Valneva reports further positive results for his Chikungunya vaccine candidate
The unblinded results of Phase 1 through month 7 showed an excellent immunogenicity and a safety profile that confirm the exclusive Valneva single shot vaccine vaccine.
These results strongly support a further acceleration of development
– VLA1553 was generally safe in all dosage groups or well tolerated in low and medium dose. (Superior safety profile, including viremia, compared to the high dose group) o Excellent local tolerability – Excellent immunogenicity profile in all dosage groups after a single vaccination or 100% seroconversion1 achieved at day 14 after a single vaccination in all dose groups or 100% supported after six months
Saint Herblain (France), 22 May 2019 – Valneva SE ("Valneva" or "the Company"), a biotechnology company that develops and markets vaccines for infectious diseases with important unmet medical needs, announced further positive results of Phase 1 for his chikungunya vaccine candidate, VLA1553.
The objectives of the phase 1 study VLA1553-101 were to evaluate the general safety and immunogenicity profile after a single vaccination on three dose levels. Today's analysis (part B) of the ongoing study includes the overall safety and immunogenicity results up to month 7, unblocked at the group level and including the first results of the "intrinsic human viral challenge".
VLA1553 was generally safe in all dosage groups. The low and medium dose groups were well tolerated and showed a higher safety profile, including viremia, than the high dose. No adverse events of particular interest (eg Chikungunya infection) were reported until month 7 and the candidate's local tolerability profile of the product was excellent.
The results showed an excellent immunogenicity profile in all dose groups vaccinated after a single vaccination with 100% seroconversion achieved at day 14 after a single vaccination in all dose groups and fully supported at 100% per month 6.
A subset of study subjects was re-vaccinated after 6 months. For these subjects, an anamnestic response that shows that a single vaccination of VLA1553 is sufficient to induce sustained, high titre and neutralizing antibodies was not observed. The vaccines have been protected from vaccine-induced viremia that serves as an "intrinsic human viral challenge".
Wolfgang Bender, MD, Ph.D., Chief Medical Officer of Valneva commented: "We are thrilled with these exciting results which confirm that we have identified a highly immunogenic and safe candidate for the final product, which we now aim to progress in pivotal trials as much as quickly as possible. In addition, as hoped, the data indicate that the vaccinated subjects are protected by the chikungunya viremia. This marks a very important milestone making us a step forward towards a highly competitive differentiated vaccine that faces a serious threat to public health. "
Valneva has pledged to advance its chikungunya vaccine as quickly as possible and expects to be able to announce a plan, agreed with the regulatory authorities, to obtain the license for its short-term candidate VLA1553 FDA during its invested day of research and development, on 9 July in New York (details to be announced at a later date)
Phase 1 clinical trial information VLA1553-101 This study is a randomized, double-blind, observer phase 1 clinical trial in an escalating dose that examines three dose levels of VLA1553 after a single immunization. The study enrolled 120 healthy volunteers, aged 18 to 45, in the United States. Subjects were randomized into three different study groups to receive one of three dose levels (30 subjects in low and medium and 60 subjects in the high dose group). The protocol includes a revaccination at month 6 or month 12 to confirm that a single vaccination will be sufficient to induce high neutralizing titre antibodies and protect the subjects from Chikungunya viremia (intrinsic viral challenge). Study participants will be followed up until 13 months after initial vaccination. An independent drug safety monitoring committee (DSMB) continuously supervises the study and analyzes the data. Additional information, including a detailed description of the study design, eligibility criteria and investigator sites, is available on ClinicalTrials.gov (NCT03382964).
About Chikungunya Chikungunya is a mosquito-borne viral disease caused by the Chikungunya virus (CHIKV), a Togaviridae virus, transmitted by Aedes mosquitoes. Clinical symptoms include the acute onset of fever, debilitating joint and muscle pain, headache, nausea and rash, which can potentially turn into long-term and serious health disabilities. The Chikungunya virus causes a clinical illness in 72-92% of infected humans about 4 to 7 days after an infected mosquito bite. Complications resulting from the disease include visual, neurological, cardiac and gastrointestinal manifestations; dead cases have been reported (mortality rates from 0.1% to 4.9% from epidemics) in elderly patients at higher risk. The Chikungunya outbreaks have been reported in Asia, Africa, the Americas and recently (2017) in Europe. As of 2017, there have been more than one million cases reported in the Americas and the economic impact is considered significant (for example, the Colombia epidemic 2014: 73.6 million dollars). The medical and economic burden is expected to increase as the main CHIKV mosquito carriers continue to spread geographically. There are no preventive vaccines or effective treatments available and, as such, Chikungunya is considered a serious threat to public health.
About VLA1553VLA1553 is a single-dose, monovalent vaccine candidate, attenuated in vivo for protection against Chikungunya and obtained Fast Track designation by the Food and Drug Administration (FDA) in the United States in December 2018. The candidate vaccine is designed for active, single-dose prophylactic immunization against Chikungunya in humans over the age of one year. The vaccine aims at long-term protection and an expected safety profile similar to vaccines authorized for active immunization in adults and children. The target population segments are travelers, military personnel and at-risk individuals living in endemic regions. The global vaccine market against Chikungunya is estimated at 500 million euros a year.VLA1553 is based on an infectious clone (CHIKV LR2006-OPY1) attenuated by eliminating an important part of the gene that codes for the non-replicable complex protein of the nsP3 replicant, aiming to protect against various phylogroups and Chikungunya virus outbreak strains. In pre-clinical development, a single vaccine shot was shown to be highly immunogenic in vaccinated non-human primates (NHP) (cynomolgus macaques) and showed no signs of viremia after the challenge. In NHP, VLA1553 induced a strong, long-lasting neutralizing antibody response (over 300 days) comparable to wild-type CHIKV infections, combined with a good safety profile.
About Valneva SEValneva is a biotech company that develops and markets vaccines for infectious diseases with the main 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, the prevention of diarrhea caused by ETEC. The Company has various vaccines under development, including a unique Lyme disease vaccine. Valneva has offices in Austria, Sweden, the United Kingdom, France, Canada and the United States with over 450 employees. Further information is available at www.valneva.com.
Valneva Investors and Media Contacts Laetitia Bachelot-Fontaine Global Investor Relations Manager and Teresa Pinzolits Corporate Communications Specialist Corporate Communication T +43 (0) 1 20620 1116 M +33 (0) 6 4516 7099 email@example.com investors @ valneva .com
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Seroconversion is defined as the proportion of subjects who obtain a neutralizing antibody titre specific for CHIKV of NT50 greater than or equal to 20.
 CHI, PAHO
 PAHO / WHO data: number of reported cases of Chikungunya Fever in the Americas – EW 51 (22 December 2017)
 Cardona-Ospina et al., Trans R Soc Trip Med Hyg 2015
 Valneva PR: Valneva awarded the FDA Fast Track designation for the Chikungunya vaccine candidate
 Support of company estimates by an independent market study
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 Roques et al. 2017JCI Insight 2 (6): e83527