Emergent BioSolutions and Valneva Report Positive Phase 1 Results for Their Vaccine Candidate Against the Zika Virus

GAITHERSBURG, MD, USA and SAINT-HERBLAIN, France I November 19, 2018 I 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 schedule-dependent 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.”

About the Phase 1 Clinical Study VLA1601-101
VLA1601-101 is a first-in-human, randomized, placebo-controlled and observer-blinded study.  It is assessing the safety and immunogenicity of two different dose levels of the alum adjuvanted, inactivated whole virus Zika vaccine candidate VLA1601 in 67 healthy, flavivirus-naïve adults aged 18-49 years.  The study is being conducted in Knoxville, TN, U.S.

Participants received two vaccinations with a lower (3AU) or higher dose (6AU) – either 7 or 28 days apart.

The current analysis includes full, final data for all analyses (safety and immunogenicity) up to day 56 after the first vaccination.

The final analysis at day 208 after first vaccination, which is expected in the first quarter 2019, will include additional immunogenicity data such as Geometric Mean Titres (GMTs), rate of subjects with seroconversion and fold-increase of ZIKA virus specific neutralizing antibodies titres as compared to base-line, measured by PRNT.

Additional information, including a detailed description of the study design and eligibility criteria is available at ClinicalTrials.gov using identifier NCT03425149.

About Zika Virus
The Zika virus is a mosquito-borne flavivirus that was first discovered in 1947. The first human cases were detected in 1952. Since then, outbreaks have been reported in tropical Africa, Southeast Asia, the Pacific Islands, and, in 2015, in the Americas.

According to the World Health Organization, there is scientific consensus that ZIKV is a cause of microcephaly and Guillain-Barré syndrome. Since 2013, 31 countries and territories have reported cases of microcephaly and other central nervous system malformations associated with ZIKV infection.

About VLA1601
VLA1601 is a highly purified inactivated vaccine candidate against the Zika virus, developed using the same manufacturing platform as Valneva’s IXIARO^® (JESPECT^®) Japanese Encephalitis (“JE”) vaccine. In pre-clinical development, VLA1601 demonstrated excellent purity and had an overall biological, chemical and physical profile comparable to the commercially produced JE vaccine. Valneva has an established manufacturing process in its dedicated clinical JE vaccine facility.

About the exclusive worldwide license for Valneva’s Zika vaccine technology
On July 26, 2017 Emergent and Valneva announced the execution of an exclusive worldwide license agreement for Valneva’s Zika vaccine technology. Under the terms of the agreement, the parties share all costs until the availability of final Phase 1 data in the U.S. Valneva is responsible for the program’s execution until completion of the Phase 1 trial through a joint governance structure. Upon availability of final Phase 1 data, Emergent will have the option to continue the development and commercialization of a Zika vaccine 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 for exclusive commercialization rights in Europe. As part of any further development, 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.

About Emergent BioSolutions
Emergent BioSolutions Inc. is a global life sciences company seeking to protect and enhance life by focusing on providing specialty products for civilian and military populations that address accidental, intentional, and naturally occurring public health threats. We aspire to be a Fortune 500 company recognized for protecting and enhancing life, driving innovation, and living our values. Additional information about the company may be found at www.emergentbiosolutions.com. Find us on LinkedIn and follow us on Twitter @emergentbiosolu and Instagram @life_at_emergent.

About Valneva SE
Valneva is a fully integrated, commercial stage biotech company focused on developing innovative life-saving vaccines.

Valneva’s portfolio includes two commercial vaccines for travelers: IXIARO^®/JESPECT^® indicated for the prevention of Japanese encephalitis and DUKORAL^® indicated for the prevention of cholera and, in some countries, prevention of diarrhea caused by ETEC. The Company has proprietary vaccines in development including a unique vaccine against Lyme disease. Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the US with over 450 employees. More information is available at www.valneva.com.