Dispatch Biotherapeutics Inc. is taking aim at solid tumors with a new viral vector/antigen technology backed by major industry names such as Arch Venture Partners and Bristol Myers Squibb Co. With offices in Philadelphia and San Francisco, Dispatch has raised $216 million since its founding in 2022. The firm’s platform delivers a cell-specific viral vector carrying a novel, universal antigen called Flare that tags solid, epithelial-derived tumor cells. Acting as a beacon, the Flare antigen directs the immune system to find and clear the cancer cells without harming healthy tissue.
The fate of IL-33-targeting astegolimab will be determined by talks with regulators, after Roche AG’s Genentech unit rolled out mixed results from a pair of studies testing the compound vs. placebo on top of standard-of-care (SOC) maintenance therapy in subjects with moderate to very severe chronic obstructive pulmonary disease (COPD).
As Wall Street awaits key phase III data from Abivax SA with microRNA-124 (miR-124)-targeting obefazimod in ulcerative colitis, due this quarter, the inflammatory bowel disease (IBD) space – which also takes in Crohn’s disease – continues to grow and shift with new findings across varied fronts.
Sarepta Therapeutics Inc. made known a third gene therapy death, this time with SRP-9004 for limb-girdle muscular dystrophy. The patient was a late-stage, non-ambulatory 51-year-old man participating in the phase I Discovery trial, who expired about a month ago of acute liver failure, as did the two previous subjects who passed away after they were treated with Elevidys (delandistrogene moxeparvovec), Cambridge, Mass.-based Sarepta’s gene product for Duchenne muscular dystrophy.
The rough ride presaged by briefing documents came to pass for GSK plc with the drug first approved by the U.S. FDA as Blenrep (belantamab mafodotin, bel-maf), as the agency’s Oncologic Drugs Advisory Committee (ODAC) appraised the possibility that the antibody-drug conjugate could return to market for relapsed/refractory multiple myeloma (r/r MM).
Takeda Pharmaceutical Co. Ltd.’s dual phase III victories in narcolepsy type 1 (NT1) with oral orexin receptor 2 (OX2R)-selective agonist oveporexton (also known as TAK-861) had Wall Street mulling what the outcome might mean for others trying the mechanism of action, and questions linger about side effects on eyesight.
As the July 23 PDUFA date nears for GSK plc’s Blenrep (belantamab mafodotin), the U.S. FDA’s Oncologic Drugs Advisory Committee will decide July 17 on whether available data justify the return to market of the antibody-drug conjugate as a therapy for relapsed/refractory multiple myeloma, and briefing documents made public ahead of the meeting laid out the issues.
Takeda Pharmaceutical Co. Ltd.’s dual phase III victories in narcolepsy type 1 (NT1) with oral orexin receptor 2 (OX2R)-selective agonist oveporexton (also known as TAK-861) had Wall Street mulling what the outcome might mean for others trying the mechanism of action, and questions linger about side effects on eyesight.
Rhythm Pharmaceuticals Inc. will be sitting down with regulators in the U.S. and Europe to discuss phase III plans in the wake of positive phase II data from the study testing bivamelagon (formerly LB5-4640), an oral melanocortin-4 receptor agonist, in patients with acquired hypothalamic obesity.
Tickling Wall Street’s already strong interest in the mechanism of action was Aurinia Pharmaceuticals Inc., which June 30 made public positive results from the phase I single ascending-dose study with aritinercept (AUR-200), the company’s dual inhibitor of B cell-activating factor (BAFF) and a proliferation-inducing ligand (APRIL).
