Novavax Publishes Positive Preclinical Efficacy Data Against Influenza A(H7N9)

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| Source: Novavax, Inc.
  • Positive efficacy data from its A(H7N9) vaccine published in the peer-reviewed scientific journal Vaccine
  • Novavax vaccine-induced immunity provided 100% protection against lethal wild-type A(H7N9) influenza challenge versus 0% survival in control (H5N1) vaccine and placebo groups
  • Achieved complete cross-protection with its H7N3 VLP vaccine against H7N9 challenge
  • Animal model efficacy data supports clinical development of an H7N9 VLP vaccine

ROCKVILLE, Md., July 29, 2013 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX) today announced positive preclinical data for the company's virus-like particle (VLP) vaccine candidate against A(H7N9) influenza. The data were published online in the peer reviewed journal Vaccine.

The study examined the immunogenicity and efficacy of two doses of its A(H7N9) VLP vaccine candidate against a lethal wild-type challenge mouse model. Three control groups included Novavax' non-homologous A(H7N3) VLP vaccine candidate, its A(H5N1) VLP vaccine candidate, and a placebo. All vaccine candidates were administered with or without Iscomatrix®, a saponin-based adjuvant.

Highlights of the published article:

  • A(H7N9) VLP vaccine candidate induced hemagglutination-inhibition (HAI) antibody titers of ≥1:64 against H7N9 in all animals (n=8) at the lowest dose tested of unadjuvanted vaccine (0.7 micrograms)
  • A(H7N9) VLP vaccine candidate demonstrated cross-reactive HAI against H7N3, with 3- to 4-fold higher HAI responses when used with adjuvant
  • A(H7N9) VLP vaccine elicited anti-neuraminidase (NA) antibodies against H7N9 , with 3- to 4-fold higher responses in corresponding adjuvanted subgroups
  • 100% survival of all animals receiving H7N9 and H7N3 VLP vaccine candidates against a lethal murine wild type A/Anhui/1/2013 (H7N9) challenge, versus 0% survival in the H5N1 vaccine candidate and placebo receiving groups.

"On May 10, 2013, only 28 days after the recent A/Anhui/1/13-like H7N9 strain was sequenced, the Novavax team announced it had immunized animals with VLPs produced by our platform technology. Just weeks after initiation of this experiment, the resulting animal data demonstrates complete protection of by our A(H7N9) and A(H7N3) VLP vaccine candidates in a lethal live H7N9 virus challenge. Additionally, the study showed complete cross-protection when the VLP vaccine was not a perfect match for the challenge virus. We believe the combined rapid manufacture, animal efficacy data and evidence of cross-protection substantiate the potential of the Novavax vaccine technology as applied to emerging pandemic strains. These animal data add to our confidence that the vaccine candidate will elicit protective immune responses in humans," said Dr. Gregory Glenn, Novavax' Chief Medical Officer. "The publication of this data in a high quality peer reviewed journal such as Vaccine reflects recognition of the quality and importance of this study."

"Alongside our positive clinical results with our H5N1 VLP vaccine candidate from last October, these recently gathered animal data against A(H7N9) influenza give further confirmation that the Novavax vaccine platform deserves to play a key role in emerging pandemic threats," added Stanley C. Erck, President and Chief Executive Officer. "We remain focused on expanding this campaign, as evidenced by the start of the first H7N9 vaccine clinical trial, which we announced on July 8."

The paper was authored by a team of experienced researchers and clinicians, including Novavax' Dr. Gale Smith, Vice President, Vaccine Development, Dr. Gregory Glenn, Senior Vice President and Chief Medical Office, and Dr. Louis Fries, Vice President, Clinical and Medical Affairs. The paper represents the first peer-reviewed publication of positive immunogenicity data for an A(H7N9) vaccine candidate. The paper is available at www.sciencedirect.com/science/article/pii/S0264410X13009870.

About VLPs and Novavax' Vaccine Program

VLPs are self-assembling protein structures that resemble the external structure of viruses, elicit broad and strong antibody and cellular immune responses but lack the live genetic material that causes viral replication and infection. VLPs contain three of the major structural virus proteins that are important for fighting influenza: hemagglutinin and neuraminidase, both of which stimulate the body to produce antibodies that neutralize the influenza virus and prevent its spread through the cells in the respiratory tract, and matrix 1, which stimulates cytotoxic T lymphocytes to kill cells that may already be infected. VLPs can be designed quickly to match individual viral strains and be produced efficiently using portable recombinant cell-culture technology. Novavax' VLP-based vaccine candidates are produced more rapidly than egg-based vaccines because of our cell-culture technology platform combined with single-use bioprocessing technology employed strategically throughout the manufacturing process.

About Novavax

Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage biopharmaceutical company creating vaccines to address a broad range of infectious diseases worldwide. Using innovative recombinant nanoparticle technology, as well as new and efficient manufacturing approaches, the company produces vaccine candidates to combat diseases, with the goal of allowing countries to better prepare for and more effectively respond to rapidly spreading infections. Novavax is committed to using its technology platform to create geographic-specific vaccine solutions and is therefore involved in several international partnerships, including collaborations with Cadila Pharmaceuticals of India, LG Life Sciences of Korea and PATH. Together, these organizations support Novavax' worldwide commercialization strategy and have the global reach to create real and lasting change in the biopharmaceutical field. Additional information about Novavax is available on the company's website, www.novavax.com.

Forward-Looking Statements

Statements herein relating to the future of Novavax and Novavax's vaccine 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, 2012, and 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 www.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.

Barclay A. Phillips
Senior Vice President, Chief Financial Officer
Novavax, Inc.
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