NexCAR19: The Future of Lymphoma Treatment in India, and IP’s Essential Role
This post is one of a series in the #Innovate4Health policy research initiative. #Innovate4Health is a joint research project by the University of Akron IP Center (UAIP), the Information Technology & Innovation Foundation (ITIF), and the Geneva Network. This project highlights how intellectual-property-driven innovation can address global health challenges. If you have questions, comments, or a suggestion for a story we should highlight, we’d love to hear from you. Please contact UAIP Research Fellow Douglas Park at dpark@uakron.edu for more information.
Brian Thomson
Existing treatments for leukemia and lymphoma are not always effective. Even when treatment succeeds, it may be too expensive or simply inaccessible, especially in less wealthy countries such as India. Fortunately, Indian companies like ImmunoACT are actively developing novel treatments like the recently approved NexCAR19 T-cell therapy.
According to the National Cancer Institute, in 2020 over 570,000 people worldwide lost their lives to blood cancers, including leukemia and lymphoma, and estimates suggest that 70,000 of those deaths happen in India. India’s Shalby Hospitals network states that India sees one new case of blood cancer every five minutes.
Many patients in India are unable to treat their cancers because of inadequate accessibility or financial hardships. While these treatments are cheaper in India than in other nations, the average out-of-pocket cost still exceeds $4000 per patient per year, if treatment is available at all.
However, recent progress in the development of new treatments presents an opportunity to improve both the availability and affordability of cancer treatments in India and other less wealthy nations. One major impetus to this forward progress is the domestic development and production of innovative drugs and therapies in India.
One of these innovations is ImmunoACT’s NexCAR19 therapy, developed in partnership with the Indian Institute of Technology Bombay (IIT). This new drug allows a patient’s immune system more fully to combat leukemias and B-cell lymphoma, and ImmunoACT hopes that NexCAR19 will provide relief where other treatments and therapies have failed.
This new therapy is also noteworthy for being one of the first cancer therapies developed and created entirely within India. NexCAR19 was recently approved by India’s Central Drugs Standard Control Organization (CDSCO), paving the way for its implementation as the first of its kind in the Indian market.
ImmunoACT’s website describes in detail how NexCAR19 is administered. First, white blood cells are extracted from the patient at the hospital and placed in a special containment vessel called a “Leukopak,” then shipped to an ImmunoACT facility under refrigeration.
At the ImmunoACT facility, scientists modify these white blood cells to target the patient’s cancerous cells. The scientists develop a culture of the same white blood cells to build up multiple doses’ worth, which are then cryopreserved and extensively tested to ensure identity, purity, safety, and potency. The doses of modified white blood cells are then shipped back to the hospital, where the patient receives special chemotherapy to condition their body for the intravenous infusion of the modified white blood cells.
ImmunoACT and IIT began development of NexCAR19 in 2015 and spent eight years developing and testing it. The patients who participated in these trials suffered from either leukemia or lymphoma and had already attempted more conventional therapies with little or no success. During testing, 58% of patients experienced a complete remission of their symptoms, and another 12% experienced partial remission. Based on these numbers, NexCAR19 could save hundreds of thousands of lives every year if made available worldwide.
The biggest hurdle to broad availability is the cost to develop, produce, and distribute cancer therapies. The cost of research alone for a given cancer drug/therapy can exceed one billion USD, and only about one in a dozen treatments studied in early-stage clinical trials make it to the market. Even when those new treatments fail to reach the market, pharmaceutical companies still need to recoup those costs to afford new clinical trials, without which new drugs will never become available at all.
One way to recoup these research costs is through the sale of successful new drugs. However, if competitors can copy a drug without taking on any research and development costs themselves, then they can sell it for less than the original drug developers could. To prevent this freeriding, the original developers need to obtain patents on their innovation.
Patents grant developers a temporary right to exclude others from free-riding on the developers’ investments in their inventions. This allows the pharmaceutical companies to try to earn a return on their investments and incentivizes investment from third parties. Without these returns, pharmaceutical companies would be unable to continue funding the development of additional drugs and therapies, and no new treatments would become available to patients.
Prior to the 1990s, obtaining pharmaceutical patents in India was next to impossible because the Patents Act of 1970 made methods of treatment and mere mixtures of known substances unpatentable. This stifled pharmaceutical innovation for decades, crippling India’s ability to compete in the global innovation economy.
Fortunately, the Patents Act of 1970 was amended and made more permissive after India became a member of the World Trade Organization. An amendment to India’s Patent Act in 2005 allowed pharmaceutical patents on new chemical entities or improved efficacy with known entities.
While still more restrictive than patent systems in most other nations, these amendments have enabled more inventors to obtain patent protections in India. Because of these changes, healthcare innovations have started to take off in India in recent decades.
For example, IIT has filed for patent protections on NexCAR19 through the Patent Cooperation Treaty (PCT) has sought patents in India and the US. The PCT allows IIT more easily to pursue concurrent protections in up to 155 countries. These patent rights have enabled ImmunoACT and IIT to try and recoup the resources they have invested in developing NexCAR19.
Moreover, with a patent, ImmunoACT was able to secure the funds necessary to develop NexCAR19 and have the financial backing to consider development of future cancer treatments. Innovators like ImmunoACT and IIT themselves rarely have the funds necessary for the long and incredibly expensive development and testing for new pharmaceutical therapies like NexCAR19. It is therefore essential that they work with outside investors to fund this stage of NexCAR19’s development. Patent protections are essential for attracting such outside funding, as patents protect the investors’ contributions as well.
The development of cancer treatments like NexCAR19 has helped to put India on the map when it comes to healthcare research and development. India has the potential to become a pharmaceutical powerhouse with its wealth of brilliant scientists and abundance of resources, and the recent changes in India’s IP laws empower companies and research institutions like ImmunoACT and IIT to invest time and resources into developing drugs like NexCAR19. Having stronger IP protections will unleash this pharmaceutical potential, allowing Indian companies and scientific institutions to preserve and prolong the lives of patients across India and around the world.
