Cell and gene therapy advancements, ecosystem efforts in CCUS and semiconductors, new photonic materials and more
Deep Science Ecosystem Updates
- The Infosys Science Foundation announced the laureates of the 2023 Infosys Prize, spanning six categories: Engineering and Computer Sciences, Humanities, Life Sciences, Mathematical Sciences, Physical Sciences and Social Sciences.
- A national conference "Crystals for Quantum Technology” was held at INST Mohali, where Principal Scientific Adviser Dr. Ajay Sood emphasized the importance of the National Quantum Mission and ongoing research in the field.
- The 1st annual SemiX summit was held at IIT Bombay, bringing together researchers, investors and other industry stakeholders in India’s nascent semiconductor space.
- A new deeptech accelerator program, SAMRIDHI, was inaugurated at IIT Ropar. The program will focus on deeptech innovations in the agriculture and water spaces.
- The DST ran a consultative brainstorming session on India’s path to net zero, with Prof. Abhay Karandikar, secretary of DST, leading the discussion on carbon capture, utilization and storage technologies.
News from the research community
- The 6th National Post-Doc Symposium (NPDS) took place in Ashoka University with three sub-themes: (a) Vision for life science research in India, (b) Transitions in academia, and (c) Transition to industry & entrepreneurship.
- The DBT and Vinnova, Sweden’s Innovation Agency, have launched a joint call for grants for innovations in the fields of AI and healthcare, circular economy and biodesign.
- Researchers from Centre for Nano and Soft Matter Sciences and Manipal Academy of Higher Education have discovered a method to tune soft photonic crystals to emit and control light emitted in all directions, paving a way for sophisticated photonic devices.
- Dr. Muniyandi Sankaralingam, a DST Inspire Faculty Fellow has synthesized earth-abundant metal complexes that can serve as catalysts for organic processes used in industry.
Deep Science Thoughts
Cell and Gene Therapy in India
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 cell therapy product in October this year. Funded by Laurus Labs, which owns close to 34% of the company, they have developed a humanized CD19-targeted CAR-T cell therapy for treating relapsed/refractory B-cell lymphomas and leukaemia. The product is called NexCAR19. 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. This will make the treatment affordable to a larger population around the world.
Affordable personalized medicine is the need of the hour to improve access.
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.
Among the many advancements that have happened over the last two decades, the culmination of big data analysis tools including AI/ML with the availability of large biological data (due to lower sequencing costs) has been a key driver for the rise in personalization medicine. The total number of new genetic tests as of November 2022 stands at 106,007, rising from just 1081 in 2012. Analysis of the data using big data tools has translated into discovery of novel disease biomarkers and eventually led to the development of personalized medicine products which can target specific locations in the genetic makeup of an individual and create a very specific intervention. 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. In November 2023, the UK became the first country in the world to approve a CRISPR based medicine for treating sickle cell disease and beta thalassemia.
Despite these advancements, 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.
ImmunoACT’s success will pave a way for the personalized medicine industry in India, similar to the pharma industry.
ImmunoACT conducted a multi-center phase I/II trial on 60 patients with relapsed/refractory B-cell lymphomas and leukemia. The data showed that the technology had an overall response rate of 70% with a favourable safety profile, lower toxicity and minimum side effects. ImmunoACT’s success will help accelerate other companies to develop similar products. For example, 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. India stands a chance to replicate the pharmaceutical model and become the cell and gene therapy manufacturing capital of the world.
