Valneva Initiates Phase 3 Clinical Lot Consistency Study for its Single-Shot Chikungunya Vaccine Candidate

Saint-Herblain (France), February 22, 2021 – Valneva SE (“Valneva” or “the Company”), a specialty vaccine company focused on prevention of infectious diseases with significant unmet medical need, today announced that it has initiated the clinical lot-to-lot consistency Phase 3 study for its single-shot chikungunya vaccine candidate, VLA1553. This study will run in parallel to the ongoing, pivotal Phase 3 study, VLA1553-301, which includes the determination of seroprotection based on an immunological surrogate¹.The objective of this study is to show manufacturing consistency of the vaccine by demonstrating that three consecutively manufactured lots elicit equivalent immune responses measured by neutralizing antibody titers on Day 29 after vaccination. Study volunteers will be followed for a total of six months.Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, commented, “This study initiation signifies another important step in the development of VLA1553 towards licensure. The chikungunya virus continues to represent a major public health threat, and we are working as fast as we can to bring a preventive solution to those who need it most. We would like to thank our employees, partners and study participants for making this trial possible despite the ongoing COVID-19 pandemic.”VLA1553 is the only chikungunya vaccine candidate in Phase 3 clinical trials. The sponsor of the first chikungunya vaccine Biologics License Application (BLA) to be approved in the U.S. will be eligible to receive a Priority Review Voucher (PRV)².About Chikungunya
Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus (CHIKV), a Togaviridae virus, transmitted by Aedes mosquitoes. Infection leads to symptomatic disease in 72-92% of humans after 4 to 7 days following the mosquito bite. While mortality with CHIKV is low, morbidity is high. Clinical symptoms include acute onset of fever, debilitating joint and muscle pain, headache, nausea and rash. 4.1%-78.6% of infections develop into chronic arthralgia (> 3 months). Chikungunya virus often causes sudden large outbreaks with high attack rates, affecting one-third to three-quarters of the population in areas where the virus is circulating. The highest risk areas of infection for travelers are places where chikungunya virus-carrying mosquitos are endemic, including the Americas, parts of Africa, and Southeast Asia.  As of September 2020, there have been more than 3 million reported cases in the Americas³  and the economic impact is considered to be significant (e.g. Colombia outbreak 2014: $73.6 million⁴). The medical and economic burden is expected to grow as the CHIKV primary mosquito vectors continue to further spread geographically. There are no preventive vaccines or effective treatments available and, as such, chikungunya is considered to be a major public health threat.About VLA1553
VLA1553 is a live-attenuated, single dose vaccine candidate for protection against chikungunya disease and currently tested in clinical Phase 3. VLA1553 has been designed by deleting a part of the chikungunya virus genome. As a live-attenuated vaccine, VLA1553 is particularly well suited to target long-lasting protection.
Valneva is the first company to advance a chikungunya vaccine candidate into Phase 3. The sponsor of the first chikungunya vaccine Biologics License Application (BLA) to be approved in the U.S. will be eligible to receive a Priority Review Voucher (PRV) ⁵.
VLA1553 would expand Valneva’s existing travel vaccine portfolio and as such, Valneva intends to commercialize this vaccine, if approved, leveraging its existing manufacturing and commercial operations. The global market for vaccines against chikungunya is estimated to exceed $500 million annually by 2032⁶.
VLA1553 Phase 1 data in 120 volunteers were published in The Lancet Infectious Diseases⁷. The vaccine was well tolerated at the dose level selected for Phase 3. No vaccine-related serious adverse events were reported during 12 months of follow-up. Neutralizing antibodies were developed in 100% of volunteers within 14 days after a single vaccination and were maintained up to one year. Based on these encouraging results, Phase 3 testing was initiated in September 2020. The program was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) in December 2018⁸ and PRIME designation by the European Medicines Agency (EMA) in October 2020⁹.
To make VLA1553 also accessible to Low and Middle Income Countries (LMIC), Valneva and Instituto Butantan in Brazil signed an agreement for the development, manufacturing and marketing of VLA1553. The collaboration falls within the framework of the funding agreement between Valneva and the Coalition for Epidemic Preparedness Innovations (CEPI) in July 2019, which provides for funding of up to $23.4 million.