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17 September 2019PatentsIain Armstrong

Immunotherapy patents: Why CAR-T is driving up patent activity

Immunotherapies are a hugely promising therapeutic area, in terms of both clinical benefits and potential market size. These treatments augment the body’s own immune response to improve its effectiveness in fighting diseases, particularly cancer.

Immunotherapies such as monoclonal antibodies and checkpoint inhibitors have already demonstrated real benefits for patients, but perhaps the highest hopes are held for “adoptive immunotherapies” such as CAR-T cells.

CAR-T cells overcome the ability of cancer cells to “hide” from the immune system among normal cells in the patient’s body. The patient’s own white blood cells are taken and genetically engineered to express proteins (chimeric antigen receptors [CARs]) that include an extracellular part based on an antibody to a target of interest. These recognise characteristic markers on the surface of cancer cells, allowing the CAR-T cells to bind to, and kill, the cancer.

The need to genetically manipulate, and then return, the patient’s cells makes treatment complicated and expensive. However, CAR-T cells have proved remarkably effective in trials, and within the last two years their clinical use has been approved in the US and Europe. The first two products approved are Novartis’ Kymriah and Gilead’s Yescarta, both of which target CD19, a protein expressed by cancerous B cells in acute lymphoblastic leukaemia or large B cell lymphoma.

Commercial interest

The worldwide market for CAR-T therapies is expected to top $3 billion by 2025 according to reports by Marketwatch.com and BCC Research. This has prompted a series of acquisitions by companies keen to establish their presence in the marketplace, including Gilead’s purchase of Kite Pharma (the original developer of Yescarta), and Celgene’s takeover of Juno Therapeutics.

Commercial and technological developments have also driven a huge rise in patent filings. More than 450 Patent Cooperation Treaty applications were published in 2018, compared to around 60 in 2014. Leading filers include the University of Pennsylvania (where much of this technology was first developed), Novartis, Cellectis, and University College London. The subject matter of the patent filings provides a good indication of the commercial and technological aims driving those working in this field.

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