Glenmark Pharmaceuticals on Monday said its unit has received approval from the Drug Controller General of India (DCGI) to conduct phase 1 clinical trials of its novel molecule on patients with advanced solid tumors.
Glenmark Specialty SA has received approval from the 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 Innovative Medicines Group specialising in the development of novel molecular entities for critical unmet medical needs.
The Mumbai-based drug major said, 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, it added.
The company said it will initiate Phase 1 clinical trial in India by June 2022, and also plans to file an IND (Investigational New Drug) application in the US and clinical trial applications in Europe to kick-off a fully global clinical study programme.
"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," Glenmark Pharmaceuticals Chairman & Managing Director Glenn Saldanha noted.
Glenmark has a presence across specialty, generics and OTC businesses. It focuses on the key therapeutic areas of respiratory, dermatology and oncology. The company has ten manufacturing facilities spread across four continents and operations in over 80 countries.
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