nothing.”\u003c/p>\n\u003cp>As for why no one has reported CRISPR’d mice getting cancer, Haapaniemi said, “This is a good question.” One reason might be that “laboratory mice are killed early,” perhaps leaving too little time for them to develop cancer.\u003c/p>\n\u003cp>But Corn said he and others “have all been looking for the possibility of cancer. So far, no one has seen evidence of [it] based on p53 status or induced by editing.”\u003c/p>\n\u003cp>Nevertheless, he called the two papers “important, since they remind everyone that genome editing isn’t magic.”\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"floatright"},"numeric":["floatright"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\u003cem>This\u003ca href=\"https://www.statnews.com/2018/06/11/crispr-hurdle-edited-cells-might-cause-cancer/\" target=\"_blank\" rel=\"noopener\"> story\u003c/a> was originally published by STAT, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery.\u003c/em>\u003c/p>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/futureofyou/442526/major-hurdle-for-crispr-edited-cells-might-cause-cancer-find-two-studies","authors":["byline_futureofyou_442526"],"categories":["futureofyou_1","futureofyou_1064"],"tags":["futureofyou_1521","futureofyou_103","futureofyou_1077","futureofyou_94","futureofyou_17","futureofyou_295"],"collections":["futureofyou_1093","futureofyou_1094"],"featImg":"futureofyou_442536","label":"source_futureofyou_442526"},"futureofyou_441220":{"type":"posts","id":"futureofyou_441220","meta":{"index":"posts_1591205157","site":"futureofyou","id":"441220","score":null,"sort":[1525204384000]},"guestAuthors":[],"slug":"the-take-from-courtside-uc-berkeley-probably-not-going-to-win-crispr-patent-dispute","title":"The Take From Courtside: UC Berkeley Probably Not Going to Win CRISPR Patent Dispute","publishDate":1525204384,"format":"aside","headTitle":"KQED Future of You | KQED Science","labelTerm":{},"content":"\u003ch3>The university clearly failed to win over at least one of the three judges and, at best, did not lose too much ground with a second.\u003c/h3>\n\u003cp class=\"danger-zone\">The University of California, which has been losing the fight over U.S. patents on the revolutionary genome-editing technology CRISPR-Cas9, did not pull any rabbits out of a hat during \u003ca href=\"https://www.statnews.com/2018/04/27/crispr-patent-fight-round-two/\" target=\"_blank\" rel=\"noopener\">oral arguments\u003c/a> Monday in its appeal of the case.\u003c/p>\n\u003cp class=\"danger-zone\">The university clearly failed to win over at least one of the three judges and, at best, did not lose too much ground with a second (while the third asked almost no questions and so did not tip his hand).\u003c/p>\n\u003cp class=\"danger-zone\">“UC came into this argument from a tough spot, and I doubt that oral arguments from either side moved the needle much,” said patent attorney Michael Stramiello of Paul Hastings, who attended the arguments at the U.S. Court of Appeals for the Federal Circuit, where attorneys for the University of California fought to get a patent win by the Broad Institute of MIT and Harvard reversed.\u003c/p>\n\u003cp class=\"danger-zone\">“It was closer than I expected,” said patent expert Jacob Sherkow of New York Law School, who also attended the argument. “But it’s still going to be tough for UC.”\u003c/p>\n\u003cp class=\"danger-zone\">That’s because in order to \u003ca href=\"https://www.statnews.com/2018/04/27/crispr-patent-fight-round-two/\" target=\"_blank\" rel=\"noopener\">reverse the Broad’s win\u003c/a>, the appeals court will have to find that the patent office committed serious legal errors, as UC’s new attorney (and former solicitor general) Donald Verrilli argued. He marshaled both legal and scientific evidence to make his case for what experts call his only path to success: persuading the judges that the patent office did not have “substantial evidence” for its decision in favor of the Broad.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>The problem for UC is that the legal definition of “substantial” differs from the plain English meaning.\u003c/p>\n\u003cfigure id=\"attachment_441233\" class=\"wp-caption alignright\" style=\"max-width: 413px\">\u003ca href=\"https://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2018/05/FengZhang_413x315.png\">\u003cimg src=\"https://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2018/05/FengZhang_413x315.png\" alt=\"\" width=\"413\" height=\"315\" class=\"size-full wp-image-441233\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2018/05/FengZhang_413x315.png 413w, https://ww2.kqed.org/app/uploads/sites/13/2018/05/FengZhang_413x315-160x122.png 160w, https://ww2.kqed.org/app/uploads/sites/13/2018/05/FengZhang_413x315-240x183.png 240w, https://ww2.kqed.org/app/uploads/sites/13/2018/05/FengZhang_413x315-375x286.png 375w\" sizes=\"(max-width: 413px) 100vw, 413px\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">Biotechnologist Feng Zhang of the Broad Institute was awarded a patent for CRISPR gene-editing technology in 2014. \u003ccite>(Broad Institute)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>“It means just enough for a reasonable person to find it persuasive,” Sherkow said. In other words, when the patent office decided that the Broad gets to keep its key CRISPR patents, did it base that on a reasonable assessment of the relevant evidence about, in particular, whether the Broad’s breakthroughs were “obvious” extensions of research by UC scientists. “You can ignore some evidence that still meet the requirement of ‘substantial evidence,'” said law professor Dmitry Karshtedt, who attended the hearing.\u003c/p>\n\u003cp>Judge Kimberly Moore, in particular, seemed unconvinced by Verrilli’s arguments. “That’s how science works, Mr. Verrilli,” she said toward the end of the 35-minute hearing. Verrilli spent much of his allotted 15 minutes, and much of the written briefs, arguing that because half a dozen labs, besides that of the Broad’s \u003ca href=\"https://www.statnews.com/2015/11/06/hollywood-inspired-scientist-rewrite-code-life/\">Feng Zhang\u003c/a>, quickly got CRISPR to work in mammalian cells after UC scientists showed that it worked on DNA in a test tube, and used conventional techniques to do so, the Broad’s work was an obvious extension of UC’s and thus not deserving of patents.\u003c/p>\n\u003cp>But getting CRISPR to work in mammalian cells, and the fact that all the labs used conventional techniques of molecular biology to do it, “doesn’t mean they thought it would work,” Moore said. In pushback that could be fatal for UC, she continued, “It’s hard for me to say there wasn’t substantial evidence” to back up the patent office’s ruling against UC. When Verrilli tried to jump in, he got a sharp, “Please don’t interrupt me.”\u003c/p>\n\u003caside class=\"pullquote alignright\">'That’s how science works, Mr. Verrilli.'\u003ccite>Judge Kimberly Moore to UC Berkeley attorney Donald Verrilli\u003c/cite>\u003c/aside>\n\u003cp>The Broad issued a statement at the conclusion of the hearing: “Based on the oral arguments today, we are even more confident the Federal Circuit will affirm the PTAB’s judgment,” the Broad said. “We call on UCB and the companies that control its IP to join our ongoing efforts to simplify, share, and open the IP landscape.”\u003c/p>\n\u003cp>Not surprisingly, the University of California had a different take: “We presented compelling arguments today that the PTAB committed several legal errors, including disregarding Supreme Court and Federal Circuit precedent,” Charles F. Robinson, UC general counsel said in a statement. “Based on the questioning today, we are optimistic that the court has serious doubts about several aspects of the PTAB’s decision.”\u003c/p>\n\u003cp>To recap the plot thus far: In June 2012, UC Berkeley biochemist Jennifer Doudna and her colleagues reported that CRISPR-Cas9 could be turned into a “programmable” genome-editing tool, as they demonstrated on DNA in a test tube. They’d filed their first patent application on the technique the month before. Seven months later, the Broad Institute filed for a CRISPR patent on Zhang’s discovery of how to use the system to edit the genomes of eukaryotic cells, as he reported in January 2013.\u003c/p>\n\u003cp>Although UC filed first for a CRISPR patent, under the law at the time, patents went to the first to invent, and Zhang submitted lab notebooks showing he managed his feat before Doudna’s paper was published. In April 2014, the Broad won a far-reaching patent on the use of CRISPR-Cas9 for editing genomes in eukaryotic cells. A year later, UC asked the patent office to declare an “interference in fact”: to decide that the Broad’s CRISPR patents (which by then numbered 10) covered inventions so similar to what UC applied for (and was still waiting for) a patent on that they should be deemed invalid.\u003c/p>\n\u003cp>In February 2017, the Patent Trial and Appeal Board \u003ca href=\"https://www.statnews.com/2017/02/15/crispr-patent-ruling/\">ruled\u003c/a> that the Broad’s 2014 CRISPR patent did not “interfere” with UC’s pending ones: The Broad’s, which covers the use of CRISPR-Cas9 to edit genomes in eukaryotic cells, was different enough from UC’s and not an obvious extension of Doudna’s work to be valid.\u003c/p>\n\u003cp>UC appealed, and the oral arguments were heard on Monday.\u003c/p>\n\u003cp>The only arguments an appeals court entertains, whether about a conviction for murder or a ruling on patent interference, are those about whether the previous tribunals conducted the proceedings properly, interpreting and applying the law correctly. In this case, that means UC must persuade the three judges that PTAB did not have “substantial evidence” to support its finding of no-interference-in-fact; that PTAB made a material legal error, such as in what evidence or testimony it allowed; or that it failed to consider certain evidence.\u003c/p>\n\u003cp>Verrilli got out barely two sentences before chief judge Sharon Prost jumped in. The main ground for overturning PTAB’s decision, she pointed out, would be a finding that the board did not have substantial evidence for it. But PTAB’s long, detailed written decision suggests that it did not exactly base its decision on a whim. “How do we get around that?” Prost asked Verrilli.\u003c/p>\n\u003cp>When he tried to answer, Moore interrupted, pointing out “problems with the cases” Verrilli had cited to support his position and the low bar for evidence to be “substantial.” “Do you see the problem I’m having?” she asked him. (Shortly after, Moore had a coughing fit and excused herself from the bench, an almost unheard-of occurrence, but told the attorneys to carry on; she returned a few minutes later.)\u003c/p>\n\u003cp>Arguing for the Broad, Raymond Nimrod of Quinn Emanuel had a somewhat easier time but did not get off scot-free. Prost zeroed in on the success that those half a dozen labs had using CRISPR in mammalian cells in the months after Doudna’s success with CRISPR on test-tube DNA. UC has argued throughout the patent saga that the success by so many labs indicates that it was an obvious extension of Doudna’s work, “obviousness” that would include what Zhang achieved.\u003c/p>\n\u003cp>“What about the [patent] board’s not placing much weight on how several people came up with it in a short period of time” after Doudna’s work, Prost asked Nimrod. He replied that PTAB did not dismiss that evidence, but simply found it not to support UC’s claim.\u003c/p>\n\u003cp>The fact that PTAB considered that argument might be enough to meet the fairly low requirement that its decisions be based on “substantial evidence,” Sherkow said.\u003c/p>\n\u003cp>A ruling is expected by late summer.\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\u003cem>This \u003ca href=\"https://www.statnews.com/2018/04/30/crispr-patent-appeal-hearing/\" target=\"_blank\" rel=\"noopener\">story\u003c/a> was originally published by STAT, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery. \u003c/em>\u003c/p>\n\n","blocks":[],"excerpt":"In the ongoing dispute over ownership of key CRISPR patents, UC Berkeley is going to have a tough time getting a court to overturn a patent office ruling in favor of the rival Broad Institute.","status":"publish","parent":0,"modified":1535388964,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":20,"wordCount":1499},"headData":{"title":"The Take From Courtside: UC Berkeley Probably Not Going to Win CRISPR Patent Dispute | KQED","description":"In the ongoing dispute over ownership of key CRISPR patents, UC Berkeley is going to have a tough time getting a court to overturn a patent office ruling in favor of the rival Broad Institute.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"The Take From Courtside: UC Berkeley Probably Not Going to Win CRISPR Patent Dispute","datePublished":"2018-05-01T19:53:04.000Z","dateModified":"2018-08-27T16:56:04.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"disqusIdentifier":"441220 https://ww2.kqed.org/futureofyou/?p=441220","disqusUrl":"https://ww2.kqed.org/futureofyou/2018/05/01/the-take-from-courtside-uc-berkeley-probably-not-going-to-win-crispr-patent-dispute/","disqusTitle":"The Take From Courtside: UC Berkeley Probably Not Going to Win CRISPR Patent Dispute","source":"Your Genes","nprByline":"Sharon Begley\u003cbr />\u003ca href=\"https://www.statnews.com/\">STAT\u003c/a>","path":"/futureofyou/441220/the-take-from-courtside-uc-berkeley-probably-not-going-to-win-crispr-patent-dispute","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003ch3>The university clearly failed to win over at least one of the three judges and, at best, did not lose too much ground with a second.\u003c/h3>\n\u003cp class=\"danger-zone\">The University of California, which has been losing the fight over U.S. patents on the revolutionary genome-editing technology CRISPR-Cas9, did not pull any rabbits out of a hat during \u003ca href=\"https://www.statnews.com/2018/04/27/crispr-patent-fight-round-two/\" target=\"_blank\" rel=\"noopener\">oral arguments\u003c/a> Monday in its appeal of the case.\u003c/p>\n\u003cp class=\"danger-zone\">The university clearly failed to win over at least one of the three judges and, at best, did not lose too much ground with a second (while the third asked almost no questions and so did not tip his hand).\u003c/p>\n\u003cp class=\"danger-zone\">“UC came into this argument from a tough spot, and I doubt that oral arguments from either side moved the needle much,” said patent attorney Michael Stramiello of Paul Hastings, who attended the arguments at the U.S. Court of Appeals for the Federal Circuit, where attorneys for the University of California fought to get a patent win by the Broad Institute of MIT and Harvard reversed.\u003c/p>\n\u003cp class=\"danger-zone\">“It was closer than I expected,” said patent expert Jacob Sherkow of New York Law School, who also attended the argument. “But it’s still going to be tough for UC.”\u003c/p>\n\u003cp class=\"danger-zone\">That’s because in order to \u003ca href=\"https://www.statnews.com/2018/04/27/crispr-patent-fight-round-two/\" target=\"_blank\" rel=\"noopener\">reverse the Broad’s win\u003c/a>, the appeals court will have to find that the patent office committed serious legal errors, as UC’s new attorney (and former solicitor general) Donald Verrilli argued. He marshaled both legal and scientific evidence to make his case for what experts call his only path to success: persuading the judges that the patent office did not have “substantial evidence” for its decision in favor of the Broad.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>The problem for UC is that the legal definition of “substantial” differs from the plain English meaning.\u003c/p>\n\u003cfigure id=\"attachment_441233\" class=\"wp-caption alignright\" style=\"max-width: 413px\">\u003ca href=\"https://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2018/05/FengZhang_413x315.png\">\u003cimg src=\"https://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2018/05/FengZhang_413x315.png\" alt=\"\" width=\"413\" height=\"315\" class=\"size-full wp-image-441233\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2018/05/FengZhang_413x315.png 413w, https://ww2.kqed.org/app/uploads/sites/13/2018/05/FengZhang_413x315-160x122.png 160w, https://ww2.kqed.org/app/uploads/sites/13/2018/05/FengZhang_413x315-240x183.png 240w, https://ww2.kqed.org/app/uploads/sites/13/2018/05/FengZhang_413x315-375x286.png 375w\" sizes=\"(max-width: 413px) 100vw, 413px\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">Biotechnologist Feng Zhang of the Broad Institute was awarded a patent for CRISPR gene-editing technology in 2014. \u003ccite>(Broad Institute)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>“It means just enough for a reasonable person to find it persuasive,” Sherkow said. In other words, when the patent office decided that the Broad gets to keep its key CRISPR patents, did it base that on a reasonable assessment of the relevant evidence about, in particular, whether the Broad’s breakthroughs were “obvious” extensions of research by UC scientists. “You can ignore some evidence that still meet the requirement of ‘substantial evidence,'” said law professor Dmitry Karshtedt, who attended the hearing.\u003c/p>\n\u003cp>Judge Kimberly Moore, in particular, seemed unconvinced by Verrilli’s arguments. “That’s how science works, Mr. Verrilli,” she said toward the end of the 35-minute hearing. Verrilli spent much of his allotted 15 minutes, and much of the written briefs, arguing that because half a dozen labs, besides that of the Broad’s \u003ca href=\"https://www.statnews.com/2015/11/06/hollywood-inspired-scientist-rewrite-code-life/\">Feng Zhang\u003c/a>, quickly got CRISPR to work in mammalian cells after UC scientists showed that it worked on DNA in a test tube, and used conventional techniques to do so, the Broad’s work was an obvious extension of UC’s and thus not deserving of patents.\u003c/p>\n\u003cp>But getting CRISPR to work in mammalian cells, and the fact that all the labs used conventional techniques of molecular biology to do it, “doesn’t mean they thought it would work,” Moore said. In pushback that could be fatal for UC, she continued, “It’s hard for me to say there wasn’t substantial evidence” to back up the patent office’s ruling against UC. When Verrilli tried to jump in, he got a sharp, “Please don’t interrupt me.”\u003c/p>\n\u003caside class=\"pullquote alignright\">'That’s how science works, Mr. Verrilli.'\u003ccite>Judge Kimberly Moore to UC Berkeley attorney Donald Verrilli\u003c/cite>\u003c/aside>\n\u003cp>The Broad issued a statement at the conclusion of the hearing: “Based on the oral arguments today, we are even more confident the Federal Circuit will affirm the PTAB’s judgment,” the Broad said. “We call on UCB and the companies that control its IP to join our ongoing efforts to simplify, share, and open the IP landscape.”\u003c/p>\n\u003cp>Not surprisingly, the University of California had a different take: “We presented compelling arguments today that the PTAB committed several legal errors, including disregarding Supreme Court and Federal Circuit precedent,” Charles F. Robinson, UC general counsel said in a statement. “Based on the questioning today, we are optimistic that the court has serious doubts about several aspects of the PTAB’s decision.”\u003c/p>\n\u003cp>To recap the plot thus far: In June 2012, UC Berkeley biochemist Jennifer Doudna and her colleagues reported that CRISPR-Cas9 could be turned into a “programmable” genome-editing tool, as they demonstrated on DNA in a test tube. They’d filed their first patent application on the technique the month before. Seven months later, the Broad Institute filed for a CRISPR patent on Zhang’s discovery of how to use the system to edit the genomes of eukaryotic cells, as he reported in January 2013.\u003c/p>\n\u003cp>Although UC filed first for a CRISPR patent, under the law at the time, patents went to the first to invent, and Zhang submitted lab notebooks showing he managed his feat before Doudna’s paper was published. In April 2014, the Broad won a far-reaching patent on the use of CRISPR-Cas9 for editing genomes in eukaryotic cells. A year later, UC asked the patent office to declare an “interference in fact”: to decide that the Broad’s CRISPR patents (which by then numbered 10) covered inventions so similar to what UC applied for (and was still waiting for) a patent on that they should be deemed invalid.\u003c/p>\n\u003cp>In February 2017, the Patent Trial and Appeal Board \u003ca href=\"https://www.statnews.com/2017/02/15/crispr-patent-ruling/\">ruled\u003c/a> that the Broad’s 2014 CRISPR patent did not “interfere” with UC’s pending ones: The Broad’s, which covers the use of CRISPR-Cas9 to edit genomes in eukaryotic cells, was different enough from UC’s and not an obvious extension of Doudna’s work to be valid.\u003c/p>\n\u003cp>UC appealed, and the oral arguments were heard on Monday.\u003c/p>\n\u003cp>The only arguments an appeals court entertains, whether about a conviction for murder or a ruling on patent interference, are those about whether the previous tribunals conducted the proceedings properly, interpreting and applying the law correctly. In this case, that means UC must persuade the three judges that PTAB did not have “substantial evidence” to support its finding of no-interference-in-fact; that PTAB made a material legal error, such as in what evidence or testimony it allowed; or that it failed to consider certain evidence.\u003c/p>\n\u003cp>Verrilli got out barely two sentences before chief judge Sharon Prost jumped in. The main ground for overturning PTAB’s decision, she pointed out, would be a finding that the board did not have substantial evidence for it. But PTAB’s long, detailed written decision suggests that it did not exactly base its decision on a whim. “How do we get around that?” Prost asked Verrilli.\u003c/p>\n\u003cp>When he tried to answer, Moore interrupted, pointing out “problems with the cases” Verrilli had cited to support his position and the low bar for evidence to be “substantial.” “Do you see the problem I’m having?” she asked him. (Shortly after, Moore had a coughing fit and excused herself from the bench, an almost unheard-of occurrence, but told the attorneys to carry on; she returned a few minutes later.)\u003c/p>\n\u003cp>Arguing for the Broad, Raymond Nimrod of Quinn Emanuel had a somewhat easier time but did not get off scot-free. Prost zeroed in on the success that those half a dozen labs had using CRISPR in mammalian cells in the months after Doudna’s success with CRISPR on test-tube DNA. UC has argued throughout the patent saga that the success by so many labs indicates that it was an obvious extension of Doudna’s work, “obviousness” that would include what Zhang achieved.\u003c/p>\n\u003cp>“What about the [patent] board’s not placing much weight on how several people came up with it in a short period of time” after Doudna’s work, Prost asked Nimrod. He replied that PTAB did not dismiss that evidence, but simply found it not to support UC’s claim.\u003c/p>\n\u003cp>The fact that PTAB considered that argument might be enough to meet the fairly low requirement that its decisions be based on “substantial evidence,” Sherkow said.\u003c/p>\n\u003cp>A ruling is expected by late summer.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"floatright"},"numeric":["floatright"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\u003cem>This \u003ca href=\"https://www.statnews.com/2018/04/30/crispr-patent-appeal-hearing/\" target=\"_blank\" rel=\"noopener\">story\u003c/a> was originally published by STAT, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery. \u003c/em>\u003c/p>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/futureofyou/441220/the-take-from-courtside-uc-berkeley-probably-not-going-to-win-crispr-patent-dispute","authors":["byline_futureofyou_441220"],"categories":["futureofyou_1","futureofyou_73","futureofyou_1064"],"tags":["futureofyou_91","futureofyou_94","futureofyou_80","futureofyou_89"],"featImg":"futureofyou_441233","label":"source_futureofyou_441220"},"futureofyou_439177":{"type":"posts","id":"futureofyou_439177","meta":{"index":"posts_1591205157","site":"futureofyou","id":"439177","score":null,"sort":[1517865433000]},"guestAuthors":[],"slug":"new-crispr-method-targeting-blindness-in-mice-could-one-day-treat-hundreds-of-diseases","title":"New CRISPR Method Targeting Blindness In Mice Could Treat Hundreds Of Inherited Diseases","publishDate":1517865433,"format":"standard","headTitle":"KQED Future of You | KQED Science","labelTerm":{"term":1094,"site":"futureofyou"},"content":"\u003cp>It might seem that scientists have never met a chunk of DNA they couldn’t edit in mice or isolated cells using\u003c/p>\n\u003cp>CRISPR\u003cstrong> —\u003c/strong> from mutations causing \u003ca href=\"https://www.nature.com/articles/nature25164\" target=\"_blank\" rel=\"noopener\">deafness\u003c/a> to those for \u003ca href=\"http://advances.sciencemag.org/content/4/1/eaap9004\" target=\"_blank\" rel=\"noopener\">Duchenne muscular dystrophy.\u003c/a> In fact, they are learning what every pencil- or Word-wielding editor knows: It’s much easier to improve something that’s in terrible shape than writing that’s near perfect.\u003c/p>\n\u003cp>In genome-editing, the challenge for CRISPR-wielding scientists is to edit only one of the two copies, or alleles, of every gene that people have, repairing the ever-so-slightly broken one and leaving the healthy one alone.\u003c/p>\n\u003cp>Now, in one of the first research papers scheduled for publication in the first journal dedicated to research on CRISPR, scientists in Boston \u003ca href=\"https://www.biorxiv.org/content/early/2018/01/29/197962\" target=\"_blank\" rel=\"noopener\">report\u003c/a> “allele specific” editing of a gene that, when mutated, destroys the eye’s photoreceptors and causes the form of blindness called retinitis pigmentosa.\u003c/p>\n\u003cp>[contextly_sidebar id=\"4VdUEhIyuniYpIiGF8VW99wqTQ1JaiBO\"]The achievement might one day help people with retinitis pigmentosa, which affects about 100,000 people in the U.S. But its greater significance is as a proof-of-concept. The hope is that the same trick might work in the hundreds of diseases, including Huntington’s disease and Marfan syndrome, where inheriting a single mutated gene (from mom \u003cem>or\u003c/em> dad) is enough to cause problems despite the presence of a healthy copy, too.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>“You want to target only the mutant allele without messing up the healthy one,” said Linzhao Cheng, of Johns Hopkins University School of Medicine, who is \u003ca href=\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4351458/\" target=\"_blank\" rel=\"noopener\">developing\u003c/a> allele-specific techniques for blood disorders. “But the alleles might differ in only one nucleotide,” one of the molecular “letters” that spell out the genetic code. “That makes allele-specific editing probably the most challenging situation for CRISPR.”\u003c/p>\n\u003cp>The Boston scientists, led by Dr. Qin Liu of the Ocular Genomics Institute at Massachusetts Eye & Ear Infirmary, aimed to remove the misspelled copy of the gene for rhodopsin, which makes up the rods (of rods and cones fame) in the eye. The misspelling consisted of a single wrong nucleotide. That seemingly minor glitch, called P23H, is enough to produce a rogue rhodopsin that is toxic to the healthy rhodopsins produced by the healthy copy.\u003c/p>\n\u003cp>“It just kills the photoreceptors,” said Dr. Stephen Rose, chief research officer at the Foundation Fighting Blindness, which helped fund Liu’s research. “But what if you could repair that one mutation and turn it back to the normal form? That’s the holy grail, to wave a magic wand and change a single wrong nucleotide to the right one.”\u003c/p>\n\u003caside class=\"pullquote alignright\">“You want to target only the mutant allele without messing up the healthy one.”\u003ccite>Linzhao Cheng, Johns Hopkins University.\u003c/cite>\u003c/aside>\n\u003cp>That’s what Liu and her colleagues report doing in the paper to be published in\u003cstrong> \u003c/strong>\u003ca href=\"http://online.liebertpub.com/toc/crispr/0/0\" target=\"_blank\" rel=\"noopener\">The CRISPR Journal\u003c/a>, whose first issue is due this month. They built standard CRISPR molecules: a target-finding molecule called a guide RNA and a snip-the-nucleotide enzyme, in this case a version of Cas9. They injected their CRISPR molecules under the retinas of days-old mice bred to have one good rhodopsin gene and one mutated copy.\u003c/p>\n\u003cp>The editing flopped. The target-finding molecule couldn’t tell the healthy gene from the one-letter-off copy.\u003c/p>\n\u003cp>Back at the drawing board, the scientists, who included Editas Medicine co-founder J. Keith Joung of Massachusetts General Hospital, created target-finding molecules that looked for shorter regions of DNA, hoping to avoid editing the healthy gene. That produced better results: Cas9 edited only the mutant allele. But it did so in very few of the cells. As long as there is a lot of mutant rhodopsin compared to healthy rhodopsin, the mutant proteins will kill the eyes’ rods.\u003c/p>\n\u003cp>The third time was the charm.\u003c/p>\n\u003cp>In addition to using the short target-finding molecules, the scientists also tweaked Cas9 so it made a beeline for tiny DNA mile markers (called PAMs). The mile markers nearest the disease-causing allele are, luckily, different from those near the healthy one. Including the go-to-PAM instruction in their CRISPR produced accurate editing and a lot of it: There were nearly three times as many healthy rhodopsin molecules as mutant ones, compared to similar numbers of healthy and mutant rhodopsin in cells that had not been CRISPR’d. That translated into healthier eyes, with treated mice having five or six rows of photoreceptors compared with three or four in untreated mice. (The mice were not tested for eyesight, however.)\u003c/p>\n\u003cp>[contextly_sidebar id=\"sdpN9QvSR4CNAVKzz3djOr9Ogv4R5axT\"]As always with CRISPR, there is a danger of editing unintended regions of DNA. The scientists checked potential “off target” sites; nine were fine, and one was inadvertently edited in 3 percent of treated cells, though with no apparent ill effects.\u003c/p>\n\u003cp>“It’s nice work,” said biologist Tara Moore of Ulster University, who is \u003ca href=\"https://www.nature.com/articles/s41598-017-16279-4\" target=\"_blank\" rel=\"noopener\">developing\u003c/a> allele-specific CRISPR editing for eye diseases. Exploiting DNA’s tiny mile markers, the PAMs, offers the best shot at allele-specific editing, she said: “Otherwise it’s “a challenge,” and the chance of hitting the disease-causing DNA but sparing the healthy copy “is low.”\u003c/p>\n\u003cp>The mouse study raises hopes that allele-specific editing might work not only for the mutation in retinitis pigmentosa but also “for most, if not all, human dominant alleles,” the scientists wrote.\u003c/p>\n\u003cp>Liu said she was not permitted to speak to reporters about the paper until The CRISPR Journal published it. The study was also funded by the National Institutes of Health and Mass. General.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>\u003cem>This \u003ca href=\"https://www.statnews.com/2018/02/02/crispr-blindness-retinitis-pigmentosa/\" target=\"_blank\" rel=\"noopener\">story\u003c/a> was originally published by STAT, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery.\u003c/em>\u003c/p>\n\n","blocks":[],"excerpt":"Scientists say new CRISPR method could one day treat other diseases involving a single mutated allele.","status":"publish","parent":0,"modified":1517935014,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":20,"wordCount":1004},"headData":{"title":"New CRISPR Method Targeting Blindness In Mice Could Treat Hundreds Of Inherited Diseases | KQED","description":"Scientists say new CRISPR method could one day treat other diseases involving a single mutated allele.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"New CRISPR Method Targeting Blindness In Mice Could Treat Hundreds Of Inherited Diseases","datePublished":"2018-02-05T21:17:13.000Z","dateModified":"2018-02-06T16:36:54.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"disqusIdentifier":"439177 https://ww2.kqed.org/futureofyou/?p=439177","disqusUrl":"https://ww2.kqed.org/futureofyou/2018/02/05/new-crispr-method-targeting-blindness-in-mice-could-one-day-treat-hundreds-of-diseases/","disqusTitle":"New CRISPR Method Targeting Blindness In Mice Could Treat Hundreds Of Inherited Diseases","nprByline":"Sharon Begley\u003c/BR>\u003cstrong>\u003ca href=\"https://www.statnews.com/\">STAT\u003c/a>\u003c/strong>","path":"/futureofyou/439177/new-crispr-method-targeting-blindness-in-mice-could-one-day-treat-hundreds-of-diseases","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>It might seem that scientists have never met a chunk of DNA they couldn’t edit in mice or isolated cells using\u003c/p>\n\u003cp>CRISPR\u003cstrong> —\u003c/strong> from mutations causing \u003ca href=\"https://www.nature.com/articles/nature25164\" target=\"_blank\" rel=\"noopener\">deafness\u003c/a> to those for \u003ca href=\"http://advances.sciencemag.org/content/4/1/eaap9004\" target=\"_blank\" rel=\"noopener\">Duchenne muscular dystrophy.\u003c/a> In fact, they are learning what every pencil- or Word-wielding editor knows: It’s much easier to improve something that’s in terrible shape than writing that’s near perfect.\u003c/p>\n\u003cp>In genome-editing, the challenge for CRISPR-wielding scientists is to edit only one of the two copies, or alleles, of every gene that people have, repairing the ever-so-slightly broken one and leaving the healthy one alone.\u003c/p>\n\u003cp>Now, in one of the first research papers scheduled for publication in the first journal dedicated to research on CRISPR, scientists in Boston \u003ca href=\"https://www.biorxiv.org/content/early/2018/01/29/197962\" target=\"_blank\" rel=\"noopener\">report\u003c/a> “allele specific” editing of a gene that, when mutated, destroys the eye’s photoreceptors and causes the form of blindness called retinitis pigmentosa.\u003c/p>\n\u003cp>\u003c/p>\u003cp>\u003c/p>\u003cp>The achievement might one day help people with retinitis pigmentosa, which affects about 100,000 people in the U.S. But its greater significance is as a proof-of-concept. The hope is that the same trick might work in the hundreds of diseases, including Huntington’s disease and Marfan syndrome, where inheriting a single mutated gene (from mom \u003cem>or\u003c/em> dad) is enough to cause problems despite the presence of a healthy copy, too.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>“You want to target only the mutant allele without messing up the healthy one,” said Linzhao Cheng, of Johns Hopkins University School of Medicine, who is \u003ca href=\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4351458/\" target=\"_blank\" rel=\"noopener\">developing\u003c/a> allele-specific techniques for blood disorders. “But the alleles might differ in only one nucleotide,” one of the molecular “letters” that spell out the genetic code. “That makes allele-specific editing probably the most challenging situation for CRISPR.”\u003c/p>\n\u003cp>The Boston scientists, led by Dr. Qin Liu of the Ocular Genomics Institute at Massachusetts Eye & Ear Infirmary, aimed to remove the misspelled copy of the gene for rhodopsin, which makes up the rods (of rods and cones fame) in the eye. The misspelling consisted of a single wrong nucleotide. That seemingly minor glitch, called P23H, is enough to produce a rogue rhodopsin that is toxic to the healthy rhodopsins produced by the healthy copy.\u003c/p>\n\u003cp>“It just kills the photoreceptors,” said Dr. Stephen Rose, chief research officer at the Foundation Fighting Blindness, which helped fund Liu’s research. “But what if you could repair that one mutation and turn it back to the normal form? That’s the holy grail, to wave a magic wand and change a single wrong nucleotide to the right one.”\u003c/p>\n\u003caside class=\"pullquote alignright\">“You want to target only the mutant allele without messing up the healthy one.”\u003ccite>Linzhao Cheng, Johns Hopkins University.\u003c/cite>\u003c/aside>\n\u003cp>That’s what Liu and her colleagues report doing in the paper to be published in\u003cstrong> \u003c/strong>\u003ca href=\"http://online.liebertpub.com/toc/crispr/0/0\" target=\"_blank\" rel=\"noopener\">The CRISPR Journal\u003c/a>, whose first issue is due this month. They built standard CRISPR molecules: a target-finding molecule called a guide RNA and a snip-the-nucleotide enzyme, in this case a version of Cas9. They injected their CRISPR molecules under the retinas of days-old mice bred to have one good rhodopsin gene and one mutated copy.\u003c/p>\n\u003cp>The editing flopped. The target-finding molecule couldn’t tell the healthy gene from the one-letter-off copy.\u003c/p>\n\u003cp>Back at the drawing board, the scientists, who included Editas Medicine co-founder J. Keith Joung of Massachusetts General Hospital, created target-finding molecules that looked for shorter regions of DNA, hoping to avoid editing the healthy gene. That produced better results: Cas9 edited only the mutant allele. But it did so in very few of the cells. As long as there is a lot of mutant rhodopsin compared to healthy rhodopsin, the mutant proteins will kill the eyes’ rods.\u003c/p>\n\u003cp>The third time was the charm.\u003c/p>\n\u003cp>In addition to using the short target-finding molecules, the scientists also tweaked Cas9 so it made a beeline for tiny DNA mile markers (called PAMs). The mile markers nearest the disease-causing allele are, luckily, different from those near the healthy one. Including the go-to-PAM instruction in their CRISPR produced accurate editing and a lot of it: There were nearly three times as many healthy rhodopsin molecules as mutant ones, compared to similar numbers of healthy and mutant rhodopsin in cells that had not been CRISPR’d. That translated into healthier eyes, with treated mice having five or six rows of photoreceptors compared with three or four in untreated mice. (The mice were not tested for eyesight, however.)\u003c/p>\n\u003cp>\u003c/p>\u003cp>\u003c/p>\u003cp>As always with CRISPR, there is a danger of editing unintended regions of DNA. The scientists checked potential “off target” sites; nine were fine, and one was inadvertently edited in 3 percent of treated cells, though with no apparent ill effects.\u003c/p>\n\u003cp>“It’s nice work,” said biologist Tara Moore of Ulster University, who is \u003ca href=\"https://www.nature.com/articles/s41598-017-16279-4\" target=\"_blank\" rel=\"noopener\">developing\u003c/a> allele-specific CRISPR editing for eye diseases. Exploiting DNA’s tiny mile markers, the PAMs, offers the best shot at allele-specific editing, she said: “Otherwise it’s “a challenge,” and the chance of hitting the disease-causing DNA but sparing the healthy copy “is low.”\u003c/p>\n\u003cp>The mouse study raises hopes that allele-specific editing might work not only for the mutation in retinitis pigmentosa but also “for most, if not all, human dominant alleles,” the scientists wrote.\u003c/p>\n\u003cp>Liu said she was not permitted to speak to reporters about the paper until The CRISPR Journal published it. The study was also funded by the National Institutes of Health and Mass. General.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>\u003cem>This \u003ca href=\"https://www.statnews.com/2018/02/02/crispr-blindness-retinitis-pigmentosa/\" target=\"_blank\" rel=\"noopener\">story\u003c/a> was originally published by STAT, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery.\u003c/em>\u003c/p>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/futureofyou/439177/new-crispr-method-targeting-blindness-in-mice-could-one-day-treat-hundreds-of-diseases","authors":["byline_futureofyou_439177"],"categories":["futureofyou_1"],"tags":["futureofyou_94","futureofyou_17","futureofyou_61","futureofyou_23","futureofyou_271"],"collections":["futureofyou_1094"],"featImg":"futureofyou_439182","label":"futureofyou_1094"},"futureofyou_437942":{"type":"posts","id":"futureofyou_437942","meta":{"index":"posts_1591205157","site":"futureofyou","id":"437942","score":null,"sort":[1513974354000]},"guestAuthors":[],"slug":"trying-to-slow-lou-gehrigs-disease-with-crispr-cas9","title":"Trying to Slow Lou Gehrig's Disease With CRISPR-Cas9","publishDate":1513974354,"format":"standard","headTitle":"KQED Future of You | KQED Science","labelTerm":{"site":"futureofyou"},"content":"\u003cp>Researchers have taken the first step toward a possible cure for \u003cspan class=\"example\">Lou Gehrig's disease \u003c/span>based on gene editing. The study, though limited in scope, provides a possible way forward to address some genetically driven cases of the disease.\u003c/p>\n\u003cp>[contextly_sidebar id=\"Zj5jMJb0LrYIQhKiETUb8gCvIGVfUWhp\"]An estimated 20,000 Americans live with the disease, which is also called amyotrophic lateral sclerosis, or ALS. The condition causes muscles to waste away and is fatal. Eventually sufferers lose use of muscles essential for breathing. Two drugs have been approved by U.S. health officials, but they are minimally effective, increasing survival by \u003ca href=\"https://link.springer.com/article/10.1007/s00415-003-1026-z\" target=\"_blank\" rel=\"noopener\">only a few months\u003c/a>.\u003c/p>\n\u003cp>The researchers, at UC Berkeley, the University of Illinois and the University of Pittsburgh, are working on a new approach: altering a mutated gene that contributes to some cases of the disease. In mice, the technique increased average life span by about 25 percent and delayed onset of the disease by nearly 40 percent. The \u003ca href=\"http://advances.sciencemag.org/content/3/12/eaar3952\" target=\"_blank\" rel=\"noopener\">study\u003c/a> is published the Dec. 20 issue of\u003cem> Science Advances\u003c/em>.\u003c/p>\n\u003cp>\"If this were to translate to humans it would be clinically very meaningful for patients,\" says co-author David Schaffer, of UC Berkeley.\u003c/p>\n\u003cp>[contextly_sidebar id=\"gi0jm5XjbAQNm096mmQndorYwApHqftD\"]The mice used in the study were genetically engineered to express a mutated human gene, known as SOD1, that causes 1 in 5 inherited cases of ALS. To disable the mutation, the researchers engineered a virus carrying a pair of molecular scissors in the form of a Cas9 protein, designed to knock out the SOD1 gene. The scientists targeted the neurons in the spinal cord, which the SOD1 mutation cause to prematurely die.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>Schaffer and others are now at work optimizing the technique for humans.\u003c/p>\n\n","blocks":[],"excerpt":"Researchers at UC Berkeley have taken the first step toward a possible cure for Lou Gehrig's disease based on gene editing. ","status":"publish","parent":0,"modified":1513976057,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":8,"wordCount":282},"headData":{"title":"Trying to Slow Lou Gehrig's Disease With CRISPR-Cas9 | KQED","description":"Researchers at UC Berkeley have taken the first step toward a possible cure for Lou Gehrig's disease based on gene editing. ","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"Trying to Slow Lou Gehrig's Disease With CRISPR-Cas9","datePublished":"2017-12-22T20:25:54.000Z","dateModified":"2017-12-22T20:54:17.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"disqusIdentifier":"437942 https://ww2.kqed.org/futureofyou/?p=437942","disqusUrl":"https://ww2.kqed.org/futureofyou/2017/12/22/trying-to-slow-lou-gehrigs-disease-with-crispr-cas9/","disqusTitle":"Trying to Slow Lou Gehrig's Disease With CRISPR-Cas9","path":"/futureofyou/437942/trying-to-slow-lou-gehrigs-disease-with-crispr-cas9","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>Researchers have taken the first step toward a possible cure for \u003cspan class=\"example\">Lou Gehrig's disease \u003c/span>based on gene editing. The study, though limited in scope, provides a possible way forward to address some genetically driven cases of the disease.\u003c/p>\n\u003cp>\u003c/p>\u003cp>\u003c/p>\u003cp>An estimated 20,000 Americans live with the disease, which is also called amyotrophic lateral sclerosis, or ALS. The condition causes muscles to waste away and is fatal. Eventually sufferers lose use of muscles essential for breathing. Two drugs have been approved by U.S. health officials, but they are minimally effective, increasing survival by \u003ca href=\"https://link.springer.com/article/10.1007/s00415-003-1026-z\" target=\"_blank\" rel=\"noopener\">only a few months\u003c/a>.\u003c/p>\n\u003cp>The researchers, at UC Berkeley, the University of Illinois and the University of Pittsburgh, are working on a new approach: altering a mutated gene that contributes to some cases of the disease. In mice, the technique increased average life span by about 25 percent and delayed onset of the disease by nearly 40 percent. The \u003ca href=\"http://advances.sciencemag.org/content/3/12/eaar3952\" target=\"_blank\" rel=\"noopener\">study\u003c/a> is published the Dec. 20 issue of\u003cem> Science Advances\u003c/em>.\u003c/p>\n\u003cp>\"If this were to translate to humans it would be clinically very meaningful for patients,\" says co-author David Schaffer, of UC Berkeley.\u003c/p>\n\u003cp>\u003c/p>\u003cp>\u003c/p>\u003cp>The mice used in the study were genetically engineered to express a mutated human gene, known as SOD1, that causes 1 in 5 inherited cases of ALS. To disable the mutation, the researchers engineered a virus carrying a pair of molecular scissors in the form of a Cas9 protein, designed to knock out the SOD1 gene. The scientists targeted the neurons in the spinal cord, which the SOD1 mutation cause to prematurely die.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>Schaffer and others are now at work optimizing the technique for humans.\u003c/p>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/futureofyou/437942/trying-to-slow-lou-gehrigs-disease-with-crispr-cas9","authors":["11088"],"categories":["futureofyou_1","futureofyou_1064"],"tags":["futureofyou_983","futureofyou_94","futureofyou_295"],"featImg":"futureofyou_437949","label":"futureofyou"}},"programsReducer":{"possible":{"id":"possible","title":"Possible","info":"Possible is hosted by entrepreneur Reid Hoffman and writer Aria Finger. 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