IIT-B Startup ImmunoACT Breakthrough
In a remarkable milestone for the Indian medical community, a pioneering startup originating from the esteemed institution IIT Bombay, ImmunoACT, has been granted official approval by the Central Drugs Standard Control Organization (CDSCO), India’s leading drug regulatory body, for its cutting-edge CAR-T cell therapy named NexCAR19. The revolutionary therapy, developed in collaboration with pharmaceutical giant Laurus Labs, is poised to transform the treatment landscape for specific types of blood cancers in the country.
NexCAR19, a humanized CD19-targeted Chimeric Antigen Receptor T cell (CAR-T) therapy, has successfully secured the distinction of being the first of its kind in India to gain regulatory approval. Intended for the treatment of relapsed or refractory (r/r) B-cell lymphomas and leukaemia, this groundbreaking treatment promises hope to numerous patients battling these challenging conditions across the nation.
While the specific pricing details of the NexCAR19 therapy remain undisclosed at this juncture, ImmunoACT has pledged to ensure that the treatment becomes accessible to partner hospitals as swiftly as possible. Notably, earlier announcements from ImmunoACT’s CEO, Rahul Purwar, hinted at a considerably lower price range for the therapy, estimated to be between Rs 30 lakh and Rs 40 lakh per patient. This stands in starkcontrast to the existing treatment costs, which typically soar to a staggering 3-4 crore (INR) per patient, highlighting the potential for a significant reduction in the financial burden on patients and their families.
The pivotal approval of NexCAR19 by the CDSCO stems from the promising outcomes of a comprehensive multi-centre phase I/II clinical trial spearheaded by the distinguished Dr. Hasmukh Jain. The extensive trial, encompassing 60 patients grappling with relapsed or refractory B-cell lymphomas and leukaemia, showcased an encouraging overall response rate (ORR) of 70%. Notably, the therapy demonstrated a remarkably favourable safety profile, characterized by minimal toxicity and limited side effects such as cytokine release syndrome (CRS), underscoring its superior efficacy compared to other commercially available CD19-directed CAR-T cell therapies, as outlined in a recent report.
The inception of NexCAR19 marks the culmination of a decade-long collaborative effort between the revered institutions IIT Bombay and Tata Memorial Centre (TMC), with instrumental contributions from visionaries such as Atharva Karulkar, Alka Dwivedi, and a dedicated team led by Rahul Purwar, an esteemed associate professor at IIT Bombay. The therapy underwent a meticulously integrated process of development and manufacturing under current Good Manufacturing Practice (cGMP) standards at ImmunoACT, while clinical investigations and translational studies were adeptly conducted by Dr. Hasmukh Jain, alongside Dr. Gaurav Narula and their adept teams at Tata Memorial Hospitals.
Expressing his fervent optimism, Rahul Purwar, the esteemed Founder and CEO of ImmunoACT, voiced his conviction that the approval of NexCAR19 will usher in a new era of hope for patients in India and other resource-constrained regions, providing them with access to a life-saving therapeutic intervention at an affordable cost. Drawing a poignant analogy, Purwar likened this groundbreaking achievement to a metaphorical “moon shot,” underscoring its pivotal role in positioning India among an elite league of nations equipped with advanced CAR-T therapy capabilities.
Acknowledging the instrumental role played by Laurus Labs, a prominent Hyderabad-based pharmaceutical entity, Purwar lauded their steadfast support, culminating in a substantial investment exceeding $18 million, dedicated to bolstering ImmunoACT’s extensive research, development, and commercialization endeavours. With this momentous regulatory approval, countless patients can now anticipate gaining access to a potentially life-altering treatment at a significantly reduced and more manageable cost, promising renewed hope and improved prospects in their arduous battle against blood cancer.
IIT-B Startup ImmunoACT Breakthrough