EMERGENT BIOSOLUTIONS AND VALNEVA REPORT POSITIVE PHASE 1 RESULTS FOR THEIR VACCINE CANDIDATE AGAINST THE ZIKA VIRUS
GAITHERSBURG, Md. and Saint-Herblain, France, November 19, 2018 – Emergent BioSolutions Inc. (NYSE: EBS) and Valneva SE (VLA) today announced positive interim results for the Phase 1 study evaluating VLA1601, their vaccine candidate against the Zika virus.
The highly purified inactivated vaccine candidate, VLA1601, met the study’s primary endpoint showing a favorable safety profile in all doses and schedules tested.
VLA1601 was also immunogenic in all treatment groups and induced both dose- and scheduledependent neutralizing antibodies against the Zika virus with the kinetics expected for an inactivated, alum-adjuvanted whole-virus vaccine. Seroconversion Rates (SCR) reached up to 85.7% on Day 35 (Interim Analysis of Data up to Day 56).
The Phase 1 study was designed to assess safety and immunogenicity. It is being co-financed by Emergent and Valneva as part of an exclusive, worldwide license agreement signed in July 2017. The agreement includes pre-defined post-Phase 1 opt-in rights for Emergent.
Wolfgang Bender, MD, PhD, chief medical officer of Valneva commented, “We are pleased to see progress of this promising vaccine candidate for the prevention of infections caused by the Zika virus and their serious implications during pregnancy. The excellent safety profile supports further optimization of the elicited immune response to cover an unmet medical need in the most vulnerable populations.”
Kelly Lyn Warfield, PhD, vice president, Vaccines and Anti-Infectives Research and Development at Emergent BioSolutions, added, “Emergent’s continued focus on the development of prevention and treatment strategies for emerging infectious diseases is part of its broader mission – to protect and enhance life. Through our work, we are committed to making a positive impact on public health across the globe.”