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

新冠肺炎中断了一种新型抗癌仿生药物的专利保护*申请者LIFNanoRx(LNT)发明了一种基于IL-6的仿生纳米粒子来治疗癌症，例如“IL-6-MOF”。*专利保护迫在眉睫：由于新冠肺炎公司阻止了必要的原型生产和测试，以支持专利。*该项目将使专利申请到2021年5月\.背景*尽管新药已经成功地治疗了一些癌症，大多数固体肿瘤类型的死亡率保持不变，特别是肺脏，特别是受到冠状病毒损害的肺部可能面临更高的风险。作为药物的一种替代治疗方法，新的方法利用患者自己的免疫系统，称为免疫肿瘤学(IO)*IO的一个方面是使用嵌合抗原受体-T(CAR-T)细胞介导的杀伤癌细胞--对血液系统恶性肿瘤成功，但对实体癌有限。CAR-T的一个致命弱点是需要进行基因操作以及随后的GMP--制造克隆--这会导致高昂的成本和重大的环境影响。*尽管CAR-T细胞方法在生物学上很复杂，但作为传统治疗方法的替代方法，CAR-T细胞方法已经迅速扩展，特别是对白血病和淋巴瘤。CAR-T公司激增，高风险和Pharma并购(M&A)，包括Celgene和Juno Treeutics在2018年以90亿美元收购，Gilead在2017年以119亿美元收购Kite Pharma。虽然这一商业活动扩大了，但CAR-T方法的关键挑战仍然存在，包括：严重的毒副作用；糟糕的CAR-T细胞获得肿瘤的机会；糟糕的CAR-T细胞在体内的存活率；制造能力；以及调节障碍_(NatureRevision临床肿瘤学2019)。创新：生物模拟纳米粒引发抗肿瘤攻击_原位_*我们对CAR-T障碍的生物模拟解决方案是完全绕过对CAR-T的需要。我们使用我们专有的IL-6-MOF仿生药物来激活肿瘤内的内源性“杀手”T细胞。这为IO提供了一种更简单、更清洁的合成方法，这种方法可扩展并适用于所有肿瘤。*我们的长期目标是治疗间皮瘤，这是一种罕见的间皮癌--一种排列在胸膜腔内并在肺部周围形成囊的薄片组织。由于暴露在石棉中有大约50年的滞后时间，在确诊后呼吸受阻的情况下存活约12个月。由于肿瘤内的淋巴细胞在生理上是沉默的，我们的目标是使用导管将IL-6-MOF直接输送到胸腔：合理的是，IL-6-MOF将与沉默的肿瘤常驻淋巴细胞结合，并触发其活动，将它们转变为“杀手”T淋巴细胞。这些杀手T细胞将协调对间皮瘤癌细胞的免疫攻击。PUBLIC资金*这一奖项将在三个层面上发挥关键作用：(I)为英国领导的免疫肿瘤学(IO)带来一种新的“原位”方法；(Ii)极大地减少IO的不利环境影响和成本--潜在适用于所有类型的实体肿瘤；(Iii)为英国带来整个工业供应链的新就业机会，以及来自制药的外来投资。*公共资金将对公众利益产生变革性影响。

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 .