Two sNDAs, one from Bristol Myers Squibb Co. (BMS) and the other from Mirum Pharmaceuticals Inc., have received U.S. FDA approval to further expand their treatment indications.
Researchers from Shanghai Institute of Materia Medica of the Chinese Academy of Sciences and affiliated organizations published preclinical data for a new class of mucosa-associated lymphoid tissue lymphoma translocation protein 1 (MALT1) inhibitors being developed as candidates for the treatment of lymphoma.
More than 30 years after entering the scene as a first-generation monoclonal antibody pioneer, Morphosys AG is to be acquired by Novartis AG for €2.7 billion (US$2.9 billion). The all-cash deal, announced after Nasdaq closed on Feb. 5, will see Novartis paying €68 per share, a premium of 94% to the average daily price in the month leading up to Jan. 25, when rumors of a takeover started swirling.
HST-1021 is a novel mucosa-associated lymphoid tissue lymphoma translocation protein (MALT1) allosteric inhibitor identified using the Smart Allostery Platform, and is being developed for the potential treatment of tumors.
Researchers from Weill Cornell Medicine and Scenic Biotech BV presented promising preclinical data on SC-2882, a first-in-class specific glutaminyl-peptide cyclotransferase-like (QPCTL) inhibitor that induces secondary proteolytic degradation of the monocyte chemo attractants CCL2 and CCL7 and inactivation of the “don’t-eat-me” signal CD47, as a novel therapeutic for diffuse large B-cell lymphoma (DLBCL).
Hangzhou Unogen Biotech Ltd. has divulged protein arginine N-methyltransferase 5 (PRMT5) inhibitors reported to be useful for the treatment of lymphoma.
Simultaneous inhibition of phosphoinositide 3-kinase (PI3K) and histone deacetylase (HDAC) is considered a good strategy in cancer treatment, although current PI3K/HDAC dual inhibitors have limitations, such as low selectivity and moderate toxicity levels.
From the start of the Nov. 16 Oncologic Drugs Advisory Committee meeting, the U.S. FDA made it clear that withdrawing Acrotech Biopharma Inc.’s peripheral T-cell lymphoma drugs, Folotyn (pralatrexate) and Beleodaq (belinostat), from the market until a long-overdue confirmatory trial is completed is not an option given the current treatment landscape.
If there had been any lingering market concerns following the temporary partial clinical hold earlier this year for Arcellx Inc.’s multiple myeloma CAR T-cell therapy, CART-ddBCMA, they were likely put to rest as partner Gilead Sciences Inc.’s Kite unit expanded the scope of the firms’ late 2022 collaboration to include lymphomas. At the same time, Kite exercised an option to negotiate a license for Arcellx’s ARC-Sparx program, ACLX-001, in multiple myeloma.
If everything goes according to the current plan, the U.S. FDA would get the final report of a confirmatory trial for Acrotech Biopharma Inc.’s Folotyn (pralatrexate) and Beleodaq (belinostat) in 2030 – more than two decades after Folotyn received accelerated approval to treat relapsed or refractory peripheral T-cell lymphoma and 16 years after Beleodaq was granted accelerated approval for the same indication.
