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Valneva initiates a Phase 3 clinical lot consistency study for its single-shot chikungunya vaccine candidate
Saint-Herblain, France, February 22, 2021 – Valneva SE (“Valneva” or “the Company”), a specialty vaccines company focused on the prevention of infectious diseases with significant unmet medical needs, announced today that it has the clinical lot initiated phase 3 batch-to-batch consistency study for its single-shot chikungunya vaccine candidate VLA1553. This study is being carried out in parallel to the ongoing, central phase 3 study VLA1553-301, in which seroprotection is determined using an immunological substitute1. The aim of this study is to demonstrate the manufacturing consistency of the vaccine by showing that three batches prepared in sequence elicit equivalent immune responses as measured by neutralizing antibody titers on day 29 post vaccination. Volunteer students are observed for a total of six months. Juan Carlos Jaramillo, MD, Valneva’s Chief Medical Officer, commented, “This trial initiation marks another important step in VLA1553’s evolution towards licensing. The Chikungunya virus continues to pose a major threat to public health and we are working as soon as possible to provide a preventative solution to those who need it most. We would like to thank our employees, partners and study participants for making this study possible despite the ongoing COVID-19 pandemic. “VLA1553 is the only Chikungunya vaccine candidate in Phase 3 clinical trials. The sponsor of the first US-approved Chikungunya Vaccine Biologics License Application (BLA) can receive a Priority Review Voucher (PRV) 2. About Chikungunya Chikungunya is a mosquito-borne viral disease caused by Chikungunya virus (CHIKV), a Togaviridae virus transmitted by Aedes mosquitoes. Infection leads to symptomatic illness in 72-92% of people 4 to 7 days after the mosquito bite. While mortality with CHIKV is low, morbidity is high. Clinical symptoms are acute 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 rates of attack, affecting a third to three quarters of the population in areas where the virus circulates. The areas at greatest risk of infection for travelers are places where mosquitoes are endemic to Chikungunya virus, including America, parts of Africa, and Southeast Asia. More than 3 million cases have been reported in America as of September 20203 and the economic impact is considered significant (e.g. Colombia outbreak 2014: $ 73.6 million4). Medical and economic stress is expected to increase as CHIKV’s primary mosquito vectors continue to spread geographically. There are no preventive vaccines or effective treatments, and as such, chikungunya is viewed as a major public health threat. About VLA1553 VLA1553 is a live-dose attenuated vaccine candidate for protection against Chikungunya disease and is currently in Phase 3 clinical trials. VLA1553 was developed by deleting part of the Chikungunya virus genome. As a live attenuated vaccine, VLA1553 is particularly suitable for long-term protection. Valneva is the first to promote a Chikungunya vaccine candidate to Phase 3. The Sponsor of the First Approved Chikungunya Vaccine Biologics License Application (BLA) A Priority Review Voucher (PRV) can be obtained in the US. 5.VLA1553 would expand Valneva’s existing travel vaccine portfolio. Valneva therefore intends to commercialize this vaccine, if approved, using its existing manufacturing and trading activities. The global market for chikungunya vaccines is estimated at over $ 500 million per year through 20326. Phase 1 data from VLA1553 in 120 volunteers were published in The Lancet Infectious Diseases7. The vaccine was well tolerated at the dose selected for phase 3. No vaccine-related serious adverse events were reported during the 12 month follow-up period. Neutralizing antibodies were developed in 100% of the volunteers within 14 days of a single vaccination and were maintained for up to a year. Based on these encouraging results, phase 3 tests were initiated in September 2020. The program was recognized as Fast Track by the US Food and Drug Administration (FDA) in December 20188 and PRIME by the European Medicines Agency (EMA) in October 20209. In order to make VLA1553 also available to low and middle income countries (LMIC), Valneva and Instituto Butantan in Brazil have signed an agreement to develop, manufacture and commercialize VLA1553. The collaboration falls under the funding agreement between Valneva and the Coalition for Epidemic Preparedness Innovation (CEPI) in July 2019, which provides funding of up to $ 23.4 million. About the phase 3 study VLA1553-302 VLA1553-302 Clinical lot-to-lot consistency The phase 3 study is a prospective, multicentre, randomized, central phase 3 study with approximately 400 participants aged 18 to 45 years. Lyophilized VLA1553 is administered as a single intramuscular immunization. The equivalence of immune responses is determined based on neutralizing antibody titers. The main objective of the study is to evaluate a pairwise comparison of the 95% CI with the GMT ratio on day 29 after vaccination in the three vaccine lots. The two-sided 95% CI of the GMT ratio should be within 0.67 and 1.5. Volunteer students are observed for a total of six months. Overall, the study is expected to last approximately eight months. Additional information, including a detailed description of the study design, eligibility criteria, and trial sites, will be posted on ClinicalTrials.gov. About Valneva SE Valneva is a specialty vaccines company focused on the prevention of infectious diseases with significant unmet medical needs. The company has several vaccines in development, including unique vaccines for Lyme disease, COVID-19, and Chikungunya. Valneva’s portfolio includes two commercial vaccines for travelers: IXIARO® / JESPECT® for the prevention of Japanese encephalitis and DUKORAL® for the prevention of cholera and, in some countries, the prevention of diarrhea by ETEC. Valneva operates in Austria, Sweden, Great Britain, France, Canada and the USA with over 500 employees. Valneva Investor and Media ContactsLaetitia Bachelot-FontaineDirector Investor Relations & Corporate CommunicationsM +33 (0) 6 4516 7099investors@valneva.com Teresa PinzolitsCorporate Communications SpecialistT +43 (0) 1 20620 1116communications@valneva.com Forward-Looking Statements This press release contains certain statements in forward-looking statements Regarding Valneva’s business, including in relation to the progress, timing and completion of research, development and clinical trials for product candidates, the ability to manufacture, commercialize, market and market up for product candidates, the ability to protect intellectual property and to operate the business without infringing the intellectual property rights of others, estimates of future performance and estimates of expected operating losses, future revenues, capital requirements and the need for additional funding. Even if actual results or developments of Valneva coincide with the forward-looking statements contained in this press release, these results or developments of Valneva may not be an indication of their future development. In some instances, you may identify forward-looking statements by using words such as “may,” “should,” “may,” “expects,” “anticipates,” “believes,” “intends,” “estimates,” “aims”. “” Objectives “or similar words. These forward-looking statements are based largely on Valneva’s current expectations 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 could cause actual results, performance or achievements to be material They are different from future results, accomplishments or successes expressed or implied in these forward-looking statements.In particular, Valneva’s expectations could be caused by, among other things, uncertainties in the development and manufacture of vaccines, unexpected clinical trial results, unexpected regulatory actions or delays, competition in general, currency fluctuations, the effects of the global and European credit crunch, and the ability to obtain or maintain patents or other protected intellectual property rights In view of these risks and uncertainties, no guarantee can be given that the forward-looking statements made in this presentation will actually be implemented. Valneva makes the information in these materials available as of this press release and disclaims any intention or obligation to publicly update or revise any forward-looking statements as a result of new information, future events or otherwise. 1 Valneva initiates phase 3 clinical trial for its chikungunya vaccine candidate VLA1553 2 https://priorityreviewvoucher.org/3 PAHO / WHO data: Number of reported cases of chikungunya fever in America. https://www.paho.org/data/index.php/en/mnu-topics/chikv-en/550-chikv-weekly-en.html. Last accessed October 13, 2020.4 Cardona-Ospina et al. 2015, Trans R Soc Trip Med Hyg 109: 793-802.5 https://priorityreviewvoucher.org/ 6 VacZine Analytics Vaccines Against Chikungunya Virus Global Demand Analysis. February 2020 7 Wressnigg et al. 2020, Lancet ID; 20 (10): 1193-1203.8 Valneva PR: Valneva Receives FDA Fast Track Award for Chikungunya Vaccine Candidate[9] Valneva’s Chikungunya vaccine candidate receives EMA Prime Designation Attachment 2021_02_22_VLA1553_L2L_Phase3_Initiation_PR_EN_Final
