Extending its efforts in the booming antibody-drug conjugate (ADC) space, Beigene Co. Ltd. tapped Duality Biologics Co. Ltd. in a deal that could be worth a potential $1.3 billion, picking up an option for rights to a preclinical-stage ADC candidate targeting select solid tumors. It marks the seventh $1 billion-plus ADC-focused deal so far in 2023 and the second for Dualitybio, which inked a potential $1.7 billion deal in April.
Nanobiotix SA has landed Johnson & Johnson Inc. subsidiary Janssen Pharmaceutica NV as commercialization partner for NBTXR-3, a radioenhancer for boosting the effectiveness of standard radiotherapy, in a deal worth up to $1.86 billion for the initial indications. That headline figure covers current programs in head and neck cancers and lung cancers. There is the potential for Nanobiotix to earn up to $650 million more if Janssen decides to pursue up to five new indications that it will select, while for new indications that Nanobiotix selects to develop in alignment with Janssen, Nanobiotix will receive up to $220 million per program.
China’s Center for Drug Evaluation and South Korea’s Ministry of Food and Drug Safety cleared Transcenta Holdings to begin phase III pivotal trials of osemitamab (TST-001) in combination with nivolumab and chemotherapy for first-line treatment of HER2-negative, Claudin 18.2 expressing locally advanced or metastatic gastric or gastroesophageal cancer.
The U.S. FDA has removed the partial clinical hold it placed in April 2022, prompted by a patient’s death, on Curis Inc.’s phase I/IIa study of emavusertib in treating leukemia. The company also said it just raised $15 million to keep everything going.
China’s Center for Drug Evaluation has cleared Jacobio Pharmaceuticals Group Co. Ltd.’s KRAS G12C inhibitor, glecirasib (JAB-21822), to begin a phase III pivotal study for pancreatic cancer.
Privately held F-star Therapeutics Inc. and Takeda Pharmaceutical Co. Ltd. have completed their third license agreement, one that could bring F-star about $1 billion. The new collaboration is focused on R&D against undisclosed cancer targets.
Most drug developers working in the immunotherapy space focus on existing therapeutic targets when developing cancer drugs, optimizing ways of drugging them via engineering modalities such as CAR T-cell approaches, CRISPR editing or antibody-drug conjugates that deliver toxic payloads. The angle of one company – Cartography Biosciences – is the opposite to this. Its modus operandi is to pinpoint the immunological targets first, leveraging tools that already exist, before building therapies around them.
South Korean pharmaceutical giant Yuhan Corp. gained Korea’s MFDS approval to expand indications for its potent oral third-generation tyrosine kinase inhibitor Leclaza (lazertinib) as a first-line treatment for EGFR T790M mutation-positive non-small-cell lung cancer (NSCLC).
The trophoblast cell surface antigen 2 (TROP2) class chalked mix news by way of Astrazeneca plc and Daiichi Sankyo Co. Ltd. as the pair disclosed phase III data from the closely watched Tropion-Lung 1 trial with datopotamab deruxtecan (dato-dxd) against non-small-cell lung cancer.
Haemalogix Ltd.’s monoclonal antibody Kappamab met all primary endpoints in a phase IIb trial that combined the MAb with lenalidomide and dexamethasone in kappa-type multiple myeloma patients who had relapsed or become refractory to other treatments.