Glenmark Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) to conduct a Phase 1/2 clinical trial of its new drug candidate GRC 54276. The orally available small molecule HPK1 inhibitor is designed to boost the immune system’s natural response to cancerous cells, with potential applications in the treatment of advanced solid tumors and lymphomas.
The drug candidate has shown promise in an ongoing trial in India, where it is being evaluated as a monotherapy or in combination with Anti PD-1 or Anti PDL-1 therapy. The US trial will assess the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of GRC 54276 in adults with advanced solid tumors and lymphomas.
Glenmark’s Chief Scientific Officer and President of the Innovative Medicine Group, Nikhil Amin, described the FDA approval as an important milestone for the company’s oncology pipeline. He noted that GRC 54276’s ability to inhibit HPK1, a key regulator of the cancer-immunity cycle, could have significant implications for the treatment of some of the most challenging forms of cancer. The Phase 1/2 trial is expected to begin soon, with the aim of determining the drug’s efficacy in enhancing the immune system’s natural defenses against cancer.