Saint-Herblain (France), April 20, 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 is now focusing on bilateral discussions, on a country by country basis, to supply its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001, and is consequently deprioritizing the ongoing centralized discussions with the European Commission (EC).
This follows the recent announcement on April 6, 2021 of positive initial results from the Phase 1/2 clinical trial of VLA2001[1].
Valneva previously announced the advanced stage of its discussions, which started in the third quarter of 2020, with the EC on January 12, 2021[2]. In September 2020, Valneva announced a collaboration with the UK government to provide up to 190 million doses of VLA2001 through 2025[3], of which 100 million doses have already been ordered.
Thomas Lingelbach, Chief Executive Officer von Valneva , said, “We’ve committed significant time and effort to try to meet the needs of the central EC procurement process. Despite our recent clinical data, we have not made meaningful progress and have not yet secured a supply agreement. We are therefore now focusing our efforts on those European Union member states, and interested parties outside the EU, who would like to include our inactivated approach within their vaccination strategy. We are convinced that VLA2001 has an important role to play in the future, including boosters or potential modifications to the vaccine to address variants.”
Valneva has the only inactivated vaccine candidate in clinical trials against COVID-19 in Europe and is preparing a pivotal, comparative immunogenicity Phase 3 clinical trial expected to commence by the end of April 2021 with the aim of making regulatory licensure submissions 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[4]. It has been declared a pandemic by the World Health Organization (WHO).
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
This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to the progress, timing, results and completion of research, development and clinical trials for product candidates, timing and volume expectations with respect to the manufacture of our product candidates; the ability to 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 sustained in the future. In some cases, you can identify forward-looking statements by words such as “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] Valneva Reports Positive Phase 1/2 Data for Its Inactivated, Adjuvanted COVID-19 Vaccine Candidate, VLA2001
[2] Valneva in Advanced Discussions with European Commission to Supply up to 60 Million Doses of Inactivated, Adjuvanted COVID-19 Vaccine Candidate
[3] Valneva Announces Major COVID-19 Vaccine Partnership with U.K. Government
[4] https://www.worldometers.info/coronavirus/