Two phase III failures with Roche Holding AG subsidiary Genentech Inc.’s gantenerumab in staving off mild cognitive impairment tied to Alzheimer’s disease (AD) revealed the level of amyloid-beta removal was lower than the company expected. The protein amyloid beta accumulates in the brains of AD patients and its removal is suspected to be an eventual boon to AD patients. But there are still plenty of doubts. Top-line results from Genentech’s phase III Graduate I and II studies show gantenerumab, a fully human monoclonal IgG1 antibody, missed the primary endpoints of slowing clinical decline in those with mild cognitive impairment due to AD and mild AD dementia. Read More
Ardelyx Inc. could have a rocky row to hoe when it makes its case for tenapanor, as a hyperphosphatemia therapy in adults with chronic kidney disease, before the U.S. FDA’s Cardiovascular and Renal Drugs Advisory Committee Nov. 16. The big question facing the adcom is whether the change in baseline serum phosphorous levels achieved by the drug is clinically meaningful. Clearly, FDA reviewers don’t think so, as that question already has resulted in delayed PDUFA dates, a complete response letter and two formal dispute resolution requests. Read More
Que Oncology Inc.’s Q-122 significantly reduced the frequency and severity of moderate and severe vasomotor symptoms, or hot flashes, in women taking endocrine therapy for breast cancer, and phase II results showed associated improvement in quality of life, compared with placebo. Read More
Zenas Biopharma LLC has raised $118 million in a series B round to support a global phase III trial of its lead asset as well as other immunotherapies for autoimmune diseases in its pipeline. The study, expected to begin in 2023, will evaluate obexelimab for the treatment of patients with immunoglobulin G4-related disease in late 2022. Read More
Trisalus Life Sciences Inc. agreed to merge with Medtech Acquisition Corp. (MTAC) in a deal that allows the drug/device company’s management to meet three out of three goals: quick cash, retained control and faster completion of key clinical trials. Read More
Nona Biosciences Co. Ltd., a subsidiary of Harbour Biomed Therapeutics Ltd. launched in November to provide “idea to IND” services, has struck a deal with Moderna Inc. to develop nucleic acid-based immunotherapies. The candidates will be based on Harbour’s heavy chain only antibody discovery platform. Read More
New and updated preclinical and clinical data presented by biopharma firms at the Society for Immunotherapy of Cancer Annual Meeting including: Adagene, Agenus, Aim, Alligator, Candel, Carisma, Cellectis, Corbus, Evolveimmune, Hotspot, Imcheck, Immunome, Immutep, Kalivir, Marengo, Medicenna, Myeloid, Nanobiotix, Nektar, Nutcracker, Nurix, Oncolytics, Onconano, Pact, Portage, Rigel, Scholar Rock, Seagen, Sotio, Triumvira, Vaccinex, Xencor. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Apollo, Appili, Diffusion, HCR, Indivior, Mannin Research, Medicox, Nrx, Opiant, Oramed, Q Biomed, Redhill, Relief, SK Biopharmaceuticals, Telix, Urogen. Read More
