Immunoadoptive Cell Therapy Private Limited (ImmunoACT), an IIT Bombay spin-off, backed by Hyderabad-based leading pharmaceutical and biotechnology multinational company (Laurus Labs) received the CDSCO approval of India’s first indigenously produced Chimeric Antigen Receptor (CAR) -T cell therapy, NexCAR19 (Actalycabtagene autoleucel), for the treatment of relapsed/refractory B-cell lymphomas and leukaemia on 13th October 2023.
Development and approval of this therapy is a consequence of a research synergy between IIT Bombay and Tata Memorial Centre (TMC) for about a decade. Protected by patent application IN201921036138, this therapy includes activation of an inducible cytokine response element (DICCRE) by dimerization upon exposure to a synthetic dimerizing drug to induce cytokine specific signaling domain used in individual DICCRE construct for rapid immune-cell activation. This not only eliminates cytokine toxicity but also augments anti-tumor effect of the immune cells without affecting bystander cell populations.
The developers are confident that the therapy, in most likelihood, will be priced in the Rs 30-40 lakh a dose range which is an advancement towards making life-saving therapies available to the patient population in Low- or Middle-Income Countries (LMIC) at an affordable cost.
In the Cell and Gene therapy (CGT) space, another industry–academia collaboration between Laurus Labs and IIT Kanpur’s Department of Biological Sciences and Bioengineering (BSBE) is expected to bring novel gene therapy products for inherited disorders like Leber congenital amarousis, Hemophilia and Muscular dystrophy, to the market. With BSBE’s strong intellectual property (IP) portfolio around these products such as IN202311044001, IIT Kanpur will transfer several gene therapy assets through in-licensing to Laurus Labs, who will provide a research grant to facilitate their progression through pre-clinical development. Laurus Labs will also fund the necessary clinical trials and spearhead the launch of these cutting-edge products not only in India but also in emerging markets.
Such industry–academia collaborations have been possible due to joint efforts of Department of Biotechnology (DBT) and Biotechnology Industry Research Assistance Council (BIRAC) who have been instrumental in supporting startups and academic institutes by raising funds and mentoring innovation research for affordable product development to achieve the ambitious goal of India’s biotechnology industry to successfully generate USD 100 billion revenues by the year 2025.