Saint-Herblain (France), October 16, 2020 – Valneva SE (“Valneva” or “the Company”) a specialty vaccine company focused on prevention of diseases with major unmet needs, today announced that the European Medicines Agency (EMA) has granted PRIority MEdicines (PRIME) designation for its single-shot Phase 3 chikungunya vaccine candidate VLA1553. This new designation from the EMA complements the Fast Track designation received by the U.S. Food and Drug Administration (FDA) in December 2018.
The PRIME designation is awarded by the EMA to promising medicines that demonstrate the potential to address substantial unmet medical need based on initial clinical data. The EMA considers PRIME designations a priority and provides medicine developers with special support, including enhanced interactions and dialogue, as well as a pathway for accelerated evaluation and review.
Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, commented, “We are very pleased to receive PRIME designation for our chikungunya vaccine candidate. It provides further validation of our clinical data and recognition of the significant unmet medical need for chikungunya. We look forward to working closely with the EMA to expedite the availability of our single-shot vaccine to people living in the European Union.”
On September 8, 2020, Valneva announced the initiation of a pivotal Phase 3 clinical trial for VLA1553, becoming the first company worldwide to advance a chikungunya vaccine candidate into Phase 3.
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 Americas and the economic impact is considered to be significant (e.g. Colombia outbreak 2014: $73.6 million). 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.
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) .
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 2032.
VLA1553 Phase 1 data in 120 volunteers were published in The Lancet Infectious Diseases. 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.
Additional information, including a detailed description of the study design, eligibility criteria and investigator sites, is available at ClinicalTrials.gov (Identifier: NCT04546724).
About Valneva SE
Valneva is a specialty vaccine company focused on prevention against diseases with major unmet needs. Valneva’s portfolio includes two commercial vaccines for travelers: IXIARO®/JESPECT® indicated for the prevention of Japanese encephalitis and DUKORAL® indicated for the prevention of cholera and, in some countries, prevention of diarrhea caused by ETEC. The Company has various vaccines in development including unique vaccines against Lyme disease, chikungunya and COVID-19. Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the US with over 500 employees. For more information, visit the Company website at www.valneva.com and follow Valneva on LinkedIn.
|Valneva Investor and Media Contacts
Director Investor Relations
& Corporate Communications
M +33 (0)6 4516 7099
Corporate Communications Specialist
T +43 (0)1 20620 1116
This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to the progress, timing and completion of research, development and clinical trials for product candidates, the ability to manufacture, market, commercialize and achieve market acceptance for product candidates, the ability to protect intellectual property and operate the business without infringing on the intellectual property rights of others, estimates for future performance and estimates regarding anticipated operating losses, future revenues, capital requirements and needs for additional financing. In addition, even if the actual results or development of Valneva are consistent with the forward-looking statements contained in this press release, those results or developments of Valneva may not be indicative of their in the future. In some cases, you can identify forward-looking statements by words such as “could,” “should,” “may,” “expects,” “anticipates,” “believes,” “intends,” “estimates,” “aims,” “targets,” or similar words. These forward-looking statements are based largely on the current expectations of Valneva as of the date of this press release and are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievement expressed or implied by these forward-looking statements. In particular, the expectations of Valneva could be affected by, among other things, uncertainties involved in the development and manufacture of vaccines, unexpected clinical trial results, unexpected regulatory actions or delays, competition in general, currency fluctuations, the impact of the global and European credit crisis, and the ability to obtain or maintain patent or other proprietary intellectual property protection. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made during this presentation will in fact be realized. Valneva is providing the information in these materials as of this press release, and disclaim any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.
 PAHO/WHO data: Number of reported cases of chikungunya fever in the Americas. https://www.paho.org/data/index.php/en/mnu-topics/chikv-en/550-chikv-weekly-en.html. Last accessed 13 Oct 2020.
 Cardona-Ospina et al. 2015, Trans R Soc Trip Med Hyg 109:793-802.
 VacZine Analytics Chikungunya virus vaccines Global demand analysis. February 2020
 Wressnigg et al. 2020, Lancet ID;20(10):1193-1203.