Vicore Pharma AB

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.

Plus, news about IN8bio, Sanofi, Vicore Pharma, Cartherics, Zephyrm Bioscience, Tharimmune and Intract Pharma: Biohaven’s $250M offering: The move comes after Biohaven announced Monday that it started a pivotal Phase 2 study of its oral TRPM3 antagonist for migraines. The company also expects to grant the underwriters another $37.5 million of common shares. — Katherine Lewin Activist firm grows stake in Galapagos: EcoR1 crossed the 10% ownership threshold tied to voting securities, according to a disclosure on Monday . EcoR1 believes the Dutch biotech is “deeply undervalued” and previously said it would speak to the board and management about a “variety of topics” including board composition. — Max Bayer IN8bio’s $12.4M raise: The New York gamma-delta T cell therapy biotech priced the private placement a few weeks after announcing plans to prioritize its pipeline and halve its workforce. — Kyle LaHucik Sanofi invests $10M in Vicore Pharma: The Stockholm-based company is beginning a Phase 2b trial investigating its drug, buloxibutid, in patients with idiopathic pulmonary fibrosis who are either untreated or receiving the current standard of care. — Katherine Lewin Cartherics raises about $10 million: The money is set to go toward a clinical trial next year for the Melbourne-based company’s preclinical lead cell therapy for ovarian cancer, dubbed CTH-401. According to Cartherics, CTH-401 is the only natural killer cell therapy currently under development that includes a CAR that targets the adenocarcinoma specific antigen called TAG-72. — Katherine Lewin Zephyrm Bioscience files for IPO in Hong Kong: The seven-year-old startup wants to go public on the Hong Kong Stock Exchange to fund its pipeline of pluripotent stem cell therapies. Its lead therapy is expected to enter Phase 3 next year for two indications: acute exacerbation of interstitial lung disease, and acute graft versus host disease. — Kyle LaHucik Tharimmune, Intract Pharma to merge: The clinical-stage I&I biotech wants to combine with Intract, which makes a delivery system for oral biologics. The merger is slated to close in the first quarter of 2025, and Intract shareholders will own 49% of the combined company. — Kyle LaHucik

Insilico Medicine, a biotech company with offices in both China and the US, announced this week that its lead candidate drug had met its primary endpoint of safety and its secondary efficacy endpoints. INS018_055 (also known as ISM001-055) is a small molecule drug candidate targeting TRAF2- and NCK-interacting kinase (TNIK). TNIK inhibitors are being investigated ​ for potential anticancer properties, but are also thought to have anti-fibrotic properties that could be effective for treating lung diseases such as idiopathic pulmonary fibrosis (IPF). The phase 2a trial of INS018_055/ISM001-055 enrolled 71 patients in China with IPF who were randomly assigned to receive: placebo, 30mg once daily, 30mg twice daily, or 60mg once daily for 12 weeks. A similar phase 2a trial is currently recruiting in the US. In a statement released this week, the company reported that its candidate therapy had met its primary endpoint of safety and tolerability at all doses. It also said secondary efficacy endpoints were also met, with the highest improvement in forced vital capacity (FVC) seen with the highest dose of 60mg once daily. The company will now design a phase 2b trial in consultation with regulators. Notably, Insilico has not yet released full data from the trial, making it difficult to judge the degree of efficacy of the candidate therapy. In a press statement it said that complete topline data would be released at an upcoming medical conference and that the clinical trial results would be submitted for publication in a peer-reviewed journal. googletag.cmd.push(function () { googletag.display('text-ad1'); }); "These results are very encouraging, particularly the dose-dependent response in FVC. IPF is a devastating disease, and seeing improvements in lung function over just 12 weeks of treatment is a promising indication that ISM001-055 may provide a new therapeutic option for patients," said Toby Maher, an expert in interstitial lung disease who is involved with the Insilico clinical trials program for this drug candidate, in the company press statement. Insilico is not the only company targeting IPF, Boehringer Ingelheim reported positive phase 3 results ​ for its new IPF candidate earlier this week and Vicore Pharma, Bridge Therapeutics and Pliant Therapeutics all have candidates that have reached phase 2. Whether Insilico’s candidate is effective enough to compete with others in the space remains to be seen. AI-based drug design ​ Insilico specializes in using generative artificial intelligence (AI) to look for new drug targets and speed up the early stages of drug-discovery before the potential therapies enter clinical trials. It was one of the first company’s in the space to propose and apply the use of generative AI to drug development, publishing a paper ​ on the topic in 2016. Since 2021, the company has announced 12 different preclinical therapeutic candidates in development for treatment of conditions such as cancer, Covid-19, inflammatory bowel disease, and kidney fibrosis and advanced three of them to clinical trials. Its lead candidate and indication targets IPF and INS018_055 was the first drug designed with generative AI to enter phase 2 trials ​ in 2023. “This study result represents a critical milestone in AI-powered drug discovery and in my life to date,” said Alex Zhavoronkov, co-CEO of Insilico Medicine. “While we expected the drug to be safe, we did not expect to see such a clear dose-dependent efficacy signal after such a short dosing period. IPF is a very diverse disease, and it is very rare to see improvement in FVC.”