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Landmark Achievement: India’s First CAR-T Cell Therapy by IIT-B Startup, ImmunoACT, Receives Regulatory Approval

NextEdge Admin

09 Jan 2024

3 min 28 sec

The Central Drugs Standard Control Organization (CDSCO) has granted market authorization for CAR-T (Chimeric Antigen Receptor-T) cell therapy, a groundbreaking treatment for relapsed/refractory (r/r) B-cell lymphomas and leukemia, heralding the imminent launch of the indigenous NexCAR19 in India. This significant development is the result of collaborative efforts between ImmunoACT, an incubated company at IIT Bombay, and the Tata Memorial Centre (TMC).

Dr. Rahul Purwar, the founder and CEO of ImmunoACT, confirmed the market authorization and expressed the need to secure a manufacturing license from the state’s food and drugs administration to commence commercial usage of NexCAR19. CAR-T cell therapy, developed indigenously, is a type of cancer immunotherapy that involves genetically modifying T cells in a laboratory setting to enhance their ability to identify and eradicate cancer cells. This innovative therapy offers new hope to patients in India and resource- constrained nations. Dr. Purwar highlighted that the cost of CAR-T cell therapy abroad is approximately ₹3-4 crore per patient, while NexCAR19 will be available at a significantly reduced cost of ₹30-40 lakh per patient, which is just 1/10th of the international price. India sees around 25,000 B-cell lymphoma patients annually, and this treatment will be accessible in approximately 20 government and private hospitals across major cities.

Dr. Hasmukh Jain, who oversaw a multicenter Phase I/II pivotal clinical trial involving 60 r/r B-cell lymphoma and leukemia patients, reported remarkable results with an overall response rate (ORR) of approximately 70%. This therapy demonstrates a favorable balance between efficacy and toxicity, making it a promising option for patients with the CD19 marker in B cells, a protein commonly associated with B-cell-related cancers such as B-cell lymphomas, acute lymphoblastic leukemia, and chronic lymphocytic leukemia.

The development of NexCAR19 involved key contributions from Dr. Atharva Karulkar, Dr. Alka Dwivedi, and a team led by Dr. Purwar at IIT-Bombay, while clinical investigations and translational studies were led by Dr. Hasmukh Jain and Dr. Gaurav Narula, alongside their teams at TMC. With this breakthrough, India has solidified its position among nations with access to CAR-T therapy, offering affordable treatment options and renewed hope for cancer patients.