HQ Team
October 16, 2023: India’s Immunoactive Cell Therapy Ltd., has got a marketing authorisation from the drug regulator for a therapy to treat leukaemia and cancer of the lymphatic system.
The Mumbai-based company’s chimeric antigen receptor (CAR) T-cell therapy gets immune cells called T cells — a type of white blood cell — to fight cancer by changing them in the laboratory so they can find and destroy cancer cells.
The Central Drugs Standard Control Organisation gave the approval for the company’s NexCAR19 treatment in humanised CD19-targeted CAR T-cell therapy for relapsed or refectory B-cell lymphomas and leukaemia.
The cost of the treatment is between 30-40 lakhs.
The mid-stage clinical trials recorded a 70% overall response rate among 60 patients, according to a company statement.
The safety profiles indicated a “significant improvement” over the other CD-directed CAR T-cell therapies and is the first such therapy to be approved in India, according to the statement.
ImmunoACT, founded in 2018, is a company incubated by the Indian Institute of Technology, Mumbai, under the aegis of the Society for Innovation and Entrepreneurship.
Laurus Labs has invested $18 million in the early stage. ImmunoACT will make the therapy available to its partner hospitals “as soon as possible,” according to the statement.
