The Phase 1 clinical trial is a randomized, observer-blinded, placebo-controlled, single center study. This study, in approximately 65 healthy adults, will investigate two dose levels of VLA1601 when administered using two different vaccination schedules.
Initial data from the trial are expected to be available in late 2018 or early 2019.
Emergent BioSolutions business operations executive vice president Adam Havey said: “Emergent’s commitment to our mission – to protect and enhance life – fuels our pursuit for preparedness solutions against Zika virus, the consequences of which remain a public health challenge that requires attention.
“Our collaboration with Valneva on this Phase 1 study intends to make meaningful contributions to global research in this field.”
Valneva president & CEO Thomas Lingelbach said: “We are delighted that our collaboration with Emergent has resulted in the clinical progression of a very promising vaccine candidate.
“This vaccine candidate has already demonstrated an excellent preclinical profile comparable to Valneva’s licensed Japanese Encephalitis vaccine.”
Under the terms of the agreement signed in July 2017, the parties will share all costs until the availability of Phase 1 data in the U.S. Valneva will be responsible for the program’s execution until completion of the Phase 1 trial through a joint governance structure.
Upon availability of Phase 1 data, Emergent will have the option to continue the development and commercialization of a Zika vaccine under its worldwide exclusive license agreement with Valneva for a milestone payment of €5 million.
The agreement provides Valneva potential additional milestone payments of up to €44 million related to product development, approval, commercialization, and product sales, future royalties on annual net sales, and the right, prior to a Phase 3 clinical trial, to negotiate with Emergent exclusive commercialization rights in Europe.
The companies are expected to enter into a technology transfer agreement at a later time to enable transfer of Valneva’s technology to Emergent’s Bayview manufacturing facility in Baltimore, Maryland.