AGMB-129

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.”

Agomab Therapeutics is benefiting from Sanofi’s push to become an immunology powerhouse. The Antwerp-based biotech said Friday that the French drug giant and Invus are new investors in its $89 million Series D that arrived one year after its $100 million Series C . Pfizer and Boehringer Ingelheim have also backed Agomab. The company wasn’t seeking additional money. “The $100 million is still in the bank,” Agomab CEO Tim Knotnerus said in an interview. But after receiving inbound interest from Sanofi, the biotech’s execs discussed it with the board and then did a “very selective reach-out” to other investors. It took only a month to close the round, the CEO said. The new financing will fund an ongoing Phase 2a of Agomab’s lead therapy — an oral small molecule for a subset of Crohn’s disease patients — and another oral drug candidate already in Phase 1 for idiopathic pulmonary fibrosis. It also plans to take a MET agonistic antibody into human studies in the first half of next year for liver cirrhosis. Agomab anticipates interim data for the first 40 of 90 patients from the Phase 2a of AGMB-129 in early 2025. Investigators are testing the gut-restricted ALK5 inhibitor in patients with fibrostenosing Crohn’s disease, which impacts about half the people with the inflammatory bowel disease. It has the FDA fast track tag. “Can we indeed avoid the known cardio toxicity that is associated with ALK5?” Knotnerus said. “We believe we can because of the way our compound has been designed, so that we have high local exposure of our ALK5 asset in the gastrointestinal tract and very low systemic exposure.” In the first half of next year, the biotech also expects to have the first batch of healthy volunteer data from the Phase 1 trial in IPF for its ALK5 inhibitor that is lung-restricted, according to Knotnerus. IPF leads to difficulties with breathing and impairs multiple other functions, eventually leading to death for many patients within about five years. Boehringer and Roche each market medicines for IPF, and both were approved by the FDA 10 years ago. Many drug developers are following up with next-generation medicines. Amid a broader restructuring of its business, Sanofi has continued to bet on oncology and I&I. In recent months, it invested in several companies developing IPF medicines like Vicore Pharma and Graviton Bioscience . The company also earmarked up to $1.5 billion for the anti-TL1A race in a partnership with Teva . Agomab broke cover in 2019 with a $23 million Series A. It snagged a $74 million Series B in 2021 and bought Spanish startup Origo Biopharma later that year. The 60-employee startup also now has an office in Cambridge, MA. It added former Seagen leader David Epstein to its board this summer, and Pierre Kemula — who headed finance at CureVac when it went public — is set to start as CFO on Nov. 1.