Public Funding for Activirosomes Limited

Chikungunya virus is prevalent in more than 200 countries worldwide. Although infection causes illness that is usually non-lethal, it is responsible for development of arthralgia which leaves patient(s) debilitated and sometimes permanently unable to work or perform day-to-day functions. Thus it affects quality of life and causes significant economic losses. Active Virosome Technology" enables intracellular delivery of multiple mRNA molecules efficiently for use as vaccines. We have used it to develop novel vaccine agents for prevention of Chikungunya virus infection which induced a strong immune response, to proof of concept stage. This project undertakes preclinical characterization of our lead chikungunya vaccine candidate.

"Activirosomes develops effective, affordable vaccines to respond quickly to new infection outbreaks and to prevent and protect against serious illnesses in humans and other animals. We have developed a series of Active Virosomes (AV) vaccines to pre-clinical proof of concept stage: we demonstrated that they are immunogenic and create a protective effect in small animal models of the relevant infectious diseases. We must characterise and optimise them before starting toxicology and pharmacokinetic studies, and as an essential requirement for regulatory approval. However, we have four analysis and characterisation problems that are currently a barrier to progress. This project explores solutions. This project aims to demonstrate feasibility of solving them using a series of analytical methods proposed by our A4I partner, NPL. Activirosomes and NPL bring together the expertise and facilities to perform the study described in this application and will work together to interpret and apply the results. The results of the studies and their interpretation may identify other barriers or related sub-problems that need investigation before we can implement the solutions. The results will also enable us to determine whether additional facilities or expertise are needed to solve the problem, in addition to those used in this study. We will explore these additional barriers in follow-up studies."

This project demonstrates pre-clinical proof of “Active Virosome Vaccines” for prevention of Chikungunya, Zika and Ebola virus infections. It will not only produce new, inherently safe, low cost and easy to produce vaccine agents for prevention of these infections and so suitable for responding quickly to outbreaks of these and other viral diseases, including in the countries where they are endemic. The project uses the "Active Virosome" technology platform, which is a simple, safe and efficient biotechnology for producing candidate vaccines, and can be easily modified to produce vaccines for new viral infection outbreaks, simply by slotting in a suitable "cassette" of genetic information. ActiVirosomes UK Limited, a young UK based biotechnology company, leads the project. The project lasts one year and costs £448,950. It will demonstrate pre-clinical proof of concept of up to 3 candidate vaccines for single viral diseases and two candidate vaccines designed to give protection against more than one viral disease at once: the candidate vaccines will continue through development and safety testing from April 2018 and could start clinical trials in humans as soon as 2020. Active Virosomes have many advantages compared to other vaccines against viral infections, including their safety and low cost of development and manufacture, which makes them particularly suitable for development and use in low and middle income countries which suffer from viral infections carried by mosquitos.