Enesi Pharma, an innovative biotechnology company developing next-generation vaccination products targeting infectious diseases and emergent threat pathogens enabled by its ImplaVax technologies, announces it is collaborating with Prof. Robin Shattock, a leading infectious disease and vaccine expert, and his group at Imperial College London, to develop RNA vaccines, including against SARS-CoV-2, that are stable at ambient temperatures and up to 40o Celsius (104o Fahrenheit).

The ability to create such vaccines could minimize or eliminate the cold chain requirements for global deployment and mass vaccination programmes with RNA-based vaccines.

The collaboration will investigate the potential of combining Enesi’s ImplaVax technology for the creation of thermostable, solid dose vaccines with RNA vaccines based on Imperial’s self-amplifying RNA (saRNA) technology and novel Polyplex DNA/RNA stabilisation technologies. ImplaVax technology enables the development of solid dose vaccines of a fixed (unit) dose that are designed to be delivered using a needle-free device into the dermal layer of the skin and with minimal administrator training.

An early phase of the collaboration – to assess the feasibility of creating a thermostable and immunogenic, solid dose DNA vaccine employing Enesi’ ImplaVax and Imperial’s Polyplex technologies – has been completed successfully. Based on these results, Enesi and Imperial are advancing their collaboration into a new phase to develop and evaluate the effectiveness of RNA vaccines using saRNA, Polyplex and ImplaVax technologies.

The successful production of a solid dose RNA vaccine, and demonstration of an appropriate immune response could lead to a further partnership to develop at pace an ImplaVax version of Imperial’s RNA vaccine against SARS-CoV-2, which is based on the virus’ spike protein and is being investigated in a Phase I/II trial in over 400 healthy subjects.

David Hipkiss, Enesi Pharma CEO, said: “Vaccines have been front-page news in recent months with astonishing progress being made since the outbreak of the Covid-19 pandemic. This global awareness has highlighted not only the potential of novel vaccine design and development technologies such as mRNA and adenoviral vectors but also the challenges of mass vaccination and in some cases the need for extreme ultra-cold chains for the distribution and storage of products, and the highly complex challenge of deployment and administration that follows.

“We believe that our ImplaVax technology may hold the key to solving these issues and we have already established in-vivo proof of concept with multiple vaccine formats currently being used and in development for a wide range of infectious diseases, including those being use for Covid-19.

Currently hundreds of millions of doses need to be produced, stored and transported in a cold chain, and then administered using a needle and syringe and diluents which adds cost, complexity and risk requiring a high degree of skill for administration.

“We are particularly excited with the progress in our collaboration with Prof. Shattock and his group at Imperial given the breakthroughs made with mRNA vaccines. We are hopeful that our collaboration combining our next-generation technologies, will solve these challenges for the benefit of the global population and facilitate the administration of mRNA vaccines anywhere, any time and by anyone independent of geography or socioeconomic circumstance.”

Prof. Robin Shattock, Head of Mucosal Infection and Immunity within the Department of Infectious Disease at Imperial College London said:

“Our innovative saRNA technology used in our COVID-19 vaccine holds great potential in the fight against this disease, and many others. However there remains a number of challenges to address to be able to provide broad coverage against the virus throughout the world population, including in terms of storing, shipping and administering a vaccine at such an unprecedented scale. As we make good progress towards evaluating the efficacy of our vaccine, it is critical that in parallel we explore ways to potentially address those challenges, particularly in terms of minimising and ideally eliminating cold chain supply and the use of needle and syringes, which could be an important barrier to rapid deployment of vaccination efforts globally.”