New experimental vaccine produces immune response against MERS virus

University of Maryland School of Medicine study published in Vaccine highlights first potential effective means for preventing MERS coronavirus outbreak

2014-04-30

(Press-News.org) The University of Maryland School of Medicine (UM SOM) and Novavax, Inc. (NASDAQ: NVAX) today announced that an investigational vaccine candidate developed by Novavax against the recently emerged Middle East Respiratory Syndrome Coronavirus (MERS-CoV) blocked infection in laboratory studies. UM SOM and Novavax also reported that a vaccine candidate against Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV) developed by Novavax on a similar platform also inhibited virus infection. Researchers reported these findings in an article published in the April 13, 2014 issue of Vaccine1. Historically, vaccine strategies for emerging pathogens have been limited due to the sudden nature in which the virus first appears and delayed by the protracted traditional vaccine development process. This peer-reviewed manuscript describes a novel method to rapidly develop vaccines against previously unknown viruses, such as MERS-CoV, which appear suddenly and cause severe illnesses in humans. The experimental vaccines, which were tested in conjunction with Novavax' proprietary adjuvant Matrix-M™, induced neutralizing antibodies, or immune responses, that prevent viruses from infecting cells. "Our protein nanoparticle vaccine technology is proving to have the potential to respond rapidly to emerging viruses such as MERS-CoV and certain potential pandemic influenza strains, addressing what are clearly urgent public health needs," said Gale Smith, Ph.D., Vice President of Vaccine Development at Novavax. "Novavax will continue to evaluate this technology to produce highly immunogenic nanoparticles for coronavirus, influenza, and other human disease pathogens with the potential for pandemic and sustained human to human transmission." "The emergence of SARS-CoV and MERS-CoV demonstrates how coronaviruses can spillover from animals into humans at any time, causing lethal disease," said Matthew B. Frieman, Ph.D., Assistant Professor of Microbiology and Immunology at the University of Maryland School of Medicine and corresponding author on the publication. "Despite efforts to create a vaccine against SARS-CoV, no vaccine candidate has, to date, been successfully licensed for use. We have demonstrated that this novel method rapidly creates SARS-CoV and MERS-CoV vaccines that induce neutralizing antibodies in mice."

"The University of Maryland School of Medicine investigators are continually working toward a better understanding of the interactions between the human immune system and a variety of known and novel harmful microbes," said E. Albert Reece, Vice President of Medical Affairs, the University of Maryland and the John Z. and Akiko Bowers Distinguished Professor and Dean, University of Maryland School of Medicine. "This makes our faculty poised to respond to emerging infectious diseases, such as MERS-CoV, which threaten the health and wellbeing of the global population." The vaccine candidates were made using Novavax' recombinant nanoparticle vaccine technology and based on the major surface spike (S) protein, a SARS-CoV and MERS-CoV surface protein responsible for attaching the virus to cells. Novavax previously demonstrated that spike protein nanoparticles could protect animals against lethal live challenge using the SARS-CoV virus2. INFORMATION: About MERS-CoV MERS-CoV, first identified in 2012, is one of a family of viruses with the potential to rapidly spread from a benign infection of animals to cause severe disease in humans. In 2003, a previously unknown coronavirus called SARS-CoV caused an outbreak that raised health alarms by infecting over 8,000 individuals and killing 775. According to the World Health Organization, the novel MERS-CoV thus far has resulted in 107 deaths out of 345 infections, the majority of which are characterized by severe illness and hospitalizations. Both diseases were marked by a jump from animals to people and while SARS-CoV spread more quickly in humans, MERS-CoV is proving to be more deadly. About University of Maryland School of Medicine Established in 1807, the University of Maryland School of Medicine was the first public medical school in the United States, and the first to institute a residency-training program. The School of Medicine was the founding school of the University of Maryland and today is an integral part of the 11-campus University System of Maryland. On the University of Maryland's Baltimore campus, the School of Medicine serves as the anchor for a large academic health center which aims to provide the best medical education, conduct the most innovative biomedical research and provide the best patient care and community service to Maryland and beyond. http://www.medschool.umaryland.edu. 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, PATH and recently acquired Isconova AB, a leading vaccine adjuvant company located in Sweden. 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.

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, The International Society for Vaccines and The Japanese Society for Vaccinology. http://www.elsevier.com/locate/vaccine References: 1. C. M. Coleman et al. Purified coronavirus Spike protein nanoparticles induce coronavirus neutralizing antibodies in mice. Vaccine. In press, April 13, 2014. 2. Y. Liu et al. Chimeric severe acute respiratory syndrome coronavirus (SARS-CoV) S glycoprotein and influenza matrix 1 efficiently form virus-like particles (VLPs) that protect mice against challenge with SARS-CoV, 2011; 29(38): 6606-6613. Copies of the paper are available to credentialed journalists upon request; please contact Elsevier's Newsroom at newsroom@elsevier.com or +31-20-4853564.

Novavax Inc., 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.

Media Contacts:

Christopher Hardwick
(chardwick@som.umaryland.edu)
University of Maryland School of Medicine
410-706-5260

Barclay A. Phillips
SVP, Chief Financial Officer and Treasurer
Novavax, Inc.
240-268-2000
David Schull or Andrea Flynn, Ph.D.
david.schull@russopartnersllc.com
andrea.flynn@russopartnersllc.com
Russo Partners
212-845-4271

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