Millie Nelson, Editor

April 9, 2024

5 Min Read

The Coalition for Epidemic Preparedness Innovations (CEPI) created its 100 Days Mission – a project that aims to manufacture safe and effective vaccines within 100 days of an epidemic or pandemic ­– to aid preparation, transformation, and connection across the globe so it can respond quickly to what the firm has called “Disease X” in just three months.

“If the world had developed a coronavirus vaccine within 100 days, the first injections might have been given in April 2020, when there were just 2.3 million cases of COVID-19 rather than on the 8th of December, when more than 68 million people had already been infected with the disease,” June Kim, CMC lead at CEPI, said at BPI Europe in Vienna, Austria this week.

To drive this mission, Kim outlined several of CEPI’s call-for-proposals and provided an overview of what each one entails.

Turning up the temperature

Firstly, she discussed the call for innovations and the need to “develop heat-stable vaccine technology.”

To meet this aim, CEPI forged partnerships with an array of different companies. In January 2023, CEPI teamed with Vaxxas to develop its needle-free vaccine patch delivery technology, which could potentially remove the requirement for cold chain storage and transportation.

Vaxxas’ HD-MAP platform works by using a high-density array of projections that are invisible to the human eye and it is applied to the skin as a patch. Once applied to the skin, the patch delivers the vaccine to the patients’ immune cells below the skin surface.

One month later, CEPI provided 20Med with up to $850,000 to develop its bioresponsive polymeric nanoparticle technology, which, like Vaxxas, could also end the need for cold chain storage and thus provide easier distribution and fairer access to vaccines.

Additionally, CEPI inked a deal worth up to an initial $1.2 million with Jurata Thin Film in December 2023 to advance development of its thermostable under-the-tongue messenger RNA (mRNA) vaccine as a needle-free delivery method.

RNA platform development

According to Kim, the objective for this is to develop a novel RNA platform that has “substantial advantages over existing technologies, such as multivalency, improved immunogenicity, storage and stability, productive, cost-of-goods, and response time.”

CEPI formed a partnership to develop Celestial Therapeutics’ self-adjuvating mRNA vaccine platform in June 2023. Two months later, the organization signed a deal with Gennova Biopharmaceuticals to invest up to $3.6 million to drive advancement of the firm’s self-amplifying mRNA (saRNA) platform.

Clarivate’s 2023 report entitled “Where pharma are investing for the future of medicine,” cited saRNA’s as one of the most promising platforms as the industry looks beyond COVID-19 for RNA applications.

This year, the organization signed two deals in January. Firstly, CEPI collaborated with South Korean firm Lemonex to develop DegradaBALL, its mRNA drug delivery technology. Then, it teamed with scientists at the Houston Medicine Research Institute (HMRI) to further enhance circular RNA (circRNA) vaccines that could offer a more stable and cost-effective option.

Manufacturing for speed, scale, and access

Kim told the audience CEPI has set itself a speed target with a goal of reducing “the time needed to manufacture vaccines by 20%.” To meet this aim, she discussed a series of focus areas (FA’s):

  • FA1: Platform process development and acceleration.

  • FA2: Analytical technologies to accelerate batch release.

  • FA3: Methods to accelerate cell-based manufacturing steps, including synthetic approach.

  • FA4: Any other innovations accelerating clinical trial material (CTM) availability.

To improve scalability and fairer access, CEPI decided on three further FA’s:

  • FA3a: Accelerate and support scale-up, scale-out and tech transfer at the right commercial scale.

  • FA3b: technologies and innovations that can reduce the cost of goods.

  • FA3c: Technologies and innovations that facilitate equitable access, distribution, and delivery in all regions.

Platforms with purpose

With a “very aggressive timeline” goal, Kim placed emphasis on the importance of RNA vaccine platform technologies and vaccine library advancement. The overall objective for this call-for-proposal was to “invest in advanced mRNA vaccine platform technologies [and to] develop vaccines – one to license and the other to Phase I/IIa.”

In October 2022, CEPI partnered with SK Bioscience to progress the development of mRNA-based vaccine technologies to enable rapid response to Disease X. Additionally, the organization agreed to pay up to $40 million in initial funding to support mRNA vaccine candidates against Japanese Encephalitis virus (Flaviviridae) and Lassa Fever virus (Arenaviridae). Dependent on preclinical studies, a further $100 million could be granted to support late-stage trials and licensure to validate the platform so it is ready to use if an outbreak occurs.

CEPI also roped in the big players in the mRNA space, BioNTech and Moderna to reach its objective.

Manufacturing network

With the ambition of its 100 Days Mission, CEPI could not leave out the requirement for a global manufacturing network and said we need “sustainable RNA manufacturing in any part of the globe.”

As a result, CEPI has made a string of investments and deals to make this vision a reality.

In February 2024, the Serum Institute of India (SII), the world’s largest vaccine manufacturer became the fourth member of CEPI’s global network after Aspen Pharmacare in South Africa, Institut Pasteur de Dakar in Senegal, and Bio Farma in Indonesia.

CEPI agreed to invest up to $30 million to expand SII’s vaccine production capabilities to promote sustainability during inter-epidemic periods and scale-up its outbreak response capacity in preparation for any future infectious disease outbreaks.

To close the discussion, Kim referred to Formula One and reminded delegates that “in the 1950s changing a wheel took around one minute but now it only takes two seconds because every step was perfected. That is the goal we have.”

About the Author(s)

Millie Nelson

Editor, BioProcess Insider

Journalist covering global biopharmaceutical manufacturing and processing news and host of the Voices of Biotech podcast.

I am currently living and working in London but I grew up in Lincolnshire (UK) and studied in Newcastle (UK).

Got a story? Feel free to email me at [email protected]

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