Glenmark receives approval for Trial of its new drug in patients with Advanced Solid Tumors and Hodgkin’s Lymphoma
Glenmark Pharmaceuticals, on Monday, announced that it has 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.
GRC 54276 is one of the many novel molecules from Glenmark’s resident Innovative Medicines Group. The company said, ‘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.’
The molecule 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.
“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 in providing holistic solutions for cancer treatment,”Glenn Saldanha, Chairman & Managing Director, Glenmark Pharmaceuticals Limited
Glenmark said that 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. The company 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.