Pharma Focus America

CEPI Collaborates with Lemonex to Progress mRNA Vaccine Delivery for Addressing Future Pandemic Threats

Monday, January 08, 2024

CEPI has collaborated with Lemonex Inc., a biotechnology company based in the Republic of Korea, to advance their mRNA drug delivery technology known as DegradaBALL®. This cutting-edge platform aims to minimize post-mRNA vaccination side effects and enhance accessibility to future mRNA vaccines.

To support this initiative, CEPI is providing up to US $4.6 million in funding for a Phase I clinical study at Seoul National University Hospital, assessing the safety of the DegradaBALL® mRNA vaccine platform. Additionally, the funding will facilitate the development of a freeze-dried formulation, with the goal of reducing complex-cold chain vaccine storage requirements and increasing the use of mRNA vaccines, particularly in regions with limited resources.

This partnership aligns with CEPI's strategy to expand the utilization and accessibility of novel RNA innovations against potential epidemic or pandemic threats, including unknown pathogens (Disease X). The collaborative 100 Days Mission, involving CEPI and the Republic of Korea, aims to accelerate vaccine development within 100 days from identifying a virus to effectively prevent the next pandemic.

Dr. Richard Hatchett, CEO of CEPI, underscores the critical role of mRNA vaccines in responding to infectious disease threats. Acknowledging current limitations such as reactogenicity, cold-chain requirements, and thermostability, Dr. Hatchett views Lemonex's DegradaBALL® as a potential solution to address these challenges and contribute to more equitable responses to future infectious disease outbreaks.

mRNA technology is a pivotal component of the 100 Days Mission, offering flexibility for rapid-response vaccine development. Despite the generally mild and short-lived nature of side effects from current mRNA vaccines, Lemonex's DegradaBALL® aims to minimize these reactions by increasing the drug residual rate and improving mRNA stability.

Cheolhee Won, CEO of Lemonex Bio, highlights the advantages of DegradaBALL®, including pre-production before mRNA synthesis, room-temperature storage, and a simple mixing process at the point of use. This approach could address issues related to ultra-cold chain requirements and production delays associated with current lipid nanoparticle (LNP)-mRNA vaccines.

The partnership between CEPI and Lemonex is committed to ensuring equitable access to the outcomes of their collaboration, aligning with CEPI’s Equitable Access Policy. This commitment includes prioritizing vaccine availability for at-risk populations at an affordable price, should a related vaccine be developed with CEPI funding. Project results and data will be published openly for the benefit of the global scientific community.



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