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.

EnsiliTech 与 Afrigen 和 Emervax 合作，打算开发一种针对汉坦病毒 (HTNV) 的耐热硅化信使核糖核酸脂质纳米颗粒 (mRNA-LNP) 疫苗，该疫苗可以在全球快速、公平地部署。汉坦病毒家族的汉坦病毒主要存在尽管这种情况发生在全球各地，但发生在亚洲。它通过啮齿类动物（本例中为田鼠）作为人类携带者传播，引起肾综合征出血热 (HFRS)，导致感染者死亡率高达 15%，全球每年估计有 20 万例病例。目前还没有商业化的疫苗。我们相信，我们的共同努力和资源可以为开发针对这种病毒的安全、有效和现代的疫苗做出贡献。我们强烈希望世界能够公平地获得能够预防被忽视的传染病的最新疫苗。 Emervax 将提供他们在研究其他汉坦病毒（例如安第斯病毒）方面的知识和经验，以开发编码所需抗原的 mRNA 盒。 Afrigen 将生产原料药（即活性药物成分 API）和包括 LNP 内封装的药品。 EnsiliTech 将利用硅化技术研究 mRNA 和 mRNA-LNP 的稳定性，使其成为室温稳定的疫苗。这使得冷链物流变得过时，并通过延长保质期和增强热稳定性来提高可及性和可用性。我们相信这与资助竞赛的范围和目标直接一致。我们预计该项目的结果将为我们提供：*通过挑战研究支持的_体外_和_体内_免疫原性证明了一种对HTNV有效的新型抗原mRNA构建体随后的第一代 mRNA-LNP；* mRNA-LNP 青化及其稳健方案的建立；* 通过青化的耐热疫苗配方；* 通过青化实现保护性免疫功效啮齿类动物体内肌肉注射。该项目的影响将是该工作流程能够以其他被忽视的疾病为模板，并为那些新出现的传染性病原体（例如疾病 X）提供一个平台。该项目还解决了该路线的所有关键方面将最终疫苗配方推向市场。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，我们的共同努力将为该联盟提供进一步的机会，成为改善全球健康的重要贡献者。