IGM Biosciences, Inc.

Agomab’s lead candidate is being investigated as a treatment for patients with fibrostenosing Crohn’s disease (FSCD). Credit: Hananeko_Studio via Shutterstock. Agomab Therapeutics has secured $89m in Series D funding to support clinical trials of its fibrotic disease treatments, with some help from Sanofi . Belgium-based Agomab announced that Sanofi and Invus have joined as new investors in its latest funding round, following on from a $100m Series C round in October 2023, and a $114m Series B where Pfizer led an extension round. The funds will be used to advance the development of Agomab’s lead candidate AGMB-129, a treatment for patients with fibrostenosing Crohn’s disease (FSCD). The oral small molecule inhibitor of ALK5 (TGFβ1R) is currently being investigated in the Phase IIa STENOVA trial (NCT05843578). The company expects to share interim results from the 90-patient trial in early 2025. Positive data from the Phase I trial (NCT04933565) of AGMB-129 was reported in February 2023, where the candidate demonstrated high local exposure in the ileum, with no drug-related safety signals or dose-limiting toxicities. Patients with FSCD have strictures in the intestines caused by inflammation and scarring, for which there is no cure. The company also has an inhaled treatment for idiopathic pulmonary fibrosis (IPF), named AGMB-447, and a liver cirrhosis candidate AGMB-101. AGMB-447 is being investigated in a Phase I trial (NCT06181370) and Agomab plans to start clinical development of AGMB-101, which is “in the final stages of IND-enabling studies”. See Also: Dyno and Roche collaborate on neurological gene therapies Takeda and BMC partner to decarbonise US healthcare sector Sanofi continues to assert itself in the immunology space, signing deals with parties such as Recludix, Teva Pharmaceutical and IGM Biosciences . The company expanded its immunology pipeline further in June 2024, entering a $700m strategic partnership with Belharra Therapeutics to spur the development of small molecule therapies for immunological diseases. Sanofi and Regeneron’s immune-targeting biologic Dupixent (dupilumab) has been picking up label expansions since its 2017 US Food and Drug Administration (FDA) approval for atopic dermatitis. The drug earned $11.6bn last year, as per Regeneron’s financials, and is set to generate $23.6bn in 2030, according to GlobalData consensus forecasts. GlobalData is the parent company of Pharmaceutical Technology. In the announcement accompanying the funding, Agomab’s CEO Tim Knotnerus said: “We are thrilled to have Sanofi and Invus joining our investor syndicate. Their investment as well as the continued support from our existing shareholders is another validation of the trailblazing work our team is conducting in the fields of fibrostenosing Crohn’s disease and idiopathic pulmonary fibrosis.”

Alongside IGM Biosciences' strategic shift, CEO Fred Schwarzer, Chief Scientific Officer Bruce Keyt, Ph.D., and Chief Medical Officer Chris Takimoto, M.D., Ph.D., are all leaving their roles. IGM Biosciences ended last year laying off staff and streamlining its cancer pipeline. Now, the company has become the latest to join a hot trend in cell therapy biotech—pivoting from oncology to autoimmune disease.The strategic shift—which comes with a side order of a C-suite shake-up and hints of further layoffs—shouldn’t be a huge surprise. Back in December 2023, IGM confirmed that while it was halting work on two candidates aimed at blood cancer and solid tumors, it was persevering in colorectal cancer and autoimmune diseases.Now, the company has announced a “strategic pivot to focus exclusively on autoimmunity disease.” In practice, it means that the biotech’s resources will be channeled toward its pipeline of T-cell engagers being lined up in autoimmunity conditions.These are led by imvotamab, a CD20 x CD3 bispecific T cell engager that is already being evaluated in clinical trials for rheumatoid arthritis, systemic lupus erythematosus and myositis. Those studies are due to start reading out this year and into next. Next in the queue is IGM-2644, a CD38 x CD3 bispecific set to begin a clinical trial for generalized myasthenia gravis before the end of 2024.The flip side of this refocus is that spending on the IgM antibody aplitabart as well as IGM’s other oncology R&D will be “minimized.” In a post-market release Sept. 30, the company alluded to “emerging data” from the ongoing trial of aplitabart in colorectal cancer as one of the reasons for the decision, along with the “significant opportunity in autoimmunity.”IGM’s workforce suffered a 22% reduction as part of the last round of pipeline changes in December, and it sounds like more layoffs could be in store for the biotech’s staff.“The company has decided to immediately begin taking steps, including a reduction in force, to minimize its future spending on the research and clinical development of aplitabart and other oncology candidates,” IGM explained in the release.The company had previously expected to end this year with $180 million in cash and investments, which should fund its operations into the second quarter of 2026. Yesterday’s pipeline changes mean IGM’s cash runway will now stretch into 2027, it said.Alongside the strategic shift, IGM is making some major changes to its C-suite, with CEO Fred Schwarzer, Chief Scientific Officer Bruce Keyt, Ph.D., and Chief Medical Officer Chris Takimoto, M.D., Ph.D., all leaving their roles—although Schwarzer and Keyt will remain as consultants. Mary Beth Harler, M.D., a Bristol Myers Squibb veteran who joined IGM in 2021 to head up the biotech's autoimmune R&D, will step into the CEO role.“Our early pivot to using T cell engagers in autoimmune disease has enabled significant progress on these programs at IGM, and I am excited to lead the company at this transformational stage,” Harler said in the release.“We’ve made great progress in our clinical development of imvotamab in autoimmune indications and we believe the clinical, and ultimately commercial, potential of our pipeline of T cell engaging antibodies in treating autoimmune diseases is significant,” the new CEO added.IGM is treading a well-worn path of oncology cell therapy companies taking an increased interest in the autoimmune space, including the likes of Poseida Therapeutics, Allogene and Caribou Biotherapeutics.

Today, a brief rundown of news from IGM Biosciences and Metsera, as well as updates from Gritstone Bio, UCB and Moderna that you may have missed.IGM Biosciences is shifting its focus to autoimmune disease research, the company said Monday. IGMs most advanced candidate had been a cancer drug in testing against against colorectal tumors. But emerging data from that trial, as well as the potential for a pair of its T cell engagers to treat inflammatory conditions, has led the company to change course, the company announced. IGM is taking immediate steps, including job cuts, to minimize oncology spending going forward. Its also named former Bristol Myers Squibb executive Mary Beth Harler as CEO. IGMs two T cell engagers are being tested against a range of immune diseases, among them lupus, myositis and myasthenia gravis. Delilah AlvaradoObesity drug startup Metsera said Tuesday it has signed a deal with manufacturing firm Amneal Pharmaceuticals to produce, package and supply its weight-loss therapies in the U.S., Europe and other developed markets. Amneal will spend $150 million to $200 million to build two new manufacturing facilities related to the work. The company will also get rights to commercialize Metsera products in certain emerging markets as well. A spokesperson also confirmed that Whit Bernard, a co-founder and managing director of investment firm Population Health Partners, has taken over as CEO for Clive Meanwell, who led the company through its launch earlier this year. Jonathan GardnerGritstone Bio is looking into potential value-maximizing strategies, and has tapped the investment bank Raymond James to serve as a financial adviser in its search. The cancer vaccine developer didnt outline what kinds of strategies its considering. But, when biotechnology companies conduct these so-called strategic reviews, they often explore whether there might be buyers interested in assets or the entire company. Gritstone tucked news of the review into an announcement touting data from a clinical trial evaluating one of its most advanced vaccines in colorectal cancer patients. Jacob BellBelgium-based drugmaker UCB is planning a first-of-its-kind, head-to-head trial that will pit its drug Bimzelx against AbbVies Skyrizi to see which anti-inflammatory agent is better at treating a type of arthritis. The late-stage study aims to enroll around 550 participants and should have results by 2026. Bimzelx and Skyrizi inhibit different members of a large protein family that regulates the immune system. First approved last fall, Bimzelx generated 215 million euros, or $230 million, during the first six months of this year. Net revenue from Skyrizi, meanwhile, totaled $4.7 billion over that period. Jacob BellModerna has dosed the first U.S. participantsin a Phase 3 trial of an experimental vaccine for norovirus. The trial will evaluate the safety, effectiveness and ability of the shot, dubbed mRNA-1403, to induce an immune response in people at least 18 years of age. Norovirus is a foodborne illness and the leading cause of diarrheal disease in the U.S. Moderna plans to enroll approximately 25,000 people in the study, and see whether the vaccine can protect against moderate to severe novovirus acute gastroenteritis, a type of stomach bug caused by viral infections. Delilah Alvarado '