The whopper June buyout of by Morphosys AG of Constellation Pharmaceuticals Inc. brought renewed attention to myelofibrosis (MF) and other players in the space, such as Sierra Oncology Inc.
Advaxis Inc.’s long journey is ending happily by way of a merger with Biosight Ltd. that leaves the new firm with $50 million to help advance aspacytarabine (BST-236), a prodrug of cytarabine for acute myeloid leukemia and myelodysplastic syndromes.
Alector Inc. Chief Operating Officer Shehnaaz Suliman said her company’s deal with Glaxosmithkline plc (GSK) – worth as much as $2.2 billion – “allows us to expand into indications that we have been quite thoughtful about doing, but in a more expeditious manner. This is really an opportune time to continue to explore the biology of these programs across multiple indications.”
Diamedica Therapeutics Inc.’s chief medical officer, Harry Alcorn, said that “due to the complexity [of diabetic kidney disease (DKD)], there's not a clear answer” as to why such patients did less well in the company’s Redux phase II trial with DM-199 (recombinant human tissue kallikrein 1 [KLK1]). “But I wouldn't say that there wasn't a response in the DKD group,” he said, citing upside in 30% of subjects.
CEO John Leonard said Intellia Therapeutics Inc. plans “to share information on a cohort-by-cohort basis, so we get a consistent readout” and, as the year goes on, longer-term follow-up findings will emerge from the phase I trial with the company’s lead in vivo genome editing candidate, NTLA-2001.
Fulcrum Therapeutics Inc.’s phase IIb data with losmapimod in facioscapulohumeral muscular dystrophy (FSHD) brought renewed hope for patients in what historically has proved a challenging therapeutic space. Though the firm’s oral p38 mitogen-activated protein kinase inhibitor missed its primary biomarker endpoint – changes in DUX4-driven gene expression – other indicators of benefit in the study called ReDUX4 painted a bright picture.
Wall Street must wait a while longer to find out if Gilead Sciences Inc. will exercise its $275 million option for Arcus Biosciences Inc.’s TIGIT binder, domvanalimab. Meanwhile, investors took heart from an optimistic – albeit vague – interim report on the phase II ARC-7 trial.
CEO Samantha Singer said Abata Therapeutics Inc. “spent a considerable amount of time finding the right indication” for its approach, which deploys autologous regulatory T cells (Tregs) made to express T-cell receptors (TCRs). That disease is progressive, non-relapsing multiple sclerosis (MS). “We’re going to be able to succeed with these patients where other options have failed,” she told BioWorld.
More than two weeks after the FDA gave its go-ahead to Biogen Inc.’s Aduhelm (aducanumab), controversy still rages over the accelerated approval as well as the price for the anti-amyloid beta monoclonal antibody for Alzheimer’s disease (AD). Embattled U.S. regulators made the uncommon move of releasing documents – with more due to be made public later – that show the internal deliberations that led to Aduhelm’s clearance.
Bristol Myers Squibb Co. and Eisai Co. Ltd. inked a potential $3.1 billion agreement to co-develop and co-commercialize the antibody-drug conjugate MORAb-202 for advanced solid tumors.
