ImmunoACT is an IIT Bombay incubated company-backed by drug maker Laurus Labs on Friday said it has received approval from Indian drug regulator the Central Drugs Standard Control Organization (CDSCO) for its CAR-T cell therapy NexCAR19 (actalycabtagene autoleucel), for the treatment of certain types of blood cancers.
NexCAR19 will be the first humanized CD19-targeted Chimeric Antigen Receptor T cell (CAR-T) therapy indigenously developed in India to be approved.
commercially approved CD19-directed CAR-T cell therapies.
Clinical investigations and translational studies were led by Dr Hasmukh Jain and Dr Gaurav Narula and their teams at Tata Memorial Hospitals.
“Now our patients in India and countries with limited resources will have access to this life-saving drug at an affordable cost,” said Purwar, Founder and CEO of ImmunoACT.
“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,” Purwar added.
Hyderabad-based drug maker Laurus Labs has been the early backer of ImmunoACT and has invested over $18 million to support ImmunoACT to scale its R&D and commercialization efforts.