Glenmark Pharma shares gain on DCGI nod to clinical trial of #39;novel#39; small molecule

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Glenmark will initiate Phase 1 clinical trial in India by June 2022 for its small molecule, GRC 54276, a hematopoietic progenitor kinase 1 (HPK1) inhibitor

Glenmark Pharmaceuticals

Glenmark Pharmaceuticals

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Glenmark Pharmaceuticals’ share price gained over a percent intraday on April 11 after the company received the approval of the Drug Controller General of India (DCGI) for a Phase 1 clinical trial of a “novel” small molecule.

“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 small molecule, GRC 54276, a hematopoietic progenitor kinase 1 (HPK1) inhibitor,” the company said in a press release.

GRC 54276 is one of the many novel molecules from Glenmark’s resident, Innovative Medicines Group, headed by Dr Nikhil Amin, Chief Scientific Officer, specialising in the development of novel molecular entities for critical unmet medical needs, the company added.

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.

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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“Glenmark’s endeavor has been to provide innovative treatment solutions in its core therapeutic areas. We are delighted that our first novel molecule from the newly formed ‘Innovative Medicines Group’ within Glenmark has received approval from India’s drug regulator to initiate a Phase 1 clinical trial,” said Glenn Saldanha, Chairman & Managing Director, Glenmark Pharmaceuticals Limited.

This reinforces Glenmark’s growing capabilities of innovative clinical research and is a step closer in providing holistic solutions for cancer treatment,” Saldanha added.

At 10.33 am, Glenmark Pharma was quoting at Rs 481.70, up Rs 2.50, or 0.52 percent, on the BSE.

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