A SYNTHETIC BIO-MIMETIC TO TREAT CANCER: Patent protection of UK's global lead in cell-free Immune Oncology.

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COVID-19 HAS INTERRUPTED PATENT PROTECTION OF A NOVEL ANTI-CANCER BIO-MIMETIC* Applicant LIFNanoRx (LNT) has invented an IL-6-based bio-mimetic nanoparticle to treat cancer, exemplified by "IL-6-MOF".* PATENT PROTECTION is urgent : Government lock-down due to COVID-19 prevented essential prototype production and testing to underpin the Patent.* This Project will enable Patent filing by May 2021\.BACKGROUND* Although new drugs have brought success in treatment of some cancers for most solid tumour types mortality rates remain unchanged, including lung where, notably, COVID-damaged lungs may be at increased risk. As a treatment alternative to drugs, new approaches tap into the patient's own immune system, known as Immune Oncology (IO)* One aspect of IO is use of CHIMERIC ANTIGEN RECEPTOR - T (CAR-T) cell-mediated killing of cancer cells - successful for haematological malignancies but limited for solid cancers. An achilles heel of CAR-T is need for genetic manipulation and thereafter GMP- manufacture of clones - incurring high cost and major environmental impact.* Despite their biological complexity, the CAR-T cell approach has rapidly expanded as an alternative to conventional treatments, especially for leukaemias and lymphomas. CAR-T companies have proliferated, with high stakes and Pharma mergers and acquisitions (M&A) including Celgene and Juno Therapeutics for $9 billion 2018 and Gilead acquiring Kite Pharma for $11.9 billion in 2017\. Whilst this commercial activity expands, key challenges to the CAR-T approach remain, including _severe toxicities_; _poor CAR-T cell access to tumour_; _poor CAR-T cell survival in vivo_; _manufacture capacity_; and _regulatory hurdles_ (NatureReviews Clinical Oncology 2019).INNOVATION: BIO-MIMETIC NANOPARTICLES TO TRIGGER ANTI-TUMOUR ATTACK _IN SITU_* Our bio-mimetic solution to the hurdles of CAR-T is to bypass need for CAR-T totally. We activate endogenous "killer" T cells within the tumour using our proprietary IL-6-MOF biomimetic. This provides a simpler, cleaner, synthetic approach to IO that is scalable and universal for all tumours.* Our longer term aim is to treat Mesothelioma, a rare cancer of the mesothelium - the thin sheet of tissue that lines the pleural cavity and forms a sac around the lungs. Caused by exposure to asbestos with some 50 year lag-time, survival is around 12 months after diagnosis with breathing becoming obstructed. Since the lymphocytes within the tumour are physiologically silent, we aim to deliver IL-6-MOF directly into the pleural cavity using a catheter: the rational is that the IL-6-MOF will bind to, and trigger the silent tumour-resident lymphocytes into activity, turning them into "killer" T lymphocytes. These killer T cells will orchestrate immune attack against the mesothelioma cancer cells.PUBLIC FUNDING* This award will be pivotal at three levels: (i) bringing a new _"IN SITU"_ approach to Immune Oncology (IO) led by the UK; (ii) vastly reducing adverse environmental impact and cost of IO - with potential applicability to all types of solid tumour; (iii) bringing to the UK new employment across the industrial supply chain, and inward investment from Pharma.* Public funding will be transformative for public gain .