Saint-Herblain (France), April 21, 2021 – Valneva SE, a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need, today announced it has initiated a pivotal Phase 3 clinical trial for its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001.
The Phase 3 trial “Cov-Compare”, (VLA2001-301), will compare Valneva’s SARS-CoV-2 vaccine candidate, VLA2001, against AstraZeneca’s conditionally approved vaccine, Vaxzevria[1], in a comparative immunogenicity trial.
Approximately 4,000 participants will receive two doses of either vaccine. The primary endpoint of Cov-Compare will be to determine the immune response (Geometric Mean Titer (GMT)) of SARS-CoV-2-specific neutralizing antibodies) two weeks after completion of a two-dose immunization schedule administered in a four-week interval. The trial is powered to demonstrate superiority of VLA2001 in terms of GMT ratio (VLA2001/Vaxzevria). The trial will be conducted in the U.K. and is supported by the National Institute for Health Research (NIHR).
Adam Finn, Chief investigator for the VLA 2001-301 program, Professor of Paediatrics at the University of Bristol and Consultant at the Bristol Royal Hospital for Children said, “Following very encouraging safety and immune response results from our Phase 1/2 trial, along with my investigator colleagues, I am really looking forward to starting on this important next stage of the clinical development of this important new vaccine. We definitely need more vaccines to help us out of this pandemic and this one is a very promising candidate.”
Thomas Lingelbach, Chief Executive Officer von Valneva , kommentierte: This Phase 3 initiation marks a significant milestone in the development of the only inactivated vaccine candidate against COVID-19 in clinical trials in Europe. As COVID-19 continues to impact people’s daily lives, we remain fully focused on developing another safe and efficacious vaccine solution. We believe that VLA2001 has an important role to play including boosters or potential modifications to the vaccine to address variants. While Cov-Compare is progressing we are planning to conduct additional, complementary trials.”
UK Minister for COVID-19 Vaccine Deployment, Nadhim Zahawi, added, “The UK has been at the forefront of cutting-edge innovation throughout this pandemic, with Valneva’s vaccine set to be made in Scotland, if approved. We have an incredible infrastructure in place for trialing these extraordinary medical advances, and I am delighted the UK will be home to another promising vaccine trial. I’ve taken part in a vaccine clinical trial myself and would urge all those thinking about signing up to go for it, and to play a part in helping protect your loved ones and saving lives.”
The initiation of the Cov-Compare trial follows the announcement of initial results from Valneva’s Phase 1/2 clinical trial, which demonstrated that the safety profile and immunogenicity were supportive of further development[2]. Subject to successful Phase 3 data, Valneva aims to make regulatory submissions for initial approval in the autumn of 2021.
About the Novel Coronavirus SARS-CoV-2 and COVID-19 Disease
SARS-CoV-2 is a new coronavirus identified in late 2019 and belongs to a family of enveloped RNA viruses that include MERS and SARS, both of which caused serious human infections of the respiratory system. The virus, which causes a disease named COVID-19, has never before been found in humans. Since this outbreak was first reported, the virus has caused millions of deaths globally[3]. It has been declared a pandemic by the World Health Organization (WHO).
About Phase 3 Trial Cov-Compare (VLA2001-301)
Cov-Compare (VLA2001-301) is a randomized, observer-blind, controlled, comparative immunogenicity trial in approximately 4,000 Adults.
Primary objectives are to demonstrate the superiority of VLA2001 compared to Vaxzevria administered in a two-dose immunization schedule four weeks apart, in terms of Geometric Mean Titer ratio of SARS-CoV-2-specific neutralizing antibodies at two weeks after the second vaccination (i.e. Day 43) in adults aged 30 years and older. It will also evaluate the safety and tolerability of VLA2001 at two weeks after the second vaccination in adults aged 18 years and older.
The trial will be conducted at approximately 25 sites in the U.K. Approximately 3,000 participants 30 years of age and older will be randomized in a 2:1 ratio to receive two intramuscular doses of either VLA2001 (n=2,000) or Vaxzevria (n=1,000) at the recommended dose level, 28 days apart, on Days 1 and 29. For immunogenicity analyses, samples from approximately 1,200 participants (600 per group) who have been tested sero-negative for SARS-CoV-2 at screening will be analyzed. Approximately 1,000 participants that are under 30 years of age will be placed in a non-randomized treatment group and receive VLA2001 28 days apart.
Über VLA2001
VLA2001 ist derzeit der einzige inaktivierte, adjuvantierte Ganzvirus-Impfstoffkandidat gegen COVID-19 in Europa. Er ist für die aktive Immunisierung von Risikopopulationen zur Verhinderung der Einschleppung und symptomatischen Infektion mit COVID-19 während der laufenden Pandemie und möglicherweise später für die Routineimpfung sowie zur Bekämpfung neuer Varianten vorgesehen. VLA2001 kann auch für Booster-Impfungen geeignet sein, da sich wiederholte Booster-Impfungen mit inaktivierten Ganzvirusimpfstoffen als gut wirksam erwiesen haben. VLA2001 wird auf Valnevas etablierter Vero-Zell-Plattform hergestellt, die die Herstellungstechnologie von Valnevas lizenziertem Impfstoff gegen Japanische Enzephalitis, IXIARO®®. VLA2001 consists of inactivated whole virus particles of SARS-CoV-2 with high S-protein density, in combination with two adjuvants, alum and CpG 1018. This adjuvant combination has consistently induced higher antibody levels in preclinical experiments than alum-only formulations and shown a shift of the immune response towards Th1. CpG 1018 adjuvant, supplied by Dynavax Technologies Corporation (Nasdaq: DVAX), is a component of the US FDA- and EMA-approved HEPLISAV-B® vaccine. The manufacturing process for VLA2001, which has already been upscaled to final industrial scale, includes inactivation with BPL to preserve the native structure of the S-protein. VLA2001 is expected to conform with standard cold chain requirements (2 degrees to 8 degrees Celsius).
Über Valneva SE
Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. We take a highly specialized and targeted approach to vaccine development, beginning with the identification of deadly and debilitating infectious diseases that lack a prophylactic vaccine solution and for which there are limited therapeutic treatment options. We then apply our deep understanding of vaccine science, including our expertise across multiple vaccine modalities, as well as our established vaccine development capabilities, to develop prophylactic vaccines to address these diseases. We have leveraged our expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.
Kontakte für Investoren und Medien
Laetitia Bachelot-Fontaine
Director Investor Relations & Corporate Communications
M +33 (0)6 4516 7099
investors@valneva.com
Dan Sharp
Government & Public Affairs Manager
T +44-(0)7436-244309
communications@valneva.com
Valneva Zukunftsgerichtete Aussagen
Diese Pressemitteilung enthält bestimmte zukunftsgerichtete Aussagen in Bezug auf die Geschäftstätigkeit von Valneva, einschließlich des Fortschritts, des Zeitplans, der Ergebnisse und des Abschlusses der Forschung, der Entwicklung und der klinischen Studien für Produktkandidaten sowie der Schätzungen für die zukünftige Leistung. Selbst wenn die tatsächlichen Ergebnisse oder Entwicklungen von Valneva mit den in dieser Pressemitteilung enthaltenen zukunftsgerichteten Aussagen übereinstimmen, kann es sein, dass diese Ergebnisse oder Entwicklungen von Valneva in der Zukunft nicht aufrechterhalten werden. In einigen Fällen können Sie zukunftsgerichtete Aussagen an Worten wie “könnte,” “sollte,” “könnte” “erwartet,” “antizipiert,” “glaubt,” “beabsichtigt,” “schätzt,” “strebt an,” “zielt darauf ab,” oder ähnlichen Worten erkennen. Diese zukunftsgerichteten Aussagen beruhen weitgehend auf den aktuellen Erwartungen von Valneva zum Zeitpunkt dieser Pressemitteilung und unterliegen einer Reihe von bekannten und unbekannten Risiken und Unsicherheiten sowie anderen Faktoren, die dazu führen können, dass die tatsächlichen Ergebnisse, Leistungen oder Erfolge erheblich von den in diesen zukunftsgerichteten Aussagen ausgedrückten oder implizierten Ergebnissen, Leistungen oder Erfolgen abweichen. Insbesondere könnten die Erwartungen von Valneva unter anderem durch Unwägbarkeiten bei der Entwicklung und Herstellung von Impfstoffen, unerwartete Ergebnisse klinischer Studien, unerwartete behördliche Maßnahmen oder Verzögerungen, den Wettbewerb im Allgemeinen, Währungsschwankungen, die Auswirkungen der globalen und europäischen Kreditkrise und die Fähigkeit, Patente oder anderen Schutz geistigen Eigentums zu erlangen oder aufrechtzuerhalten, beeinflusst werden. Der Erfolg in präklinischen Studien oder früheren klinischen Versuchen ist möglicherweise kein Indikator für die Ergebnisse zukünftiger klinischer Versuche. In Anbetracht dieser Risiken und Ungewissheiten kann nicht garantiert werden, dass die in dieser Präsentation gemachten zukunftsgerichteten Aussagen auch tatsächlich eintreten werden. Valneva stellt die Informationen in diesen Unterlagen zum Zeitpunkt dieser Pressemitteilung zur Verfügung und lehnt jede Absicht oder Verpflichtung ab, zukunftsgerichtete Aussagen öffentlich zu aktualisieren oder zu revidieren, sei es aufgrund neuer Informationen, zukünftiger Ereignisse oder aus anderen Gründen.
[1] Approved by MHRA under reg. 174 and by the European Commission as conditional approval
[2] Valneva Reports Positive Phase 1/2 Data for Its Inactivated, Adjuvanted COVID-19 Vaccine Candidate, VLA2001
[3] https://www.worldometers.info/coronavirus/