Decibel Therapeutics Inc. has received clearance from the FDA for its IND application to initiate a phase I/II trial of DB-OTO in pediatric patients, potentially in infants younger than 2 years of age.
Lyell Immunopharma Inc. has received FDA clearance for its IND application to initiate a phase I trial for LYL-845, an investigational tumor-infiltrating lymphocyte (TIL) therapy enhanced with Lyell's Epi-R technology for patients with relapsed and/or refractory metastatic or locally advanced melanoma and other select solid tumors.
Transcenta Holding Ltd. has received IND clearance from the FDA for TST-004, its best-in-class, humanized monoclonal antibody targeting mannose-binding protein-associated serine protease 2 (MASP2), for IgA nephropathy (IgAN).
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.
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.
Innocare Pharma Ltd. has received IND approval from China's National Medical Products Administration (NMPA) to begin clinical trials of its B-cell lymphoma-2 (BCL2) inhibitor ICP-248.
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