Glenmark Pharmaceuticals set to begin clinical trial of GRC 54276 in US

Glenmark Pharmaceuticals, through its subsidiary Glenmark Specialty, is set to begin a first-in-human, phase 1/2 clinical study of GRC 54276 in the US for the treatment of advanced solid tumors and lymphomas.

This was after Glenmark Specialty’s investigational new drug (IND) application for GRC 54276 was accepted by the US Food and Drug Administration (FDA).

Glenmark Pharmaceuticals developed GRC 54276 as an orally available, small molecule hematopoietic progenitor kinase 1 (HPK1) inhibitor.

According to the Indian pharma company, HPK1-regulated functions play a role in almost every stage of the cancer-immunity cycle, thereby making it a promising treatment for cancer immunotherapy. Through the blocking of HPK1, GRC 54276 is designed to possibly boost the immune system of patients to fight cancer.

A phase 1/2 multicenter, open-label trial to assess the safety and tolerability of the drug candidate along with its pharmacokinetics and preliminary anti-tumor properties of GRC 54276 is being conducted in India.

GRC 54276 is being evaluated as a monotherapy, or in combination with Anti PD-1 or Anti PDL-1 therapy in adult patients suffering from advanced lymphomas and solid tumors.

At present, 16 patients with different types of cancers that are advanced have been included in the ongoing study in India. Glenmark Pharmaceuticals is planning to extend the clinical study to locations outside of India in the coming months.

Nikhil Amin — Glenmark Pharmaceuticals Chief scientific officer said: “Now that the FDA has accepted our IND application, we look forward to initiating the ongoing Phase 1/2 study at the US sites. This is an important milestone for Glenmark as we continue to advance our oncology pipeline.

“We are excited about the prospects of what this new class of immune-oncology medicines may mean for patients in need.”