Glenmark Pharmaceuticals Ltd.’s subsidiary, Glenmark Specialty SA, has received acceptance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for GRC 54276. The drug will now proceed to Phase 1/2, first-in-human clinical study 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 that inhibits HPK1 to enhance the patient’s own immune system to fight cancers. HPK1-regulated functions are involved in nearly every step of the cancer-immunity cycle, making it an attractive target for immuno-oncology.
The Phase 1/2 clinical study of GRC 54276 is currently underway in India to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of the drug 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 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. With the FDA’s acceptance of its IND application, Glenmark expects to initiate the ongoing Phase 1/2 study at US sites soon.
This is a significant milestone for Glenmark as it continues to advance its oncology pipeline. “We are excited about the prospects of what this new class of immune-oncology medicines may mean for patients in need,” said Nikhil Amin, MD, Chief Scientific Officer and President, Innovative Medicine Group, Glenmark Pharmaceuticals Ltd. The company hopes to provide a promising new option for patients battling advanced solid tumors and lymphomas, and this FDA acceptance brings them one step closer to achieving that goal.