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. This allows Glenmark to proceed with a Phase 1/2, first-in-human clinical study of the molecule for the treatment of patients with advanced solid tumors and lymphomas.
GRC 54276 is a small molecule hematopoietic progenitor kinase 1 (HPK1) inhibitor designed to potentially enhance the patient’s own immune system to fight cancers. The Phase 1/2 multicenter, open-label study is currently underway in India and will evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of GRC 54276 as monotherapy or in combination with Anti PD-1 or Anti PDL-1 therapy in adults with advanced solid tumors and lymphomas. With the FDA’s acceptance of the IND application, Glenmark plans to expand the study at ex-India research sites in the subsequent months.