Glenmark Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) to begin clinical trials of its new drug candidate GRC 54276. The drug, which inhibits hematopoietic progenitor kinase 1 (HPK1), has shown potential in boosting the immune system’s response to cancerous cells. It will be tested in a Phase 1/2, first-in-human clinical trial for patients with advanced solid tumors and lymphomas.
HPK1 is involved in many stages of the cancer-immunity cycle, making it a promising target for immuno-oncology. By blocking HPK1, GRC 54276 may enable the immune system to fight cancer more effectively. The drug has already shown promise in an ongoing trial in India, with 16 patients enrolled to date. The US trial will evaluate the drug’s safety, tolerability, pharmacokinetics and anti-tumor activity in adults with advanced solid tumors and lymphomas.
Glenmark’s Chief Scientific Officer and President of the Innovative Medicine Group, Nikhil Amin, said the FDA approval was an important milestone for the company’s oncology pipeline. He added that the potential for GRC 54276 to enhance the immune system’s natural defenses against cancer was an exciting prospect for patients in need. The trial is expected to begin soon, with the aim of assessing the drug’s efficacy in treating some of the most challenging forms of cancer.
