- Seasonal influenza nanoparticle
approach replaces VLP program
- HHS BARDA contract will complete its
term as scheduled in September 2016
- Nanoparticle design builds on
advances achieved with RSV F Vaccine
- Animal immunogenicity and efficacy
data demonstrate broadly neutralizing antibodies
- Data presented at Keystone
Symposia
GAITHERSBURG, Md., June 02, 2016
(GLOBE NEWSWIRE) -- Novavax, Inc., (Nasdaq:NVAX) a clinical-stage
vaccine company focused on the discovery, development and
commercialization of recombinant nanoparticle vaccines and
adjuvants, today announced Dr. Louis F. Fries, III, Senior Vice
President and Chief Medical Officer, presented data on Novavax'
nanoparticle program at the New Approaches to Vaccines for Human
and Veterinary Tropical Diseases Keystone Symposia in Cape Town,
South Africa.
Data included in the presentation
demonstrate Novavax' progress in developing seasonal influenza
nanoparticles that are protective in a ferret influenza challenge
model when combined with our proprietary adjuvant, Matrix-M(TM).
The vaccine candidate is based on a hemagglutinin
nanoparticle and elicited broadly neutralizing antibodies to all
three types of influenza viruses: A(H3N2), A(H1N1), and B, with
specificity to both contemporary and historical influenza
strains.
The presentation can be accessed
at: http://www.novavax.com/download/files/presentations/Novavax_Nanoparticle%20Vaccines%20for%20Keystone.pdf
Nanoparticle Design Builds on Advances Achieved with RSV F
Vaccine
"Our seasonal influenza nanoparticle
approach builds on the advances achieved with our RSV nanoparticle.
Our breakthrough in RSV vaccine development leverages conserved
sites within the F protein to provide protection from contemporary
and historical strains of RSV. We have replicated that approach in
developing our seasonal influenza nanoparticle. Novavax pioneered
the use of palivizumab-competing antibodies as a metric for an
effective immune response to RSV and we have developed a similar,
influenza-specific, broadly neutralizing monoclonal antibody
competition assay to test responses to our new influenza vaccine,"
said Gregory Glenn M.D., President of Research and Development.
"Our seasonal influenza nanoparticle antigens elicit antibodies
that neutralize the influenza virus at nanomolar concentrations and
interact with epitopes that lead to traditional
hemagglutination-inhibition, as well as other protective epitopes.
The capacity of these antibodies to neutralize across drifted
influenza A and B strains and the two B strain lineages suggest our
seasonal influenza nanoparticles may offer improved protection and
address the frequent mismatch of vaccine versus circulating
strains.
We also demonstrated that we can
combine the RSV F and influenza nanoparticle vaccines, bringing
together a vaccine approach that induces broadly neutralizing
antibodies against both influenza and RSV. A vaccine with
these attributes covering both influenza and RSV, which together
are the major cause of serious respiratory infections in older
adults and pediatrics, would be a major advance for public
health. Matrix-M adjuvant, which enhances the
broadly-neutralizing preclinical antibody response, will be used
together with the nanoparticle vaccines in a Phase 1/2 clinical
trial early next year."
Advantages of Nanoparticle Influenza Vaccine versus
VLP
Using lessons learned from the
development of our RSV and Ebola nanoparticle vaccines we have
identified several advantages, representing an evolution in
vaccinology that have guided our strategic approach:
- Influenza nanoparticles are
engineered to display conserved antigenic regions, which elicit
broadly neutralizing antibodies;
- Improved manufacturing yields;
and
- Use of Matrix M adjuvant, shown to
be well-tolerated and highly effective at stimulating enhanced
immunity.
HHS BARDA Contract Will Complete its Term as Scheduled in
September 2016
Since 2011, Novavax has been
developing influenza vaccines as part of a project that has been
funded under our contract with the U.S. Department of Health and
Human Services, Biomedical Advanced Research and Development
Authority (HHS BARDA). The scope of the HHS BARDA contract
(HHSO100201100012C) has been to develop seasonal and pandemic
influenza vaccine candidates, based on our proprietary virus-like
particle (VLP) technology. The advances in our seasonal
influenza nanoparticle program have resulted in a natural
conclusion of our activities under the HHS BARDA contract, which
will continue through the completion of its term in September
2016.
"Although our efforts have progressed
beyond the scope of our current HHS BARDA contract and VLP
vaccines, we are very excited to develop a differentiated seasonal
influenza approach that builds on the proven success of our RSV F
Vaccine," said Stanley C. Erck, President and CEO. "We also see
enormous value in a combination respiratory vaccine that combines
our seasonal influenza nanoparticle vaccine with our RSV F Vaccine.
The next step in our program will be to conduct a multi-arm Phase
1/2 clinical trial of our seasonal influenza nanoparticles alone
and in combination with our RSV F Vaccine, with and without our
potent Matrix-M adjuvant. We expect to initiate this trial in early
2017."
About Novavax
Novavax, Inc. (Nasdaq:NVAX) is a
clinical-stage vaccine company committed to delivering novel
products to prevent a broad range of infectious diseases. Its
recombinant nanoparticles and Matrix-M(TM) adjuvant technology are
the foundation for ground-breaking innovation that improves global
health through safe and effective vaccines. 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, 2015 as 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.