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.
Synendos Therapeutics AG has received approval from the European Medicines Agency (EMA) to initiate a first-in-human trial of its lead asset, SYT-510, a first-in-class inhibitor that modulates a newly identified drug target in the endocannabinoid system (ECS) to restore healthy brain physiology.
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.
Solid Biosciences Inc.’s SGT-003 has been granted orphan drug designation by the FDA. The company’s next-generation Duchenne muscular dystrophy gene therapy candidate was also granted fast track designation last month.
CSPC Pharmaceutical Group Ltd. has announced FDA approval of an IND application for JMT-106, a bispecific fusion protein drug, for glypican-3 (GPC3)-positive solid tumors.
Guangzhou Fermion Technology Co. Ltd. has announced IND clearance by China’s National Medical Products Administration (NMPA) for FZ-008-145 to treat pain.
Corbus Pharmaceuticals Holdings Inc. has obtained FDA clearance of its IND application for CRB-601, a TGF-β-blocking monoclonal antibody targeting the integrin αvβ8. Enrollment in a first-in-human phase I study will open in the first half of this year.