The Coalition for Epidemic Preparedness Innovations (CEPI), the high-profile public-private vaccine initiative launched in 2017, has signed its first company agreement, granting Themis an investment of up to $37.5 million to develop new vaccines against Lassa fever and MERS.
The grant spans a five-year period and will support Themis through phase 2 testing, providing safety and immunological data plus the manufacturing of investigational supplies for efficacy trials or emergency deployment during outbreaks.
Discoveries made by Institut Pasteur and the Paul Ehrlich Institut are set to become the basis for Themis’ Lassa and MERS candidates, respectively. Those two research institutions have identified antigens for inclusion in vaccine compositions and have demonstrated proof of concept in animal studies, Themis CEO Erich Tauber told FierceVaccines.
Themis will apply its measles vector platform—which it exclusively licensed from Institut Pasteur—to design the vaccines. The platform has been used in the company's lead program for Chikungunya, which is in phase 2 trials in 600 patients in the U.S. and Europe. Its Zika candidate also uses the platform and has entered human testing, while other assets against norovirus, RSV and CMV are in preclinical stages.
“The fact that Themis has developed a versatile technology platform for the discovery, development and production of vaccine approaches is very attractive,” CEPI spokeswoman Rachel Grant told FierceVaccines. “This means as well as focusing on MERS and Lassa we hope this technology will have value beyond those specific diseases. ”
No additional financial details were disclosed, but given CEPI’s founding principle of equitable access, Grant said the agreement contains provisions that support providing vaccines at affordable costs to people in need.
CEPI focuses on epidemic vaccine development, especially where there’s unfavorable market incentives but potentially big public health benefits. The idea is to fund promising vaccine candidates so that they’re available immediately when an outbreak begins.
Officially launched in 2017 by governments and nonprofits such as the Bill & Melinda Gates Foundation and Wellcome Trust, the group has also attracted major vaccine makers including GlaxoSmithKline, Merck, Johnson & Johnson, Pfizer, Sanofi and Takeda. It has so far collected $630 million of its $1 billion target funding. The European Commission has also promised a contribution of €250 million that will support relevant projects through its own mechanisms.
To start, CEPI selected Lassa, MERS and Nipah as initial diseases to target, none of which have approved vaccines. The coalition actually aims to develop two promising vaccine candidates against each of these diseases, and Grant said CEPI is going through intensive technical and legal due diligence with a number of companies to finalize additional agreements over the coming months.
For a second project that will identify platforms for rapid vaccine development against unknown pathogens, Grant said a call for proposal has received 35 high-caliber applications. They're currently being shortlisted through an external peer review process, and CEPI's scientific advisory committee will reach a conclusion by the end of June.
The grant comes as Nigeria suffers an unprecedented Lassa fever outbreak. The overall fatality rate is 1%, but for this year, it has reached 22% among confirmed and probable cases in the current Nigerian outbreak, the WHO reported.
MERS, first identified in 2012, causes severe respiratory illness, and it resulted in 186 cases and 36 deaths during an outbreak in South Korea in 2015.
A partnership between Inovio and South Korea’s GeneOne, with help from the Walter Reed Army Institute of Research, currently has the most advanced MERS vaccine program in phase 1 testing.
As for Lassa, according to a comprehensive summary by CEPI, no vaccine has progressed out of preclinical stages. Inovio, for one, is working on a candidate with the U.S. Army Medical Research Institute for Infectious Diseases.