IIT Bombay-incubated company Immunoadoptive Cell Therapy (ImmunoACT), in which drugmaker Laurus Labs holds about 34% stake, has received Central Drugs Standard Control Organisation’s (CDSO) marketing authorisation approval of the first humanised CD19-targeted Chimeric Antigen Receptor T cell (CAR-T cell) therapy product for relapsed/refractory B-cell lymphomas and leukaemia in India.
ImmunoACT said it intends to make NexCAR19 (Actalycabtagene autoleucel), the CAR-T cell therapy, available to its partner hospitals as soon as possible. The indigenously-developed product will put the country on the world map of advanced cell-and-gene therapies, the company said.
Laurus Labs has been the early backer of ImmunoACT and invested over $18 million to support it to scale research and development as well as commercialisation efforts.
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NexCAR19 is the result of a collaborative effort across a decade between IIT Bombay and Tata Memorial Centre (TMC). Designed and developed at IIT Bombay, NexCAR19 subsequently underwent integrative process development and manufacturing under cGMP at ImmunoACT. Clinical investigations and translational studies were conducted by teams at TMH.
ImmunoACT’s said its vision is to provide a high quality and affordable CAR-T cell therapy platform to all sections of the society. “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,” founder and CEO of ImmunoACT Rahul Purwar said on the successful completion of clinical trials.
The multi-centre Phase I/ II pivotal clinical trial was conducted with 60 patients of r/r B-cell lymphomas and leukaemia. The clinical data indicates about 70% overall response rate. The safety profile in terms of cytokine release syndrome and absence of neurotoxicity indicates a significant improvement over the other commercially approved CD19-directed CAR-T cell therapies, the company said in a release. ImmunoACT was founded in 2018 under the aegis of SINE (Society for Innovation and Entrepreneurship) with the intention to be able to translate academic research into a commercially viable product.
“We are happy and proud to be part of this indigenously developed Cell therapy product for blood cancer treatment,” Laurus founder-CEO Satyanarayana Chava said.
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