ImmunoGen maps new path to accelerated approval; BioNTech scores €50M funding from European bank
→ Earlier this year, struggling ImmunoGen was shooed away by the FDA with their case for an accelerated approval of their antibody-drug conjugate mirvetuximab soravtansine, which had failed a Phase III study for ovarian cancer. But the company now has some hopeful news to report as the FDA stated that a “new single-arm study in platinum-resistant ovarian cancer could support accelerated approval” of the drug. The biotech will now initiate that trial, SORAYA, to test the efficacy of the monotherapy in women with folate receptor alpha (FRα)-high platinum-resistant ovarian cancer who have been previously treated with Avastin.
→ Wall Street newbie BioNTech has obtained a €50 million (around $55 million) loan from the European Investment Bank to back an expansion in the production capacities for its mRNA-based product candidates and fund R&D as well as market access work.
→ Switzerland’s Cellestia Biotech has brought its total haul to $50 million by bringing in new Asian investors to its $20 million Series B. FC Capital of Shanghai, PPF Group and Partners Investment of Seoul, alongside a group of private investors, are buying into the potential of a drug discovery platform targeting the NOTCH transcription complex. The lead drug, a small molecule inhibitor dubbed CB-103, is currently in Phase I.
→ Since debuting six years ago with the support of the late Henri Termeer, Amylyx Pharmaceuticals has laid relatively low, but today the company is breaking out some positive data from their CENTAUR study testing the efficacy of their drug, AMX0035, for people with ALS. The study met the primary endpoint, by showing a statistically significant slowing of ALS with use of the drug compared to placebo.
→ Belgium-based liver-focused stem cell therapy developer Promethera Biosciences — which bagged €39.7 million (about $44.4 million) in May — has made an addition of €7.5 million to that amount. The round was led by new investors Sony Innovation Fund by IGV and Pegasus Tech Ventures, among others. The funds will be used toward the advancement of the company’s clinical programs in NASH and acute-on-chronic liver failure (ACLF) — with planned launches during 2020 — as well as to accelerate Promethera’s growth in Asian markets.