Immuneering Corp. has received FDA clearance of its IND application for IMM-1-104, paving the way for the company to initiate a phase I/IIa trial of this oral, once-daily small molecule in development for the treatment of advanced RAS-mutant solid tumors.
Verismo Therapeutics Inc. has received U.S. orphan drug designation from the FDA for Synkir-110 for the treatment of patients with mesothelin-expressing mesotheliomas.
Ambulero Inc., a spinout from the University of Miami Miller School of Medicine, has received a positive response from a type B pre-IND meeting with the FDA on the development of AMB-301 as a treatment for the vascular disease Buerger's disease.
Akouos Inc. has received IND clearance from the FDA to initiate a first-in-human phase I/II pediatric trial of AK-OTOF, a gene therapy intended for the treatment of patients with otoferlin gene (OTOF)-mediated hearing loss.
Transcenta Holding Ltd. has received IND clearance from the FDA for TST-003, its first-in-class, high-affinity, humanized monoclonal antibody targeting gremlin-1.
The FDA has granted orphan drug designation to Iecure Inc.'s lead product candidate GTP-506, an investigational product for the treatment of ornithine transcarbamylase (OTC) deficiency.
Tenaya Therapeutics Inc. has received FDA clearance of its IND application to begin clinical testing of TN-301, a highly selective small-molecule inhibitor of histone deacetylase 6 (HDAC6) initially being developed for heart failure with preserved ejection fraction (HFpEF).
Monte Rosa Therapeutics Inc. has received FDA clearance of its IND application for MRT-2359, a potent and selective GSPT1-directed molecular glue degrader (MGD).