Glenmark Specialty S.A. receives approval for conducting Phase 1 Clinical Trial of its Novel Molecule GRC 54276 in patients with Advanced Solid Tumors and Hodgkin's Lymphoma
– GRC 54276 is one of the many novel molecules from Glenmark’s resident, Innovative Medicines Group, specializing in the development of novel molecular entities for critical unmet medical needs
– Glenmark will initiate a Phase 1 clinical trial by June 2022 to determine the safety, tolerability, and preliminary anti-tumor activity of its novel molecule in patients with advanced solid tumors and Hodgkin’s lymphoma
– Glenmark also plans to file an Investigational New Drug (IND) application in the US and Clinical Trial Applications in Europe to initiate a fully global clinical study program
MUMBAI, India, April 11, 2022 /PRNewswire/ — Glenmark Pharmaceuticals Limited, an innovation-driven, global pharmaceutical company, 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. GRC 54276 is one of the many novel molecules from Glenmark’s resident, Innovative Medicines Group, headed by Dr. Nikhil Amin, Chief Scientific Officer, specializing in the development of novel molecular entities for critical unmet medical needs. HPK1 is a key regulator of T cell, B cell and dendritic cell-mediated immune responses, which improves antitumor immunity by activating and priming T cells. 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.
The study will evaluate 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 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.
“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.
About Glenmark Pharmaceuticals Ltd
Glenmark Pharmaceuticals Ltd. (BSE: 532296 | NSE: GLENMARK) is an innovation-driven global pharmaceutical company with a presence across Specialty, Generics and OTC businesses. It focuses on the key therapeutic areas of respiratory, dermatology and oncology. The company has 10 world-class manufacturing facilities spread across 4 continents and operations in over 80 countries. Glenmark is ranked among the world’s top 100 biopharmaceutical companies (Top 100 Companies Ranked by Pharmaceutical Sales, 2020, by In Vivo/Scrip 100) and among the world’s top 50 companies in the off-patent sector (Top 50 Generics and Biosimilars Companies ranked by Sales, 2020, by Generics Bulletin/In Vivo). The company was listed on the Dow Jones Sustainability Index (DJSI), one of the world’s most respected and widely accepted sustainability benchmarks, under the category of emerging markets (2021) for the fourth consecutive year in a row. For more information, visit www.glenmarkpharma.com
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