Valneva Completes Recruitment for Pivotal Phase 3 Trial of Chikungunya Vaccine Candidate and Initiates Antibody Persistence Trial - Seite 2

About VLA1553
VLA1553 is targeting the chikungunya virus, which has spread to more than 100 countries. VLA1553 is a live-attenuated, single dose vaccine candidate for protection against chikungunya disease. It has been designed by deleting a part of the chikungunya virus genome. To Valneva’s knowledge, VLA1553 is the only chikungunya vaccine candidate in Phase 3 clinical trials and the Company believes that it is differentiated from other clinical stage chikungunya vaccine candidates since VLA1553 is the only candidate that targets long-term protection with a single administration.
In the Phase 1 clinical trial of VLA1553, Valneva observed development of antibodies to chikungunya virus resulting in 100% seroconversion of the 120 healthy participants. These results were sustained after 12 months. Based on these results and Valneva’s discussions with regulators, VLA1553 has advanced into Phase 3 clinical development. The Company has also received confirmation for its proposal to seek licensure under the accelerated approval pathway from the FDA. Under this pathway, Valneva plans to seek licensure of the vaccine based on a surrogate of protection agreed with the FDA that is reasonably likely to predict protection from chikungunya infection.
The program was granted Fast Track designation by the FDA in December 2018 and PRIME designation by the European Medicines Agency (EMA) in October 2020.
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 2032⁴.
To make VLA1553 more 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) signed in July 2019, which provides funding of up to $23.4 million.

About Phase 3 trial VLA1553-301
VLA1553-301 Phase 3 trial was initiated in September 2020 and Valneva has now completed enrollment for this trial. Valneva expects to report topline data in mid-2021. VLA1553-301 is a prospective, double-blinded, multicenter, randomized, pivotal Phase 3 trial comprising 4,131 participants aged 18 years or above. Lyophilized VLA1553 or placebo were administered as a single intramuscular immunization. The primary objective of the trial 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. Additional information, including a detailed description of the trial design, eligibility criteria and investigator sites, is available at ClinicalTrials.gov (Identifier: NCT04546724).