IIT Bombay Startup ImmunoACT Receives Approval For India’s First CAR-T Cell Therapy; Check Details Here

New Delhi: Immunoadoptive Cell Therapy Private Limited (ImmunoACT) is a firm created in 2018 by IIT Bombay with the goal of turning academic research into a commercially viable product. 

The company is run by SINE (Society for Innovation and Entrepreneurship), an umbrella group for business incubation at IIT Bombay.

According to a press release issued by IIT Bombay on October 13, 2023, ImmunoACT has received approval from the Central Drugs Standard Control Organisation (CDSCO) for India's first humanised CD19-targeted Chimeric Antigen Receptor T cell (CAR-T cell) therapy, NexCAR19 (Actalycabtagene autoleucel), for the treatment of r/r B-cell lymphomas and leukaemia.

NexCAR19 is a CD19-targeted CAR-T cell therapy that prioritises sophisticated cell and gene therapies.

Dr Hasmukh Jain, Professor of Medical Oncology, Tata Memorial Hospital (TMC) Mumbai, led the Phase I and Phase II pivotal clinical trials, which included 60 patients with r/r B-cell lymphomas and leukaemia. 

The clinical data showed a 70% overall response rate (ORR), and the product's safety profile in terms of cytokine release syndrome (CRS) and lack of neurotoxicity was significantly better than the other commercially licenced CD19 directed CAR-T cell treatments.

NexCAR19 is the outcome of a decade-long collaboration between IIT-Bombay and TMC. Dr Atharva Karulkar, Dr Alka Dwivedi, and the team led by Dr. Rahul Purwar, Associate Professor at IIT Bombay created and developed the NexCAR19, which was then manufactured under cGMP at ImmunoACT. 

Dr Hasmukh Jain and Dr Gaurav Narula, as well as their teams at TMC, India's foremost cancer research and treatment institute, led clinical investigations and translational studies.

Dr. Rahul Purwar, Founder & CEO of ImmunoACT, commented on the positive outcome of clinical studies, stating "This is like a dream come true and an incredible win for the patients in the country." Our patients in India and other low-income nations will now be able to obtain this life-saving medication at a reasonable cost."

Concerning the technical feat, he stated that it is equivalent to lifesaving treatment at a low cost, as well as the moonshot that placed India on the select list of countries with access to CAR-T therapy.

ImmunoACT's aim is to provide all segments of society with a high-quality, low-cost CAR-T cell treatment platform. They also hope to make NexCAR19 (Actalycabtagene autoleucel) therapy available to their partner hospitals as soon as possible.

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