Glenmark Pharmaceuticals, a global innovation-driven pharmaceuticals company, has announced that the US Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for GRC 54276. The company plans to proceed with a Phase 1/2 clinical study of GRC 54276 in patients with advanced solid tumors and lymphomas.
GRC 54276 is an orally available small molecule that inhibits hematopoietic progenitor kinase 1 (HPK1). 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 Phase 1/2 multicenter, open-label study is currently underway in India, where 16 patients with various types of advanced cancers have been enrolled. The study aims to 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. The company also plans to expand the study to include ex-India research sites in the coming months.
Nikhil Amin, MD, Chief Scientific Officer and President, Innovative Medicine Group, Glenmark Pharmaceuticals Ltd. said, “We are thrilled to receive the FDA’s acceptance of our IND application for GRC 54276. This is an important milestone for Glenmark as we continue to advance our oncology pipeline. We look forward to initiating the Phase 1/2 study at US sites and the prospects of what this new class of immune-oncology medicines may mean for patients in need.”
The acceptance of Glenmark’s IND application by the FDA is a significant step forward in the development of GRC 54276, and it offers new hope to patients with advanced solid tumors and lymphomas. Glenmark’s continued focus on innovation and advancement in oncology research holds the potential to make a significant impact in the fight against cancer.