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Novavax Highlights Positive Results From Partner's Clinical Trial of Vaccine Using Matrix-M(TM)

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  • Genocea Biosciences' Herpes Simplex Therapeutic Vaccine uses Matrix-M adjuvant
  • Phase 1/2A U.S.-based clinical trial enrolled 143 volunteers with moderate-to-severe HSV-2
  • Two highest dose Matrix-M adjuvanted cohorts demonstrated statistically significant reductions in viral shedding
  • Genocea's Phase 2 planned for 2014

ROCKVILLE, Md., Sept. 13, 2013 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX), a clinical-stage biopharmaceutical company creating novel recombinant nanoparticle vaccines and vaccine adjuvants, today reported that its partner, Genocea Biosciences Inc., announced positive, interim topline data from a Phase 1/2A clinical trial of its lead candidate, GEN-003, a first-in-class investigational protein subunit vaccine for patients with moderate-to-severe herpes simplex virus type 2 (HSV-2) infection. Genocea's herpes simplex virus-2 therapeutic vaccine candidate uses the Novavax proprietary adjuvant known as Matrix-M.

Genocea's results showed that vaccination with GEN-003 potentiated by the Matrix-M adjuvant can significantly blunt HSV-2 infection and reduce viral shedding. The two highest dose cohorts, both adjuvanted with Matrix-M, demonstrated significant reductions in viral shedding (51% and 30%, respectively, each p<0.001). No serious adverse events were related to the vaccine.

The partnership agreement with Genocea covers the use of Matrix-M in the development of vaccines against specific diseases including herpes simplex virus type 2.

"The strong showing of Genocea's vaccine candidate, which includes our proprietary adjuvant Matrix-M, underscores the potential of the adjuvant to Novavax, and the value of our recent acquisition of Isconova," said Stan Erck, President and Chief Executive Officer of Novavax.

"The early clinical response to GEN-003 in this trial is unprecedented in HSV-2. We are proud to be pioneers in the field of T cell-directed vaccines," noted Chip Clark, President and Chief Executive Officer of Genocea.

To read Genocea's published press release, follow the link:

http://www.genocea.com/news-events/press-releases/press_release_GEN003_ICAAC_091213.pdf

About Matrix-M™

Matrix-M is a patented vaccine adjuvant being developed and produced by Novavax . Adjuvants enhance the efficacy of a vaccine while maintaining safety; they increase the vaccine's ability to produce antibodies and induce a cellular response that is important for modern vaccines.

About HSV-2

Herpes simplex virus type 2 (HSV-2), the most common cause of genital herpes, is a sexually transmitted disease that is estimated to infect more than 500 million people worldwide, and one out of six people aged 14 to 49. In the U.S., an estimated 50-60 million people are affected. HSV-2 infection can cause recurring, painful genital sores and, due to the stigma associated with this disease, can impact patients' ability to form and maintain relationships, resulting in considerable psychological distress in patients. No vaccine is currently approved to prevent or treat the disease.

About Genocea Biosciences

Genocea Biosciences is harnessing the power of T cell immunity to develop the next generation of vaccines. T cells are increasingly recognized as a critical element of a protective immune response to a wide range of infectious disease pathogens, but are difficult to target using traditional vaccine discovery methods. Genocea is uniquely able to identify protective T cell antigens in humans exposed to a pathogen using ATLAS™, its proprietary technology platform that mimics the human immune response in the laboratory, potentially improving the effectiveness of vaccine candidates and drastically reducing the time needed to create them. Genocea's pipeline of novel T cell vaccines includes GEN-003 for HSV-2 therapy, GEN-004, a protein vaccine directed at pneumococcus that is expected to enter the clinic in the fourth quarter of 2013, and earlier-stage programs in chlamydia, HSV-2 prophylaxis and malaria.

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 protein nanoparticle vaccine technology, the company produces vaccine candidates to efficiently and effectively respond to both known and newly emergent diseases. Novavax is involved in several international partnerships, including collaborations with Cadila Pharmaceuticals of India, LG Life Sciences of Korea, and PATH. Together, Novavax' network supports its global commercialization strategy to create real and lasting change in the biopharmaceutical and vaccinology fields. Additional information about Novavax is available on the company's website, novavax.com.

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, 2012, and Form 10-Q for the period ended June 30, 2013, both 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 Phillips SVP, Chief Financial Officer and Treasurer Novavax, Inc. 240-268-2000

Source:Novavax, Inc.