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Novavax' H7N9 Avian Influenza VLP Vaccine Candidate With Matrix-M(TM) Delivers Positive Phase 1/2 Clinical Data

  • Vaccine and adjuvant were well-tolerated, consistent with the company's prior studies with saponin-based adjuvants
  • Hemagglutination-inhibiting antibody responses similar to prior Novavax studies of A(H7N9) with another saponin adjuvant
  • Strong neuraminidase inhibiting antibody responses in adjuvanted vaccine groups
  • Matrix-M demonstrated a clear dose response

GAITHERSBURG, Md., Sept. 23, 2014 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX) a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, today announced positive top-line data from a Phase 1/2 clinical trial of its H7N9 Avian Influenza VLP Vaccine Candidate (H7N9 VLP) with proprietary adjuvant Matrix-M™. This trial was conducted under the company's contract with HHS-BARDA (HHSO100201100012C) for the development of VLPs to address influenza strains with pandemic potential.

The study was conducted in 610 healthy subjects to evaluate the safety and immunogenicity of the H7N9 VLP with Matrix-M. The study was designed as a dose-ranging, randomized, observer-blinded, placebo-controlled clinical trial, to determine the contribution of Matrix-M to potential antigen dose sparing regimens. Subjects were administered two identical doses of either placebo, 15 µg of H7N9 VLP alone, or 3.75, 7.5 or 15 µg of H7N9 VLP in combination with either 25 or 50 µg of Matrix-M. Serology was taken on day 0, 21 and 42.

The H7N9 VLP, with and without Matrix-M, was well tolerated and demonstrated a safety profile similar to the company's prior experience with another saponin-based adjuvant. Matrix-M adjuvanted formulations demonstrated a clear immunogenicity benefit relative to unadjuvanted antigen, and a dose-response within the adjuvanted groups. Antigen dose-sparing was shown, such that even the 3.75µg dose of antigen with either tested dose of adjuvant gave immune responses statistically significantly greater than 15µg dose without adjuvant. Geometric mean titers of hemagglutination-inhibiting antibody after two vaccine doses were comparable to those reported in prior studies with another saponin adjuvant when similar antigen and adjuvant doses were compared. The vaccine also elicited anti-neuraminidase (NAI) antibodies against N9, with 89 to 100% sero-response rates in the adjuvanted vaccine groups, and greater than 11-fold increases in geometric mean titers.

"This study represents the first clinical trial of Matrix-M with our VLPs. We are pleased with the performance of Matrix-M in this study, which increases our confidence in the value of this adjuvant and its future application in this and other recombinant nanoparticle products," said Stan Erck, President and CEO of Novavax. "Based on the data from this trial, we will discuss future clinical studies with our partner, BARDA. Given the Matrix-M safety profile and dose response observed in this study, we believe additional such studies are warranted to identify the best combination of antigen and adjuvant to achieve the greatest practical antigen dose sparing, consistent with a strong immune response, thus potentially making available the maximum number of doses in a pandemic emergency."

About the Novavax BARDA Contract (HHSO100201100012C)

In February 2011, Novavax was awarded a contract valued at up to $179 million by BARDA for the advanced development of recombinant influenza vaccine products and manufacturing capabilities for pandemic preparedness. During the contract's 43-month base period, Novavax has been developing and testing its novel recombinant virus-like particle (VLP) influenza vaccines to address BARDA's commitment to advancing recombinant-based technology as a component of pandemic preparedness. An Option Period has been awarded by BARDA to extend the period of performance by 24 months. The milestones under the option period are focused on activities leading up to initiation of Phase 3 clinical trials.

About Novavax

Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage biopharmaceutical company creating novel vaccines and vaccine adjuvants to address a broad range of infectious diseases worldwide. Using innovative proprietary recombinant nanoparticle vaccine technology, the company produces vaccine candidates to efficiently and effectively respond to both known and newly emergent diseases. Additional information about Novavax is available on the company's website, novavax.com.

Novavax 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, 2013, 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.

CONTACT: Barclay A. Phillips SVP, Chief Financial Officer and Treasurer Novavax, Inc. 240-268-2000

Source:Novavax, Inc.