Glenmark Pharma on Thursday said its investigational new drug (IND) application for potential cancer drug GRC 54276 was accepted by USFDA.

The USFDA approval paves the way for Glenmark’s subsidiary Glenmark Specialty to proceed with a Phase 1/2, first-in-human, clinical study of GRC 54276 for the treatment of patients with advanced solid tumors and lymphomas.

GRC 54276 is an oral small molecule hematopoietic progenitor kinase 1 (HPK1) inhibitor developed by Glenmark. By blocking HPK1, GRC 54276 is designed to potentially enhance the patient’s own immune system to fight cancers.

A Phase 1/2 multicenter, open-label study to evaluate the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of GRC 54276 is currently underway in India. GRC 54276 is being studied 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.

“Now that the FDA has accepted 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 at Glenmark.