The U.S. FDA accepted for review Daiichi Sankyo Co. Ltd.’s and Astrazeneca plc’s BLA for datopotamab deruxtecan to treat adults with unresectable or metastatic hormone receptor-positive, HER2-negative breast cancer who have received prior systemic therapy for unresectable or metastatic disease.
Sino Biopharmaceutical Ltd. and Boehringer Ingelheim International GmbH are partnering to develop innovative cancer therapies in mainland China. They will jointly develop and commercialize three clinical Boehringer assets, including brigimadlin, zongertinib, BI-764532, and other unnamed early stage assets.
After reviewing data from its phase II trial of farnesoid X receptor agonist ASC-42 in primary biliary cholangitis, Ascletis Pharma Inc. said it was quitting development of the molecule in all indications.
“A biotech company cannot survive on ‘drug efficacy’ alone,” former Korea Drug Development Fund (KDDF) CEO Hyunsong Muk said recently, “because novel drug development is not just a scientific problem.” Financial toxicity is, in fact, a major obstacle for biotech companies trying to advance preclinical candidates to early stage clinical trials, Muk said at Novo Nordisk A/S’ Partnering Day and Symposium on April 4 in Seoul, South Korea.
Global Health Drug Discovery Institute has disclosed N6-adenosine-methyltransferase catalytic subunit (METTL3) inhibitors reported to be useful for the treatment of cancer and viral infections.
M-9140 (Merck KGaA) is an antibody-drug conjugate (ADC) that carries a DNA topoisomerase 1 (TOP1) inhibitor payload plus an antibody directed against carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5). CEACAM5 is a cell surface protein that is overexpressed in colorectal cancer and other solid tumors.
Windtree Therapeutics Inc. has entered into an asset purchase agreement with Varian Biopharmaceuticals Inc. to acquire certain Varian assets, including a proprietary atypical protein kinase C iota inhibitor (aPKCi).
ABM Therapeutics Inc. presented a novel small-molecule, ATP-uncompetitive, phosphorylated MEK (pMEK) inhibitor – ABM-4095 – that potently prevents phosphorylation of MEK by RAF with moderate inhibition of MEK kinase activity; it is being investigated for the potential treatment of pancreatic cancer.
At the AACR meeting, Innovent Biologics Inc. discussed the discovery and preclinical evaluation of a B7-H3/EGFR bispecific antibody-drug conjugate (bsADC).