MedTherapy details India manufacturing plans for CAR-T and gene therapies

MedTherapy, a cancer gene therapy biotechnology company with its global manufacturing facility based in NOIDA within New Delhi NCR, outlined its manufacturing strategy focused on CAR-T cell therapy (Chimeric Antigen Receptor T-cell therapy) and gene therapies from India.

CAR-T cell therapy for cancer, first approved by the US FDA in 2017, has shown clinical responses in multiple cancer indications. However, manufacturing complexity, high costs, and long production timelines continue to limit wider accessibility of these therapies globally. Gene therapies use genetic engineering approaches to repair, replace, or modify genes for the treatment of diseases including cancer, genetic disorders, metabolic conditions, hematological diseases, and infectious diseases. Industry experts have identified manufacturing scalability and affordability as key challenges in the wider adoption of these therapies.

MedTherapy, which operates technology facilities in Boston, US, and manufacturing operations in New Delhi NCR, said it has developed manufacturing platforms aimed at reducing production timelines and costs associated with CAR-T therapies and viral vectors. The company operates as a Contract Development and Manufacturing Organization (CDMO) for CAR-T therapies and viral vectors, while also developing its own CAR-T therapy pipeline.

The company stated that its oncology pipeline includes CAR-T therapies targeting blood cancers and solid tumors including brain, breast, lung, skin, and bone cancers. According to the company, its blood cancer CAR-T therapy programme has completed clinical studies in the US and is preparing for clinical trials in India.

MedTherapy is funded by TATA Sons. It was incorporated in India in 2020 and has been working in collaboration with twenty-two global organisations in India, USA, Canada, and Europe including Harvard University and CIPLA Limited.

“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. Our integrated manufacturing model ameliorates all the major constraints and provides efficient, compliant and speedy manufacturing of both – viral vectors, and CAR-T cell therapy products at global scales. We are able to manufacture for any organization working in CAR-T cell therapy worldwide at dramatically reduced manufacturing costs and time as CDMO for their products” commented Dr Bikash Verma, MD, DVM, CEO of the company who had earlier served as medical director and faculty at Harvard University Medical School in Boston, US and at Novartis.

The company said its CDMO services cover manufacturing support from discovery and pre-clinical stages through clinical and commercial production for CAR-T cells and other gene therapies. It also manufactures viral vectors through its partnership with Dr Vladimir Slepushkin, MD, PhD, Chief Technology Officer, MedTherapy.

The advantages MedTherapy offers as a gene therapy global CDMO include its next generation manufacturing platforms; next generation of viral vectors; full-spectrum end-to-end manufacturing services; dramatically reduced cost and time; US-India global facilities to serve global clients; GMP and non-GMP production; analytics, clinical development, translational, cell lines and vector design.

India has all the prerequisites to become the global manufacturing hub for such an advanced sector as gene therapies including one of the largest technical manpower in the world. Towards that end, MedTherapy is implementing its global strategies to catapult India as a global manufacturing hub for gene therapies through next generation manufacturing technology for CAR-T cell and viral vectors; public-private academia partnerships including with Harvard University; US-India collaboration; next generation pipeline of armored CAR-T cells for blood and solid cancers including breast, lung, bone, and brain.

India’s leadership in gene therapies would help both, the Indian patients and the Indian economy. Our efforts will make these ‘million dollars’ treatment available at affordable and accessible costs. Towards helping the Indian economy, this could potentially generate billion of dollars in revenue and Foreign Direct Investment (FDI), foster medical tourism, and develop a robust indigenous ecosystem of ancillary industries.

Dr Dinesh Pendharkar, one of the leading oncologists in India, strongly supported MedTherapy as a CDMO for CAR-T cells. He said, “World is moving ahead in the field of cell and gene therapy with unbelievable speed. India will only be able to match if we organize our manufacturing sector building CDMO like MedTherapy in this field. Single product based and single manufacturing units will never be able to meet world speed.”.

Kewal Handa, former MD of Pfizer (India) and former Chairman of Union Bank of India, a veteran of both the pharmaceutical and financial worlds endorsed MedTherapy’s strategy for CAR-T therapies both as a CDMO and its pipeline for patients in India and globally while also being very successful commercially with impressive returns on investment (ROI) and potential to become a ‘billion dollar company’.

Dr Daniel DeAngelo, MD, PhD, Professor of Medicine at Harvard Medical School and Chief of the Division of Leukemia at Dana-Farber Cancer Institute, Boston, US, serving as MedTherapy’s board member strongly advocated its mission to make CAR-T therapy more affordable and accessible globally.

MedTherapy aims to transform the CAR-T cell therapy landscape in India with its ‘Best in Class’ low-cost manufacturing technology which will then help lower cost of CAR-T cell therapies for cancer patients in a resource poor country like India.

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