Glenmark Pharma arm gets USFDA acceptance on human trial of cancer-treating drug

Glenmark Specialty SA, the subsidiary of drug major Glenmark Pharma on Thursday said that it has received acceptance from US Food and Drug Administration (FDA) for first-in-human clinical study on its Investigational New Drug (IND) application for the treatment of patients with advanced solid tumors and lymphomas.

"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," the company said in a regulatory filing.

As per the official press release, GRC 54276 is designed to potentially enhance the patient’s own immune system to fight cancers. Developed by Glenmark, the novel molecule is an orally available and 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.

"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," said Nikhil Amin (MD), Chief scientific officer and President, innovative Medicine Group, Glenmark Pharmaceuticals Ltd.

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.

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

Studied as monotherapy, GRC 54276’s phase 1/2 multicenter, open-label study to evaluate the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity is currently underway in India.

Moreover, the company in a stock exchange filing also mentioned that to date, 16 patients with various type of advanced cancers have been enrolled in this ongoing study in India and company plans to expand the study at ex-India research sites in the subsequent months.