Shanghai Henlius Biotech Inc. has announced IND approval by the FDA for HLX-42 for injection, an antibody-drug conjugate (ADC) developed under a collaboration between Henlius and Medilink Therapeutics.
South Korean pharmaceutical Voronoi Inc. said that New Jersey-based Pyramid Biosciences Inc. terminated its previous $846 million deal for Voronoi’s solid and breast cancer drug candidate, VRN-08, in a letter dated Oct. 24, 2023.
Polaris Pharmaceuticals Inc. has submitted the first part of its rolling BLA to the FDA for lead product, ADI-PEG 20, for systemic treatment of patients with malignant pleural mesothelioma with non-epithelioid histology in combination with a platinum agent and pemetrexed. The BLA is supported by the pivotal phase III Atomic study in which pegargiminase (pegylated arginine deiminase/ADI-PEG 20) met the primary endpoint of a statistically significant improvement in overall survival and the secondary endpoint of a significant improvement in progression-free survival in patients with malignant pleural mesothelioma.
Two-year-old Ensem Therapeutics Inc. landed a deal potentially worth $1.33 billion, if all milestones are met, with Beigene Ltd. to advance its lead IND-ready oral cyclin-dependent kinase 2 (CDK2) inhibitor. Beigene, which has a presence in Basel, Switzerland, Beijing, and Cambridge, Mass., plans to fold the inhibitor into its breast cancer efforts, which includes its internally discovered phase I CDK4 inhibitor. Rights to the Ensem product are exclusive and global.
The U.S. and China biotech Apollomics Inc. on Nov. 16 gained the NMPA’s conditional approval for its cellular mesenchymal-epithelial transcription inhibitor for lung cancer called vebreltinib (APL-1010) through its Beijing-based partner, Avistone Biotechnology Co. Ltd.
Immvira Group Co. plans to progress its intravenous oncolytic herpes simplex virus (oHSV) MVR-T3011-IV to phase II trials after completing a phase I study in the U.S. in patients with late-stage solid tumors. The Shenzhen, China-based company is the first to conduct clinical trials via intravenous administration of oHSVs.
Legend Biotech Corp. is entering what it no doubt hopes will be another fruitful collaboration with big pharma. Legend’s wholly owned subsidiary, Legend Biotech Ireland Ltd., will work with Novartis AG in an exclusive global development and license agreement for chimeric antigen receptor T-cell therapies targeting DLL3.
The U.S. FDA approved Takeda Pharmaceutical Co. Ltd.’s Fruzaqla (fruquintinib) nearly 20 days ahead of its Nov. 30 PDUFA date for adults with previously treated metastatic colorectal cancer. “Fruzaqla is the first targeted therapy approved in the U.S. for mCRC regardless of biomarker status or prior types of therapies in more than a decade,” Stefanie Granado, head of Takeda’s U.S. Oncology business unit, told BioWorld.
Israeli biotech Biolinerx Ltd. will hand off the rights to its stem cell mobilizer, motixafortide, in Asia to China’s Gloria Biosciences Co. Ltd. via an out-licensing deal worth up to $280 million, news that sent stocks soaring nearly 13% on Oct. 31.
Hitching onto the emerging drug class of degrader-antibody conjugates (DAC), U.S. pharma giant Bristol Myers Squibb Co. (BMS) is picking up rights to the U.S. and Korean biotech Orum Therapeutics Inc.’s blood cancer candidate, ORM-6151, in a potential $180 million deal.
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