Novavax's H5N1 Vaccine Candidate Demonstrates Immunogenicity in Preclinical Study
Novavax (NASDAQ:NVAX) has announced promising preclinical data for its H5N1 avian pandemic influenza vaccine candidate, published in Nature Communications. The vaccine, utilizing Novavax's recombinant protein-based nanoparticle technology and Matrix-M® adjuvant, demonstrated strong immune responses in nonhuman primates through both intranasal and intramuscular administration.
The study revealed that a single dose induced significant neutralizing antibody responses (intranasal: 1:54; intramuscular: 1:1,160), exceeding the protective threshold of 1:40 titer. The vaccine showed potential effectiveness against forward-drift variants of currently circulating H5N1 strains. Novavax plans to pursue funding, partnership, and licensing opportunities for this vaccine candidate as part of its corporate growth strategy.
Novavax (NASDAQ:NVAX) ha annunciato dati preclinici promettenti per il suo candidato vaccino contro l'influenza pandemica aviaria H5N1, pubblicati su Nature Communications. Il vaccino, che utilizza la tecnologia a nanoparticelle basata su proteine ricombinanti di Novavax e l'adjuvante Matrix-M®, ha mostrato forti risposte immunitarie in primati non umani sia con somministrazione intranasale che intramuscolare.
Lo studio ha evidenziato che una singola dose ha indotto risposte significative di anticorpi neutralizzanti (intranasale: 1:54; intramuscolare: 1:1.160), superando la soglia protettiva di titolo 1:40. Il vaccino ha mostrato potenziale efficacia contro varianti a deriva in avanti degli attuali ceppi H5N1 circolanti. Novavax intende cercare finanziamenti, partnership e opportunità di licenza per questo candidato vaccino come parte della sua strategia di crescita aziendale.
Novavax (NASDAQ:NVAX) ha anunciado datos preclínicos prometedores para su candidato a vacuna contra la influenza pandémica aviar H5N1, publicados en Nature Communications. La vacuna, que utiliza la tecnología de nanopartículas basadas en proteínas recombinantes de Novavax y el adyuvante Matrix-M®, demostró fuertes respuestas inmunitarias en primates no humanos mediante administración tanto intranasal como intramuscular.
El estudio reveló que una única dosis indujo respuestas significativas de anticuerpos neutralizantes (intranasal: 1:54; intramuscular: 1:1,160), superando el umbral protector de título 1:40. La vacuna mostró potencial efectividad contra variantes con deriva hacia adelante de las cepas H5N1 actualmente circulantes. Novavax planea buscar financiamiento, asociaciones y oportunidades de licencia para este candidato a vacuna como parte de su estrategia de crecimiento corporativo.
노바백스 (NASDAQ:NVAX)가 조류 인플루엔자 H5N1 팬데믹 백신 후보물질에 대한 유망한 전임상 데이터를 Nature Communications에 발표했습니다. 이 백신은 노바백스의 재조합 단백질 기반 나노입자 기술과 Matrix-M® 보조제를 활용하여 비인간 영장류에서 비강 내 및 근육 내 투여 모두에서 강력한 면역 반응을 나타냈습니다.
연구 결과 단일 1회 투여로 중화항체 반응이 유의미하게 유도되었으며(비강 내: 1:54, 근육 내: 1:1,160), 보호 역가 기준인 1:40을 초과했습니다. 이 백신은 현재 유행 중인 H5N1 변종에 대한 전방 이동 변이에 대해 잠재적 효과를 보였습니다. 노바백스는 이 백신 후보물질에 대해 자금 조달, 파트너십 및 라이선스 기회를 모색할 계획입니다.
Novavax (NASDAQ:NVAX) a annoncé des données précliniques prometteuses pour son candidat vaccin contre la grippe aviaire pandémique H5N1, publiées dans Nature Communications. Le vaccin, utilisant la technologie des nanoparticules à base de protéines recombinantes de Novavax et l’adjuvant Matrix-M®, a démontré de fortes réponses immunitaires chez des primates non humains, tant par administration intranasale qu’intramusculaire.
L’étude a révélé qu’une dose unique induisait des réponses significatives d’anticorps neutralisants (intranasal : 1:54 ; intramusculaire : 1:1 160), dépassant le seuil protecteur de titre à 1:40. Le vaccin a montré un potentiel d’efficacité contre les variants à dérive progressive des souches H5N1 actuellement en circulation. Novavax prévoit de rechercher des financements, des partenariats et des opportunités de licence pour ce candidat vaccin dans le cadre de sa stratégie de croissance d’entreprise.
Novavax (NASDAQ:NVAX) hat vielversprechende präklinische Daten für seinen Impfstoffkandidaten gegen die H5N1-Vogelgrippe-Pandemie veröffentlicht, die in Nature Communications publiziert wurden. Der Impfstoff, der Novavax’ rekombinante proteinbasierte Nanopartikel-Technologie und den Matrix-M® Adjuvans nutzt, zeigte starke Immunantworten bei nichtmenschlichen Primaten sowohl bei intranasaler als auch bei intramuskulärer Verabreichung.
Die Studie zeigte, dass eine Einzeldosis signifikante neutralisierende Antikörperantworten auslöste (intranasal: 1:54; intramuskulär: 1:1.160) und damit die schützende Schwelle von 1:40 Titer übertraf. Der Impfstoff zeigte potenzielle Wirksamkeit gegen vorwärtsdriftende Varianten der derzeit zirkulierenden H5N1-Stämme. Novavax plant, Finanzierungs-, Partnerschafts- und Lizenzierungsmöglichkeiten für diesen Impfstoffkandidaten im Rahmen seiner Unternehmenswachstumsstrategie zu verfolgen.
- Vaccine demonstrated robust immune response with both single and two-dose administration
- Achieved protective antibody levels above 1:40 titer threshold with single dose
- Shows potential protection against forward-drift variants
- Flexibility in administration routes (intranasal and intramuscular)
- Still in preclinical stage, requiring further clinical trials
- Requires external funding or partnerships to advance development
Insights
Novavax's H5N1 vaccine shows promising preclinical results with single-dose potential, representing advancement in pandemic preparedness capabilities.
Novavax's preclinical data for their H5N1 avian influenza vaccine candidate demonstrates significant scientific progress in the pandemic preparedness space. The study published in Nature Communications reveals that their recombinant protein-based nanoparticle technology with Matrix-M® adjuvant generated robust immune responses in nonhuman primates via both intranasal and intramuscular administration routes.
The most compelling finding is that a single dose produced neutralizing antibody titers above the generally accepted protective threshold of 1:40 (with intranasal delivery reaching 1:54 and intramuscular achieving 1:1,160). This single-dose potential represents a major advantage in pandemic response scenarios where rapid protection is critical. Two-dose regimens showed even stronger immunity.
The vaccine's ability to elicit broad antibody responses against potential forward-drift variants is particularly significant given H5N1's propensity for mutation. This breadth of protection addresses one of the primary challenges in influenza vaccine development – preparing for virus evolution.
While promising, it's important to note these are preclinical results in nonhuman primates. The pathway to human approval requires successful progression through Phase 1-3 clinical trials demonstrating safety and efficacy. Novavax's strategy to pursue partnerships and external funding for this program aligns with their corporate growth approach of creating value through early-stage development before seeking collaboration opportunities.
- Peer-reviewed data shows Novavax's H5N1 vaccine candidate demonstrated immunogenicity against currently circulating variants following either single or two-dose administration
- Potential for single intranasal or intramuscular dose could differentiate Novavax's vaccine as part of pandemic emergency preparedness efforts
"These preclinical results underscore the promise and potential of our pandemic influenza program as well as the strength of our technology platform and our ability to deliver against our corporate growth strategy," said Ruxandra Draghia-Akli, MD, PhD, Executive Vice President and Head of Research and Development, Novavax. "Our R&D pipeline focuses on delivering assets ready for partnership and prioritizing areas of unmet medical need, including vaccines for avian pandemic influenza, where we see clear potential advantages for our technology compared with other vaccines that are licensed or in development."
Results showed that a single dose administered by either IN or IM routes induced neutralizing antibody responses (IN: 1:54; IM: 1:1,160), at or above the 1:40 titer generally considered to be a protective antibody response. The data showed even higher levels of immunity after two doses. These data suggest that even a single IN dose has the potential to provide protective immunity in individuals previously exposed to seasonal influenza either by vaccination or infection. Further, data showed Novavax's H5N1 vaccine candidate elicited broad antibody responses, suggesting the potential to protect against forward-drift variants from currently circulating strains of the H5N1 virus.
H5N1, a highly pathogenic and dynamic avian pandemic influenza virus, is of concern due to its potential to mutate into a strain adapted for sustained human-to-human transmission. To date, there have been 70 confirmed total reported human cases in the
As part of its corporate growth strategy, Novavax is making targeted investments in early-stage development programs to create value. Novavax intends to pursue funding, partnership and licensing opportunities for its H5N1 vaccine candidate.
About Novavax
Novavax, Inc. (Nasdaq: NVAX) tackles some of the world's most pressing health challenges with its scientific expertise in vaccines and its proven technology platform, including protein-based nanoparticles and its Matrix-M adjuvant. The Company's growth strategy seeks to optimize its existing partnerships and expand access to its proven technology platform via research and development (R&D) innovation, organic portfolio expansion in infectious disease and beyond, and forging new partnerships and collaborations with other companies. Please visit novavax.com and LinkedIn for more information.
Forward-Looking Statements
Statements herein relating to the future of Novavax, its operating plans and prospects, its partnerships, and the potential for a single intranasal or intramuscular dose differentiating Novavax's H5N1 vaccine, are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, challenges pursuing additional partnership opportunities; challenges satisfying, alone or together with partners, various safety, efficacy, and product characterization requirements, including those related to process qualification, assay validation and stability testing, necessary to satisfy applicable regulatory authorities; challenges or delays in conducting clinical trials or studies for its product candidates; challenges or delays in obtaining regulatory authorization for its product candidates, including for future COVID-19 variant strain changes, its CIC vaccine candidate, its stand-alone influenza vaccine candidate or other product candidates; manufacturing, distribution or export delays or challenges; Novavax's substantial dependence on Serum Institute of India Pvt. Ltd. and Serum Life Sciences Limited for co-formulation and filling Novavax's COVID-19 vaccine and the impact of any delays or disruptions in their operations; difficulty obtaining scarce raw materials and supplies including for its proprietary adjuvant; resource constraints, including human capital and manufacturing capacity; constraints on Novavax's ability to pursue planned regulatory pathways, alone or with partners; challenges in implementing its global restructuring and cost reduction plan; challenges in obtaining commercial adoption and market acceptance of its updated COVID-19 vaccine or any COVID-19 variant strain containing formulation, or for its CIC vaccine candidate and stand-alone influenza vaccine candidate or other product candidates; challenges meeting contractual requirements under agreements with multiple commercial, governmental, and other entities, including requirements to deliver doses that may require Novavax to refund portions of upfront and other payments previously received or result in reduced future payments pursuant to such agreements and challenges in amending or terminating such agreements; challenges related to the seasonality of vaccinations against COVID-19; challenges related to the demand for vaccinations against COVID-19 or influenza; challenges in identifying and successfully pursuing innovation expansion opportunities; Novavax's expectations as to expenses and cash needs may prove not to be correct for reasons such as changes in plans or actual events being different than its assumptions; and those other risk factors identified in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Novavax's Annual Report on Form 10-K for the year ended December 31, 2024, and subsequent Quarterly Reports on Form 10-Q, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at www.sec.gov and www.novavax.com, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.
Contacts:
Investors
Luis Sanay, CFA
240-268-2022
ir@novavax.com
Media
Giovanna Chandler
(844) 264-8571
media@novavax.com
References
U.S. Centers for Disease Control and Prevention. H5 Bird Flu: Current Situation. 2025. Available at: https://www.cdc.gov/bird-flu/situation-summary/index.html
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