Advancements in Cellular and Genetic Therapies: Pioneering Developments in India
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By Suraj Nair, Deep Science and Technology Investments, Ankur Capital
What is going on?
Immunoadoptive Cell Therapy or ImmunoACT, a company incubated in IIT Bombay, became the first in India to receive the Central Drugs Standard Control Organisation’s (CDSCO) marketing authorization approval for a humanized CD19-targeted CAR-T cell therapy for treating relapsed/refractory B-cell lymphomas and leukaemia in October this year. The product is called NexCAR19. Immuneel Therapeutics announced India’s first Phase II clinical trials for CAR-T cancer therapies. The company also secured $15 million Series A funding. Eyestem Research is developing cell therapy for Dry age-related macular degeneration (dry AMD). The company recently submitted an Investigational New Drug (IND) application to the CDSCO to begin first in-human trials of Eyecyte-RPE for medium- and late-stage geographic atrophy, secondary to dry AMD. The company raised a Series A funding of $6.4 million in August 2022.
What does it mean?
This marks a significant milestone towards developing affordable personalized medicine from India. The product is expected to hit the markets in early 2024 and will be priced between 30-40 lakh rupees per patient, a reduction of around 10 times from the existing price points.
Why does it matter?
💸For markets:
As of 2022, there were 13 cell or gene therapies with US FDA approval, 5 of which were approved in 2022 itself. 12 new drug molecules identified as personalized medicine were approved in 2022, which represented a third of the total number of drugs approved by the US FDA. However, personalized medicine has been inaccessible to a large population, primarily due to its high cost. In 2022, the US FDA approved the first gene therapy to treat haemophilia B, a genetic disease that impairs blood clotting. The price of the treatment is $3.5 million per patient, making the therapy, called Hemgenix, the most expensive drug in the world. The major cost involved in developing gene/cell therapy is in producing, handling and controlling the cells or vectors used in the process. The amortization of these costs is challenging due to the low number of patients to administer the therapy compared to a pharmaceutical drug. ImmunoACT, on the other hand has been able to reduce the cost of the product due to its lower manufacturing costs, lower R&D expenses and also the availability of a number of reagents and cell handling technologies in the country. The cost of conducting a clinical trial is also significantly lower in India. ImmunoACT’s patented CAR-T cell therapy platform provides a unique design algorithm to develop new CAR-T cells.
🧑🏿🤝🧑🏻For society:
A traditional approach to therapy is a one-size fits all drug delivery method, based primarily on large population averages. While this may work in a few cases, the effects of the therapy vary greatly from patient to patient. Genetic makeup of individuals vary and this has an effect on the extent of impact from the drug treatment, a field of study known as pharmacogenomics. Developing affordable personalized medicine can go a long way in treating specific disease conditions for patient types and geographies.
🔮What’s next?
Personalized medicine in the form of cell and gene therapy is expected to be the next frontier in the field of medicine. India, similar to vaccines and the biosimilars industry can develop affordable quality products for the world for specific target diseases in oncology, autoimmune and other rare diseases. The next step for companies such as ImmunoACT would be to scale up the production capacities, treatment centers across the country and build technical and operational capabilities to carry out cell and gene therapy.
Note: Read more about Ankur Capital and our work in deep science technologies here.