The FDA has approved Pharmaessentia Corp.'s Besremi (ropeginterferon alfa-2b) for the rare blood disorder polycythemia vera, the interferon offering an alternative to JAK inhibitor therapy. PV is a rare, chronic and life-threatening blood cancer caused by a mutation in stem cells in the bone marrow, resulting in overproduction of blood cells. Besremi, which is already approved in Taiwan, Europe and South Korea, is a monopegylated, long-acting interferon, which counteracts the effects of the mutated bone marrow cells and is initially taken fortnightly. Read More
Recludix Pharma Inc. launched with a $60 million series A round to target Src homology 2 (SH2) domains, and the new money will get the San Diego-based firm to reach the IND-enabling stage, CEO Nancy Whiting told BioWorld. Read More
Ankyra Therapeutics Inc., a company developing new cytokine immunotherapies to boost localized antitumor immune responses, closed a $45 million series B financing. Proceeds from the round will be used to advance the Boston-based company's lead molecule, ANK-101, through IND-enabling studies and into phase I trials starting at the beginning of 2023, as well as to advance additional cytokine programs, it said. Read More
LONDON – Cancer immunotherapy specialist Valo Therapeutics Oy has raised €11 million (US$12.6 million) in an oversubscribed round that will fund the final preparations to move the lead program into the clinic at the start of 2022, and to prepare for an IPO later next year. The phase I will be the first test in humans of Valo’s Pepticrad (peptide-coated conditionally replicating adenovirus technology), which combines two different approaches for which there is there is separate clinical proof: oncolytic adenoviruses and peptide cancer vaccines. Read More
LONDON – There’s not yet proof of the pudding, but Omass Therapeutics Ltd.’s new structure-based technology has passed a key test, in enabling the discovery of orally available small molecules aimed at intractable and poorly drugged membrane and complex-bound protein targets. The targets, including G protein-coupled receptors (GPCRs), intracellular protein complexes and solute carriers, are relevant to immunology indications and rare diseases with high unmet need. Read More
New hires and promotions in the biopharma industry, including: Alchemab, Autolus, Biogencell, Catamaran, Coave, Coimmune, Diurnal, Nektar, Oblique, Oncopeptides, Rani, Valo. Read More
New and updated preclinical and clinical data presented by biopharma firms at The Liver Meeting of the American Association for the Study of Liver Diseases, including: 89bio, Akero, Cymabay, Intercept, Protagonist, Sagimet, Surrozen, Versantis. Read More
New and updated preclinical and clinical data presented by biopharma firms at the Society for Immunotherapy of Cancer annual meeting, including: Antengene, Carisma, Celularity, CG Oncology. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amgen, Apellis, Ascendis, Beigene, Carsgen, Celltrion, Chemocentryx, Coherus, Eli Lilly, Galapagos, Gannex, Hebabiz, Hyloris, Innocare, Junshi, Kyowa Kirin, Mimivax, Moderna, Newbridge, Novavax, Novo, Nrx, Nurix, Pharmaessentia, Regeneron, Relief, Rhythm, Roche, Sanofi, SK Bioscience, Vertex, Viridian. Read More
