08 Aug 2023
8 August 2023, OSLO Norway: The Coalition for Epidemic Preparedness Innovations (CEPI) and Pune-based Gennova Biopharmaceuticals Ltd, today 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.
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 molecules (ie, a nanoemulsion). This approach makes the manufacturing of potential vaccine candidates readily scalable and easily transferable between manufacturers, if needed.
CEPI is committed to enabling equitable access to the vaccines, products and innovations it supports. Through its agreement to enter into partnership with CEPI, Gennova has demonstrated its shared commitment to ensuring equitable access to its technology in line with CEPI’s Equitable Access Policy, notably committing to vaccines being available first to populations at risk when and where they are needed at an affordable price. This also includes the potential application of its technology to future vaccine development of interest to CEPI, including a commitment to technology transfer.
Dr Melanie Saville, Executive Director of Vaccine R&D said: “Advances in RNA-vaccine technology were critical to the global response to COVID-19 and will be crucial for future epidemic and pandemic responses. To make sure the world has access to such technology quickly and equitably the next time Disease X strikes, CEPI is supporting novel RNA vaccine technologies with significantly improved attributes—in terms of scalability, thermostability, immunogenicity, and affordability—that could provide versatile platforms for rapid response against emerging infectious threats.”
Dr Sanjay Singh, Chief Executive Officer, said: “We are very pleased to be entering into a funding agreement with CEPI. Gennova’s decade-long collaborations with eminent research institutes across the world like the USFDA, NIH, JHU, OSU, WEHI, LSHTM, SSI etc. in the field of infectious diseases and vaccinology, prepared Gennova to rise to the challenge of making an mRNA-based pandemic-ready manufacturing platform. When the COVID-19 pandemic hit and paralyzed the world, Gennova developed two of its mRNA-based vaccines for COVID-19, which got EUA in India, validating the platform technology. The effort was supported by the Department of Biotechnology (DBT) through partial strategic seed funding from the COVID-19 Consortium under the Ind-CEPI Mission, ‘Epidemic preparedness through rapid vaccine development: Support of Indian vaccine development aligned with the global initiative of the Coalition for Epidemic Preparedness Innovations (CEPI)’. On a bigger canvas, we look forward to working together with CEPI to further improve the saRNA-technology platform aiding in vaccine democratization and equitable access”.
Dr Swarnendu Kaviraj, R & D head and PI of this project, said: “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”.
CEPI is an innovative partnership between public, private, philanthropic, and civil organisations, launched at Davos in 2017, to develop vaccines against future epidemics. Prior to COVID-19, CEPI’s work focused on developing vaccines against the Ebola Virus Disease, Lassa virus, Middle East Respiratory Syndrome coronavirus, Nipah virus, Rift Valley Fever virus and Chikungunya virus. It has over 20 vaccine candidates against these pathogens in development. CEPI has also invested in new platform technologies for rapid vaccine development against unknown pathogens (Disease X).
During the COVID-19 pandemic, CEPI initiated multiple programmes to develop vaccines against SARS-CoV-2 and its variants with a focus on speed, scale and access. These programmes leverage the rapid response platforms developed by CEPI’s partners prior to the emergence of COVID-19, as well as new collaborations. The aim is to advance clinical development of a diverse portfolio of safe and effective COVID-19 candidates and to enable fair allocation of these vaccines worldwide through COVAX.
CEPI’s 5-year plan lays out a $3.5 billion roadmap to compress vaccine development timelines to 100 days, develop a broadly protective vaccine against COVID-19 and other betacoronaviruses, and create a “library” of vaccine candidates for use against known and unknown pathogens. The plan is available at https://endpandemics.cepi.net.
To read more about how the world can work together to #endpandemics, check out DISEASE X – The 100 Days Mission to End Pandemics, by CEPI’s Chief Scientific Writer Kate Kelland, available here at Bookshop.org. All author proceeds go to the World Health Organization Foundation’s COVID-19 Response.
About Gennova Biopharmaceuticals Ltd
Gennova Biopharmaceuticals Ltd., headquartered in Pune, India, is a biotechnology company dedicated to the research and development, production, and commercialization of biotherapeutics and vaccines to address life-threatening diseases.
Gennova is transforming healthcare by creating efficient and effective solutions for manufacturing and successfully commercializing bio-therapeutics across cardiovascular, neurology, nephrology, ophthalmology, and oncology segments.
Gennova Biopharmaceuticals has developed an mRNA-based platform technology for COVID-19 vaccines, including India’s first mRNA vaccine, GEMCOVAC®-19. Gennova has also developed an Omicron-specific vaccine, GEMCOVAC®-OM, as a booster dose. Both vaccines have received Emergency Use Authorization from the Drug Controller General of India (DCGI), highlighting their safety and efficacy in combating the pandemic.
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