Valneva’s Chikungunya Vaccine Candidate Awarded EMA Prime Designation - Seite 2

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) ⁶.
VLA1553 would expand Valneva’s existing travel vaccine portfolio and as such, Valneva intends to commercialize this vaccine leveraging its existing manufacturing and commercial operations. The global market for vaccines against chikungunya is estimated to exceed $500 million annually by 2032⁷.
VLA1553 Phase 1 data in 120 volunteers were published in The Lancet Infectious Diseases⁸. 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, pivotal Phase 3 testing was initiated in September 2020 for the program which was granted Fast Track designation by the U.S. Food and Drug Administration (FDA).
To make VLA1553 also accessible to Low and Middle Income Countries (LMIC), Valneva and Instituto Butantan in Brazil signed a binding term sheet in May 2020 for the development, manufacturing and marketing of VLA1553. The collaboration will be effective upon the signing of definitive agreements and will fall within the framework of the $23.4 million funding which Valneva received from the Coalition for Epidemic Preparedness Innovations (CEPI) in July 2019.

About Phase 3 study VLA1553-301
VLA1553-301 Phase 3 study was initiated in September 2020. It is a prospective, double-blinded, multicenter, randomized, pivotal Phase 3 study comprising approximately 4,000 participants aged 18 years or above. Lyophilized VLA1553 or placebo will be administered as a single intramuscular immunization. The primary objective of the study is to evaluate the immunogenicity and safety of the final dose of VLA1553 28 days following a single immunization. Safety data collection and immunogenicity will continue to be assessed until Month 6; further long-term follow up is planned.