Mumbai: June 4, 2021 turned out to be a historic day for cancer care in India as the first Chimeric Antigen Receptor T-cell (CAR-T) therapy (a type of gene therapy) was done at the Bone Marrow Transplant unit at ACTREC, Tata Memorial Center in Mumbai. The CAR-T cells were designed and manufactured at Bioscience and Bioengineering (BSBE) department of Indian Institute of Technology (IIT) Bombay. This was a “first in India” gene therapy in early phase pilot clinical trial, partly supported by BIRAC-PACE scheme.
The TMC-IIT Bombay team were further supported to extend this project for conducting Phase I/II trial of their CAR-T product by Government of India’s Department of Biotechnology (DBT) and a not-for-profit Public Sector Enterprise, Biotechnology Industry Research Assistance Council (BIRAC), set up by DBT as an interface agency to empower the emerging biotech enterprise to undertake strategic research and innovation, , through National Biopharma Mission.
The CAR-T therapy has emerged as a breakthrough in cancer treatment. Clinical trials conducted globally have shown promising results in end stage patients, especially in patients suffering from Acute Lymphocytic Leukemia. Though this technology has a remarkable therapeutic potential for cancer patients, at present this technology is not available in India. Each patient’s CAR-T cell therapy costs Rs. 3-4 crore. The challenge therefore was to develop this technology in cost-effective manner and make it available for the patients.
As it was, the manufacturing complexity was a major reason for the therapy cost. In order to promote and support development of CAR-T cell technology against cancer and other diseases, BIRAC and DBT have taken initiatives and launched specialized calls to invite proposals in the last 2 years.
For the dedicated efforts and collaboration between IIT Bombay and Tata Memorial Hospital, Mumbai, the central government’s National Biopharma Mission-BIRAC had approved 19.15 Cr crore to the team for conducting a first-in-human phase-1/2 clinical trial of the CAR-T cells. The clinical trials were being done by Dr. (Surg. Cdr.) Gaurav Narula, Professor of Paediatric Oncology and Health Sciences, and his team from TMC, Mumbai, and the novel CAR-T cells that act as drugs were manufactured by Professor Rahul Purwar, Bioscience and Bioengineering (BSBE) department and his team at IIT Bombay. The design, development, and extensive pre-clinical testing was carried out by IIT-B as a collaborative project with Tata Memorial Center, Mumbai by the two investigators.
IIT-B director Subhasis Chaudhuri said this was a significant feat for the institute as well as the country. “We at IIT-B are delighted that our scientists along with Tata Memorial Hospital have come out with the most sophisticated therapy in cancer treatment. If the trials are successful, it may save millions of lives by making the treatment available in India at an affordable cost. It is a research of IIT-B that is expected to touch the lives of all,” Chaudhuri said .
National Biopharma Mission is also supporting the development of Lentiviral vector manufacturing facility for packaging plasmids used to transfer the modified T cell inside the body, cGMP facility for T-cell transduction and expansion for CAR T-cell manufacturing to two other organizations. The development of CAR-T cell technology for diseases including acute lymphocytic leukemia, multiple myeloma, glioblastoma, hepatocellular carcinoma and type-2 diabetes is supported through DBT.
– global bihari bureau
