The Zika vaccine field will soon see another candidate head into human testing as Valneva and Emergent BioSolutions have agreed to co-develop ZIKV-VLA1601. The shot will enter phase 1 in late 2017 or early 2018.
Valneva developed the purified inactivated vaccine (PIV) candidate based on a manufacturing platform it exclusively licensed from the Walter Reed Army Institute of Research (WRAIR) and used in its FDA-approved Japanese encephalitis vaccine Ixiaro.
To get things started, Emergent will pay Valneva €1 million for exclusive rights to the technology. Then, the two will share costs until they complete a six-month phase 1 safety and immunogenicity clinical trial. Once phase 1 data are available, Emergent could follow with a €5 million payment in exchange for an option to continue development. Potential additional milestones could add up to €44 million.
After phase 1, the companies would sign an agreement to finalize the transfer of Valneva’s technology to Emergent’s manufacturing facility in Baltimore for production needed for later testing and potential commercialization.
Emergent, a Maryland-based biotech, is known for making government deals and in June 2016 received a 30-month, $21.9 million task order from HHS’ Biomedical Advanced Research and Development Authority to develop and manufacture a BARDA Zika candidate for use in a phase 1 clinical trial.
Valneva has said that its Zika candidate has demonstrated great in vivo neutralization of the virus and that the PIV technology is preferable to other approaches like live-attenuated vaccines since the primary target population for a Zika shot is women of child-bearing age. Given that there’s already an approved product with the same technology, the French vaccine maker “believes that regulatory risk can be minimized, resulting in the most efficient path to market,” it said on its website.
WRAIR is also partnered with Sanofi Pasteur on Zika purified inactivated virus technology, an arrangement that has generated plenty of publicity surrounding pricing. Critics have said Sanofi should agree to pricing limits on a technology that taxpayers helped develop, but the partners said it's too early to talk about pricing for a vaccine that may never make it to market. The partners haven't signed off on a license yet.