In August 2023 CEPI and Gennova Biopharmaceuticals Ltd announced a funding agreement of up to $3.6 million to advance the development of Gennova’s self-amplifying mRNA (saRNA) platform. This will be used to develop vaccine candidates against Disease X, the next unknown threat. The agreement will support the optimisation of the saRNA platform technology, production process, and yield. Within the plan to prepare against Disease X, a candidate for rabies will also be tested. By testing a vaccine candidate against a known virus, with accepted correlates of protection, the concepts behind the technology can be assessed.  

Novel technologies 

The funding announcement highlights CEPI’s intention to encourage novel RNA vaccine platform technologies for emerging and select endemic infectious diseases. The hope is that these new technologies could offer advantages over existing mRNA technologies, like “multivalency, improved immunogenicity, storage and stability, productivity, response time, and cost-of-goods”. The platform could become part of a group of RNA technologies driven by CEPI to enable the 100 Days Mission which aims to have vaccines ready for deployment within 100 days of a new threat identification.  

How does saRNA work? 

Vaccines that are based on mRNA technology use the body’s “machinery” to make antigenic protein, instead of injecting the antigen into the body. With saRNA vaccines, genetic information from a group of viruses is incorporated with an antigen of interest. This genetic information programmes the host cell to generate multiple copies of the saRNA, which is where the term “self-amplification” comes from. The amplified saRNA means that the antigen has many copies and triggers greater generation of the antigen protein within the host cell. Therefore, there is potential to reduce the dose needed without sacrificing effectiveness. 

Gennova’s platform 

Gennova’s unique CLNE delivery system attaches the RNA molecules to the surface of fatty molecules (a nanoemulsion) instead of encapsulating them in a fatty shell. This improves scalability and allows for easier transfer between manufacturers if needed. Dr Swarnendu Kaviraj, R&D Head and PI of the project says that Gennova has developed a process for “producing thermostable mRNA vaccine that does not require ultra-low temperature infrastructure for storage and delivery”.  

“Gennova’s mRNA platform is readily deployable to masses where low-temperature logistics are unavailable. Moreover, this platform technology can support pre-pandemic stockpiling of vaccines.” 

We know that CEPi is committed to encouraging equitable access, as Dr Matthew Downham emphasised in our interview in April. Thus, partnerships with other organisations strive to promote this end as well, and Gennova aims to ensure that vaccines are available to at-risk populations at affordable prices.  

Dr Melanie Saville, Executive Director Vaccine R&D commented that “advances in RNA-vaccine technology were critical” during COVID-19 and will continue to be critical for future responses. 

“To make sure the world has access to such technology quickly and equitably next time Disease X strikes, CEPI is supporting novel RNA vaccine technologies with significantly improved attributes – in terms of scalability, thermostability, immunogenicity, and affordability.”  

Dr Sanjay Singh, Gennova’s CEO, is “very pleased” with the agreement, believing that Gennova is “prepared” to “rise to the challenge”.  

“We look forward to working together with CEPI to further improve the saRNA-technology platform aiding in vaccine democratisation and equitable access.” 

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