AGMB-129

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.

Agomab is now eligible for market exclusivity and a range of financial incentives. Image credit: Shutterstock / HammadKhn. Six months after kicking off a Phase I trial for idiopathic pulmonary fibrosis (IPF) treatment AGMB-447, Agomab Therapeutics has now secured a US Food and Drug Administration (FDA) orphan drug designation for the asset. Recommended Buyer's Guides Buyer's Guide Leading Guide to Packaging Materials, Containers and Containment Services for the Pharmaceutical Industry Buyer's Guide Leading Guide to Compliance Software for the Pharmaceutical Industry The Belgium-based biotech will now be in line for tax credits for US-based clinical trials and, if the therapy is approved, the potential for seven years of market exclusivity in the designated indication. IPF is a rare, chronic lung disease that affects the air sacs – called alveoli – in the lungs. The condition is characterised by thickening of lung tissue that becomes stiff, causing breathing difficulties. It is not known what causes the disease, though the risk is increased with smoking and a family history of IPF. There are currently two FDA-approved drugs for IPF, Boehringer Ingelheim’s Ofev (nintedanib) and Genentech’s Esbriet (pirfenidone). Ofev is a tyrosine kinase inhibitor whilst Esbriet targets TGF-beta, a chemical mediator that plays a role in development of fibrosis. Agomab has gone down a similar route to Genentech, with AGMB-447 blocking the action of the TGFβ type 1 receptor. Agomab’s USP is that AGMB-447, which is inhaled, inhibits the TGFβ type 1 receptor, also known as ALK5, only in the lung. The biotech has achieved this by designing the drug to be rapidly metabolised through hydrolysis in the plasma, preventing exposure throughout the whole body. See Also: The tiny pills that may send shockwaves across immunology Roche’s PI3K inhibitor secures breakthrough status in breast cancer Agomab is evaluating AGMB-447 in a placebo-controlled Phase I trial that aims to enrol 76 patients with IPF. Participants will either receive a single dose or multiple doses of AGMB-447, the latter treatment will occur in two cohorts over seven days or 14 days. The randomised trial has primary endpoints comprising safety assessments up to eight weeks after therapy. Secondary endpoints include pharmacokinetic measurements. The biotech dosed the first patient in December 2023. Agomab’s chief medical officer Philippe Wiesel said: “As we progress through our ongoing first-in-human Phase I trial, we look forward to evaluating the data from the single ascending dose and multiple ascending dose evaluation of AGMB-447 in healthy subjects and IPF patients.” Agomab secured $100m in Series C financing in October 2023. In a statement at the time, the biotech said it would use part of the funds to progress Crohn’s disease candidate AGMB-129 – also an ALK5 inhibitor – through Phase II trials. Agomab’s designation comes only a few weeks after Alentis Therapeutics won orphan drug status for its candidate lixudebart in IPF. In the same announcement as its orphan drug designation, Alentis reported positive safety results from a Phase I trial evaluating lixudebart in IPF patients.