Heat proofing Immunity: Pioneering a Thermally Resilient Ensilicated mRNA-LNP Vaccine Platform

耐热免疫：开创耐热硅化 mRNA-LNP 疫苗平台

• 批准号: 10086064
• 金额: $ 226.43万
• 依托单位: ENSILICATED TECHNOLOGIES LTD
• 依托单位国家: 英国
• 项目类别: Small Business Research Initiative
• 财政年份: 2023
• 资助国家: 英国
• 起止时间: 2023 至 无数据
• 项目状态: 未结题
• 来源: https://gtr.ukri.org/projects?ref=10086064
• 关键词: Heat; proofing; Immunity; Pioneering; Thermally

EnsiliTech working with Afrigen and Emervax intend to develop a thermostable ensilicated messenger ribonucleic acid in lipid nanoparticle (mRNA-LNP) vaccine against the Hantaan virus (HTNV) that can be rapidly and equitably deployed globally.The Hantaan virus of the hantavirus family is predominantly present in Asia, although it occurs around the globe. It is transmitted through rodents, in this case the field mouse, as carriers to humans and causes haemorrhagic fever with renal syndrome (HFRS) that results in mortality up to 15% of infected individuals with yearly estimates of 200,000 cases globally. There is no vaccine commercially available.We believe that our combined effort and resources can contribute to the development of a safe, effective and modern vaccine against this virus. We strongly envision a world with equitable access to the latest vaccines that can prevent neglected infectious diseases. Emervax will provide their knowledge and experience in working on other Hantaviruses such as the Andes virus to the development of an mRNA cassette encoding the desired antigen. Afrigen will manufacture the drug substance (i.e. active pharmaceutical ingredient, API) and drug product which includes encapsulation within the LNP. EnsiliTech will investigate stabilisation of mRNA and mRNA-LNP using the ensilication technology, making it a room-temperature stable vaccine. This renders the cold chain logistics obsolete and increases accessibility and availability by extending shelf life and enhanced thermal stability. We believe this directly aligns with the scope and aims of the grant competition.We anticipated the results of this project to provide us with:* A novel antigenic mRNA construct efficacious against the HTNV demonstrated through _in vitro_ and _in vivo_ immunogenicity supported by challenge studies with subsequent first generation of mRNA-LNPs;* The establishment of mRNA-LNP ensilication and robust protocol thereof;* Thermostable vaccine formulation through ensilication;* Protective immunisation efficacy through intramuscular delivery _in vivo_ in rodents.The impact of the project would be the ability of this workflow to be templated on other neglected diseases and provide a platform for those emerging infectious pathogens such as Disease X. This project also addresses all key aspects towards the route to market for the final vaccine formulations. The created intellectual property (IP) will enable governmental bodies or non-governmental organisations to take a licence and support the manufacturing and distribution. Overall, our combined effort would intercalate and provide further opportunity for this consortium to become important contributors in the effort to improve global health.

与Afrigen和Emervax合作，打算在脂质纳米颗粒（mRNA-LNP）疫苗中开发可为Hantaan病毒（HTNV）开发可热的信使核糖核酸（MRNA-LNP）疫苗，该疫苗可以迅速且可公平地在全球范围内部署。它是通过啮齿动物传播的，在这种情况下为野外小鼠，作为人类的携带者，并引起肾脏综合征（HFRS）的出血热，导致死亡率高达15％的感染者，年度估计为全球200,000例估算200,000例。我们相信，我们的综合努力和资源可以为针对该病毒的安全，有效和现代的疫苗开发开发。我们强烈地设想了一个可以公平获取最新疫苗的世界，这些疫苗可以防止被忽视的传染病。 Emervax将提供他们在研究其他汉坦病毒（例如安第斯山脉病毒）的知识和经验，以开发编码所需抗原的mRNA盒。 Afrigen将生产该药物（即活性药物成分，API）和药品，其中包括LNP内的封装。 Ensilitech将使用耐用技术研究mRNA和mRNA-LNP的稳定，使其成为一种室温稳定的疫苗。这使冷链物流过时，并通过延长货架寿命并增强热稳定性来增加可及性和可用性。我们相信这与赠款竞争的范围和目标直接相符。我们预期该项目的结果可以为我们提供：*一种新型的抗原mRNA构建有效的对通过_in vivo_和_in in vivo_ in vivo_ in vivo_的HTNV的有效性，并由挑战研究支持了挑战性研究，并随后将mRNA-lnps的第一代人类的建立;* Entrestion* mrna-Lnp;*通过耐用的表达；*通过肌肉内输送_在啮齿动物中的保护性免疫功效。该项目的影响将是该工作流程在其他被忽视的疾病上模板的能力，并为那些疾病等新兴的感染性病原体（如疾病x）提供了一个最终的键入型途径，以解决所有键x，以探讨所有键的途径，以促进所有途径，以促进所有途径，以促进所有途径，以销售所有途径。创建的知识产权（IP）将使政府机构或非政府组织能够获得许可并支持制造和分销。总体而言，我们的综合努力将使该财团成为改善全球健康的重要贡献者的进一步机会。