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The last several weeks have seen an increase in conversations around cell and gene therapies (CGT) in the country — the promise they hold as treatment, and the role India can play in making these products at a fraction of global cost.
Cutting cost, without cutting corners, is how cancer physician and author Dr Siddhartha Mukherjee recently described the CAR-T journey at Immuneel Therapeutics. Earlier this month, Immuneel rolled out its first internationally benchmarked CAR-T product for adult B-cell non-Hodgkin lymphoma (B-NHL).
In fact, Amit Mookim, Immuneel Chief Executive Officer, said they had brought “the cost down by at least 90 per cent (of the US cost)” and were working to lower it further. The US cost is pegged between $400,000 and $500,000, which increases with hospital costs and so on to $600,000-$700,000, he explained.
In December 2023, another indigenous CAR-T product had been commercialised. Born of a collaboration between Indian Institute of Technology (IIT), Bombay, and Tata Memorial Hospital, the therapy was taken to commercialisation by industry partner ImmunoAct (an IIT-B incubated company). Despite being priced at about ₹40 lakh, or one-tenth the global price (at about ₹4 crore), it is expensive, Hasmukh Jain, Professor, Medical Oncology, TMH (who led the trial of this therapy in adults), had said months into its commercialisation.
CAR-T conversations
Clearly, cost is a critical part of the conversation on these therapies. But industry insiders call for a “mission mode” to support synthetic biological products — so more research can be done on emerging therapies; and help bring down cost to patient.
The domestic CGT landscape comprises pharma majors and fledgling firms — including Aurigene Oncology (a wholly-owned subsidiary of Dr Reddy’s Laboratories Limited); Immuneel (co-founded by Biocon Group Chairperson Kiran Mazumdar Shaw in her personal capacity; Mukherjee, cancer physician, Columbia University; and Kush M Parmar, Managing Partner, 5AM Ventures); and ImmunoAct (Laurus Labs holds a stake).
Others include SunAct (founding team includes three doctors); Nkure (works on allogeneic off-the-shelf CAR-NK cell therapies); East Ocyon Bio (an allogeneic CGT startup with reported investment from Micro Labs); and Cellogen Therapeutics (investment from Natco Pharma).
The two CAR-T products available in India are autologous — involving taking the patient’s blood and separating the T cells (tasked with identifying and destroying cancer cells). This is engineered and put back into the patient to attack the cancer cells.
Research is also underway on allogeneic products — involving taking cells from a healthy donor — paving the way for off-the-shelf products.
Dr Vijay Patil, Founder, SunAct Cancer Institute, points to gamma delta T-cell therapy as promising for solid tumours. Earlier this month, the company announced Phase 2 clinical trial for this approach, in collaboration with CytoMed, Singapore.
The hope is “to bring relief to patients with difficult-to-treat cancers such as brain cancer, breast cancer, lung cancer, cervical cancer, colon cancer, renal cancer, liver cancer , lymph node cancer and several others”, the company said. GD T-cells naturally fight cancer while protecting healthy tissue, and its uniqueness is that “it uses ready-made cells from donors, making it faster, easier, and less expensive compared to traditional therapies”, it added.
Need to catch up
Dr Prem Pavoor, Managing Partner, Eight Roads Ventures (India), says the US and Europe have been pioneers in developing CAR-T therapies; closer home, China’s developing these drugs, especially for local markets. Pointing to India’s high disease burden, Pavoor calls for more affordable CAR-T therapies, besides health insurance coverage.
Outlining the ecosystem limitations for companies working on synthetic biological products, Prof Ratnesh Jain, Founder, Mumbai Biocluster (an initiative of Institute of Chemical Technology, Mumbai) calls for a “mission mode” approach, similar to the Centre’s space mission, to marshal the required resources.
Synthetic biology involves creating genes, DNA, RNA, and so on at laboratory scale, and scaling up, Jain explains, calling for heavy and continuous investment to help ‘catch up’.
Magic bullet?
Finally, it’s about patients and their expectations from emerging therapies.
Mukherjee explains that “cancer is not one disease, but many diseases”. Blood cancers are different from solid tumours; every solid tumour has a different site (colorectal cancer, ovarian cancer, and so on)
“Car-T, like any other therapy for cancer, including gene therapy, is not a magic bullet,” he says, as it is cancer-specific. But used accurately, and with high-quality CAR-T, there is remarkable prognosis in patients who have no other option, he says.
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