Novavax Announces Positive Phase 2 NanoFlu Results in Older Adults
January 03 2019 - 4:05PM
Novavax Announces Positive Phase 2 NanoFlu Results in Older
Adults
Novavax, Inc. (NASDAQ: NVAX) today announced top-line results of
its Phase 2 clinical trial of NanoFlu™. The trial compared the
safety and immune responses of various quadrivalent formulations of
NanoFlu, with or without Novavax’ Matrix-M™ adjuvant, with two
U.S.-licensed influenza vaccines in 1,375 healthy adults 65 years
of age and older.
Key findings of the Phase 2 clinical trial:
- All formulations of NanoFlu were well-tolerated and elicited
vigorous immune responses to the four strains included in the
vaccine.
- Matrix-M adjuvant resulted in significant enhancement of immune
responses when compared to the unadjuvanted formulation.
- NanoFlu is a differentiated flu vaccine, as evidenced by
significantly superior hemagglutination inhibition (HAI) antibody
responses against wild-type A(H3N2) viruses, including drifted
strains, when compared to Fluzone High-Dose, the leading flu
vaccine in older adults.
- 45% increase against vaccine-homologous virus, A/Singapore
(p<0.001)
- 22% increase against a historic drifted virus, A/Switzerland
(p=0.014)
- 42% increase against a forward drifted virus, A/Wisconsin
(p<0.001)
- NanoFlu formulation identified for the Phase 3 clinical trial
and commercialization.
“The superior immunogenicity against wild-type
H3N2 viruses holds promise that NanoFlu will more effectively
address the mismatch between circulating viruses and the strains
included in most commercial vaccines due to genetic drift and
vaccine virus egg adaptation,” said Gregory Glenn, M.D., President
of Research and Development of Novavax. “Older adults experienced
the brunt of the serious health consequences of this mismatch, with
H3N2 driving the majority of influenza hospitalizations and death
during 2017-2018, the worst flu season in four decades. Over the
past several years, influenza vaccine effectiveness has been
suboptimal in this population, and there is broad agreement that
better vaccines are needed. These confirmatory data from the second
clinical trial of NanoFlu further justify continued rapid
development of an improved vaccine.”
As Novavax previously announced, the U.S. Food
and Drug Administration (FDA) acknowledged that the accelerated
approval pathway may be available for NanoFlu, which could allow
for licensure of NanoFlu in a shorter
timeframe. Novavax will again meet with the FDA in the
first half of 2019 to discuss the Phase 2 clinical trial data, the
proposed Phase 3 trial design, and the use of accelerated approval
for licensure.
“The Phase 2 clinical trial results with NanoFlu
demonstrate the potential impact our vaccine can make in preventing
serious disease caused by influenza in older adults, a high-risk
population that has proven difficult to protect in recent years,”
said Stanley C. Erck, President and Chief Executive Officer of
Novavax. “Our goal remains to advance to the market an improved
vaccine that addresses the serious global public health threat that
exists for older adults, and ultimately to make NanoFlu available
to all populations.”
About Influenza
Influenza is a world-wide infectious disease
that causes illness in humans, with symptoms ranging from mild to
life-threatening, or even death. Serious illness occurs not only in
susceptible populations such as infants, young children and older
adults, but also in the general population largely because of
infection by continuously evolving strains of influenza which can
evade the existing protective antibodies in humans. An estimated
one million deaths globally each year are attributed to
influenza.1 Current estimates for seasonal influenza vaccine
growth in the top seven markets (U.S., Japan, France,
Germany, Italy, Spain and UK), show a potential
increase from approximately $3.2 billion in 2015 to $5.3
billion by 2021.2
About NanoFlu™ and
Matrix-M™
NanoFlu is a recombinant hemagglutinin (HA)
protein nanoparticle influenza vaccine produced
by Novavax in its Sf9 insect cell baculovirus system.
NanoFlu uses HA protein amino acid sequences that are the same as
the recommended wild-type virus HA sequences. NanoFlu contains
Novavax’ patented saponin-based Matrix-M adjuvant, which is potent,
well-tolerated and stimulates both high quality and durable
antibody responses as well as multifunctional CD4 and CD8 T-cell
responses.
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 to predict clinical benefit. For seasonal influenza
vaccines, the HAI antibody response may be an acceptable surrogate
marker of activity that is reasonably likely to predict clinical
benefit. To be considered for accelerated approval, a biologics
license application for a new seasonal influenza vaccine should
include results from one or more well-controlled studies designed
to meet immunogenicity endpoints and a commitment to conduct
confirmatory post-marketing studies of clinical effectiveness in
preventing influenza.
About Novavax
Novavax, Inc. (Nasdaq:NVAX) is a late-stage
biotechnology company that drives improved health globally through
the discovery, development, and commercialization of innovative
vaccines to prevent serious infectious diseases. ResVax™, its RSV
vaccine for infants via maternal immunization, is the only vaccine
in a Phase 3 clinical program and is designed to prevent severe
lower respiratory tract infection which is the second leading cause
of death in children under one year of age
worldwide. Novavax is also advancing NanoFlu™, its
quadrivalent influenza nanoparticle vaccine, to address key factors
that can lead to the poor effectiveness of currently approved flu
vaccines. Novavax is a leading innovator of recombinant
vaccines; its proprietary recombinant technology platform combines
the power and speed of genetic engineering to efficiently produce a
new class of highly immunogenic nanoparticles addressing urgent
global health needs.
For more information, visit www.novavax.com and
connect with us on Twitter and LinkedIn.
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, 2017 and the Quarterly Report on
Form 10-Q for the period ended September 30, 2018 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.
Contacts:
InvestorsNovavax, Inc.Erika TrahanSenior Manager, Investor &
Public Relationsir@novavax.com240-268-2000
Westwicke PartnersJohn
Woolfordjohn.woolford@westwicke.com 443-213-0506
MediaSam BrownAndrea
Cohenandreacohen@sambrown.com917-209-7163
1 Resolution of the World Health Assembly (2003)
WHA56.19.28
2 Influenza Vaccines Forecasts. Datamonitor (2013)
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