Drug firm Laurus Labs Ltd on Friday (October 13) said its associate company, Immunoadoptive Cell Therapy Private Ltd (ImmunoACT), has received approval from India's Central Drugs Standard Control Organisation (CDSCO) for the country's first CAR-T cell therapy, NexCAR19 (Actalycabtagene autoleucel).
"This significant milestone marks a momentous step forward in the treatment of relapsed/refractory (r/r) B-cell lymphomas and leukemia in India," the company said.
NexCAR19, an indigenously developed CD19-targeted Chimeric Antigen Receptor T cell (CAR-T cell) therapy, aims to offer high-quality and affordable care.
The approval comes after a multi-centre Phase I/II pivotal clinical trial involving 60 patients with r/r B-cell lymphomas and leukaemia. The clinical data demonstrated an overall response rate (ORR) of approximately 70%, the company claimed.
NexCAR19 also showcased a favourable safety profile in terms of cytokine release syndrome (CRS) and the absence of neurotoxicity, indicating significant improvement compared to other commercially approved CD19-directed CAR-T cell therapies.
Indian Institute of Technology Bombay (IIT Bombay) and the Tata Memorial Centre (TMC) collaborated in the design and development of NexCAR19.
It then underwent an integrative process development and manufacturing under current Good Manufacturing Practices (cGMP) at ImmunoACT.
ImmunoACT is an IIT Bombay-incubated company under the aegis of SINE (Society for Innovation and Entrepreneurship), founded in 2018 with an aim to translate academic research into a commercially viable product, furthering India's prominence in the field of cutting-edge medical therapies.
Shares of Laurus Labs Ltd ended at Rs 404.10, up by Rs 2.70, or 0.67%, on the BSE.
(Edited by : Vijay Anand)
First Published: Oct 13, 2023 10:17 PM IST
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