04 Jan 2024
Simulation scene of vaccination by registered nurses prior to Phase 1 clinical trial of CEPI-funded DegradaBALL® mRNA vaccine.
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.”
mRNA technology has 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.”
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).
CEPI is an innovative partnership between public, private, philanthropic, and civil organisations, launched at Davos in 2017. Its mission is to accelerate the development of vaccines and other biologic countermeasures against epidemic and pandemic threats so they can be accessible to all people in need.
CEPI has supported the development of over 30 vaccine candidates against its priority pathogens—Chikungunya virus, Ebola Virus Disease, Lassa virus, Middle East Respiratory Syndrome coronavirus, Nipah virus, Rift Valley Fever virus and SARS-CoV-2—and is a leading funder of research into broadly protective coronavirus vaccines, which could protect against future variants of COVID-19 as well as other coronaviruses with epidemic and pandemic potential. The organization has also invested in the development of rapid response platforms to develop vaccines against Disease X (the threat of an unknown virus).
CEPI has contributed to a number of scientific breakthroughs, including the first ever licensed Chikungunya vaccine and the advancement of the first ever Nipah and Lassa vaccines into Phase 1 trials. The organization played a central role in the global response to COVID-19, supporting the development of one of the world’s largest portfolios of vaccines against SARS-CoV-2, seven of which have been approved for domestic or global use. It also co-led COVAX, the global initiative to deliver fair and equitable access to COVID-19 vaccines, which has delivered approximately 2 billion doses of vaccine to 146 countries around the world.
CEPI’s five-year plan for 2022-2026 aims to dramatically reduce or even eliminate the future risk of pandemics and epidemics. Central to the plan is CEPI’s goal to compress the time taken to develop safe, effective, globally accessible vaccines against new threats to just 100 days. Achieving this ‘100 Days Mission’, which has been embraced by the G7 and G20, would give the world a fighting chance of containing a future outbreak before it can spread to become a global pandemic.
About Lemonex Inc.
Lemonex is a biotechnology company pioneering safe and effective mRNA medicine and cancer immunotherapy based on innovative non-viral drug delivery platform technology. The core drug delivery system (DDS) technology, DegradaBALL®, is a novel porous nanoparticle-based global first-in-class drug delivery system that maximizes therapeutic efficacy and minimizes systemic side effects.
DegradaBALL®, a modular next-generation drug delivery technology is Lemonex’s original technology, which enables in vivo delivery by loading various new drug candidates inside particles, and which is optimized for the development of gene therapies and immuno-oncology drugs. Recently, nano-drug delivery technologies have attracted a lot of attention; DegradaBALL® is the most advanced nanotechnology-based drug delivery system that can overcome the limitations of LNPs. DegradaBALL® can solve cold-chain issues of current LNPs and maintain its stability at room temperature.
Lemonex is developing various competitive new drug candidates based on the DegradaBALL®, such as siRNA gene therapy, mRNA vaccine, dual-acting RNA immunotherapy, and biobetter by applying the DegradaBALL® drug delivery platform. Lemonex confirmed the safety and tolerability of DegradaBALL® in healthy subjects through the phase I clinical trial of the LEM-S401, an siRNA-DegradaBALL® drug candidate.
CEPI: [email protected] | +44 7387 055214
Lemonex Inc. [email protected] | +82 2 525 7781