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.
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.
Newco T-Therapeutics Ltd. has raised £48 million (US$59 million) in a series A to advance development of T-cell receptors generated by its transgenic mouse platform for the treatment of solid tumors, autoimmune diseases and infections.
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.
Along with Enhertu, Astrazeneca plc now has another breast cancer treatment in its portfolio and it may also become a blockbuster. Truqap (capivasertib), combined with the company’s Faslodex (fulvestrant), is now U.S. FDA-approved for treating hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer.
From the start of the Nov. 16 Oncologic Drugs Advisory Committee meeting, the U.S. FDA made it clear that withdrawing Acrotech Biopharma Inc.’s peripheral T-cell lymphoma drugs, Folotyn (pralatrexate) and Beleodaq (belinostat), from the market until a long-overdue confirmatory trial is completed is not an option given the current treatment landscape.
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.
Etcembly emerged from stealth mode in August with something it regards as seemingly impossible: A machine learning platform that has the ability to predict and engineer – at never-seen-before scale and speed – T-cell receptors (TCR) that enable bispecific T-cell engager antibodies targeting cancer cells to be produced.
More than a week earlier than its PDUFA date, Bristol Myers Squibb Co. received U.S. FDA approval of its next-generation ROS1 tyrosine kinase inhibitor repotrectinib for adults with ROS1-positive locally advanced or metastatic non-small-cell lung cancer.
If there had been any lingering market concerns following the temporary partial clinical hold earlier this year for Arcellx Inc.’s multiple myeloma CAR T-cell therapy, CART-ddBCMA, they were likely put to rest as partner Gilead Sciences Inc.’s Kite unit expanded the scope of the firms’ late 2022 collaboration to include lymphomas. At the same time, Kite exercised an option to negotiate a license for Arcellx’s ARC-Sparx program, ACLX-001, in multiple myeloma.
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