Glenmark receives DCGI approval for conducting Phase 1 Clinical Trial of GRC 54276 in oncology patients

Phase 1 clinical trial is aimed at determining preliminary anti-tumor activity of its novel molecule in patients with advanced solid tumors and Hodgkin’s lymphoma.

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GRC 54276 is a hematopoietic progenitor kinase 1 (HPK1) inhibitor and a high-priority target in immuno-oncology. (Photo source: Pixabay)

Glenmark Pharmaceuticals Limited has received approval from the Drug Controller General of India (DCGI) to conduct a Phase 1 clinical trial of its novel small molecule, GRC 54276 in oncology patients. Phase 1 clinical trial is aimed at determining preliminary anti-tumor activity of its novel molecule in patients with advanced solid tumors and Hodgkin’s lymphoma. The trial which is scheduled to start by June 2022 will also determine the safety and tolerability of the novel molecule.

It also plans to file an Investigational New Drug (IND) application in the US and Clinical Trial Applications in Europe to kick-off a fully global clinical study program.

GRC 54276 is a hematopoietic progenitor kinase 1 (HPK1) inhibitor and a high-priority target in immuno-oncology. It has demonstrated tumor cell killing ability in preclinical studies as a single agent and in combination with checkpoint inhibitors.
HPK1improves antitumor immunity by activating and priming T cells as it is a key regulator of T cell, B cell and dendritic cell-mediated immune responses.

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

The Clinical trial will assess 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’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. This reinforces Glenmark’s growing capabilities of innovative clinical research and is a step closer in providing holistic solutions for cancer treatment,” said Glenn Saldanha, Chairman & Managing Director, Glenmark Pharmaceuticals Limited.

Glenmark Pharmaceuticals Ltd is a global pharmaceutical company with a presence across Specialty, Generics and OTC businesses. It focuses on the key therapeutic areas of respiratory, dermatology and oncology.

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This article was first uploaded on April eleven, twenty twenty-two, at thirty-three minutes past twelve in the night.
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