Boston-headquartered MedTherapy Biotech is scaling up its India manufacturing play with a gene therapy contract development and manufacturing organisation (CDMO) facility in Noida.
It is preparing to enter clinical trials in India for a lymphoma-focused CAR-T therapy being co-developed with Cipla that may hit the market by 2027, subject to regulatory approvals.
CAR-T cell therapy for cancer, first approved in the United States by the US Food and Drug Administration (FDA) in 2017, is seen as a potential cure for certain cancers because it genetically re-engineers a patient’s own immune cells to attack tumours.
However, high manufacturing complexity, long production timelines and steep costs have limited wider access globally.
The company, which positions itself as a low-cost manufacturing platform for cell and gene therapies, said its technology could reduce CAR-T manufacturing costs by more than 70 per cent compared to US costs, which can run into almost half a million dollars for a single therapy, while also sharply cutting production timelines.
Some estimates peg the cost to around ₹60-70 lakh per patient in India. Bikash Verma, chief executive officer (CEO), MedTherapy claimed its manufacturing model can bring treatment costs closer to those of chemotherapy over time. He added that the therapy could eventually move towards becoming a first-line treatment option for certain cancers.
MedTherapy says its technology takes a patient’s immune T-cells from blood, genetically modifies them in the lab to recognise and attack cancer cells, and then infuses them back into the patient.
Unlike conventional CAR-T therapies that can take several weeks and require complex cell-isolation equipment, the company claims its platform can manufacture the therapy directly from blood-derived peripheral blood mononuclear cells (PBMCs) in around 20–24 hours. This helps reduce time, complexity and cost.
It has set up its manufacturing facility in Noida while its technology centre is based in Boston.
Verma told Business Standard that work on the Noida facility began in 2020 and it became functional around a quarter ago. Verma added that there were plans to further scale up manufacturing with a second facility in Greater Noida. The current facility can handle therapy requirements for around 5,000 patients annually.
It has already received enquiries from Indian and foreign companies for biotech products. Verma says nearly 60 per cent of the clientele is from outside India.
He added that production can eventually be scaled up to 50,000 patients annually, although the company would need to raise additional funds for that expansion. He did not disclose investment details related to developing the technology or the Noida facility.
MedTherapy said it operates two business verticals — as a CDMO manufacturing CAR-T therapies and viral vectors for other biotech firms, and as a developer of its own CAR-T pipeline.
The company is collaborating with Cipla on a lymphoma-focused CAR-T product and is preparing for clinical trials in India. Phase I studies have already been conducted in the US, while India trials are expected to move into the next phase with a target launch timeline around 2027.
The therapy is focused on blood cancers, including non-Hodgkin’s lymphoma, where CAR-T therapies globally are often priced at several hundred thousand dollars to over $1 million per patient.
“The current manufacturing crisis faced by the CAR-T cell therapy industry in particular and the cell and gene therapy industry in general is a global crisis,” said Verma, a former faculty member at Harvard Medical School.
MedTherapy, which is funded by Tata Sons, was incorporated in India in 2020 and has been working with 22 organisations across India, the US, Canada and Europe, including Harvard University and Cipla.
Verma said its broader pipeline includes CAR-T candidates for lymphoma, multiple myeloma and solid tumours including breast, lung, bone and brain cancers.
MedTherapy added that India could emerge as a global manufacturing base for advanced gene therapies because of its scientific talent pool and lower operating costs.
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