Glenmark Specialty SA, a subsidiary of the company received acceptance from the US drug regulator for first-in-human clinical study for treatment of patients with advanced solid tumors and lymphomas.
The United States Food and Drug Administration (USFDA) gave its acceptance to Glenmark Specialty SA's investigational new drug (IND) application for GRC 54276, an orally available, small molecule hematopoietic progenitor kinase 1 (HPK1) inhibitor developed by Glenmark to proceed with a phase 1/2, first-in-human, clinical study for the treatment of patients with advanced solid tumors and lymphomas.HPK1-regulated functions are involved in nearly every step of the cancer-immunity cycle making it an attractive target for immuno-oncology. By inhibiting HPK1, GRC 54276 is designed to potentially enhance the patient's own immune system to fight cancers.
Phase 1/2 multicenter is an open-label study to evaluate the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of GRC 54276 is currently underway in India.
GRC 54276 is being studied as monotherapy or in combination with anti PD-1 or anti PDL-1 therapy in adults with advanced solid tumors and lymphomas. To date, 16 patients with various types 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.
Nikhil Amin (MD), chief scientific officer and president of innovative Medicine Group at Glenmark Pharmaceuticals said, 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. We are excited about the prospects of what this new class of immune-oncology medicines may mean for patients in need.
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Glenmark Pharmaceuticals is a global innovation-driven pharmaceutical company with presence across specialty, generics and OTC businesses.
The company's consolidated net profit rose 21.13% to Rs 290.76 crore on 8% increase in net sales to Rs 3,392.24 crore in Q3 FY23 over Q3 FY22.
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