Glenmark Pharma get USFDA nod for human trial of cancer-treating drug

Glenmark Pharmaceuticals on Thursday said its arm has received acceptance from the US health regulator to proceed with a phase 1/2, first-in-human trial for its investigational new drug aimed for treatment of patients with advanced cancers.

In a regulatory filing, the company said Glenmark Specialty SA received the acceptance from the US Food and Drug Administration (USFDA) for the investigational new drug (IND) application 'GRC 54276' for the treatment of patients with advanced solid tumours and lymphomas.

Developed by Glenmark, GRC 54276 is an orally available, small molecule hematopoietic progenitor kinase 1 (HPK1) inhibitor. HPK1-regulated functions are involved in nearly every step of the cancer-immunity cycle, making it an attractive target for immuno-oncology, the company said.

By inhibiting HPK1, GRC 54276 is designed to potentially enhance the patient's own immune system to fight cancers, it added.

"Now that the (US)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," Glenmark Pharmaceuticals Ltd Chief scientific officer and President, innovative Medicine Group, Nikhil Amin said.

A Phase 1/2 multicenter, open-label study to evaluate the safety, tolerability, pharmacokinetics and preliminary anti-tumour activity of GRC 54276 is currently underway in India, the company said.

So far 16 patients with various types of advanced cancers have been enrolled in this ongoing study in India, and the company plans to expand the study at ex-India research sites in the subsequent months, it added.