Cell and Gene Therapy

ImmunoACT gets CDSCO approval for India’s first CAR-T cell therapy for blood cancer

Published November. 29. 2023

An indigenously developed CD19-targeted CAR-T cell treatment  called NexCAR19, a  Made-in-India product, the first of its type, and a significant advancement in cutting-edge cell and gene therapies.

ImmunoACT, supported by IIT-B and Laurus Labs, announced that NexCAR19 (Actalycabtagene autoleucel), India’s first CAR-T cell therapy, has been approved by the Central Drugs Standard Control Organization (CDSCO) for the treatment of r/r B-cell lymphomas and leukemia.

The first humanized CD19-targeted Chimeric Antigen Receptor T cell (CAR-T cell) therapy product for relapsed/refractory (r/r) B-cell lymphomas and leukemia in India was approved for sale by Immunoadoptive Cell Therapy Private Limited (“ImmunoACT”).

An indigenously created CD19-targeted CAR-T cell treatment is called NexCAR19. It is the first-ever, domestically produced product of its kind and a significant advancement in cutting-edge cell and gene therapy.

NexCAR19 is the result of ten years of cooperation between the Tata Memorial Centre (TMC) and IIT Bombay . NexCAR19 was invented and developed by Dr. Atharva Karulkar, Dr.Alka Dwivedi, and Dr.Rahul Purwar, an associate professor at IIT Bombay. It was then manufactured at ImmunoACT using integrated process development and cGMP.  Dr. Hasmukh Jain and Dr.Gaurav Narula, together with their teams led clinical trials and translational research at TMH.

The clinical trial, led by Dr Hasmukh Jain, was conducted with 60 patients of r/r B-cell lymphomas and leukemia. The clinical data indicates approximately 70 percent overall response rate (ORR). The safety profile in terms of cytokine release syndrome (CRS) and absence of neurotoxicity indicates a significant improvement over the other commercially approved CD19-directed CAR-T cell therapies

ImmunoACT is an IIT Bombay incubated company under the aegis of SINE (Society for Innovation and Entrepreneurship) and was founded in 2018 with the intention to be able to translate this academic research into a commercially viable product.

Source: IIT Bombay

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