A fast track for vaccine development

The Coalition for Epidemic Preparedness Innovations (CEPI) has issued grants to a half-dozen biotech firms and non-profit organizations in its bid to accelerate vaccine development for priority pathogens. CEPI, which launched at the World Economic Forum in Davos last year with US$500 million in funding, announced its first grants in March, April, and May of this year. The grants, totalling up to US$174 million, will go toward the development of vaccine candidates against Nipah virus infection, Lassa fever, and MERS, Middle East Respiratory Syndrome.

All of these conditions are potentially fatal, and there have been outbreaks this year of all three, says Richard Hatchett, CEPI’s chief executive. Along with a current outbreak in Liberia, Nigeria had 400-plus confirmed cases and 100 fatalities due to Lassa fever as of April. There are currently small outbreaks of MERS in Saudi Arabia and the United Arab Emirates, as well as a Nipah outbreak in Kerala state in India. Each outbreak carries with it a small death toll but is nonetheless worrisome to public health officials. “It’s underlined the unpredictable nature of these outbreaks and the importance of vaccines as a weapon in our armory,” says Hatchett. “We want to advance the development of rapid-response platforms that would speed the development and manufacturing of vaccines,” he says.

Profectus Biosciences and Emergent Biosolutions will be working together to advance a vaccine candidate to prevent infection with Nipah virus that was first developed 17 years ago by Christopher Broder, director of the Uniformed Services University. Broder says the only reason the Nipah vaccine candidate was never tested in humans was a lack of financial support. The CEPI-backed effort will be supported by the Jackson Foundation, the Uniformed Services University of the Health Sciences, and the international nonprofit PATH.

Efforts to develop vaccines against Lassa fever and MERS will be the purview of three organizations, including IAVI, which is pursuing development of a replicating vesicular stomatitis virus (VSV) vector-based Lassa vaccine candidate. CEPI’s partnership with IAVI aims to not only advance the candidate but—in line with CEPI’s mission to prepare against future pandemics—create a stockpile of effective vaccine. Initial funding for the project provides $10.4 million in support, with options to invest a total of $54.9 million over five years.

The vaccine candidate employs the same VSV vector used in Merck’s Ebola vaccine with a Lassa virus glycoprotein insert. Merck’s Ebola vaccine is not licensed yet, but was found safe and effective in humans when tested during the 2014-2015 Ebola outbreak. Health workers recently deployed this experimental vaccine in the Congo to guard against another potential outbreak of the Ebola virus.

“IAVI has been working for a number of years on the VSV platform and vector system for HIV vaccine development,” says Mark Feinberg, President and CEO of IAVI. “In the effort to advance HIV vaccine development, we have built partnerships, technical expertise, and platforms that have the potential to contribute to broader public health that goes beyond HIV. To ensure the maximum contribution and the sustainability of that network, there’s value in looking outward.”

As former Merck chief public health and science officer, Feinberg helped lead the effort to develop Merck’s Ebola vaccine candidate. And it was the deadly Ebola outbreak in west Africa that spurred the development of CEPI itself, with the idea to act as a kind of insurance system against emerging pathogens in the event of future outbreaks.

Two life sciences firms will be lending their expertise to developing candidates against both Lassa fever and MERS, including two candidates that employ an antigen built using gene transcription. Inovio, a US-based infectious disease and cancer biotech, has a candidate against MERS that has gone through Phase I clinical trials, and a candidate against Lassa that has shown promise in nonhuman primate studies. Both candidates are DNA vaccines.

Austrian company Themis will bring its proprietary platform to bear in advancing vaccine candidates against Lassa and MERS through Phase II development. The Lassa fever vaccine candidate was originally developed at the Institut Pasteur, while the MERS candidate comes from the Paul Ehrlich Institut. The platform is essentially a measles vaccine vector that can be genetically modified to express proteins for a variety of pathogens.

Themis chief executive Erich Tauber says the measles vector has the capacity to incorporate large recombinant genes, and that both the Lassa and MERS candidates deliver their antigens to macrophages and dendritic cells. “They are the most potent antigen-presenting cells and trigger a specific immune response,” Tauber says. “The measles vector can continuously replicate within the cell and express antigens even after immunization,” which is why Tauber says the candidates are expected to confer long-term immunity.

Themis is also developing a Chikungunya vaccine candidate, which is currently in Phase II testing.

“Emerging diseases pose a rapidly increasing threat to developing and developed countries alike. Climate change and mass tourism are fueling this raise in outbreaks worldwide, which are no longer confined to tropical regions of the world,” Tauber says. “There are no effective treatments or vaccinations available yet for many diseases, and vaccines are one of the most important, safe, and efficient interventions to protect people. We see it as an important mission.”

Hatchett says CEPI has raised $630 million so far to support these efforts and is looking to continue raising more money and developing new partnerships. He says he expects that CEPI will have close to 20 vaccine candidates under development against priority pathogens by the end of the year.

Michael Dumiak, based in Berlin, reports on global science, public health, and technology.