The first CAR-T cell therapy, a type of gene therapy, to treat cancers of blood and lymphatic system is likely to be available in India from 2023, offering hope to patients who can’t afford to travel abroad for the expensive treatment.
On June 11, ImmunoACT, an Indian Institute of Technology, Bombay spin-off company, launched its facility to start production on a large scale. As of now, CAR-T cell therapy is not available in India, Patients have to travel to countries like the US and it costs nearly Rs 3-4 crore.
The indigenously developed CAR-T cell therapy was the result of intense research over the last eight years and had now been patented, Rahul Purwar, a senior IIT-Bombay faculty who is also the founder and CEO of ImmunoACT, said.
Incubated at the Society of Innovation and Entrepreneurship at IIT-B, ImmunoACT now has Hyderabad-based pharmaceutical major Laurus Labs as a partner and is looking to make the treatment available at Rs 20-30 lakh a patient in India, the company said.
The facility has the capacity to treat nearly 1,200 patients a year.
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, which are engineered in the laboratory to fight cancer.
It is mostly effective in blood cancer and lymphoma (cancer beginning in the cells of the lymph system), though studies are on to assess its role in solid tumours and auto-immune diseases as well.
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As of now, the therapy is usually offered as second-line treatment for late-stage leukemia and lymphoma patients who are either not responding to conventional treatments like chemotherapy and bone-marrow transplant or have a case of relapsed cancer.
Research from abroad has shown that the therapy can be effective in 40-50 percent 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 said that the majority of B cell malignancies have normal to high levels of CD19.
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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.