Prometheus Biosciences, Inc.

Teva and Sanofi announced positive mid-stage results ahead of schedule for their inflammatory bowel disease candidate as they look to keep pace in an anti-TL1A race with Merck and Roche. The duo’s duvakitug met the primary endpoints in a Phase 2b trial evaluating patients with ulcerative colitis and Crohn’s disease, two forms of IBD, Teva and Sanofi said Tuesday morning. In ulcerative colitis, 36.2% of patients taking a low dose of duvakitug and 47.8% of patients taking a high dose achieved clinical remission, compared to 20.45% of placebo patients at week 14. P-values came in at 0.05 and 0.003 for the low and high doses, respectively. In Crohn’s disease, 26.1% of low-dose duvakitug patients and 47.8% of high-dose patients saw an endoscopic response as measured by a scoring system for Crohn’s severity, compared to 13% on placebo (p-values were 0.058 for the low dose and <0.001 for the high dose). While 0.05 is typically considered the gold standard for assessing statistical significance, a Teva spokesperson said the Phase 2 study had a “one-sided test at a significance of 0.1.” The partners said duvakitug was “generally well-tolerated,” with similar rates of treatment-emergent adverse events occurring in the treatment and placebo arms. Sanofi put down €469 million ($500 million) upfront in a deal to co-develop and co-commercialize duvakitug with Teva in October 2023. The anti-TL1A contest also includes Roche, which put down $7.1 billion upfront in late 2023 to acquire Roivant’s subsidiary Telavant and RVT-3101. Merck is also a rival, following its acquisition of Prometheus Biosciences and its MK-7240 in a deal worth $10.8 billion. The duvakitug topline results came earlier than expected, due to “significant acceleration in patient recruitment,” Sanofi and Teva said back in July. As a result, they skipped an interim analysis which was originally planned for the second half of this year. Now, the partners said they plan to initiate a Phase 3 trial in 2025 in IBD “pending regulatory discussions.” A Teva spokesperson declined to share further specifics on the timing of Phase 3 initiation or the dose that will be taken forward. Each company will share the development costs globally, while Sanofi will lead Phase 3 development. Teva will lead commercialization in Europe, Israel and certain other countries, and Sanofi will take the commercial lead in North America, Japan and other parts of Asia, and the rest of the world. Editor’s Note: A correction has been made to reflect that Teva and Sanofi are studying duvakitug in inflammatory bowel disease, not irritable bowel disease.

Dive Brief:An experimental drug co-developed by Teva and Sanofi met its main objectives in a mid-stage clinical trial in inflammatory bowel disease, showing what the partners claimed to be best-in-class potential.Around half of people with ulcerative colitis who received a high dose of the drug, duvakitug, in a Phase 2 trial had their symptoms resolve after 14 weeks, versus just over 20% of those on placebo. A similar, roughly 48% of Crohns disease patients given a high dose of duvakitug experienced meaningful improvement on a measure of disease severity, compared to 13% of people on placebo, Sanofi and Teva said Tuesday.The companies didnt provide details, which will be presented at a medical meeting next year. Still, they said the drugs effects were consistent across subgroups and rates of treatment-related side effects were similar between both study groups. The partners intend to start late-stage development, pending discussions with regulators.Dive Insight:While the results are from a short Phase 2 trial, Sanofi and Tevas findings suggest duvakitug could be the most potent drug among a handful of closely watched antibody therapies for inflammatory bowel disease, or IBD, wrote Jefferies analyst Peter Welford.These drugs are aimed at a protein called TL1A, which regulates inflammation and fibrosis. Theyve caught the attention of pharmaceutical companies because of their potential to drive hard-to-treat cases of IBD into remission more powerfully and durably than existing treatments.Merck & Co. spent nearly $11 billion on Prometheus Biosciences in April 2023 largely to get a hold of a TL1A blocker that had shown promise in Phase 2 testing for instance. Roche followed with a $7 billion purchase of Televant months later and, earlier this year, AbbVie joined the chase, too.Duvakitug trails Mercks and Roches prospects; Merck has already initiated Phase 3 testing. But Tevas executives have long argued the drug could prove superior and, in Oct. 2023, Sanofi bought in, paying Teva $500 million to collaborate on development. The drug has since become more important to both companies, giving Teva known for its generics a chance at a branded blockbuster medicine, and Sanofi an opportunity to build investor confidence in its pipeline.While cross-trial comparisons can mislead, duvakitugs performance in Phase 2 testing appears strong. Mercks drug led to a placebo-adjusted remission rate of 25% in a Phase 2 trial in ulcerative colitis. Roches therapy was associated with an 18 to 23 percentage-point difference versus placebo in a similar trial, depending on the dose.Duvakitugs roughly 27% delta, and higher rates of disease improvement in Crohns disease, suggest the drugs different design versus its peers could perhaps translate to better efficacy, wrote Jefferies analyst Welford.If the magnitude of effect persists in the Phase 3 program, we believe we will have a differentiated medicine for IBD, said Sanofi R&D chief Houman Ashrafian, in the companies statement.Teva shares surged nearly 20% in early Tuesday trading, while Sanofis climbed by almost 5%.The programs advancement into Phase 3 will trigger a $600 million milestone payment from Sanofi to Teva. '

Co-Founders Nathaniel "Ned" David, PhD, and Norman "Ned" Sharpless, MD, will apply decades of experience to establish a scalable biotech foundry $70 million raised to evaluate, found and operate biotech companies pursuing unmet needs in cancer and disease areas in which cancer biology provides insight Founding investors Mission BioCapital and Mayo Clinic joined by other longtime life science investors SAN FRANCISCO, Nov. 19, 2024 (GLOBE NEWSWIRE) -- Jupiter Bioventures ("Jupiter"), a biotechnology venture foundry that builds bold, science-driven therapeutics companies, today announced the closing of a $70 million initial financing. The syndicate includes co-founding investors Mission BioCapital and Mayo Clinic. New investors include Alexandria Venture Investments, Bioventure Partners, Cedars-Sinai Intellectual Property Company, CU Healthcare Innovation Fund, Eric Ball, Eshelman Ventures, Fox Ventures, The Brent and Julie Callinicos Trust and Vault Fund. Proceeds from this financing will advance eight to ten companies developing therapeutics to treat cancer and other diseases where cancer biology provides insight. Jupiter was founded by two biotech entrepreneurs with decades of experience forming and operating biotech ventures: Nathaniel “Ned” David, PhD, previously co-founded Syrrx (acquired by Takeda), Achaogen, Kythera Biopharmaceuticals (acquired by Allergan) and UNITY Biotechnology. Norman “Ned” Sharpless, MD, was previously Director of both the National Cancer Institute and UNC’s Lineberger Comprehensive Cancer Center, Acting Commissioner of the US Food and Drug Administration, is currently a Member of the National Academy of Medicine and was a co-founder of G1 Therapeutics (acquired by Pharmacosmos). Between them, Drs. Sharpless and David’s previous companies have generated five approved medicines, four IPOs and three corporate acquisitions. Jupiter is built on the premise that a “science first” model can return higher multiples on invested capital than conventional venture funds. Jupiter starts by evaluating potential projects—dubbed “Moons”—using a set of business and scientific criteria. Jupiter then deploys a team and small amounts of seed capital to secure intellectual property and experimentally validate the core idea. The most promising Moons receive additional investment from both Jupiter and non-Jupiter investors to become freestanding, high-value biotech companies with sufficient capital to demonstrate proof-of-concept in humans. “We love bold science, but we hate risk,” said Jupiter co-founder Dr. Ned David. “By experimentally confirming the science first, we kill bad projects early, so we can focus on the winners.” “Ned and I have been building companies and medicines for decades,” said Jupiter co-founder Dr. Ned Sharpless. “We built Jupiter to identify the next set of world-changing ideas and efficiently remove the risks that stand in their way. It is our mission to build companies that improve patient lives.” “Mayo Clinic is committed to producing meaningful, effective change that transforms health and medicine. Clinical excellence requires continual discovery, translation and innovation. We’re eager to see what innovations show promise through this unique biotech model,” said Vijay Shah, MD, Kinney Executive Dean for Research at Mayo Clinic. “Ned and Ned are among the most talented drug hunters and entrepreneurs we’ve worked with. We’re thrilled to work with Jupiter in scaling their approach to build transformational therapeutics companies,” said Zach Collins, PhD, Partner at Mission BioCapital. Coincident with the financing, Jupiter announced that Fred Eshelman, the founder of Eshelman Ventures LLC, an investment company primarily interested in private healthcare companies, will join the Board of Directors. Dr. Eshelman is a successful life science entrepreneur who founded and served as CEO and Executive Chairman of Pharmaceutical Product Development before the sale of the company to private equity interests. He also brings significant board experience as Founding Chairman and largest shareholder of Furiex Pharmaceuticals, Chairman of The Medicines Company and board member of Valeant Pharmaceuticals. “Jupiter’s approach to biotechnology company formation is a truly disruptive innovation, and I’m excited to be part of it,” said Dr. Eshelman. “It will be a pleasure to work collaboratively with Ned David, Ned Sharpless and my fellow directors to execute a science-first strategy to bring groundbreaking therapeutic breakthroughs to patients.” “Jupiter’s strategic mission aligns with Cedars-Sinai’s approach to technology, commercialization and research to improve patient outcomes and advance healthcare solutions,” said James Laur, JD, Chief Executive, Intellectual Property & Health Ventures at Cedars-Sinai. Nirdesh K. Gupta, PhD, managing partner of the Cedars-Sinai Intellectual Property Company, will join the Board of Directors at Jupiter. Dr. Gupta has overseen multiple drug development projects resulting in clinical candidates that are now in late-stage trials in oncology, immune-mediated conditions and rare diseases. This work has resulted in the formation of several companies with significant financial exits, including Prometheus Biosciences. Dr. Gupta expressed, “We look forward to forging a productive relationship with the team through this foundry and to their science-first approach which has worked very well for us all along.” About Jupiter BioventuresJupiter Bioventures (“Jupiter”) is a biotechnology venture foundry that builds bold, science-driven startups from the ground up. Jupiter creates opportunities at scale by validating groundbreaking science quickly to produce de-risked venture-stage companies with therapeutic candidates. Partnering with world-leading scientists, Jupiter supports and manages a system of “Moons”—its portfolio of start-up companies. These Moons address unmet needs in cancer and related diseases. Jupiter’s managing directors are proven serial entrepreneurs with decades of expertise in company-building, strategic transactions and high-impact leadership. For more information, visit www.jupiter.bio. Media Contact:Janine McCargo 6 DegreesPhone +1 (646) 528-4034Email: jmccargo@6degreespr.com