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

Novavax, Inc. 

13.09.2013 15:11
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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_091
213.pdf 

About Matrix-M(tm)

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(tm), 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. 




         Barclay Phillips
         SVP, Chief Financial Officer and Treasurer
         Novavax, Inc.
         240-268-2000
News Source: NASDAQ OMX



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Language:     English
Company:      Novavax, Inc.
              
               
              United States
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