Glenmark Pharmaceuticals’ subsidiary Glenmark Specialty has received the Drugs Controller General of India (DCGI) approval to initiate the Phase I clinical trial of its new small-molecule, GRC 54276, in advanced solid tumours and Hodgkin's lymphoma patients.
The clinical trial is designed for assessing GRC 54276’s tolerability and safety as a monotherapy, as well as in combination with checkpoint inhibitors in these patients.
GRC 54276 is a hematopoietic progenitor kinase 1 (HPK1) inhibitor and is said to be one of the new molecules from Innovative Medicines Group, which is specialised in developing new molecular entities for critical unmet medical needs.
In preclinical studies, the new small molecule has demonstrated tumour cell killing ability when given as a single agent and along with checkpoint inhibitors.
By June this year, Glenmark Specialty plans to commence the Phase I clinical study in India.
It also plans to file an investigational new drug (IND) application in the US as well as Clinical Trial Applications in Europe to begin a complete global clinical study programme.
Glenmark Pharmaceuticals chairman and managing director Glenn Saldanha said: “Glenmark’s endeavour 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 I clinical trial.
“This reinforces Glenmark’s growing capabilities of innovative clinical research and is a step closer in providing holistic solutions for cancer treatment.”
The company focuses on the key therapeutic areas of oncology, dermatology, and respiratory.