Novavax' Preclinical Influenza Nanoparticle Study Published in Vaccine

Novel vaccine candidate, NanoFlu(TM), outperforms market-leading Fluzone® High Dose based on antibody titers and neutralization of recent and historic influenza viruses in a preclinical study

GAITHERSBURG, Md., Aug.  23, 2017  (GLOBE NEWSWIRE) -- Novavax, Inc., (Nasdaq:NVAX) today announced that data from a preclinical study of its nanoparticle influenza vaccine candidate with its proprietary Matrix-M(TM) adjuvant (NanoFlu(TM)) have been published in the journal Vaccine. Novavax is developing NanoFlu to protect older adults from seasonal influenza.

The manuscript describes the formulation of Novavax' novel seasonal influenza vaccine candidate, NanoFlu, based on the 2017-2018 World Health Organization (WHO) recommended influenza strains. The study, conducted in ferrets, found that NanoFlu induced hemagglutination-inhibition (HAI) and microneutralizing (MN) antibodies against a broad range of influenza subtypes. In a head-to-head comparison against standard-dose and high-dose (HD) inactivated influenza vaccines in ferrets, NanoFlu elicited higher HAI and MN antibody responses exceeding those induced by the high-dose vaccine against recent (homologous) A(H3N2) by 7-fold, A(H1N1) by 26-fold, and B strain viruses by 2-fold. Additionally, NanoFlu induced superior protection in a ferret challenge model against a homologous and a 10-year old drifted influenza strain spanning over a decade.

"These data suggest that NanoFlu has the potential to elicit a broader, more robust immune response, resulting in greater protection than the market-leading licensed influenza vaccine in older adults, Sanofi's Fluzone® High-Dose. NanoFlu outperformed standard dose Fluzone and Fluzone HD in HAI assays, an established surrogate marker of protection," said Gregory Glenn, M.D., President, Research and Development. "Further, these data suggest NanoFlu has the potential to address the problem of annual strain mismatch due to its ability to induce highly neutralizing antibodies against a broad range of influenza strains. These data show that NanoFlu provides improved protective responses to both the current recommended influenza strains as well as drifted strains."

"Novavax has over a decade of experience in developing both seasonal and pandemic influenza vaccine candidates. Based on the superior attributes of our nanoparticle based vaccine candidates, we transitioned our influenza development activities to our nanoparticle vaccine platform," said Stanley C. Erck, President and CEO. "The data in this publication further validate our nanoparticle vaccine platform and provide a strong rationale for advancing NanoFlu into a Phase 1/2 clinical trial. Our goal is to deliver a superior, differentiated vaccine to the greater than $3 billion global seasonal influenza commercial market¹."

Copies of this paper are available to credentialed journalists upon request; please contact Elsevier's Newsroom at newsroom@elsevier.com or +31 20 485 2492. "Novel hemagglutinin nanoparticle influenza vaccine with Matrix-M(TM) adjuvant induces hemagglutination inhibition, neutralizing, and protective responses in ferrets against homologous and drifted A(H3N2) subtypes," by Gale Smith, Ph.D., Ye Liu, Ph.D., David Flyer, Ph.D., Michael J. Massare, Ph.D., Bin Zhou, Ph.D., Nita Patel, Ph.D., Larry Ellingsworth, Ph.D., Maggie Lewis, Ph.D., James F. Cummings, M.D., Greg Glenn, M.D., DOI: http://dx.doi.org/10.1016/j.vaccine.2017.08.021 appears in Vaccine, published by Elsevier and is available online at www.elsevier.com/locate/vaccine.

About Vaccine
Vaccine is the pre-eminent journal for those interested in vaccines and vaccination. It is the official journal of The Edward Jenner Society and The Japanese Society for Vaccinology and is published by Elsevier, www.elsevier.com/locate/vaccine.

About Novavax

Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage biotechnology company committed to delivering novel products to prevent a broad range of infectious diseases. Our recombinant nanoparticles and Matrix-M(TM) adjuvant technology are the foundation for groundbreaking innovation that improves global health through safe and effective vaccines. Additional information about Novavax is available on the Company's website, novavax.com.

References
1. PharmaPoint Seasonal Influenza Vaccines Global Drug Forecast and Market Analysis to 2025, October 2016

Forward-Looking Statements

Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2016 and the Report on Form 10-Q for the period ended June 30, 2017, both as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, 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.

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