8 February 2024, OSLO, Norway and DÜSSELDORF, Germany

–A pioneering technology that uses plant cell extracts to accelerate the production of vaccine proteins will be tested in a new scientific study launching in Germany.

Researchers at LenioBio GmbH (LenioBio), a biotech company based in Düsseldorf, have received CEPI funding of up to US $2 million to provide preclinical proof-of-concept that their commercially available, plant-based, and cell-free technology can produce proteins for use in clinical trials testing vaccines against epidemic and pandemic threats in 20-40 days. This is approximately a quarter of the time it takes to manufacture vaccine proteins using more traditional methods, such as cell cultures.

The technology known as ALiCE®—which stands for Almost Living Cell-Free Expression—uses the protein production machinery of plant cells, like enzymes and other biological components, to rapidly express proteins in a so-called ‘cell-free’ reaction. ALiCE® already has a proven track-record of producing various types of proteins for the development of vaccines and other medicines, including a range of viral antigens, antibody formats and membrane proteins. CEPI’s funding will support further testing of the technology to investigate its potential to enable the rapid manufacture of vaccine clinical trial material.

ALiCE®’s speed may therefore support the 100 Days Mission, a goal created by CEPI and embraced by the G7 and G20, to develop vaccines against novel pathogens within 100 days of virus identification and give the world a fighting shot at stopping the next pandemic in its tracks.

“LenioBio’s technology may be a game-changer when quickly responding to future outbreaks,” explains Ingrid Kromann, CEPI’s Acting Executive Director, Manufacturing and Supply Chain. “This study will explore whether ALiCE® can support the rapid and scalable development of viable protein-based vaccine candidates and move these promising candidates more quickly into clinical trials, pushing forward our goal to achieve the 100 Days Mission.”

With its ease-of-use, ALiCE® could be rolled out for use in remote areas or low-resource settings to help bring vaccines closer to those who need them most. The technology may also help reduce the carbon emission levels associated with traditional methods of vaccine manufacturing and distribution due to its small operational footprint.

“Embarking on this collaborative study with CEPI provides us with a great opportunity to demonstrate the significant potential of our ALiCE® protein production platform,” said LenioBio’s CEO, André Goerke. “This project supports our goals of enabling accelerated discovery and development of essential medicines, and brings us a step closer to our long-term vision of creating fast access of essential medicines for patients.

New vaccine proteins

First developed in the 1980s with the launch of a Hepatitis B vaccine , protein-based vaccines are a tried and tested type of vaccine with an established safety profile. The technology, which is also the basis for several licensed COVID-19 vaccines in use worldwide, contain harmless viral proteins known as antigens which stimulate an immune response when injected.

Typically, these protein fragments are produced using ‘whole’ cells (in vivo technique). However, cell-free protein expression systems, like LenioBio’s ALiCE® technology, instead use components extracted from within these cells to manufacture the proteins. Cell-free systems offer more rapid protein production times than in vivo techniques which require cell-line development for every protein and massive volumes of slow-growing and resource-demanding cell cultures, or extensive protein purification.

Preparing for future threats

CEPI’s investment in LenioBio’s ALiCE® technology is the latest partnership from its programme to optimise and use innovations in manufacturing processes for rapid production and scaling up of vaccines, in support of the 100 Days Mission.

CEPI and LenioBio 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. Relevant project results including data generated as part of this project will be published open access for the benefit of the global scientific community.

Notes to Editors

ALiCE® is derived from tobacco plant BY2 cells. The technology has already been used to produce numerous proteins including antigens, antibodies, and vaccines. It is the only scalable eukaryotic cell-free protein production system, enabling the production of complex proteins across a range of scales (Das Gupta et al. 2023 Biotechnol. Bioeng.).

In this study, CEPI funding will support using ALiCE® technology for the accelerated production of receptor-binding domain of the SARS-CoV-2 spike protein. Work packages will explore rapid scale-up for protein production, including addressing the bottleneck of DNA template creation at large scale, and establishing the efficacy and tolerability of an ALiCE-produced vaccine compared to the same antigen produced via mammalian cell-culture. LenioBio will announce further collaborations within the project that will support these goals.

About LenioBio GmbH

LenioBio is a life-science biotechnology firm dedicated advancing transformative technology for the discovery, development, and large-scale production of proteins, liberating the process from conventional limitations of cells. Pioneered by LenioBio, ALiCE® is an innovative eukaryotic protein expression platform that empowers scientists globally to accelerate the discovery and development of life-saving medicines and vaccines. For more information visit Leniobio.com and follow LenioBio on LinkedIn.

About CEPI

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.

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Press Contacts

LenioBio GmbH: Kate Bailey, Head of Marketing and Communications, k.bailey@leniobio.com, +49171 206 7094

CEPI: press@cepi.net, +44 7387 055214

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