GEN1057

Plus, label expansions for two drugs targeting rare diseases, and Genmab scraps a Phase 1 cancer trial: 🧠 Novo’s Parkinson’s cell therapy finds a biotech home: Novo Nordisk has found a home for an early-stage Parkinson’s program after the pharma giant stopped cell therapy research last fall . A Boston-based startup called Cellular Intelligence, formerly Somite AI, announced Monday it has acquired the rights to STEM-PD, an allogeneic Parkinson’s cell therapy. The companies did not disclose financial details. This is Cellular Intelligence’s first clinical-stage program, which the Khosla Ventures-backed company says is ready to enter Phase 2. Eight Parkinson’s patients were treated in a Phase 1 study, where cells were injected into the brain in hopes they will grow into dopamine-releasing neurons. The therapy was started at the University of Cambridge and Lund University. — Andrew Dunn 🇨🇳 GSK gets help on hepatitis B drug in China: The UK pharma has enlisted Sino Biopharm’s subsidiary Chia Tai Tianqing Pharmaceutical to help roll out bepirovirsen in China. The Ionis Pharmaceuticals-derived drug is currently under priority regulatory review in the country. CTTQ will buy the drug from GSK for at least 5.5 years. GSK can also look at early-stage assets from Sino for potential collaboration pacts outside of China. — Kyle LaHucik 💉Argenx wins label expansion for injectable Vyvgart: The biotech said the subcutaneous version of its blockbuster rare disease drug is now approved to treat “all serotypes” of generalized myasthenia gravis. The approval was based on a Phase 3 study comparing the drug to placebo after four weeks. — Max Gelman ✅ FDA expands label for rare cancer drug under Commissioner’s National Priority Voucher: The drug regulator approved Bizengri for previously treated patients with advanced cholangiocarcinoma with an NRG1 gene fusion. The treatment was previously approved for certain lung and pancreatic cancers that bear an NRG1 gene fusion. Merus developed the drug, but licensed it to Partner Therapeutics to market in the US in 2024. Genmab last year bought Merus as part of an $8 billion deal. The FDA said Bizengri’s label expansion marked the seventh approval under the voucher program. — Lei Lei Wu ✂️ Genmab scraps Phase 1 cancer program: The company discontinued development of GEN1057 , a company spokesperson confirmed to Endpoints News . The experimental drug had been in a Phase 1 study for solid tumors. GEN1057 is a bispecific antibody targeting fibroblast activation protein alpha (FAPα) and death receptor 4 (DR4). — Max Gelman