Novavax Initiates Phase 1/2 Trial of NanoFlu(TM) Vaccine in Older Adults
September 19 2017 - 9:05AM
YASTEST
-
Recently published NanoFlu(TM)
preclinical data provide strong rationale for Phase 1/2 clinical
trial based on robust antibody titers and improved protective
responses against both current and drifted strains
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Data from trial expected by the
end of 2017
GAITHERSBURG, Md., Sept. 19, 2017 (GLOBE NEWSWIRE)
-- Novavax, Inc., (Nasdaq:NVAX) today announced the enrollment of
the first participant in a Phase 1/2 clinical trial of its
nanoparticle influenza vaccine candidate including its proprietary
Matrix-M(TM) adjuvant (NanoFlu(TM)) in older adults.
The trial is a randomized, observer-blinded,
active comparator-controlled trial in approximately 330 healthy
older adults. The primary objective of the trial is to assess the
safety and immunogenicity of two concentrations (15 µg or 60 µg) of
NanoFlu compared to a licensed influenza vaccine, Fluzone®
High-Dose (Fluzone HD).
"The trial is designed to identify an immune
response, characterized by hemagglutination-inhibiting (HAI) and
neutralizing antibodies, that is similar to or better than Fluzone
HD," said Gregory Glenn, M.D., President of Research and
Development. "We will evaluate immunogenicity using HAI titers,
which are the industry standard and an established surrogate marker
of protection. Data from this trial may provide the basis to
request accelerated approval for initial licensure of our NanoFlu
vaccine.
"Our recent preclinical data further indicate
NanoFlu elicits improved protective responses against drifted
strains, which could be a key differentiating factor of the
vaccine. Current influenza vaccine protection is typically limited
to strain-specific immune responses. Strain mismatch or antigenic
drift between seasonal vaccines and circulating influenza strains
can lead to reduced protection."
"The data described in our
recent Vaccine publication provided strong rationale for
advancing our NanoFlu program into the clinic," said Stanley C.
Erck, President and CEO. "Seasonal influenza remains a significant
threat to older adults, with nearly three million infections and
over 250,000 hospitalizations annually1. Our goal is
to deliver a differentiated flu vaccine to the greater than $3
billion global seasonal influenza commercial market2 and we
look forward to delivering clinical data from this trial by the end
of the year."
About Accelerated
Approval
Accelerated approval may be granted for certain
biological products that have been studied for their safety and
effectiveness in treating serious or life-threatening illnesses and
that provide meaningful therapeutic benefit over existing
treatments.
Such an approval will be based on adequate and
well-controlled clinical trials establishing that the biological
product has an effect on a surrogate endpoint that is reasonably
likely, based on epidemiologic, therapeutic, pathophysiologic, or
other evidence, to predict clinical benefit. More information on
accelerated approval can be found
here: https://www.fda.gov/biologicsbloodvaccines/guidancecomplianceregulatoryinformation/guidances/vaccines/ucm074794.htm
About Novavax
Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage
biotechnology company committed to delivering novel products to
prevent a broad range of infectious diseases. Our recombinant
nanoparticles and Matrix-M(TM) adjuvant technology are the
foundation for groundbreaking innovation that improves global
health through safe and effective vaccines. Additional information
about Novavax is available on the Company's
website, novavax.com.
References
1. Average of 3 past seasons, 2010-2013; includes vaccine averted
cases. C. Reed et al. Estimating Influenza Disease Burden from
Population-Based Surveillance Data in the United States. PLOS One.
2015, DOI:10.1371/journal.pone.0118369
2. PharmaPoint Seasonal Influenza Vaccines Global
Drug Forecast and Market Analysis to 2025, October 2016
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, 2016 and the Report on Form 10-Q
for the period ended June 30, 2017, both 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.
Contact:
Investor Relations
Novavax, Inc.
Andrea N. Flynn, Ph.D.
Director, Investor & Media Relations
ir@novavax.com
240-268-2000
Westwicke Partners
John Woolford
john.woolford@westwicke.com
443-213-0506
Media
Russo Partners, LLC
David Schull
Maggie Beller
david.schull@russopartnersllc.com
maggie.beller@russopartnersllc.com
212-845-4271
This
announcement is distributed by Nasdaq Corporate Solutions on behalf
of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: Novavax, Inc. via Globenewswire
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