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.
Pfizer Inc. proved its ongoing interest in antibody-drug conjugates (ADCs), as well as at least tentative faith in mesothelin as a target, by snatching up Nona Biosciences Inc. for up to $53 million in up-front and near-term cash along with possibly $1.05 billion in milestone payments as the drug advances.
Wall Street will be watching closely for such adverse effects as anemia that foiled Gilead Sciences Inc.’s CD47-binding magrolimab earlier this year, but so far Shattuck Labs Inc.’s SL-172154 looks strong in combination with azacitidine to treat front-line higher-risk myelodysplastic syndrome (HR-MDS) and TP53-mutant (TP53m) acute myeloid leukemia (AML).