Gene therapy trial for cancer kicks off
MUMBAI: Clinical trials of indigenously developed CAR-T technology for the treatment of blood cancer kicked off at Mumbai’s Tata Memorial Centre (TMC) on Friday. This is the first time that gene therapy, developed indigenously by researchers at the Indian Institute of Technologybombay (IIT-B), is being tested on patients in the country. CAR-T (Chimeric Antigen Receptor T) cells are cells that are genetically engineered to produce an artificial T-cell receptor, which is widely used in developed nations for immunotherapy during cancer treatment. As part of the gene therapy, these cells are used to cure certain types of blood cancers. However, the technology is not available in India yet.
But a team of researchers from the bioscience and bioengineering (BSBE) department led by professor Rahul Purwar have now designed and developed the first indigenous CAR-T cells with clinical inputs from Dr Gaurav Narula, professor of paediatric oncology and health sciences, and his team from TMC. The drug is aimed at treating leukaemia and lymphoma. The team has filed for national and international patents for the product.
The design developed by IIT-B uses lentiviral technology. In gene therapy, this is a method of inserting, modifying or deleting genes in organisms using lentivirus – a family of viruses that are responsible for diseases such as AIDS (acquired immunodeficiency syndrome).
“The first phase of clinical trials has kicked off, during which the safety aspect of the drug will be studied. We are happy to announce that the Phase-i trials have begun. This is a huge first step for India in terms of being self-reliant in cancer treatment,” said Purwar.
Dr Narula said the trials have kicked off at the Advanced Centre for Treatment, Research and Education in Cancer (ACTREC), the research and development wing of TMC. “More details of the trial will be revealed soon,” he said.
Last June, HT had reported that the Central government’s National Biopharma Mission (Nbm)-biotechnology Industry Research Assistance Council (BIRAC) had approved ₹18.96 crore to the team for conducting the first-in-human phase-1 and 2 clinical trial of the CAR-T cells. In a statement, BIRAC had then said that with the success of the trial, the drug will benefit cancer patients who currently are forced to opt for palliative care.
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 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,” said Chaudhuri.
“One of the major reasons for the therapy’s unavailability in India is that the drug is exorbitantly expensive. Pharmaceutical companies don’t see a market for such expensive treatments in India,” said Purwar.
Each of the two CAR-T products approved by the United States of America – Kymriah and Yescarta – could cost ₹5 crore per patient and go up to ₹10 crore, including hospital expenses. The IIT-B and TMC team is working on reducing this cost to ₹20 lakh. “A large part of the manufacturing cost goes towards skilled labour. While we are at an initial stage, we will try to bring the costs significantly down,” said Purwar.
While existing treatments work towards increasing the life of patients by a few years or months, CAR-T technology holds the promise of curing certain types of cancers. Unlike chemotherapy, this drug is administered only once to the patient. “Current treatment strategies, such as chemotherapy, are aimed at promoting life by a few months or years. They are not intended to cure cancer. The CAR-T cells have been fairly successful in curing cancers in some developed nations,” said Purwar.