Jeb Keiper

LucidQuest Strategic Insights (lqventures.com) >>> Gene&Cell Therapy >> At Third Arc Bio, former J&J leaders raise $165M to test oncology, autoimmune biologics: After more than a decade steering Johnson & Johnson’s oncology drug R&D, Peter Lebowitz is ready for his next challenge: shepherding the “third arc” of biologics development. “The first one was single targets for the antibody and binding to a cytokine or cell surface receptor. The second one was engineering those antibodies a little differently, either modifying the Fc, putting on a toxin, putting on a radioconjugate,” Lebowitz said in an interview with Endpoints News. “The third is multispecific antibodies that actually bind to different cell types and bring in new biology.” In that vein, Lebowitz is now running a new biologics startup named Third Arc Bio founded by another former J&J leader: Sanjaya Singh. The company raised a $165 million Series A that will be used to move three experimental multispecific antibodies for solid tumors and inflammatory and immunology (I&I) diseases into the clinic. The unveiling was announced the same morning as the launch of another biologics-focused oncology and immunology biotech. Earlier on Tuesday, Flagship Pioneering took the wraps off a $50 million commitment to its Abiologics offshoot. Founded in 2022, Third Arc Bio is working on multispecific antibodies for solid tumors, inflammatory bowel disease, rheumatoid arthritis, lupus and so-called Th2 diseases, which entail a broad scope of inflammatory conditions, according to Lebowitz. “At J&J, I saw all the platforms. We had them all. I specifically wanted to work on [multispecific antibodies] because this is the area where there is the largest opportunity to meet unmet need,” Lebowitz said. “There’s a lot of interest in ADCs now, and ADCs are very important. But this is the area that is right in the right spot of the breaking point where it goes over the edge and actually is transformational for solid tumors.” He “retired” from J&J on Jan. 1 and joined Third Arc as CEO on Jan. 2. In his role as head of oncology R&D, Lebowitz solidified the pharma giant’s work in CAR-T cell therapies with partner Legend Biotech and oversaw a series of wins in multiple myeloma, among other areas of oncology. While at J&J, he worked with Third Arc founder and chief scientific officer Singh, in addition to chief operating officer Joe Erhardt. The trio has “collectively delivered 19 new medicines,” Lebowitz said. Debi Watson, another longtime J&J leader, is the startup’s chief business officer. ‘Atypical Series A’ Oncology remains a big area of investment for biotech venture capitalists, and I&I continues to drum up large financings and M&A deals. With a pipeline spanning both areas, Third Arc was able to attract the 58th private biotech megaround of 2024, according to Endpoints’ ongoing tally.… #lucidquest #genetherapy #celltherapy

If you're going to BioTechX US, stop by and visit Gary Schneider, MSPH, ScD, founder of Delve-RW. Find us in the Start-Up Village, Booth S7. We’re particularly interested in your thoughts regarding barriers to efficient RWE study planning, conduct, QC, and dissemination. Also ask us about our Protocol and SAP Reviews. #pharmacoepidemiology #realworlddata #realworldevidence #RWD #RWE

LucidQuest Strategic Insights (lqventures.com) >>> Gene&Cell Therapy >> #ADA24: Fractyl pitches potential of GLP-1 gene therapy, but pushes clinical trials back to 2025: A small biotech company is developing a one-time gene therapy that could turn the pancreas into its own GLP-1 drug factory and eliminate the need for frequent injections of medicines like Ozempic or Wegovy. Fractyl Health previously showed that an injection of its treatment, delivered in viral vectors injected directly into the liver, caused obese mice to lose nearly 25% of their body weight in just two weeks. At a scientific conference on Sunday, the company said that mice who got a GLP-1 drug for four weeks maintained their 22% weight loss four weeks later when they switched to the gene therapy. The updated data were presented at the American Diabetes Association’s scientific sessions in Florida. In an interview with Endpoints News ahead of the conference, Fractyl CEO Harith Rajagopalan said that the yo-yo-ing weight loss and gain seen in people who go on and off GLP-1 drugs emphasizes the need for one-and-done alternatives. “The question is shifting from how do you lose weight to how do you keep it off,” Rajagopalan said. “If the effects wear off, you are talking about limited benefit for society. But if you can make those effects permanent, you can imagine what a post-obesity society looks like.” Last year at the diabetes conference, Fractyl announced plans to begin testing its gene therapy in both diabetes and obesity patients in 2024. But that ambitious timeline has slipped — as has the company’s stock, which is down about 70% since its February IPO. Rajagopalan said the company is now planning a clinical trial in patients with diabetes for 2025. The results will inform a future trial testing a slightly different gene therapy design in people with obesity, but Rajagopalan wouldn’t say when that trial might be. Longer-term studies in animals are also underway, he said. While there’s been ongoing interest from drugmakers about how to decrease the frequency of dosing for weight loss drugs and to make their effects last longer, a permanent treatment would likely raise many of its own questions. The drugs have been associated with side effects such as muscle loss, which could become a particular issue as patients age and become more frail, for example. Novo Nordisk recently opened a research center outside of Boston focused on genetic medicines. Its leaders told Endpoints in February that it is working on genetic medicines that could complement its weight loss drugs but haven’t disclosed interest in making a gene therapy version of Wegovy. And Eli Lilly, which is also opening a genetics-focused research hub in Boston, has also remained mum on the prospects for a GLP-1 gene therapy. Rajagopalan says that the company’s endoscopic procedure for shuttling… #lucidquest #genetherapy #celltherapy