Glenmark Pharmaceuticals’ arm gets USFDA’s approval for GRC 54276

16 Mar 2023 Evaluate

Glenmark Pharmaceuticals’ subsidiary -- Glenmark Specialty SA has received acceptance from the United States Food & Drug Administration (USFDA) on its Investigational New Drug (IND) application for GRC 54276 to proceed with a Phase 1/2, first-in-human, clinical study of GRC 54276 for the treatment of patients with advanced solid tumors and lymphomas.

GRC 54276 is an orally available, small molecule hematopoietic progenitor kinase 1 (HPK1) inhibitor developed by Glenmark. HPK1-regulated functions are involved in nearly every step of the cancer-immunity cycle making it an attractive target for immune-oncology. 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. GRC 54276 is being studied as monotherapy or in combination with Anti PD-1 or Anti PDL-1 therapy in adults with advanced solid tumors and lymphomas. To date, 16 patients with various type of advanced cancers have been enrolled in this ongoing study in India, and company plans to expand the study at ex-India research sites in the subsequent months. 

Glenmark Pharmaceuticals is a global research-led pharmaceutical company with presence across Generics, Specialty and OTC business with operations in over 50 countries.

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