Glenmark receives DCGI approval for Phase 1 trial for novel molecule - GRC 54276

19 Apr 2022 , 01:34 AM

Glenmark Pharmaceuticals announced that its subsidiary Glenmark Specialty SA Glenmark received approval from the Indian drug regulator Drug Controller General of India DCGI to conduct a Phase 1 clinical trial of its novel smallmolecule 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 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 Hodgkins 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