Patients with end-stage pancreatic ductal adenocarcinoma achieved unprecedented survival rates after being treated with the Engeneic dream vector nanocells, with 88% of patients doubling the historical survival rates, Engeneic Ltd. co-CEO Jennifer MacDiarmid told BioWorld.
Abbisko Therapeutics Co. Ltd. has out-licensed China rights to its colony-stimulating factor 1 receptor inhibitor, pimicotinib, to Merck KGaA in a deal worth up to $605.5 million. Pimicotinib is in phase III trials in patients with tenosynovial giant cell tumors in China, the U.S., Canada and Europe.
In less than one week, Innovent Biologics Inc. has seen two NDAs for non-small-cell lung cancer accepted for review by China’s National Medical Products Administration, and both are firsts for China. The NDA for IBI-351 under priority review marks China’s first NDA for a KRAS G12C inhibitor, and the NDA for taletrectinib is the first global submission for the ROS1 inhibitor.
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.
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