Biontech SE and Duality Biologics Co. Ltd. have progressed BNT-323/DB-1303 to pivotal phase III trials, beginning in China in patients with hormone receptor-positive and HER2-low metastatic breast cancer.
CDR-Life Inc. has announced FDA clearance of an IND application for CDR-404, its lead program in development as a precision immunotherapy for solid tumors.
NK Celltech Co. Ltd. has announced FDA clearance for a clinical trial of NK-010, a nongenetically modified allogeneic peripheral blood natural killer (NK) cell drug.
Strand Therapeutics Inc. has received IND clearance from the FDA to initiate a first-in-human phase I trial of STX-001 as a new approach for the treatment of solid tumors.
Ratio Therapeutics Inc. has closed a $50 million series B financing to expand application of its proprietary technology platforms, Trillium and Macropa, to develop novel best-in-class radiopharmaceuticals.
Presage Biosciences Inc. has announced that the FDA has issued a study may proceed notification for testing a pre-GMP drug candidate with the company’s Comparative In Vivo Oncology (CIVO) platform. Owned by Pure Biologics, the drug candidate, PBA-0405, is a ROR1-targeting compound that has been engineered to induce tumor cell killing by cytotoxic immune cells.
Axelia Oncology Pty Ltd. was spun out of Ena Respiratory Pty. Ltd., which developed a series of synthetic Toll-like receptor (TLR) 2/6 agonists for nasal delivery to treat respiratory infections, including influenza and SARS-CoV-2. Although the pegylated TLR 2/6 agonist, INNA-051, was initially focused on antiviral activity, the company discovered that it also worked in oncology models, and Axelia was spun out to focus on oncology, CEO Phil Kearney told BioWorld.
