Glenmark Pharmaceuticals Limited, an innovation-driven, the global pharmaceutical company announced that its subsidiary Glenmark Specialty S.A. (Glenmark) received approval from the Indian drug regulator, Drug Controller General of India (DCGI), to conduct a Phase 1 clinical trial of its novel small molecule, GRC 54276, a hematopoietic progenitor kinase 1 (HPK1) inhibitor.

HPK1 is a key regulator of T cell, B cell, and dendritic cell-mediated immune responses, which improves antitumor immunity by activating and priming T cells. GRC 54276 has shown tumor cell killing ability in preclinical studies as a single agent and as well in combination with checkpoint inhibitors, making it a high-priority target in immuno-oncology. GRC 54276 is one of the many novel molecules from Glenmark’s resident, Innovative Medicines Group.

Glenn Saldanha, Chairman & Managing Director, Glenmark Pharmaceuticals Limited, said:

Glenmark’s endeavor has been to provide innovative treatment solutions in its core therapeutic areas. We are delighted that our first novel molecule from the newly formed ‘Innovative Medicines Group’ within Glenmark has received approval from India’s drug regulator to initiate a Phase 1 clinical trial. This reinforces Glenmark’s growing capabilities of innovative clinical research and is a step closer TO providing holistic solutions for cancer treatment.

The study will evaluate the safety and tolerability of GRC 54276 as a monotherapy, and also in combination with checkpoint inhibitors in patients with advanced solid tumors and Hodgkin’s lymphoma. Glenmark will initiate Phase 1 clinical trial in India by June 2022, and also plans to file an IND in the US and Clinical Trial Applications in Europe to kick off a fully global clinical study program.