Harbour Biomed Ltd. has received IND clearance by the FDA to initiate clinical trials in the U.S. with HBM-1022, a monoclonal antibody generated from Harbour's integrated G protein-coupled receptor (GPCR) platform. The antibody can enhance antitumor immunity by depleting CCR8 positive regulatory T cells, activating effector T cells.
Accutar Biotechnology Inc. has received FDA clearance of its IND application for AC-0676 for the treatment of patients with relapsed/refractory B-cell malignancies.
Egret Therapeutics, a portfolio company of Turret Capital Management LP, has announced FDA clearance of its IND application for EGT-101 for the treatment of delayed cerebral ischemia following aneurysmal subarachnoid hemorrhage.
Inmagene Biopharmaceuticals Co. Ltd. has obtained IND approval from the FDA for IMG-008, the company's novel long-acting antagonistic humanized monoclonal antibody that specifically targets human IL-36 receptor (IL-36R) to treat auto-inflammatory diseases.
Pliant Therapeutics Inc. has received FDA clearance of its IND application for PLN-101095, an oral, small-molecule, dual selective inhibitor of integrins αvβ8 and αvβ1.
Greenlight Biosciences Holdings PBC has received regulatory approval from the Rwanda Food and Drugs Authority (Rwanda FDA) to start a first-in-human phase I/II trial of its mRNA vaccine candidate against COVID-19, GLB-COV2-043, as a booster for previously vaccinated individuals.
Rise Therapeutics LLC has received FDA clearance for its IND application to proceed with a phase I trial of R-3750, a synthetic biology-based cellular immunotherapy being developed for the treatment of inflammatory bowel disease. The phase I trial will enroll patients with mild to moderate ulcerative.
Deka Biosciences Inc.'s IND application has been cleared by the FDA allowing the company to proceed with a phase I trial of DK-210 (EGFR) in patients with advanced solid cancer overexpressing epidermal growth factor receptors (EGFR).
Escient Pharmaceuticals Inc. has obtained FDA clearance of its IND application for EP-262, a first-in-class, potent, highly selective small-molecule antagonist of Mas-related G-protein coupled receptor member X2 (MRGPRX2) for mast cell-mediated disorders.
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