Merus NV gained accelerated U.S. FDA approval of Bizengri (zenocutuzumab) as the first and only targeted therapy indicated for NRG1-positive pancreatic adenocarcinoma and non-small-cell lung cancer patients with advanced unresectable or metastatic disease. The approval came about seven months after the FDA accepted the BLA for filing under priority review, and two months ahead of the PDUFA goal date of Feb. 4, 2025, which had been extended by three months in November as the agency reviewed CMC information submitted in response to its request.
The collaboration will combine Rondo’s proprietary CD28 co-stimulatory platform with Lilly’s drug development and commercialization expertise to develop co-stimulatory bispecific antibodies to treat solid tumors.
Ipsen SA and Biomunex Pharmaceuticals SAS have signed an exclusive global licensing agreement for BMX-502, a preclinical novel T-cell engager with potential for solid tumors. BMX-502 is a bispecific antibody that engages and activates mucosal-associated invariant T (MAIT) cells and targets the GPC3 tumor antigen, to kill cancer cells.
Nectin-4 antibody-drug conjugate (ADC) and checkpoint inhibitor combinations have represented a great advancement in the treatment of bladder cancer, but relapse and treatment-related toxicities underscore the need for new therapeutic strategies.
AGEN-1721 was designed as an Fc-enhanced bifunctional antibody to selectively target FAP and neutralize TGF-β via an optimized TGF-βR2 TRAP moiety fused to an engineered Fc region, with the aim of maximizing effector functions.
A team from Nanjing Leads Biolabs Co. Ltd. presented the discovery and preclinical characterization of LBL-042, a novel bispecific antibody designed to simultaneously target PD-1 and LILRB1/2, with the aim of improving immune evasion of tumor microenvironment and potentially overcoming resistance to immuno-oncology therapy.
Keymed Biosciences Co. Ltd. is out-licensing global rights, excluding China, for its bispecific antibody, CM-336, to Platina Medicines Ltd. in a deal worth up to $626 million plus sales royalties.
Merck & Co. Inc. has in-licensed Lanova Medicines Ltd.’s PD-1/VEGF bispecific antibody LM-299 in a deal worth up to $2.7 billion in a move to bolster its Keytruda (pembrolizumab) fortress. Under terms of the deal, Merck (known as MSD outside the U.S.) gains an exclusive global license to develop, manufacture and commercialize LM-299 in exchange for an up-front payment of $588 million. Shanghai-based Lanova is eligible to receive up to $2.7 billion in milestone payments associated with the technology transfer, development, regulatory approval and commercialization of LM-299 across multiple indications.
RSS
