Enhancing the stability of RNA Therapeutics to improve their delivery and efficacy using universal non-toxic stabilisers

The speed with which SARS-CoV-2 vaccines were formulated, approved and rolled out to the UK public has been truly remarkable and unprecedented. In particular the development of mRNA-LNPs proved not only very fast but also highly effective compared with protein based vaccines, promising a new era of therapeutic/vaccine development in 'one hundred days or less'. Despite such rapid progress and promise, the development of mRNA-LNP technology has been a compromise between speed and utility; instability of the therapeutic/vaccine has proved to be a serious drawback requiring an ultra low temperature (-80°C) cold-chain which has directly increased the cost and complexity of vaccine rollout as well as limiting vaccination programs in high income countries. Furthermore because of the extreme fragility of mRNA, the therapeutic/vaccine dose varies depending on the integrity of the cold-chain. Based on results to date we believe we can overcome many of the manufacturing bottlenecks such as storage and dispensing, as well as transport at ambient temperature by developing a universal non-toxic stabiliser that protects the mRNA therapeutic/vaccine from the point of manufacturing through to stockpiling and transport to the clinic. We are confident that the use of our molecular stabilisers will radically change the market for RNA therapeutics/vaccines by allowing the manufacture, storage, transport and delivery of consistently intact and highly active mRNA therapeutic/vaccine treatments even in environments that are lacking a functional cold-chain and distribution system.