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NK Cell Therapy – An IP Update

Advances in CAR-T cell therapy have carved a path for improved treatments in the field of oncology, in particular haematological cancers. In 2018, the European Medicine’s Agency approved the first two CAR-T cell therapies, Kymriah® and Yescarta®, for marketing authorisation for the treatment of certain cancer.1 Since then, CAR-T cell therapy has been rolled out across Europe, largely for the treatment of large B-cell lymphoma, mantle cell lymphoma, and acute lymphoblastic leukaemia. However, the same success has not been realised for solid tumours.2

To address the challenge of cell therapy for the treatment of solid tumours, many have looked towards the power of natural killer (NK) cells as a potential therapy. In particular, CAR-NK cell therapy is thought to have several advantages over CAR-T cell therapy, such as an improved safety profile with a reduced risk of cytokine release syndrome and lower incidence of graft versus host disease.3 CAR-NK cells may also provide the much-needed improved efficacy in treating solid tumours. It is believed that CAR-NK cells may be able to overcome tumour escape problems as seen with CAR-T cells due to their retention of antigen-independent activity even when there is loss of antigen dependent killing.4

As advancements in the NK cell therapy area are gaining speed, so is the complexity of the IP landscape. International and European patent filings mentioning NK cell therapy

have been rising sharply over the last 5 years (Figure 1), with a number of large players in the game. Gilead Sciences Incorporated and Novartis AG have strong patent portfolios in this area (Figure 2), each with over 200 applications pending and 25–50 granted patents that at least mention NK cell therapy in the text of the applications. The University of Texas MD Anderson Cancer Center also holds a number of pending and granted patents directed towards methods of producing CAR-NK cells and claims towards therapeutic compositions of NK cells with engineered receptors.

To further strengthen their patent portfolios, a number of high-profile collaborations and deals have been struck. Gilead have partnered with Dragonfly Therapeutics to further strengthen their patent portfolio and to gain access to the 5T4-targeting investigational immunotherapy program and, upon completion of certain preclinical activities, a licence to use Dragonfly’s TriNKETTM technology to develop and commercialise NK cell engagers. Dragonfly Therapeutics have further capitalised on their IP position by licencing multiple NK cell therapy candidates to Merck and Bristol Myers Squibb, in the fields of oncology and neuroinflammation.

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