Glenmark’s innovative immune-oncology drug for advanced solid tumors and lymphomas receives FDA acceptance for Phase 1/2 clinical study
Glenmark Pharmaceuticals Ltd.’s subsidiary, Glenmark Specialty SA, has achieved a breakthrough in the fight against advanced solid tumors and lymphomas. The US Food and Drug Administration (FDA) has accepted the company’s Investigational New Drug (IND) application for GRC 54276, an innovative immune-oncology drug. The drug will proceed to Phase 1/2, first-in-human clinical study, potentially opening up a new chapter in cancer treatment.
GRC 54276 is a small molecule hematopoietic progenitor kinase 1 (HPK1) inhibitor developed by Glenmark. By inhibiting HPK1, GRC 54276 is designed 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 its safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity as monotherapy or in combination with anti PD-1 or anti PDL-1 therapy in adults with advanced solid tumors and lymphomas. The company plans to expand the study at ex-India research sites in the subsequent months.
“With the FDA’s acceptance of 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, MD, Chief Scientific Officer and President, Innovative Medicine Group, Glenmark Pharmaceuticals Ltd. This FDA acceptance brings the company one step closer to providing a promising new option for patients battling advanced solid tumors and lymphomas.
This news has been met with excitement in the medical community, as there is a great need for new treatment options for patients with advanced solid tumors and lymphomas. The FDA acceptance of Glenmark’s IND application for GRC 54276 is a significant step towards addressing that need. The company hopes that their innovative immune-oncology drug will provide new hope and a potentially life-saving treatment for those who need it most.