2020 Annual Business Report

Chikungunya – VLA1553

To our knowledge, VLA1553 is the only vaccine candidate in Phase 3 targeting the chikungunya virus, which has spread to more than 100 countries and infected more than three million people in the Americas since first appearing there in 2013. We believe that VLA1553 is differentiated from other clinical stage chikungunya vaccine candidates since it is the only candidate that targets long-term protection with a single administration.

Chikungunya  – VLA1553

The strength of an integrated business model

  • VLA1553 is a vaccine candidate against the chikungunya virus, a mosquito-borne virus that has spread to more than 100 countries with the potential to rapidly expand further. There are currently no preventive vaccines or effective treatments for the chikungunya virus available and, to Valneva’s knowledge, VLA1553 is the only chikungunya vaccine candidate in Phase 3 clinical trials worldwide.
  • VLA1553 is a live-attenuated, single dose vaccine candidate for protection against chikungunya disease. 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 which differentiates it when compared to other chikungunya assets that are being evaluated in clinical trials.
  • The pivotal Phase 3 trial, VLA1553-301, was initiated in September 2020. The primary objective of the trial is to evaluate the immunogenicity and safety of VLA1553 at 28 days following a single immunization in approximately 4,000 participants aged 18 years or above. Valneva has also initiated a clinical lot-to-lot consistency Phase 3 trial in February 2021 [1] to show manufacturing consistency of the vaccine. These two Phase 3 trials will run in parallel.
  • Valneva has received confirmation that it may seek licensure through the FDA’s accelerated approval pathway. Via this pathway, the Company plans to seek licensure of the vaccine based on a surrogate of protection, subject to agreement with the FDA that this surrogate endpoint is reasonably likely to predict protection from chikungunya infection. Current clinical activities are affected by the ongoing pandemic but, with more than 80% of the study enrolled to date, Valneva now projects primary endpoint read-out around mid-2021.
  • VLA1553 received Fast Track designation from the FDA and PRIME designation from the European Medicines Agency. The sponsor of the first chikungunya vaccine BLA to be approved in the United States will be eligible to receive a Priority Review Voucher.
  • To make VLA1553 also accessible to Low and Middle Income Countries, Valneva and the Butantan Institute in Brazil signed a collaboration agreement in January 2021 for the development, manufacturing and marketing of VLA1553 [2]. The collaboration falls within the framework of the $23.4 million funding agreement Valneva signed with the Coalition for Epidemic Preparedness Innovations (CEPI) in July 2019 [3].

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

[2]Valneva and Instituto Butantan Sign Final Agreement on Single-Shot Chikungunya Vaccine for Low and Middle Income Countries

[3]CEPI awards up to $23.4 million to Valneva for late-stage development of a single-dose Chikungunya vaccine