Valneva Reports Positive End-of-Phase 2 Chikungunya Meeting with the U.S. FDA; Sets Stage for Phase 3 Study

 Valneva Reports Positive End-of-Phase 2 Chikungunya Meeting with the U.S. FDA; Sets Stage for Phase 3 StudyDevelopment plan towards licensure endorsed with FDAApproval through Accelerated Approval Pathway¹ (immunological surrogate)Main Phase 3 trial planned as double-blind, placebo-controlled, multi-center studyDose Selection for Phase 3, manufacturing and industrialization strategy acceptedStudy initiation as soon as COVID-19 situation permitsCurrently anticipated for the fourth quarter 2020Primary endpoint analysis is expected six months thereafterSeamless fit with Valneva’s existing commercial and manufacturing capabilities as a plug and play asset Saint-Herblain (France), March 25, 2020 – Valneva SE (“Valneva” or “the Company”) announced today that it has successfully completed an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) and agreed on the clinical development plan towards licensure for its unique, single-shot chikungunya vaccine, VLA1553.Regulatory approval will be based on an immunological surrogate (Accelerated Approval Pathway).The main Phase 3 pivotal trial will be, subject to detailed protocol review, a double-blinded, placebo-controlled, multi-center study in approximately 4,000 healthy adults. Subjects will be randomized into two study groups to receive either vaccine or placebo; a subset will be tested for seroprotection. The primary endpoint of the study will be to demonstrate safety and immunogenicity after a single-shot vaccination with VLA1553 at Day 29 (one month after immunization). The final analysis will be conducted at Day 180 (six months after immunization). The total duration of the study is expected to be nine months.As previously announced, the chikungunya vaccine represents a seamless fit with Valneva’s existing commercial and manufacturing capabilities as a plug-and play asset.Wolfgang Bender, M.D., Ph.D., Chief Medical Officer of Valneva, commented, “We would like to thank the U.S. FDA for a productive End of Phase 2 meeting. We look forward to further demonstrating the best-in class potential of our single-shot chikungunya vaccine VLA1553 in our Phase 3 program. Providing a vaccine against chikungunya is critical as the virus is considered a major public health threat and there are currently no preventive vaccines or effective treatments available. We are thrilled about the prospect to potentially have a vaccine available by the end of 2022.”The Company is preparing for Phase 3 initiation as soon as the COVID-19 situation permits. Currently, the company assumes that Phase 3 can be initiated in the fourth quarter of this year.Valneva’s chikungunya vaccine candidate was granted Fast Track designation by the FDA in December 2018 and received confirmation for the Accelerated Approval Pathway at the end of February 2020 during the EOP2 meeting with the FDA².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)³.