Glenmark Pharmaceuticals’ subsidiary, Glenmark Specialty SA, has received acceptance from the U.S. Food and Drug Administration (FDA) on its Investigational New Drug (IND) application for GRC 54276. The clinical trial will investigate 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 immuno-oncology. By inhibiting HPK1, GRC 54276 is designed to potentially enhance the patient’s own immune system to fight cancers.
The ongoing Phase 1/2 multicenter, open-label study in India is currently evaluating the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of GRC 54276. The study has already enrolled 16 patients with various types of advanced cancers. The study is being conducted as monotherapy or in combination with Anti PD-1 or Anti PDL-1 therapy in adults.
Glenmark Pharmaceuticals Ltd. plans to expand the study at ex-India research sites in the subsequent months. This new class of immune-oncology medicines is promising, and Glenmark is excited about what it may mean for patients in need. “Now that the FDA has accepted our IND application, we look forward to initiating the ongoing Phase 1/2 study at the US sites. This is an important milestone for Glenmark as we continue to advance our oncology pipeline,” said Nikhil Amin, Chief Scientific Officer and President, Innovative Medicine Group, Glenmark Pharmaceuticals Ltd.