IIT Bombay's ImmunoACT Receives Approval for Affordable CAR-T Cell Therapy

Immunoadoptive Cell Therapy Private Limited (ImmunoACT), an IIT Bombay-incubated company operating under the aegis of SINE (Society for Innovation and Entrepreneurship), has achieved approval for its groundbreaking CAR-T cell therapy.

Known as NexCAR19, this innovation is the result of a collaborative decade-long effort between IIT-Bombay and the Tata Memorial Centre (TMC), according to the official statement. NexCAR19 stands out as an indigenously developed CD19-targeted CAR-T cell therapy and is the first of its kind—a “Made-in-India” product that firmly establishes the nation on the global map of advanced cell and gene therapies, as explained by the institute.

The company conducted a multi-center Phase 1 and 2 pivotal clinical trial, led by Hasmukh Jain, which involved 60 patients with r/r B-cell lymphomas and leukemia. The clinical data revealed an impressive ~70% overall response rate (ORR).

Hasmukh Jain noted, “The safety profile in terms of cytokine release syndrome (CRS) and the absence of neurotoxicity indicates a significant improvement over other commercially approved CD19-directed CAR-T cell therapies. NexCAR19 has demonstrated an excellent balance of efficacy and low toxicity, offering a substantial advantage in the clinical management of patients in resource-constrained settings.”

Established in 2018 with the goal of translating academic research into a commercially viable product, ImmunoACT achieved this milestone. Atharva Karulkar, Alka Dwivedi, and their team, led by Rahul Purwar, an associate professor at IIT Bombay, designed and developed NexCAR19. The therapy underwent an integrative process development and manufacturing under cGMP at ImmunoACT.

Upon the successful completion of the trial, Rahul Purwar, IIT Bombay professor and founder of ImmunoACT, expressed his enthusiasm: “This is like a dream come true and an incredible win for the patients in the country. Now our patients in India and countries with limited resources will have access to this life-saving drug at an affordable cost. In terms of technical achievement, this is comparable to the moonshot and it puts India on the elite list of select countries that have access to CAR-T therapy.”