CEPI-funded trial intended to support potential label expansion in this age group

Saint-Herblain (France), January 31, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced the initiation of a Phase 3 trial in adolescents for its single-shot chikungunya vaccine candidate, VLA1553.

Funded by the Coalition for Epidemic Preparedness Innovations (CEPI), the trial is intended to support the label extension in this age group following a potential initial regulatory approval in adults from the US Food and Drugs Administration (FDA). It is also expected to support licensure of the vaccine in Brazil, which would be the first potential approval for use in endemic populations.

Conducted in Brazil by Instituto Butantan, VLA1553-321 is a double-blinded, multi-center, randomized and placebo-controlled Phase 3 trial. 750 adolescents aged 12 to 17 years will be randomized at a 2:1 ratio to receive either VLA1553 or placebo. The primary objective of the trial is to evaluate safety and immunogenicity following a single vaccination with VLA1553. Participants will be evaluated after 28 days and followed up to twelve months. The study will also provide safety and immunogenicity data in participants previously exposed to chikungunya.

Juan Carlos Jaramillo, M.D, Chief Medical Officer of Valneva commented, “We are delighted to work with Instituto Butantan and CEPI on this new trial, which represents another major step in the development of this exciting product. We reported compelling pivotal Phase 3 results in adults and in the elderly, and we are looking forward to obtaining results in adolescents. The dreadful impact of the COVID-19 pandemic has underlined the importance of vaccines to combat public health crises. Chikungunya outbreaks have impacted over 120 countries and affected millions, yet no vaccine or specific treatment is currently available to prevent this debilitating disease.”

Prof. Dimas Tadeu Covas, President of Instituto Butantan which sponsors the VLA1553-321 trial, commented, “VLA1553 is currently the most clinically advanced chikungunya vaccine candidate worldwide having successfully completed Phase 3 in adults. Through developing, producing and commercializing Valneva’s chikungunya vaccine, Butantan reinforces even more its engagement to improve public health in developing countries.”

Dr. Melanie Saville, Direktorin für Impfstoffforschung & Development at CEPI, added, “Today, well over a billion people live in areas where chikungunya outbreaks occur – and climate change could further amplify the threat posed by this debilitating virus. Tremendous progress has been made by our partner, Valneva, to advance its chikungunya vaccine candidate in recent years and I am pleased to see these additional developments, announced today with Instituto Butantan, to evaluate the performance of its vaccine candidate in the adolescent population.”

At the beginning of August 2021, Valneva announced positive topline results for the pivotal Phase 3 trial VLA1553-301 in adults aged 18 years and above. The vaccine candidate induced protective chikungunya-virus neutralizing antibody titers in 98.5% of trial participants after a single vaccination and was well tolerated across all age groups[1]. Valneva expects to report final results from VLA1553-301 in the first quarter of 2022. The Company also reported positive primary endpoint data from its ongoing lot-to-lot manufacturing consistency trial VLA1553-302 in December 2021.These data should allow pre-submission discussions with regulators which the Company plans to start in 2022.

Um den Zugang zu VLA1553 für Länder mit niedrigem und mittlerem Einkommen (LMIC) zu erleichtern, haben Valneva und das Instituto Butantan in Brasilien im Januar 2021 eine Vereinbarung über die Entwicklung, Herstellung und Vermarktung von VLA1553 unterzeichnet[2]. Die Zusammenarbeit steht im Kontext der im Juli 2019 zwischen CEPI und Valneva unterzeichneten Vereinbarung[3], die eine Finanzierung von bis zu US$ 23,4 Mio. mit Unterstützung des "Programms Horizon" 2020 der Europäischen Union vorsieht.

Brazil had an exponential increase of chikungunya cases in 2021 in comparison to 2020, according to data from the Brazilian Vigilance Health Secretary (SVS). At the beginning of December 2021, 90,147 chikungunya cases had been registered compared to 78,808 over the same period last year. The southeast of the country, where São Paulo and Rio de Janeiro are located, presented a higher incidence with 29,700 cases of chikungunya, including 14,300 cases in São Paulo compared to 281 last year.

Über VLA1553
VLA1553 is a live-attenuated, single dose vaccine candidate targeting the chikungunya virus, which has spread to over 120 countries. It has been designed by deleting a part of the chikungunya virus genome.

In August 2021, Valneva reported positive topline results for pivotal Phase 3 clinical trial, VLA1553-301. In this double-blind, multi-center, randomized Phase 3 clinical trial, 4,115 participants aged 18 years and above were randomized 3:1 into two groups to receive either 0.5mL of VLA1553 or a placebo. The trial met its primary endpoint, inducing protective CHIKV neutralizing antibody titers in 98.5% of participants 28 days after receiving a single shot (264 of 268 subjects from the per-protocol subgroup tested for immunogenicity, 95% CI: 96.2-99.6). The seroprotective titer was agreed with the FDA to serve as a surrogate of protection that can be utilized in a potential FDA submission for approval of VLA1553 under the accelerated approval pathway. VLA1553 was highly immunogenic, with a GMT of approximately 3,270.

VLA1553 was generally well tolerated among the 3,082 subjects evaluated for safety. An independent Data Safety Monitoring Board, or DSMB, continuously monitored the study and identified no safety concerns. The majority of solicited adverse events were mild or moderate and resolved within 3 days.

Additionally, VLA1553 was highly immunogenic in elderly study participants, who achieved equally high seroprotection rates and neutralizing antibody titers as younger adults, as well as an equally good safety profile.

VLA1553-301 will continue towards final analysis including the 6-month safety data. The Company expects to report final trial results in early 2022.

VLA1553 would expand Valneva’s existing travel vaccine portfolio and as such, Valneva intends to commercialize this vaccine, if approved, leveraging its existing manufacturing and commercial operations. The global market for vaccines against chikungunya is estimated to exceed $500 million annually by 2032[4].

Über die Phase-3-Studie VLA1553-321
VLA1553-321 ist eine prospektive, doppelblinde, multizentrische, randomisierte, placebokontrollierte Phase-3-Zulassungsstudie, die an 750 Jugendlichen im Alter von 12 bis 17 Jahren in Brasilien durchgeführt wird. VLA1553 oder Placebo wird den Teilnehmern, die im Verhältnis 2:1 in zwei Studiengruppen randomisiert werden, als einmalige intramuskuläre Immunisierung verabreicht. Das primäre Ziel ist die Bewertung der Immunogenität und Sicherheit der Erwachsenendosis von VLA1553 28 Tage nach einer einmaligen Impfung. Zu den sekundären Zielen der Studie gehört die Bewertung der Sicherheit und Immunogenität bis zu zwölf Monate nach einer Einzelimpfung mit VLA1553. Die Studie wird auch Daten zur Sicherheit und Immunogenität bei Teilnehmern liefern, die zuvor mit dem Chikungunya-Virus infiziert waren.

Weitere Informationen, einschließlich einer detaillierten Beschreibung des Studiendesigns, der Zulassungskriterien und der Prüfzentren, sind auf ClinicalTrials.gov verfügbar (Kennung: NCT04650399).

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 Instituto Butantan
Das Instituto Butantan ist der wichtigste Hersteller von immunbiologischen Produkten und Impfstoffen in Brasilien. Das Instituto Butantan führt wissenschaftliche Aufträge im In- und Ausland über die panamerikanische Gesundheitsorganisation, die Weltgesundheitsorganisation, UNICEF und die Vereinten Nationen aus. Das Institut arbeitet mit anderen Behörden des Gesundheitssekretariats des Bundesstaates São Paulo und des brasilianischen Gesundheitsministeriums zusammen, um die allgemeine Gesundheit in Brasilien zu verbessern. Es arbeitet mit verschiedenen Universitäten und Einrichtungen wie der Bill & Melinda Gates Foundation zusammen, um seine institutionellen Ziele zu erreichen. Für weitere Informationen besuchen Sie bitte die Website des Instituts unter www.butantan.gov.br oder kontaktieren Sie die Pressestelle unter (+55 11) 2627-9606 / 9428 oder per E-Mail an imprensa@butantan.gov.br.

Über CEPI
CEPI ist eine innovative Partnerschaft zwischen öffentlichen, privaten, philanthropischen und zivilen Organisationen, die 2017 in Davos ins Leben gerufen wurde, um Impfstoffe zu entwickeln, die künftige Epidemien verhindern sollen. Vor dem Aufkommen von COVID-19 zählten zu den vorrangigen Krankheiten von CEPI das Ebola-Virus, das Lassa-Virus, das Coronavirus des Middle East Respiratory Syndrome, das Nipah-Virus, das Rift Valley Fever und das Chikungunya-Virus. CEPI investierte auch in Plattformtechnologien, die für die schnelle Entwicklung von Impfstoffen und Immunprophylaxe gegen unbekannte Krankheitserreger (Krankheit X) eingesetzt werden können.

CEPI hat mit großer Dringlichkeit und in Abstimmung mit der WHO auf das Auftreten von COVID-19 reagiert. CEPI hat 9 Partnerschaften zur Entwicklung von Impfstoffen gegen das neue Coronavirus initiiert. Die Programme werden sowohl die von CEPI bereits unterstützten Rapid Response Plattformen als auch neue Partnerschaften nutzen. Ziel ist es, die COVID-19-Impfstoffkandidaten so schnell wie möglich in die klinische Erprobung zu bringen.

CEPI leitet gemeinsam mit Gavi und der Weltgesundheitsorganisation die Impfstoffsäule des ACT Accelerator - bekannt als COVAX -, die sich mit der Entwicklung, dem Vertrieb und dem Einsatz von COVID-19-Impfstoffen in der Welt befasst. Erfahren Sie mehr unter http://www.cepi.net. Folgen Sie CEPI unter @CEPIvaccines.

Kontakte für Investoren und Medien

Laetitia Bachelot-Fontaine

VP Global Communications & European Investor Relations

M +33 (0)6 4516 7099

laetitia.bachelot-fontaine@valneva.com

 

Teresa Pinzolits

Senior Corporate Communications Specialist

T +43-1-206 20-1116

teresa.pinzolits@valneva.com

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, to regulatory approval of product candidates and review of existing products, and to estimates for future performance. 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 “could,” “should,” “may,” “expects,” “anticipates,” “believes,” “intends,” “estimates,” “aims,” “targets,” or similar words. These forward-looking statements are based largely 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, and the ability to obtain or maintain patent or other proprietary intellectual property protection. Success in preclinical studies or earlier clinical trials may not be indicative of results in future clinical trials. 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 these materials as of this press release, and disclaim any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

[1] Valneva Announces Positive Phase 3 Pivotal Results for its Single-Shot Chikungunya Vaccine Candidate

[2] Valneva and Instituto Butantan Sign Final Agreement on Single-Shot Chikungunya Vaccine for Low and Middle Income Countries

[3] CEPI awards up to $23.4 million to Valneva for late-stage development of a single-dose Chikungunya vaccine

[4] VacZine Analytics Chikungunya virus vaccines Global demand analysis. February 2020