Glenmark’s GRC 54276 Gets FDA Approval for Clinical Study to Treat Solid Tumors and Lymphomas

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Glenmark Pharmaceuticals Ltd.’s subsidiary, Glenmark Specialty SA, has received approval from the U.S. Food and Drug Administration (FDA) to proceed with a Phase 1/2, first-in-human clinical study of GRC 54276. The clinical trial will investigate GRC 54276 for the treatment of advanced solid tumors and lymphomas. GRC 54276 is a small molecule hematopoietic progenitor kinase 1 (HPK1) inhibitor developed by Glenmark.

The molecule works by inhibiting HPK1, potentially enhancing the patient’s immune system to fight cancers. GRC 54276 is currently being evaluated in a Phase 1/2 multicenter, open-label study in India. The ongoing study is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of GRC 54276. Sixteen patients with various types of advanced cancers have already been enrolled in this study.

Glenmark Pharmaceuticals plans to expand the study at ex-India research sites in the coming months. The company is excited about the prospects of what this new class of immune-oncology medicines may mean for patients in need. “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, Chief Scientific Officer and President, Innovative Medicine Group, Glenmark Pharmaceuticals Ltd.

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