CEPI to support development of selfamplifying mRNA vaccine technology for use against Disease X

The Coalition for Epidemic Preparedness Innovations (CEPI) and Gennova Biopharmaceuticals announced a new funding agreement to advance the development of their self-amplifying mRNA (saRNA) platform to develop vaccine candidates against unknown pathogenic threats, also referred to as Disease X.

CEPI will provide up to $3.6 million to support the optimisation of the saRNA-platform technology, the production process, and yield. A vaccine candidate will then be produced against rabies virus, part of the Rhabdoviridae family of viruses, for preclinical studies. Testing the vaccine candidate against this known virus, with accepted correlates of protection, will help to assess the concepts behind this new technology.

This funding forms part of CEPI’s programme to support novel RNA vaccine platform technologies for emerging and select endemic infectious diseases, which could offer substantial advantages over existing mRNA technologies, such as multivalency, improved immunogenicity, storage and stability, productivity, response time, and cost-of-goods. Gennova’s saRNA vaccine platform could form part of a group of RNA technologies that CEPI is supporting that could enable rapid responses to future epidemics and pandemic threats, potentially within 100 days of identification.

Self-amplifying mRNA vaccines

mRNA vaccines use the body’s own machinery to make antigenic protein rather than injecting the pure antigen directly into the body (an antigen is a foreign substance that induces an immune response).

In the case of saRNA vaccines, genetic information from a particular group of viruses is incorporated into the saRNA together with the antigen of interest. The genetic information from the virus programs the host cell to generate multiple copies of the saRNA, hence the term self-amplification. The amplification of the saRNA increases the number of genetic copies of the antigen and, consequently, increases the generation of the antigen protein within the host cell. This has the potential to reduce the dose of RNA needed while maintaining the effectiveness of the vaccine.

Unique to the saRNA technology being developed by Gennova is the CLNE delivery system. Rather than encapsulating the fragile mRNA molecules in a fatty shell (ie, lipid nanoparticles), as is the case for many mRNA vaccines, the CLNE system attaches the RNA molecules to the surface of fatty two molecules (ie, a nanoemulsion). This approach makes the manufacturing of potential vaccine candidates readily scalable and easily transferable between manufacturers, if needed.

This agreement also includes the potential application of its technology to future vaccine development of interest to CEPI, including a commitment to technology transfer.