CAR-T (chimeric antigen receptor T-cell) therapy has emerged as a breakthrough in cancer treatment. Clinical trials conducted globally have yielded promising results in end-stage patients, especially in those patients who are suffering from Acute Lymphocytic Leukemia. Though this technology has a remarkable therapeutic potential for cancer patients, at present this technology is unavailable in India. Each patient’s CAR-T cell therapy costs 3-4 crore (INR). The challenge, therefore, is to develop this technology in a cost-effective manner and make it available for the patients.
The expense of treatment is mostly due to the manufacturing complexity. In the last two years, the Biotechnology Industry Research Assistance Council(BIRAC) and the Department of Biotechnology (DBT) have taken various measures and launched specialized calls to promote and assist the development of CAR-T cell technology against cancer and other diseases.
The first CAR-T cell treatment (a type of gene therapy) was performed in the Bone Marrow Transplant unit at Advanced Centre for Treatment, Research and Education in Cancer (ACTREC), Tata Memorial Center in Mumbai on June 4, 2021, making it a momentous day for TMH, IIT Bombay, and cancer care in India. IIT Bombay’s Bioscience and Bioengineering (BSBE) department has designed and developed CAR-T cells.
This is a “first in India” gene therapy in early phase pilot clinical trial due to the dedicated efforts and excellent collaboration between IIT Bombay and Tata Memorial Hospital, Mumbai. The central government’s National Biopharma Mission-BIRAC has 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 are 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 will act as drugs that were manufactured by Prof Rahul Purwar, Bioscience and Bioengineering (BSBE) department and his team at IIT Bombay. The design, development, and extensive pre-clinical testing were carried out by IIT-Bombay as a collaborative project with Tata Memorial Center, Mumbai.
Subhasis Chaudhuri, the director of IIT-B, described the achievement as important for both the institute and 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.”
The National Biopharma Mission is also assisting two other organizations with the development of a lentiviral vector manufacturing facility for packaging plasmids used to transfer the modified T cell inside the body, as well as a cGMP facility for T-cell transduction and expansion for CAR T-cell manufacturing. CAR-T cell technology is being developed for illnesses such as acute lymphocytic leukemia and multiple myeloma, glioblastoma, hepatocellular carcinoma, and type-2 diabetes.
Under the Ministry of Science and Technology, the Department of Biotechnology (DBT) supports and accelerates the development of biotechnology in India, including its growth and use in agriculture, healthcare, animal sciences, environment, and industry.
The Biotechnology Industry Research Assistance Council (BIRAC) is a non-profit Section 8, Schedule B, public sector enterprise established by the Department of Biotechnology (DBT) of the Government of India as an interface agency to strengthen and empower the emerging biotech enterprise to conduct strategic research and innovation to address relevant product development needs.