India’s first Phase II patient trials for CAR-T cancer therapies

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Immuneel Therapeutics (‘Immuneel’), India’s biotech start-up focused on creating access to Chimeric Antigen Receptor T cell therapy (CAR-T) and other cellular immunotherapies for the management and treatment of cancers, has begun patient dosing in a CAR-T trial named “IMAGINE”. This phase II trial is the first industry sponsored CAR-T trial in India and is now actively enrolling patients at Narayana Hrudayalaya, Bengaluru.

Biocon founder and chairperson Kiran Mazumdar-Shaw, Dr. Siddhartha Mukherjee, U.S oncologist and Dr. Kush Parmar, Immuneel is on a mission to bring cell and gene therapy programs, especially with clinical data, to India at an affordable cost. With a focus on maintaining global standards, the company is developing cutting edge programs, delivered through partnerships with leading hospitals. In 2021, the company had established the first cGMP-approved integrated cell therapy development and manufacturing facility at the Mazumdar-Shaw Cancer Centre at Narayana Health City (Bengaluru).

CAR-T therapies, previously not available in India, have shown promising results for patients who have exhausted all other means of treatment in a range of blood cancers.

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The IMAGINE trial is funded by Immuneel and will include up to 24 pediatric and adult cancer patients. Immuneel has exclusive rights to ARI-0001/IMN-003A (a CD-19 CAR-T cell therapy) from Hospital Clínic de Barcelona and Institut d’Investigacions Biomèdiques August Pi i Sunyer in Spain to develop, manufacture and commercialize in India via technology transfer. ARI-0001 is approved by the Spanish Drug Agency (AEMPS) and the data available compares very favorably with U.S FDA approved products.