The FDA has cleared Cullinan Oncology Inc.'s IND application for CLN-978, a CD19/CD3 T-cell engaging antibody construct with a human serum albumin (HSA) binding domain to increase serum half-life.
Neurogene Inc. has received FDA clearance of its IND application for NGN-401 for the treatment of Rett syndrome. The company plans to initiate a phase I/II trial in female pediatric patients with Rett syndrome this year.
Harbour Biomed Ltd. has received FDA clearance of its IND application to initiate clinical trials in the U.S. with HBM-1007, a fully human monoclonal antibody targeting CD73.
Exegenesis Bio (Hangzhou Exegenesis Biotechnology Co. Ltd.) has received FDA clearance of its IND application for EXG-102-031, a recombinant adeno-associated virus (rAAV)-based gene therapy that is being studied for the treatment of neovascular age-related macular degeneration (AMD).
SFA Therapeutics Inc. has received FDA clearance of its IND application to investigate SFA-001N in patients with nonalcoholic steatohepatitis (NASH) with or without fibrosis.
CSPC Pharmaceutical Group Ltd. has received clearance from China's National Medical Products Administration (NMPA) to conduct clinical trials in China of the highly selective novel protein arginine methyltransferase 5 (PRMT5) inhibitor SYH-2045 for the treatment of advanced malignant tumors.
Hotspot Therapeutics Inc. has received FDA clearance of its IND application for HST-1011, the company's investigational small-molecule allosteric inhibitor of casitas B-lineage lymphoma-B (CBL-B), an E3 ubiquitin protein ligase critically involved in immune cell response.
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