10088670VaxStable - Bringing lipid nanoparticle based mRNA vaccines in from the coldClosedCollaborative R&DInnovate UKThe rapid development, manufacture and supply of mRNA vaccines against COVID-19 is one of the greatest success stories in modern medicine. Demonstrably safe and effective in over billion patients, the question now is not if, but how quickly, this revolutionary combination of an mRNA therapy and lipid nanoparticle (LNP) carrier can be expanded to and exploited against other diseases. A key outstanding challenge is the requirement for (ultra)cold-chain storage and distribution. This has severely limited global access to these potentially life-saving technologies, particularly in lower income countries. This project brings together four of the most innovative mRNA/LNP organizations in the UK who will work together to create the world's first thermostable LNP-mRNA vaccine, ready for use wherever and whenever it is needed in the future. To tackle this challenge, we will take a holistic, bottom-up approach to design new LNP compositions with inherent, enhanced stability profiles but without compromising efficacy or safety. Led by NanoVation Therapeutics UK, a leading LNP innovation company founded by the co-developers of the Pfizer vaccine LNP, a key focus will be the incorporation of abundant and safe, natural lipids, known to stabilize biological lipid structures. In parallel, NanoVation's 'inside-out' efforts will be intertwined with iosBio's 'outside-in' excipient technologies to further boost LNP thermostability. iosBio's pioneering work on excipient stabilization has enabled the long-term storage (cryogenic and lyophilized powder) of viral vaccines without loss of potency. Following preclinical proof of concept (PoC) demonstration, we will next investigate de-risking pharmaceutical development by investigating long-term stability and manufacturability. This will be led by the UK's RNA centre of excellence, established by the Centre of Process Innovation (CPI). By exploiting CPI's innovative open access model, we will ensure we have a viable product ready for deployment into clinical trials. Finally, our lead LNP technology will be transferred to BaseImmune - a next-generation mRNA vaccine company that utilises data driven design algorithms to create potent and variant resistant mRNA vaccines. Their platform combines genomics, immunological data, and epidemiological data with bespoke antigen design AI to generate multi-target antigens. Their lead programmes on COVID-19 and Malaria are anticipated to enter the clinic during this project, providing the ideal pathway for this project to make an impact. All companies involved have the democratisation of medicines at the heart of their mission and we are determined to realise this -- **together we will bring mRNA vaccines in from the cold!**