IIT Bombay's ImmunoACT Received The Approval For India’s First CAR-T Cell Therapy, NexCAR19
Immunoadoptive Cell Therapy Private Limited (ImmunoACT) is an IIT Bombay incubated company founded in 2018, with the objective of translating this academic research into a commercially viable product. The company is under the aegis of SINE (Society for Innovation and Entrepreneurship), an umbrella organisation at IIT Bombay for business incubation.
IIT Bombay said in a press release on Friday that ImmunoACT received the approval for India’s first humanised CD19-targeted Chimeric Antigen Receptor T cell (CAR-T cell) therapy, NexCAR19 (Actalycabtagene autoleucel), for the treatment of r/r B-cell lymphomas and leukemia from the Central Drugs Standard Control Organization (CDSCO),
NexCAR19 is an indigenously developed CD19 targeted CAR-T cell therapy proritising advanced cell-and gene therapies.
The Phase I and Phase II pivotal clinical trials were Led by Dr Hasmukh Jain, Professor – Medical Oncology, Tata Memorial Hospital (TMC) Mumbai; it was conducted with 60 patients of r/r B-cell lymphomas and leukemia. The clinical data indicated ~70% overall response rate (ORR), and the safety profile of the product in terms of cytokine release syndrome (CRS) and absence of neurotoxicity indicated a significant improvement than the other commercially approved CD19 directed CAR-T cell therapies.
NexCAR19 is the result of a collaborative effort between the IIT-Bombay, and TMC across a decade. Dr Atharva Karulkar, Dr Alka Dwivedi and the team led by Dr Rahul Purwar, Associate Professor at IIT Bombay designed and developed the NexCAR19, and it then underwent integrative process development & manufacturing under cGMP at ImmunoACT. Further, Clinical investigations and translational studies were led by Dr Hasmukh Jain and Dr Gaurav Narula and their teams at TMC, India’s leading centre for cancer research and treatment center.
On the successful completion of clinical trials, Dr Rahul Purwar, Founder & CEO 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 lifesaving drug at an affordable cost.”
Regarding the technical achievement, he added that it is comparable to the lifesaving drug at an affordable cost, and to the moonshot which places India on the elite list of select countries that have access to CAR-T therapy.
ImmunoACT’s mission is to provide a high quality and affordable CAR-T cell therapy platform to all sections of the society. Furthermore, they hopes to make the NexCAR19 (Actalycabtagene autoleucel) therapy available to its partner hospitals as soon as possible.
