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European Biopharmaceutical Review

Neoantigens: IP Considerations for an Emerging Class of Cancer Immunotherapy

The past decade has seen unprecedented advances in cancer treatment, shifting from a ‘one-size-fits-all’ approach towards the clinical development of technologies that engage a patient’s own immune system to fight off cancer cells. These cancer immunotherapies rely on the ability of the host’s immune system to recognise tumour antigens and effectively eradicate tumour cells.

Advances in Adoptive T Cell Therapies

Chimeric antigen receptor (CAR) T cell therapy, has gained lots of attention in recent years with the landmark approvals of the first two CAR T cell therapies, KymriahTM and YescartaTM, first by the FDA in 2017, with the European Medicines Agency quickly following suit in 2018. These first approvals are only the start of this new era in cancer medicine, with the FDA predicting that it will approve 10-20 cell and gene therapy products a year by 2025 (1). While there were concerns initially that current health systems might not be supportive due to the high costs associated with these one-off treatments, the manufacturers, Novartis (Kymriah) and Gilead (Yescarta), managed to successfully obtain reimbursement in many countries in Europe (2). It signals that governments and healthcare systems are keen to implement these innovative treatments, which, in turn, provides impetus for companies to invest in these treatment areas.

CAR T cell therapy uses the patients’ own modified T cells to recognise antigens expressed by cancer cells and subsequently kill those cells. However, in many cases, these antigens are also expressed by normal, non-cancerous cells and tissues – it’s just that they’re overexpressed or misregulated in the cancer cells. As these so-called ‘common’ antigens are not tumour-specific, one factor limiting the clinical application of CAR T cells are severe toxic side effects, such as cytokine release storm and neurological events. There are ongoing developments designed to minimise these side effects associated with CAR T cell therapy.

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Fran Salisbury is a partner in the Mewburn Ellis life science patent team. She works in all patent cycle stages – from invention capture, drafting and patent strategy to prosecution and global portfolio management. Fran has particular expertise in cell therapies, such as adoptive cell therapy and CAR T therapy, personalised and stratified medicine, and plant-related inventions and plant variety rights. Her clients include universities and technology transfer offices, as well as start-ups, spin-outs and SMEs. She works closely with many Singapore-based clients.

Ine Vanderleyden is a member of the Mewburn Ellis life science patent team. Her areas of expertise are immunology, in particular T cell immunology, and cell biology. Ine has a PhD in Biological Sciences from the University of Cambridge, UK. Her doctoral research focused on the role of regulatory T cells in controlling the immune response, in particular the germinal centre response. Ine’s subsequent post-doctoral research investigated the transcriptional regulation of regulatory T cell development in the thymus. She joined Mewburn Ellis LLP as a technical assistant in 2019.
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Fran Salisbury
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Ine Vanderleyden
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