Mumbai: Glenmark Specialty SA, the subsidiary of Glenmark Pharmaceuticals Ltd has received acceptance from the US Food and Drug Administration (FDA) on its Investigational New Drug (IND) application for GRC 54276 to proceed with a Phase 1/2 human clinical study in India, to evaluate the drug’s safety, tolerability, pharmacokinetics and preliminary anti-tumour activity.
GRC 54276, an orally available, small-molecule hematopoietic progenitor kinase 1 (HPK1) inhibitor, is being tested to assess its efficacy for treating patients with advanced solid tumours and lymphomas. 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.
GRC 54276 is being studied as monotherapy or in combination with Anti PD-1 or Anti PDL-1 therapy in adults with advanced solid tumours and lymphomas. To date, 16 patients with various types of advanced cancers have been enrolled in this ongoing study in India, and the company plans to expand the study at ex-India research sites in the subsequent months.
Commenting on the approval, Nikhil Amin, Chief scientific officer and President, Innovative Medicine Group, Glenmark Pharmaceuticals Ltd. said, “Now that the FDA has accepted our IND application, we look forward to initiating the ongoing Phase 1/2 study at the US sites. We are excited about the prospects of what this new class of immune-oncology medicines may mean for patients in need.”