HQ Team
March 16, 2023: Glenmark Specialty SA, a subsidiary of India’s Glenmark Pharmaceuticals, has got investigational new drug clearance from the FDA to conduct clinical trials in the US sites for its drug to treat advanced solid tumours and lymphomas.
The FDA approved the company’s GRC 54276 drug, accordant a BSE filing. The regulatory body allowed phase 1/2, first-in-human, clinical study in advanced patients.
GRC 54276 is a small molecule hematopoietic progenitor kinase 1 (HPK1) inhibitor developed by Glenmark. HPK1-regulated functions are involved in nearly every step of the cancer immunity cycle, making it an attractive target for immuno-oncology.
Hematopoietic progenitor kinase 1 is an intracellular kinase or an enzyme that plays a vital role in modulating tumour immune response. It is an attractive target for drug discovery.
Enzymes are proteins that speed up chemical reactions in the body, and kinases add chemicals called phosphates to other molecules, such as sugar or proteins. This may cause other molecules in the cell to become either active or inactive.
Oncology pipeline
“Now that the FDA has accepted our IND application, we look forward to initiating the ongoing Phase 1/2 study at the US sites,” said Nikhil Amin (MD), Chief scientific officer and President of the innovative Medicine Group of Glenmark Pharmaceuticals.
“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,” he said.
A phase 1/2 multicenter, open-label study to evaluate the safety, tolerability, pharmacokinetics and preliminary anti-tumour 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 tumours and lymphomas.
HPK1 is a crucial regulator of T cell, B cell and dendritic cell-mediated immune responses, which improves antitumor immunity by activating and priming T cells.
Bone marrow
T cells are a type of white blood cell and are part of the immune system. They develop from stem cells in the bone marrow and help protect the body from infection, and may help fight cancer. They are also called T lymphocytes and thymocytes.
By inhibiting HPK1, GRC 54276 is designed to enhance the patient’s immune system to fight cancers potentially.
Sixteen patients with various advanced cancers have been enrolled in this ongoing study in India. According to the BSE statement, the company plans to expand the study at ex-India research sites in the subsequent months.
Indian drug regulator cleared phase I trials in April last year. The company claimed that GRC 54276 had “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.”
Glenmark Pharmaceuticals has a presence across branded, generics, and OTC segments, focusing on respiratory, dermatology and oncology therapeutic areas.
The Mumbai-based company has ten manufacturing facilities across four continents and operations in over 80 countries.
