Novavax Initiates Phase 1/2 Trial of NanoFlu™ Vaccine in Older Adults
19 September 2017 - 11:05PM
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™
adjuvant (NanoFlu™) 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™ 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.
References1. 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 RelationsNovavax, Inc.Andrea N. Flynn, Ph.D.Director,
Investor & Media
Relationsir@novavax.com240-268-2000
Westwicke PartnersJohn
Woolfordjohn.woolford@westwicke.com443-213-0506
MediaRusso Partners, LLCDavid SchullMaggie
Bellerdavid.schull@russopartnersllc.com
maggie.beller@russopartnersllc.com212-845-4271
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