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

For treatment of cancer

Glenmark Pharmaceuticals 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 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 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.

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