Glenmark Pharmaceuticals’ subsidiary, Glenmark Specialty, has received acceptance from the US Food and Drug Administration (FDA) on its Investigational New Drug (IND) application for GRC 54276. The approval allows Glenmark to initiate a Phase 1/2 clinical trial of GRC 54276 in patients with advanced solid tumors and lymphomas.
GRC 54276 is an orally available, small molecule hematopoietic progenitor kinase 1 (HPK1) inhibitor developed by Glenmark. By inhibiting HPK1, GRC 54276 is designed to potentially enhance the patient’s own immune system to fight cancers. A Phase 1/2 multicenter, open-label study to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of GRC 54276 is currently underway in India, with 16 patients with various types of advanced cancers already enrolled. The study is being conducted as monotherapy or in combination with Anti PD-1 or Anti PDL-1 therapy in adults. Glenmark plans to expand the trial at ex-India research sites in the coming months.
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