Those concerns have guided the strategy of Wilson’s new company, Passage Bio, which is focused on rare genetic neurological conditions. The caption on the photo of the Regenxbio IPO was updated on Sept. 13, 2019, because it incorrectly stated the date of the IPO as Sept. 15, 2015. It’s part of a Theodore Roosevelt speech from 1910 known as “The Man in the Arena”: “It is not the critic who counts; not the man who points out how the strong man stumbles, or where the doer of deeds could have done them better. “Oh my God, you got to be kidding me,” Wilson recalls thinking. But one thing is clear. https://cen.acs.org/.../Gene-therapy-pioneer-James-Wilson/97/web/2019/02 Description of Research Dr. Wilson is an innovator and pioneer in the field of gene therapy. The company was founded by industry veterans Stephen Squinto, Ph.D., and Tachi Yamada, M.D., in a partnership with gene therapy pioneer James Wilson, M.D., Ph.D. And in April 2018, the Swiss drug giant Novartis agreed to pay $8.7 billion for a company called AveXis, the Nationwide Children’s Hospital spin-off working to commercialize the spinal muscular atrophy therapy, now known as Zolgensma. Title: The redemption of James Wilson, gene therapy pioneer. The first was the decision to permit James Wilson to conduct gene therapy experiments at Penn while maintaining a majority interest in Genovo, a biotech company that stood to make millions if the … “When you are a scientist working here, you feel like nothing is impossible,” she says. “I was cheap labor,” he quips. “Jim is at the point in his career where he is not going to take too many chances anymore,” Squinto says. Wilson admits that scientists still don’t totally understand why AAV becomes toxic at a certain dose, but it is clear that without more effective gene-delivery vessels, high doses may be the only way to correct enough cells for some conditions, particularly muscle diseases. “I actually thought, believe it or not, that by the time I finished my internship that the problem would be solved,” he says. That changed soon after their hike. The goal was to deliver a working copy of the teenager’s broken gene, but the viruses threw his immune system into overdrive. Chemical & Engineering News will not share your email address with any other person or company. Jesse Gelsinger (June 18, 1981 – September 17, 1999) was the first person publicly identified as having died in a clinical trial for gene therapy.Gelsinger suffered from ornithine transcarbamylase deficiency, an X-linked genetic disease of the liver, the symptoms of which include an inability to metabolize ammonia – a byproduct of protein breakdown. He later assumed a lead role at his father’s company Scout Bio, which is developing gene therapies for cats and dogs. (optional). “You need to find out what caused the problem,” Yamada advised. “Why couldn’t I be watching Snow White or something right now?”. By submitting your information, you are gaining access to C&EN and subscribing to our weekly newsletter. A developer of gene therapies for rare monogenic CNS diseases—whose co-founders include pioneer researcher James M. Wilson, MD, PhD—has launched with $115.5 million in Series A financing. Passage Bio employees have … Over the next few months, the duo negotiated an intimate arrangement: they would form a new company, and Wilson’s lab at Penn would function as its R&D arm. Over dinner at a Mexican restaurant in 2011, his dad, James, was talking about a hemophilia gene therapy. Jesse’s story is the subject of textbook chapters on bioethics and a case study in law journals. Wilson spoke about the medical breakthroughs he expects to … Despite that—or perhaps because of it—Wilson’s downsized and outcast lab kept plugging away with a newfound focus on finding safer viruses. “Should we morph to support the industry as it tries to get back on its feet?” Wilson recalls asking his group. Search PubMed for articles. Business news and analysis sent straight to your inbox every Tuesday morning. But a few weeks later, the child’s liver enzyme levels skyrocketed. According to his father, Jesse said the worst-case scenario was that he would die “and maybe help doctors figure out a way to save sick babies.”. Wilson directs the Gene Therapy Program and the Orphan Disease Center, which together staff an army of more than 200 people spread across multiple floors of multiple buildings at the University of … “Jim has been very worried about these high doses,” Mendell says. After Jesse’s death, the connection fostered allegations that Wilson had acted recklessly for profit. “Now there is an academic group trying to compete with that, and frankly, service them.” In his estimation, Wilson’s lab has largely become an “IND warehouse.”. The company also plans on injecting AAVs directly into the cerebrospinal fluid, which should require smaller doses than the systemic injections used in Zolgensma. Their work led to the discovery and dissemination of new AAVs, including one used in the recently approved gene therapy Zolgensma, which saves the lives of infants born with an otherwise fatal neurological disease. “I was concerned that I would not be allowed to do it.”. When the results held up, Wilson called the team together on a Saturday in spring 2002 to review the results. Wilson isn’t alone in his close ties to biotech. Eleven of those firms have obtained licenses from Regenxbio, a firm that Wilson cofounded in 2009 to commercialize his technology. “We are not going to be a passive participant in the process of translating the potential of our science into goods, products, services,” says John Swartley, director of the Penn Center for Innovation. “The community got a black eye and the funding dried up because Wall Street couldn’t distinguish between adenovirus and adeno-associated virus,” says Richard Jude Samulski, director of the University of North Carolina’s Gene Therapy Center. Key words: adeno-associated virus (AAV), gene therapy, gene transfer, gene editing, gene delivery, route of administration. Things go wrong,” Ultragenyx’s Kakkis says. “He’s an ambitious guy,” Gelsinger says. Videos of the event showed Wilson clapping alongside Mills—the CEO of Regenxbio—who rang the opening bell amid falling confetti. Multiple rooms had been converted into small manufacturing suites that churn out AAVs—the adeno-associated viruses that act as molecular mail trucks for delivering therapeutic genes into cells. Both Dr. Wilson and I have been working in the gene therapy field for over 30 years, and this deep understanding will be instrumental as we grow and advance this new world-class gene therapy company… I am afraid, seriously, that the field is moving too fast. In the course of the afternoon, the team began realizing that they had stumbled upon a new, highly diverse family of AAVs—more than 100 of them. But many virologists thought studying them was a waste of time since they weren’t associated with any diseases. Gene Therapy Pioneer James Wilson leading studies of adeno-associated viral vectors to potentially prevent COVID-19. Related: Crowds swarm gene-therapy conference as excitement hits an all-time high. “It’s all here,” he told Wilson. One iteration of the therapy even killed monkeys at high doses, so Wilson asked one of his researchers, Guangping Gao, to develop a crippled adenovirus—one that delivered genes but didn’t trigger the immune system’s T cells to attack the liver. In 2013, several programs from his lab—including one for Jesse Gelsinger’s disease, OTC deficiency—formed the basis of a Regenxbio spin-off called Dimension Therapeutics. James Wilson, a molecular biologist at the University of Pennsylvania, and his colleagues found that an AAV9 variant (AAVhu68) used to deliver a human gene to spinal cord motor neurons in rhesus monkeys and piglets resulted in severe toxicity affecting the liver and motor neurons. It’s with processes, spending hours in the lab to solidify the building blocks upon which scientific innovation can happen. The group had already dabbled in using AAVs as alternatives to adenoviruses. BREAKING: Everything we know about the COVID-19 coronavirus. That and the other protocol violations put all the participants in danger. It plans on testing three of its gene therapies in humans next year. He remained Wilson’s only graduate student for several years. James M. Wilson has led an effort to develop the field of gene therapy. Philadelphia-based Passage Bio plans to raise as much as $125 million selling stock shares to the public through an initial public offering (IPO), the Philadelphia-based firm told the Securities and Exchange Commission in a public filing Monday. J.M. He has published over 600 papers and is … The lab’s goal is gathering enough data to support investigational new drug (IND) applications—the documentation that must be submitted to the FDA before beginning clinical trials in humans—for its biotech partners. They’d begin by further developing gene therapies for five rare neurological diseases. Although clinical trials fail all the time, and in fact, other people would die during experimental gene therapy trials, Jesse’s death tapped into fears about the risks of genetic alteration. ), according to an SEC … In July 2000, the GSK cash arrived, allowing Wilson’s lab to begin developing a new generation of safer gene therapies in full force. It is typical for modern biology (and perhaps in other fields) research, that bosses take all the credit and people who did the actual work at the bench left aside (how unjust!). He says it has about 80 open positions, including veterinarians, IND application writers, and even an intellectual property scientist. “The whole field was miscast as profiteers, a truly inappropriate demonizing of very important science,” Yamada says. Rose H. Weiss Orphan Disease Center Director's Professor . “We had to pay a Wilson tax on the field.”, Wilson’s old mentor Yamada watched the fallout from the OTC deficiency trial with dismay. Dr. James Wilson, the director of the gene therapy program at the University of Pennsylvania’s medical school. Passage Bio, based on gene therapy technology developed by University of Pennsylvania biotech pioneer James Wilson, says it will use proceeds from the sale to clinically test its initial therapies and bring them closer to market. The $29.4 million that GSK provided Wilson over the next 9 years was a lifeline, but it came with strings attached: the big pharma firm owned the rights to discoveries made with its money. “But my passion is science.”. Gene therapy pioneer James Wilson’s revelation of two new types of toxicity in animals receiving high systemic doses of adeno-associated viral vectors is unlikely to herald a major disruption of the AAV space, though it remains to be seen whether they influenced his decision to resign as SAB chair of Solid Biosciences Inc. I hope that the future text books on genome therapy will correct this injustice and your and others now silent names will be written in! Gene therapy researcher James Wilson, of the University of Pennsylvania in Philadelphia, directed a clinical trial involving gene therapy that led to the death of 18-year-old Jesse Gelsinger in 1999. You could lose a child.’ ” Wilson backed off. They made it to the movie, Resident Evil, in the nick of time. James M. Wilson, MD, PhD. In 2016, Wilson’s lab recruited Juliette Hordeaux, an expert on lysosomal storage disorders, to head up an effort to develop gene therapies for a collection of 60 related rare diseases, each caused by a mutation in a different gene. The firm didn’t want other groups filing patents based on the technology; more importantly, GSK was worried that a sloppy experiment would put patients, and the whole field, in peril. “I was really intent on getting these things in the hands of everyone.” He argued that academics had an obligation to share their source materials and that anyone who wanted to use the AAVs could reverse engineer them anyway. Wilson recently moved his discovery team to a commercial building down the street. After raising additional cash from other investors, Passage Bio officially launched in February with $115.5 million. Later that afternoon, Wilson walked into Gao’s office and drilled him on his methods and interpretations. When Jesse’s body began breaking down within a day of the adenovirus injection, Wilson knew that T cells couldn’t be the culprit, since they take a week or more to mount their attack. I'm no scientist, but it is my understanding that those assays are still a good indicator of immune response. Wilson is an advisor to REGENXBIO, Dimension Therapeutics, and Solid Gene Therapy, and is a founder of, holds equity in, and receives sponsored research support from … The first two they picked, dubbed AAV7 and AAV8, were 10–100 times as good at getting genes into cells as the six previously known viruses. Sign in with a different account. By Penn’s latest count, some 42 companies are using AAVs that fall under Wilson’s patents, covering nearly 100 drug development programs. “Now everyone is happy to work with Jim and gives him a lot of money.”. James M. Wilson, researcher in gene therapy at the University of Pennsylvania. The road to hopeful start-ups such as Passage Bio has included blind alleys and reversals. V. RESURGENCE. His dad read the Ebola virus thriller The Hot Zone aloud to him as a kid. In a career spanning four decades, he has identified, isolated, and developed virus-based vectors for in vivo gene therapy. In late November, Wilson flew to Arizona to meet Paul Gelsinger. The FDA issued a scalding report outlining dozens of mistakes or failures by Wilson’s team to follow protocol and in early 2000 shut down all clinical trials at Penn’s gene therapy center. The FDA can barely keep up with the growing pipeline, and it anticipates receiving more than 200 applications from groups that want to test new cell and gene therapies next year. Vandenberghe wondered if a virus … James M. Wilson is a biomedical researcher with expertise in gene therapy. Wilson directs the Gene Therapy Program and the Orphan Disease Center, which together staff an army of more than 200 people spread across multiple floors of multiple buildings at the University of Pennsylvania. After discussing the gene therapy trial with his doctor at a semiannual checkup in April 1999, he decided to volunteer for Wilson’s study. Renew your membership, and continue to enjoy these benefits. Your account has been created successfully, and a confirmation email is on the way. As more groups began using Wilson’s viruses, it grew clear that they would want commercial licenses to develop bona fide gene therapies. “I think a lot of us sit back at meetings thinking about where the field would be if we hadn’t gone through that episode,” UNC’s Samulski says. “When I first came to Penn, working with a company was bad, evil,” Wilson says. Department: Medicine. “From Jim’s standpoint, it looked pretty easy,” Yamada says. However as a scientist and former colleague of Mauricio Alvira I was stunned that the author and senior scientists failed to acknowledge the individual who actually was in the arena putting in his blood sweat & tears towards creating what are still disseminated worldwide as the best Gene therapy vectors in the field to date. Regenxbio CEO Ken Mills (center) and James Wilson (center left) celebrate the initial public offering of their gene therapy company Regenxbio on Sept. 17, 2015, the 16th anniversary of Jesse Gelsinger's death. REGENXBIO is a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy. His work is being applied to genetic treatments by a start-up company, Passage Bio, which has applied for an initial public stock offering (IPO). Passage Bio raised $225 million since 2018 from private investors including OrbiMed Advisors, Versant Ventures, Frazier Live Sciences, LAV Prescience Limited, New Leaf Ventures, Vivo Capital, Access Industries, Boxer Capital, Highline Capital, Logos Capital and Sphera Global Healthcare. That data woke up investors to gene therapy. Gao and the team spent the next year feverishly trying to understand and test the new AAVs. Sign up for C&EN's must-read weekly newsletter, Squinto was astounded. Wilson never met Jesse. The experimental treatment was created to treat a rare metabolic liver disease. Wilson says he thought a lot about whether continuing to work on the disease would create conflicts or distractions from the goal of curing patients. The significance of my contribution explains why I'm listed as a co-inventor in all the patents related to that work even though I never finished my PhD and why I personally analyzed and deposited all of the initial sequences into Genbank. Other companies that use technology developed by Wilson include Maryland-based Regenxbio, which is developing gene therapy delivery systems for patients, and Philadelphia-based Scout Bio, which is working on ways to deliver gene therapies for pets. Dr. Wilson stepped down as head of the Institute for Human Gene Therapy effective July 1, 2002. Wilson’s son Matt recalls the moment when gene therapy … Again, GSK wouldn’t budge. Jesse was in and out of the hospital over the holidays, seizing, vomiting, and not getting any better. Pfizer, Moderna ready vaccine manufacturing networks, These new textile dyeing methods could make fashion more sustainable, Almost extinct in the US, powdered laundry detergents thrive elsewhere in the world, C&EN’s Global Top 50 chemical companies of 2018, anticipates receiving more than 200 applications, Astellas to acquire gene therapy firm Audentes for $3 billion, FDA approves second gene therapy, Zolgensma, to treat spinal muscular atrophy in infants, Crowds swarm gene-therapy conference as excitement hits an all-time high. Graduate Group Affiliations Cell and Molecular Biology; Contact information. Jim Wilson was only endangering his career, not his life. “And you know what happens to high-profile golden boys. ACS values your privacy. Jesse Gelsinger (June 18, 1981 – September 17, 1999) was the first person publicly identified as having died in a clinical trial for gene therapy.Gelsinger suffered from ornithine transcarbamylase deficiency, … Passage Bio is a genetic medicines company based in Philadelphia, PA that is developing a deep pipeline of adeno-associated virus (AAV) delivered therapeutics for the treatment of rare monogenic central … At the restaurant, his father was explaining the stunning results of a clinical trial underway at UCL that used AAV8. That same year, a bright student named Luk Vandenberghe joined Wilson’s lab—although other scientists warned him against it. Dr. Wilson was a Co-Investigator on the OTC NIH … On June 4, 2019, the Penn Center for Innovation, the university’s technology transfer office, hosted an event showcasing Penn start-ups and highlighting some of the university’s greatest successes. “This is really going to lead to a simplification of the drug development process,” Wilson says. Earlier this year, James Wilson, a gene therapy pioneer, got a call from Luk Vandenberghe, who had been a graduate student in Wilson’s lab two decades ago. Moving Forward After Two Deaths in a Gene Therapy Trial of Myotubular Myopathy Hum Gene Ther. Also appreciated the candor and cautionary note issued by Dr. Gao about the dangers of rushing towards clinical trials in what can be regarded as Gene therapy's equivalent of the financial market's period of "Irrational exuberance" in the 1990s. I was a member of that committee, which recommended minor tinkering. Money, hard to raise not long ago, is flooding into academic labs and companies developing gene therapies. The university later paid a half-million-dollar fine, and a private settlement to the patient’s family. A virus that Gao discovered in 2003 called AAV9 seemed even better. Science is not a solitary effort - gains and advances are made through the efforts of countless unnamed and unrecognized scientists at various levels on the career ladder whose dedication to their craft, profession, lab and patients needs to be highlighted as well as the individuals at the top. The editorial, published in Human Gene Therapy, is co-authored by James M. Wilson, MD, Ph.D., director of the Gene Therapy Program at the University of Pennsylvania and former Editor Human Gene … The approval of the first two gene therapies in the US and promising clinical data on many more have supercharged the field. And of all the field’s pioneers, 64-year-old Wilson may feel that tension more strongly than anyone. 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