ImmunoACT’s NexCAR19

October 14, 2023

In a remarkable achievement, ImmunoACT, backed by IIT-B and Laurus Labs, has received approval from the Central Drugs Standard Control Organization (CDSCO) for India’s first CAR-T cell therapy, NexCAR19. This revolutionary therapy is a significant development in the treatment of relapsed/refractory (r/r) B-cell lymphomas and leukemia and marks a substantial step forward in the field of advanced cell-and-gene therapies.

A Pioneering Breakthrough

NexCAR19 is a CD19-targeted CAR-T cell therapy, developed entirely in India. It is the first of its kind, made-in-India product, representing a major stride in the field of advanced cell-and-gene therapies.

Successful Clinical Trials

A clinical trial involved 60 patients with r/r B-cell lymphomas and leukemia.
The results show an impressive overall response rate (ORR) of approximately 70 percent.
NexCAR19 also exhibits a favorable safety profile, with a notable absence of cytokine release syndrome (CRS) and neurotoxicity, distinguishing it from other commercially approved CD19-directed CAR-T cell therapies.
This balance between efficacy and low toxicity makes NexCAR19 a valuable asset in the clinical management of patients in resource-constrained settings.

Impact

Now, 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.

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