Saint-Herblain (France) and New York (United States), September 28, 2021Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, and Pfizer Inc. (NYSE: PFE), today announced further positive Phase 2 results, including booster response, for Lyme disease vaccine candidate VLA15.

The Phase 2 study, VLA15-202, is evaluating the immunogenicity and safety of VLA15 in a Month 0-2-6 vaccination schedule. The study enrolled 246 healthy adults 18 to 65 years of age in the U.S. As announced in October 2020[1], the study met its primary endpoint of demonstrating that VLA15 was immunogenic across all dose groups tested and elicited high antibody responses across all serotypes (ST1 – ST6) at one month after completion of the primary vaccination series. Continued evaluation at Month 18 showed that antibody titers declined thereafter across all groups, remaining above baseline but confirming the need for a booster strategy.

VLA15 was safe and well-tolerated across all doses and age groups tested. No related Serious Adverse Events (SAEs) were observed in any treatment group.

Participants who received a complete primary vaccination series with 180 µg doses of VLA15, were invited to continue the study in a booster extension phase and were randomized to receive an additional 180 µg dose of VLA15 (N=39) or placebo (N=19) at Month 18.

VLA15’s acceptable safety profile was confirmed through one-month post-booster. Administration of a booster dose elicited a strong anamnestic response yielding a 2.9-fold (ST3) to 4.2-fold (ST1, ST4) increase (Geometric Mean Fold Rise) in anti-OspA IgG antibody titers compared with titers observed after primary immunization. All participants seroconverted to anti-OspA IgG after the booster dose, meaning Seroconversion Rates (SCRs) were 100% for all OspA serotypes. SCR was defined as the rate of subjects that changed from seronegative at baseline to seropositive. Additionally, subjects who were seropositive at baseline needed to show at least a 4-fold increase in anti-OspA IgG compared to baseline titer. Functionality of elicited antibodies was demonstrated by Serum Bactericidal activity Assays, leading to SCRs ranging from 86.8% (ST2) to 100.0% (ST3) after the booster. The study is continuing to monitor persistence of antibody responses.

Juan Carlos Jaramillo M.D., Chief Medical Officer von Valneva, commented, “Lyme disease represents a high unmet medical need which impacts the lives of millions of people in the Northern Hemisphere. We are excited by these additional Phase 2 results, which we believe take us a step closer to making a major contribution against this severe disease, subject to regulatory approval.”

“The prevalence and geographic reach of Lyme disease is growing, underscoring the major medical need for vaccination against the disease,” adds Kathrin Jansen, PhD, Senior Vice President and Head of Pfizer Vaccine Research and Development. “These positive results of the Phase 2 VLA15-202 study represent another important milestone in the development of VLA15, and we look forward to continue our development efforts in our quest to potentially protect people from Lyme disease in the future.”

Über VLA15

VLA15 is the only active Lyme disease vaccine candidate in clinical development. This investigational multivalent protein subunit vaccine uses an established mechanism of action for a Lyme disease vaccine that targets the outer surface protein A (OspA) of Borrelia burgdorferi, the bacteria that cause Lyme disease, and covers the six OspA serotypes that are prevalent in North America and Europe. OspA is one of the most dominant surface proteins expressed by the bacteria when present in a tick. VLA15 has demonstrated strong immunogenicity and safety data in pre-clinical and clinical studies so far. The program was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) in July 2017[2].

Valneva and Pfizer announced a collaboration for VLA15’s development and commercialization at the end of April 2020. The two companies are working closely together on the next development steps and are planning for a Phase 3 trial in 2022.

About Phase 2 Clinical Study VLA15-202

VLA15-202 is a randomized, observer-blind, placebo controlled trial conducted in the US.

A total of 246 healthy volunteers 18 to 65 years of age received 135 µg (N=97), or 180 µg (N=98) of VLA15 or placebo (N=51)).

VLA15 was tested as alum adjuvanted formulation and was administered intramuscularly at Month 0-2-6.

Participants were followed for an additional 12 months, with the primary immunogenicity readout at one month after completion of the primary vaccination series (Primary Endpoint). A subset of participants who received a complete primary vaccination series in the 180 µg dose level VLA15 group, were invited to continue the study into a booster phase and were randomized to receive an additional 180 µg dose of VLA15 (N=39) or placebo (N=19) at Month 18.

Study centers are located in areas where Lyme disease is endemic; volunteers with a prior history of Lyme disease were also enrolled.

Über Lyme Borreliose

Die Lyme-Borreliose ist eine systemische Infektion, die durch das Bakterium Borrelia burgdorferi verursacht wird und durch infizierte Ixodes -Zecken auf den Menschen übertragen wird[3]. It is considered the most common vector- borne illness in the Northern Hemisphere. According to the U.S. Centers for Disease Control and Prevention (CDC), approximately 476,000 Americans are diagnosed and treated for Lyme disease each year[4], and there are at least a further 200,000 cases in Europe annually[5]. betroffen sind. Frühe Symptome der Lyme-Borreliose (wie ein sich allmählich ausbreitender erythematöser Ausschlag, Erythema migrans or more unspecific symptoms like fatigue, fever, headache, mild stiff neck, arthralgia or myalgia) are often overlooked or misinterpreted. Left untreated, the disease can disseminate and cause more serious complications affecting the joints (arthritis), the heart (carditis) or the nervous system. The medical need for vaccination against Lyme disease is steadily increasing as the disease footprint widens[6].

Über Valneva SE

Valneva ist ein Impfstoffunternehmen, das sich auf die Entwicklung und Vermarktung von prophylaktischen Impfstoffen gegen Infektionskrankheiten mit hohem ungedeckten medizinischen Bedarf spezialisiert hat. Das Unternehmen verfolgt bei der Impfstoffentwicklung einen hochspezialisierten und zielgerichteten Ansatz an und wendet sein tiefes Verständnis der Impfstoffwissenschaft an, um prophylaktische Impfstoffe gegen diese Krankheiten zu entwickeln. Durch Einsatz seines Fachwissens und seiner Fähigkeiten konnte das Unternehmen zwei Impfstoffe erfolgreich vermarkten und mehrere Impfstoffkandidaten schnell in und durch die klinische Entwicklung bringen, darunter Kandidaten gegen Borreliose, das Chikungunya-Virus und COVID-19.

Über Pfizer: Breakthroughs That Change Patients’ Lives

Bei Pfizer setzen wir die Wissenschaft und unsere globalen Ressourcen ein, um den Menschen Therapien anzubieten, die ihr Leben verlängern und deutlich verbessern. Wir wollen den Standard für Qualität, Sicherheit und Nutzen bei der Entwicklung und Herstellung innovativer Medikamente und Impfstoffe setzen. Jeden Tag arbeiten Pfizer-Mitarbeiter weltweit daran das Wohlbefinden, die Prävention, Behandlungen und Heilung von schwerwiegenden Erkrankungen voranzutreiben. Als eines der weltweit führenden innovativen biopharmazeutischen Unternehmen sehen wir es als unsere Verantwortung, mit Gesundheitsversorgern, Regierungen und lokalen Gemeinschaften zusammenzuarbeiten, um den Zugang zur Gesundheitsversorgung auf der ganzen Welt zu unterstützen. Seit mehr als 170 Jahren arbeiten wir daran, etwas zu bewirken. Wir veröffentlichen regelmäßig Informationen auf unserer Website unter www.Pfizer.com. die für Investoren wichtig sein könnten. Mehr Informationen über Pfizer finden Sie unter www.Pfizer.com auf Twitter unter @Pfizer und @Pfizer News: LinkedIn: YouTube und auf Facebook unter Facebook.com/Pfizer.

Pfizer Contacts

Media Contact: Jerica Pitts

+1 (347) 224-9084

Jerica.Pitts@pfizer.com

Investor Contact: Bryan Dunn

+1 (212) 733-8917

Bryan.Dunn@pfizer.com

Valneva Contacts

Laëtitia Bachelot-Fontaine

VP Global Communications & European Investor Relations

M +33 (0)6 4516 7099

laetitia.bachelot-fontaine@valneva.com

 

Teresa Pinzolits

Corporate Communications Specialist

M +1 917 815 4520

teresa.pinzolits@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.

Pfizer Forward-Looking Statements

The information contained in this release is as of September 28, 2021. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about a Lyme disease vaccine candidate, VLA15, and a collaboration between Pfizer and Valneva for VLA15, including their potential benefits and a potential phase 3 trial, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when drug applications may be filed in any jurisdictions for VLA15; whether and when any such applications may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, whether VLA15 will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of VLA15; the impact of COVID-19 on Pfizer’s business, operations and financial results; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov und www.pfizer.com.

 

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[1] Valneva Announces Positive Initial Results for Second Phase 2 Study of Lyme Disease Vaccine Candidate VLA15

[2] Valneva Receives FDA Fast Track Designation for its Lyme Disease Vaccine Candidate VLA15

[3] Stanek et al. 2012, The Lancet 379:461–473

[4] Source: https://www.cdc.gov/lyme/stats/humancases.html

[5] Estimated from available national data. Number largely underestimated based on WHO Europe Lyme Report as case reporting is highly inconsistent in Europe and many LB infections go undiagnosed; ECDC tick-borne-diseases-meeting-report

[6] New Scientist, Lyme disease is set to explode and we still don’t have a vaccine; March 29, 2017
https://www.newscientist.com/article/mg23431195-800-lyme-disease-is-set-to-explode-and-you-cant-protect-yourself/