04 January 2024, OSLO, Norway and SEOUL, Republic of Korea – CEPI has partnered with Lemonex Inc. (Lemonex), a biotechnology company in the Republic of Korea, to advance their mRNA drug delivery technology, DegradaBALL®, which has the potential to both minimise post-mRNA vaccination side effects and improve access to future mRNA vaccines.

CEPI is providing Lemonex up to US $4.6 million in funding to evaluate the safety of the DegradaBALL® mRNA vaccine platform in a Phase I clinical study taking place at Seoul National University Hospital. The funding will also support the development of a freeze-dried formulation which could reduce complex-cold chain vaccine storage requirements and increase the use of mRNA vaccines in the Global South.

The new partnership forms part of CEPI’s plan to expand the use of and access to novel RNA innovations for potential use against a future epidemic or pandemic threat, including unknown or as-of-yet unidentified pathogens (Disease X), in alignment with the 100 Days Mission. The ambitious goal spearheaded by CEPI, and embraced by the Republic of Korea as part of their strategic plan against emerging infectious diseases, aims to condense vaccine development to 100 days from virus identification and stop the next pandemic in its tracks.

Dr. Richard Hatchett, CEO of CEPI, said: “Clinically validated for the first time during the COVID-19 pandemic, mRNA vaccines will be critical if we are to accelerate our responses to future infectious disease threats. However, current mRNA vaccines still have limitations in terms of their reactogenicity, cold-chain requirements, and thermostability. Lemonex’s DegradaBALL® may address these issues and thereby contribute to more equitable responses to future emerging infectious disease outbreaks.”

Next-generation vaccine delivery

mRNA technologyhas been identified as a pivotal enabler of the 100 Days Mission due to its flexibility as a rapid-response platform on which new vaccine candidates can be designed and quickly made ready for clinical testing and subsequent scale-up, potentially within days from the moment a new viral threat is identified.

However, although generally mild, short-lived, and an indicator that the body is responding to a vaccine and building protection, side-effects or reactions induced by current mRNA-based vaccines can occur.

Lemonex’s DegradaBALL® is designed to potentially minimize side effects associated with the use of current lipid nanoparticle (LNP)-mRNA vaccines by increasing the drug residual rate at the administration site and improving the stability of mRNA.

Cheolhee Won, CEO of Lemonex Bio, added: “Unlike LNP, DegradaBALL® can be pre-produced even before mRNA synthesis and stored in stock at room temperature. The mRNA-DegradaBALL® complex can be prepared at the point of use through a simple mixing process of mRNA and DegradaBALL®. In other words, if DegradaBALL® is pre-supplied to various parts of the world before a pandemic virus occurs, only the mRNA can be produced in that country and simply mixed and used right before administration. This process can easily resolve the ultra-cold chain issue and production & supply delay issues of LNP-mRNA vaccines. Through the new partnership of CEPI and Lemonex, we plan to develop and supply various types of mRNA vaccine formulation using DegradaBALL® technology against epidemic and pandemic threats.”

Preparing for future threats

CEPI’s investment in Lemonex is the latest in its programme to advance novel RNA vaccine platform technologies for emerging and select endemic infectious diseases. The programme aims to evaluate whether the next-generation of RNA technologies could offer substantial advantages over existing platforms, for example improved immunogenicity, storage, stability, productivity, response time, and cost-of-goods.

The prototype vaccines, data, and knowledge generated through this programme could make a vital contribution to the proposed Global Vaccine Library. Central to the 100 Days Mission, a Global Vaccine Library is envisaged as a global repository of vaccine resources, capabilities, and data which could be pulled ‘off the shelf’ and quickly adapted in response to a future outbreak, accelerating the development of life-saving vaccines.

CEPI and Lemonex are committed to enabling equitable access to the outputs of their partnership, in line with CEPI’s Equitable Access Policy. This ultimately includes commitment to vaccines being available first to populations at risk when and where they are needed at an affordable price should a related vaccine be developed further using CEPI funding. Project results including data generated as part of this project will be published open access for the benefit of the global scientific community.

The new partnership extends CEPI’s partnerships with Korean-based organisations across the academic, government and pharmaceutical sector. Other partners include SK bioscience, Chungbuk National University, and the International Vaccine Institute (IVI).