Elpiscience Biopharma Ltd. is out-licensing to Astellas Pharma Inc. two preclinical bispecific macrophage engagers – ES-019, an anti-PD-L1/SIRPα bispecific antibody, and another unnamed program – in a deal worth up to $1.7 billion. The deal marks the Shanghai-based company’s first out-licensing deal, Elpiscience CEO Darren Ji told BioWorld, noting that Astellas will have global rights to both molecules with a potential to in-license two more.
MSD had a banner year at the ESMO Asia Congress earlier this month, presenting 14 abstracts on eight different types of cancers, including gastric, esophageal, colorectal, biliary tract, kidney, urothelial, breast and gynecological cancers. Ten of these studies were focused on Asian-related data. Roche AG, meanwhile, presented Asia-specific results from the phase III Alina study in patients with ALK-positive early stage non-small-cell lung cancer.
Legochem Biosciences Inc. signed a $1.7 billion licensing deal with Janssen Biotech Inc. for its Trop2-directed antibody-drug conjugate (ADC), closing the biggest technology transfer deal in Korean biotech history after Chong Kun Dang Pharmaceuticals Corp.
As its pharma peers continue to place big bets on antibody-drug conjugates (ADCs), Sanofi SA is ditching the only advertised ADC program in its pipeline, after it failed an independent interim analysis.
Starpharma Holdings Ltd.’s DEP docetaxel phase II trial met its primary endpoints, demonstrating antitumor activity in multiple advanced, metastatic cancers, including pancreatic, gastro-esophageal, non-small-cell lung cancer and cholangiocarcinoma.
The spate of recent deals involving antibody-drug conjugates (ADC) continues in a field composed of record-breaking agreements in 2023. The newest of the deals were focused on Asia. GSK plc entered a license deal for the exclusive rights for clinical development and commercialization of Hansoh Pharmaceutical Co. Ltd.’s B7-H3-targeted ADC, HS-20093. Also, South Korea’s Dong-A ST Co. Ltd. is expanding into the ADC space by acquiring Abtis Co. Ltd. and its Abclick platform for ADC drug development.
Compugen Ltd. has entered another collaboration, this time exclusively licensing a preclinical antibody program against an IL-18 binding protein with Gilead Sciences Inc. Compugen will handle ongoing preclinical development and a phase I study of COM-503 to treat tumors, then Gilead receives to sole right to further continue developing the asset. Compugen is getting an up-front $60 million and is eligible for a $30 million milestone payment should the IND clear in 2024. Compugen also is eligible for $758 million in development, regulatory and commercial milestones, putting the deal value at $848 million.
Shares of Checkpoint Therapeutics Inc. dropped 44.8% Dec. 18 on news that the U.S. FDA issued a complete response letter (CRL), delaying potential approval of PD-L1 antibody cosibelimab in metastatic or locally advanced cutaneous squamous cell carcinoma. The FDA had accepted in March the BLA, seeking use for treating patients who are not candidates for curative surgery or radiation, setting a Jan. 3, 2024, PDUFA date.
Taiwan’s Caliway Biopharmaceuticals Co. Ltd. said it secured more than $100 million in an oversubscribed capital raise to advance CBL-514, its lead asset for subcutaneous fat reduction nearing phase III studies.
Following the recommendation of its Oncology Drugs Advisory Committee, the U.S. FDA approved U.S. Worldmeds LLC’s eflornithine 192-mg tablets for use as a maintenance therapy in patients with high-risk neuroblastoma. Branded Iwilfin, the specific, irreversible inhibitor of ornithine decarboxylase previously known as DFMO, is expected to be available in the coming weeks.
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