The first CAR-T cell therapy, a sort of gene therapy, to treat blood cancer and lymphatic system is expected to be available in India by 2023, giving patients who can’t afford to fly abroad for the costly treatment hope.
ImmunoACT, a spin-off from the Indian Institute of Technology, Bombay, opened its facilities on June 11 to begin large-scale production. CAR-T cell therapy is currently unavailable in India; patients must travel to nations such as the United States, where it costs around Rs 3-4 crore.
According to Rahul Purwar, a prominent IIT-Bombay faculty member who is also the founder and CEO of ImmunoACT, the indigenously developed CAR-T cell therapy was the outcome of extensive study over the last eight years and had finally been trademarked.
ImmunoACT, which was founded at IIT-Society B’s of Innovation and Entrepreneurship, now has Laurus Labs, a Hyderabad-based pharmaceutical business, as a partner and plans to make the treatment available in India for Rs 20-30 lakh per patient, according to the company. The facility has the capacity to treat nearly 1,200 patients a year.
Clinical trials of the therapy
As part of the therapy’s Phase-1 clinical trial at Tata Memorial Hospitals’ Advanced Centre for Treatment, Research and Education in Cancer in Mumbai, 10 lymphoma patients have been treated with no relapse so far.
The company is now looking to seek regulatory approvals from the Central Drugs Standard Control Organisation for Phase 2 trials with about 40 patients.
In its initial trials, the project received support from the Centre’s department of biotechnology and Biotechnology Industry Research Assistance Council.
What is CAR-T Cell therapy?
Chimeric Antigen Receptor (CAR) T cells are a patient’s own immune cells that have been genetically modified to combat cancer in the lab. Although research are underway to investigate its involvement in solid tumours and auto-immune illnesses, it is more effective in blood cancer and lymphoma (cancer that begins in lymph system cells).
Currently, the therapy is used as a second-line treatment for patients with late-stage leukaemia and lymphoma who have either not responded to conventional treatments like chemotherapy or a bone marrow transplant, or who have relapsed disease.
Foreign Research has shown that the therapy can be effective in 40-50 % of the patients, with slightly better results in pediatric populations.
Estimates suggest that about 40,000-50,000 new leukemia and lymphoma patients are diagnosed in India every year.
Ray of hope for cancer patients in India
According to Puwar, ImmunoACT’s patented CAR-T cell platform provides a unique design algorithm to develop novel CAR-T cells and its first product, HCAR19, showed favourable balance of efficacy and toxicity.
“It can be offered to patients with CD19 marker in B cells (the protein that is used to diagnose cancers that arise from B type of cell–white blood cells that produce antibodies such as B cell lymphomas, acute lymphoblastic leukemia, and chronic lymphocytic leukemia),” said Purwar. He also said that the majority of B cell malignancies have normal to high levels of CD19.
The majority of the commercially available CAR-T cell therapies are also associated with severe toxicity, Purwar said, adding the therapy developed in India was far better on that count.
He also said that the therapy was likely to be available at cancer hospitals after the Phase 2 trial of the research projects, while the late-stage trial would continue concurrently.
