Novavax Study Published in Vaccine: RSV F-Protein Nanoparticle Vaccine Induces Antigenic Site II Antibodies
(Thomson Reuters ONE) -
* Vaccinated Animals Generated a Broad Spectrum of Protective Antibodies
* Vaccine Induces Antibodies that are at Least as Protective as Palivizumab
* Palivizumab Competing Antibody Response from Vaccine Protects Against Both
Homologous and Heterologous Disease Strains
GAITHERSBURG, Md., Oct. 15, 2014 (GLOBE NEWSWIRE) -- Novavax, Inc.
(Nasdaq:NVAX), a clinical-stage biopharmaceutical company focused on the
discovery, development and commercialization of recombinant nanoparticle
vaccines and adjuvants, today announced that its RSV F-protein nanoparticle
vaccine candidate (RSV F Vaccine) evoked a polyclonal antibody response to
antigenic site II, the same site targeted by the monoclonal antibody palivizumab
(Synagis(®)), resulting in protection from an RSV challenge in an animal model.
Researchers at Novavax reported these findings in an online paper published by
Vaccine titled: "An insect cell derived respiratory syncytial virus (RSV) F
nanoparticle vaccine induces antigenic site II antibodies and protects against
RSV challenge in cotton rats by active and passive immunization."
"This study further characterizes the immune response to our RSV F Vaccine,
including the production of both polyclonal palivizumab competing antibodies
that target antigenic site II, as well as other neutralizing antigenic sites on
the F-protein," said Greg Glenn, SVP, Research and Development at Novavax. "In
addition, our ability to assess the safety of our RSV F Vaccine relative to Lot
100 formalin inactivated vaccine, which is known to cause disease enhancement,
and to demonstrate that our vaccine's efficacy is equivalent or better than
palivizumab, gives us greater confidence that our RSV vaccine candidate will be
both safe and effective."
RSV is the number one cause of hospitalization in infants ages 0 to 12 months in
the U.S. and is a significant cause of infant morbidity and mortality globally.
The only approved product in the U.S. for the prevention of RSV disease in this
population is palivizumab, marketed as Synagis(®) by MedImmune/AstraZeneca.
Palivizumab binds to a specific domain on the RSV F-protein known as antigenic
site II, blocking viral fusion and preventing infection. Novavax has developed a
novel RSV vaccine candidate based on the expression of a mature form of the RSV
F-protein, which exposes the antigenic site II for processing by the immune
system. The resulting immune response produces polyclonal antibodies that have
been shown to compete with palivizumab for the antigenic site II binding domain,
referred to as palivizumab-competing antibodies or PCA.
The study employed a number of antibody assays to further explore the
immunogenicity of the RSV F Vaccine and the production of vaccine-induced PCA in
the cotton rat model. These studies used palivizumab as a control, to assess
relative potency of the vaccine, both in active and passive assessments, and the
recently available Lot 100 formalin-inactivated RSV vaccine, which historically
enhanced RSV disease in clinical studies. This allowed comparative evaluation of
safety, 'functional' immunity as measured by PCA and neutralization assays, and
protection in this clinically relevant model. The vaccine was shown to be safe,
potent, to elicit high levels of neutralizing PCA and anti-F antibodies and to
be protective against both homologous strain and heterologous, or "drift",
strain viral challenges. The protection seen with active immunization could be
reproduced using passively injected immune sera and appeared as potent as, or
more potent than palivizumab. Neither active immunization of vaccine nor
passively injected immune sera were associated with disease enhancement.
Finally, the RSV F Vaccine was also found to elicit antibodies that are known to
bind other non-palivizumab F-protein binding sites associated with
neutralization.
About RSV
RSV is a major respiratory pathogen in infants, children, and adults. RSV
infections in adults represent re-infections and are generally mild to moderate
in severity, except in persons with high-risk conditions including the elderly
and adults with underlying chronic cardiac or pulmonary disease. It is estimated
that between 11,000 and 17,000 adults die of RSV infection annually in the U.S.
and up to 180,000 are admitted to hospitals with respiratory symptoms.
Currently, there is no approved RSV prophylactic vaccine available. Palivizumab
is a monoclonal antibody, licensed and sold by MedImmune as Synagis(®), that
targets the RSV F protein and is used for prophylaxis against RSV disease in
high risk infants.
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
nanoparticle vaccine technology, the company produces vaccine candidates to
efficiently and effectively respond to both known and newly emergent diseases.
Additional information about Novavax is available on the company's website,
novavax.com.
Novavax 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.
CONTACT: Barclay A. Phillips
SVP, Chief Financial Officer and Treasurer
Novavax, Inc.
240-268-2000
This announcement is distributed by GlobeNewswire on behalf of
GlobeNewswire clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Novavax, Inc. via GlobeNewswire
[HUG#1862984]
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Datum: 15.10.2014 - 14:33 Uhr
Sprache: Deutsch
News-ID 344248
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