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.
Askgene Pharma Inc. has received FDA clearance of its IND application to start a phase I study of ASKG-915, a novel and proprietary anti-PD-1/IL-15 prodrug fusion molecule for the treatment of cancer.
Transcode Therapeutics Inc. has received clearance from the FDA to proceed with a first-in-human phase 0 trial of TTX-MC138 in cancer patients with advanced solid tumors. A single dose of radiolabeled TTX-MC138 will be followed by noninvasive PET-MRI to quantify the amount of radiolabeled TTX-MC138 delivered to metastatic lesions.
Simcere Pharmaceutical Group Ltd. has received IND approval from China's National Medical Products Administration (NMPA) for two immuno-oncology bispecific antibodies, SIM-0348 and SIM-0237.
Janux Therapeutics Inc. has announced that it has submitted an IND application to the FDA for JANX-008, an epidermal growth factor receptor (EGFR)-tumor-activated T cell engager (TRACTr) in development for the treatment of EGFR-expressing solid tumors, including non-small-cell lung cancer (NSCLC), colorectal cancer (CRC), renal cell carcinoma (RCC), and squamous cell carcinoma of the head and neck (SCCHN).
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