DCGI permission for Glenmark to test its novel anti-tumour drug

April 11, 2022 0 By Team FM

India’s leading research-led drug maker Glenmark Pharmaceuticals said that its subsidiary Glenmark Specialty SA 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, in the country. 

GRC 54276 is one of the many novel molecules from Glenmark’s in-house Innovative Medicines Group, headed by Dr. Nikhil Amin, chief scientific officer, specialising in the development of novel molecular entities for critical unmet medical needs. 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 tumour 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.

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 tumours 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.
“Glenmark’s endeavour 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,” said Glenmark chairman and managing director Glenn Saldanha in a Monday statement.