ImmunoACT, backed by IIT-Bombay and Laurus Labs, recently announced the approval of India's first 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).
Immunoadoptive Cell Therapy Private Limited ("ImmunoACT") received the marketing authorization approval for the first humanized CD19-targeted Chimeric Antigen Receptor T cell (CAR-T cell) therapy product for relapsed/refractory (r/r) B-cell lymphomas and leukemia in India.
The therapy is designed to treat certain types of blood cancers
According to an ET report, The therapy is backed by drug maker Laurus Labs and is designed to treat certain types of blood cancers. NexCAR19 is the first humanized CD19-targeted Chimeric Antigen Receptor T cell (CAR-T) therapy developed in India to receive approval.
The report further added that the therapy will be used for the treatment of relapsed/refractory (r/r) B-cell lymphomas and leukemia in India.
Pricing of the therapy
Although the pricing of NexCAR19 has not been disclosed, ImmunoACT said that it aims to make the therapy available to its partner hospitals as soon as possible.
In the past, ImmunoACT's CEO, Rahul Purwar, announced that the CAR-T cell therapy would be priced between Rs 30 lakh and Rs 40 lakh per patient, significantly cheaper than existing treatments, which cost Rs 3-4 crore per patient.
The trial involved 60 patients
The approval was based on the results of a multi-centre phase I/II pivotal clinical trial led by Dr. Hasmukh Jain. The trial involved 60 patients with relapsed/refractory B-cell lymphomas and leukemia. The clinical data showed an overall response rate (ORR) of 70%.
Additionally, the therapy demonstrated a favourable safety profile, with low toxicity and minimal side effects such as cytokine release syndrome (CRS). This indicates a significant improvement over other commercially approved CD19-directed CAR-T cell therapies, the report said.
The partnership between IIT Bombay and TMC
NexCAR19 is the result of a decade-long collaboration between IIT-Bombay and Tata Memorial Centre (TMC). The design and development of NexCAR19 were led by Atharva Karulkar, Alka Dwivedi, and a team headed by Rahul Purwar, associate professor at IIT Bombay.
The therapy underwent integrative process development and manufacturing under cGMP at ImmunoACT. Clinical investigations and translational studies were conducted by Dr. Hasmukh Jain, 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. 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," said Dr Rahul Purwar, Founder & CEO of ImmunoACT.