Saint-Herblain (France), August 11th, 2021 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need, today announced the initiation of a further Phase 3 trial (VLA2001-304) for its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001.
VLA2001-304 aims to generate data in the elderly and is also designed to potentially enable variant-bridging through immune-comparability. Data from this study are expected to complement ongoing clinical trials and support additional regulatory submissions.
VLA2001-304, which will be conducted in New Zealand, will recruit approximately 150 participants aged 56 years and older (Cohort 1) with the aim of generating additional safety and immunogenicity data in this age group following vaccination with VLA2001 (two doses 28 days apart).
Juan Carlos Jaramillo M.D., Chief Medical Officer von Valneva, said, “The fight against COVID-19 continues and it’s extremely important that we continue to gather as much data as possible in all age groups across the population. Everyone should have access to technology best suited to protect them against this virus. We have also been working on Variants of Concern as part of our continued efforts to stay ahead of the virus causing COVID-19 especially since we believe that our inactivated, whole-virus platform will be adaptable across variants. Hence we are extremely pleased to be able to invest in this very important additional clinical trial”.
In June 2021, Valneva announced that it had completed recruitment for VLA2001’s pivotal Phase 3 trial “Cov-Compare” (VLA2001-301) with over 4,000 randomized participants. Valneva plans to make regulatory submissions for initial approval in the fourth quarter of 2021, subject to successful Cov-Compare data.
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® Der Herstellungsprozess für VLA2001, der bereits auf den endgültigen industriellen Maßstab hochskaliert wurde, beinhaltet eine chemische Inaktivierung, um die native Struktur des S-Proteins zu erhalten. Es wird erwartet, dass der Impfstoff VLA2001 Standard-Kühlkettenbedingungen (2 Grad bis 8 Grad Celsius) benötigt.
Trial VLA2001-304 will enroll two cohorts. Cohort 1 will include approximately 150 volunteers aged 56 years and older in an open-label manner in order to generate safety and immunogenicity data for this age group. Cohort 2 will include approximately 600 volunteers aged 12 years and older in order to compare immunogenicity data of Valneva’s original COVID-19 vaccine candidate, VLA2001, to an additional COVID-19 vaccine candidate, VLA2101, to be based on a variant strain to be confirmed. In both cohorts, vaccinations will be administered in a 2-dose immunization schedule 28 days apart. The trial will be conducted at approximately 10 trial sites in New Zealand.
ClinicalTrials.gov Identifier: NCT04956224
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. The Company takes 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. It then applies its deep understanding of vaccine science, including its expertise across multiple vaccine modalities, as well as its established vaccine development capabilities, to develop prophylactic vaccines to address these diseases. The Company has leveraged its 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.
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This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to the progress, timing, design, data read-outs, anticipated results and completion of clinical trials for VLA2001. 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 future results. 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,” or similar words. These forward-looking statements are based 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, the ability to obtain or maintain patent or other proprietary intellectual property protection and the impact of the COVID-19 pandemic. 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 this press release as of the date hereof and disclaims any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.