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NOVAVAX and the University of Massachusetts Medical School Announce Preclinical Study Results for a Respiratory Syncytial Virus ('RSV') Vaccine Candidate

Posted on: Tuesday, 9 December 2008, 11:00 CST

ROCKVILLE, Md., Dec. 9 /PRNewswire-FirstCall/ -- Novavax, Inc. (Nasdaq: NVAX) and the University of Massachusetts Medical School announced results from a preclinical study of a Respiratory Syncytial Virus ("RSV") vaccine candidate. Novavax has licensed exclusive worldwide rights from the University of Massachusetts Medical School to certain technology for the development and commercialization of Paramyxovirus vaccines incorporating certain Virus-Like-Particles ("VLPs"). This vaccine candidate is Novavax's first recombinant VLP for the prevention of RSV disease.

The preclinical study evaluated the immunogenicity and efficacy of the RSV VLP vaccine candidate in mice. The VLP contains the matrix (i.e., "core") protein of Newcastle Disease Virus decorated with a human RSV attachment glycoprotein (Ga), which is important for inducing immunity against RSV. In this study, mice were immunized with one of four doses of the RSV VLP vaccine candidate, inactivated RSV, live RSV, or a placebo. The antibody responses to the RSV VLPs were robust and higher than the antibody responses to inactivated or live RSV. Further, antibody titers increased with higher VLP doses.

Subsets of mice that had been immunized with either RSV VLPs via intraperitoneal inoculation or live RSV via intranasal inoculation received a vaccine booster dose and were challenged with live RSV intra-nasally. Unimmunized mice were evaluated as controls. The VLP-immunized mice were protected from RSV replication in the lungs. Further, the lung tissue of these mice showed no evidence of enhanced inflammation after RSV challenge/infection, which has been reported with a formalin-inactivated RSV vaccine.

In summary, the candidate VLP vaccine induced strong antibody responses against RSV, protected mice against RSV replication in the lungs, and did not lead to enhanced inflammation of the airways. These data support continued development of this and additional RSV VLP vaccine candidates containing other proteins (i.e., Gb and F) important for immunity.

"I am pleased we have been able to demonstrate that virus-like particles, based on Newcastle disease virus proteins, can be used as a platform for the development of human vaccines," said Trudy G. Morrison, PhD, professor of molecular genetics & microbiology, who presented the results of the study, supported by Novavax, at the 2nd Vaccine Congress in Boston today.

"Consistent with the strategy to expand our vaccine pipeline, this new program has the potential to address a significant unmet medical need in both infants and elderly patients over 65 years of age," said Dr. Rahul Singhvi, Novavax's President and CEO. "The initial preclinical results from this first RSV vaccine candidate in partnership with the University of Massachusetts Medical School further demonstrate the potential of our proprietary vaccine and manufacturing technologies and represent an important opportunity to enhance shareholder value."

About Respiratory Syncytial Virus

RSV is the most commonly identified cause of lower respiratory tract infection in infants and young children with repeated infections causing moderate to severe cold-like symptoms throughout life. High risk individuals (including the elderly over age 65 years, people with cardiovascular disease and children less than four years of age) may also develop lower respiratory tract infections leading to bronchiolitis and pneumonia. It is estimated that more than 8.5 million adults, including the elderly over age 65 years, are infected and 900,000 patients are hospitalized annually due to RSV infection in the US and major European countries. In the United States alone there are 177,500 hospitalizations in high risk adults including the elderly over age 65, resulting in annual medical costs exceeding $1 billion. In addition, there are up to 125,000 infants in the US who are hospitalized annually due to RSV. There is currently no approved vaccine for the prevention of RSV; the market potential for such a vaccine would be well in excess of $1 billion annually.

About UMass Medical School

The University of Massachusetts Medical School is one of the fastest growing academic health centers in the country and has built a reputation as a world-class research institution, consistently producing noteworthy advances in clinical and basic research. The Medical School attracts more than $193 million in extramural research funding annually. Research dollars enable UMMS scientists to explore human disease from the molecular level to large-scale clinical trials. Basic and clinical research has led to new approaches for diagnosis, treatment and prevention of disease. Visit http://www.umassmed.edu for additional information.

About Novavax

Novavax, Inc. is a clinical stage biotechnology company, creating novel vaccines to address a broad range of infectious diseases worldwide using advanced proprietary virus-like particle (VLP) technology. The Company produces these VLP based, potent, recombinant vaccines utilizing new, and efficient manufacturing approaches. Additional information about Novavax is available at http://www.novavax.com and in the Company's various filings with the Securities and Exchange Commission.

Forward Looking Statement

Statements herein relating to future development results and performance, conditions or strategies and other matters, including expectations regarding product and clinical developments are forward-looking statements within the meaning of the Private Securities Litigation Reform Act. Novavax cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including risks relating to the early stage of Novavax's product candidates under development; current results may not be predictive of future pandemic results, results of our seasonal influenza vaccine or any other vaccine that we may develop; further testing is required before FDA can be applied for and the FDA may not approve the pandemic vaccine even if further trial results are similar to those disclosed herein; uncertainties relating to clinical trials; dependence on the efforts of third parties; competition for clinical resources and patient enrollment from drug candidates in development by other companies with greater resources and visibility; and risks that we may lack the financial resources and access to capital to fund our operations including further clinical trials. Further information on the factors and risks that could affect Novavax's business, financial conditions and results of operations, is contained in Novavax's filings with the U.S. Securities and Exchange Commission, which are available at http://www.sec.gov. These forward-looking statements speak only as of the date of this press release, and Novavax assumes no duty to update forward-looking statements.

SOURCE Novavax, Inc.

Source: PR Newswire

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