IIT Bombay’s ImmunoACT gets approval for first CAR-T cell therapy, says affordable for all

NEW DELHI: Immunoadoptive Cell Therapy Private Limited (ImmunoACT), an IIT Bombay incubated company under the aegis of SINE (Society for Innovation and Entrepreneurship, got approval of the first CAR-T cell therapy.

NexCAR19 is the culmination of a collaborative effort across a decade, between the IIT-Bombay, and Tata Memorial Centre (TMC), the official statement read. “NexCAR19 is an indigenously developed CD19 targeted CAR-T cell therapy. It is the first-of-its kind, a Made-in-India product and puts the nation firmly on the world map of advanced cell-andgene therapies,” the institute explained.

The firm conducted a multi-center Phase 1 and 2 pivotal clinical trial which was led by Hasmukh Jain. The trial was conducted with 60 patients of r/r B-cell lymphomas and leukemia and the clinical data indicated ~70% 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.”

Hasmukh Jain said, “NexCAR19 has shown an excellent balance of efficacy and low-toxicity, which is a significant advantage in clinical management (post-infusion) of the patients in our resource-constrained settings.”

ImmunoACT was founded in 2018 with the intention to be able to translate this academic research into a commercially viable product.

Atharva Karulkar, Alka Dwivedi and the team led by Rahul Purwar, IIT Bombay associate professor designed and developed the NexCAR19, which subsequently underwent integrative process development and manufacturing under cGMP at ImmunoACT.

On the successful completion of the trial, Rahul Purwar, IIT Bombay professor and founder of ImmunoACT said: “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 moon shot and it puts India on the elite list of select countries that have access to CAR-T therapy.”