Novavax NanoFlu™ Vaccine Demonstrates Improved Immune Responses Compared to Egg-Based, High-Dose Flu Vaccine
February 28 2018 - 4:05PM
Novavax, Inc., (Nasdaq:NVAX) today announced positive top-line
results from its Phase 1/2 clinical trial in older adults of its
NanoFlu recombinant influenza vaccine, which includes its
proprietary Matrix-M™ adjuvant, compared to the leading licensed
egg-based, high-dose influenza vaccine for older adults (IIV3-HD).
Key findings from the trial include that Nanoflu vaccine
induced:
- Significantly higher hemagglutination inhibition (HAI) antibody
responses against homologous H1N1 and H3N2 strains and comparable
HAI responses against the homologous B/Brisbane strain,
- Significantly higher HAI immune responses against historic and
forward-drifted H3N2 strains, and
- Strong neutralizing antibody responses that correlate with HAI
results against H3N2 strains.
H3N2 has been a consistent public health challenge and is
associated with roughly 75% of this season’s flu-related
hospitalizations.1 Against three tested H3N2 strains, the ratio of
day 21 HAI geometric mean titers (GMTs) show significant responses
of NanoFlu vaccine over IIV3-HD:
- 47% higher NanoFlu response against homologous strain (A/Hong
Kong)
- 64% higher NanoFlu response against forward-drifted strain
(A/Singapore)
- 54% higher NanoFlu response against historic strain
(A/Switzerland)
Overall, NanoFlu vaccine was well tolerated over the three-week
trial period. Novavax now expects to begin a Phase 2 trial of its
NanoFlu vaccine in the third quarter of 2018. Novavax management
will discuss these trial results in greater detail on a conference
call following publication.
About the Phase 1/2 Clinical Trial
Novavax conducted a randomized, observer-blind,
comparator-controlled trial of NanoFlu vaccine (in two trivalent
formulations: 45µg or 180µg total HA) against IIV3-HD in healthy
adults aged 60 years or older. Vaccine immunogenicity was measured
by HAI and neutralization antibody responses against a panel of
vaccine-homologous, and historically and forward-drifted, influenza
virus strains.
About NanoFlu™ and Matrix M™
NanoFlu vaccine is a recombinant hemagglutinin (HA) protein
nanoparticle influenza vaccine candidate produced by Novavax in its
SF9 insect cell baculovirus system. NanoFlu vaccine uses HA amino
acid protein sequences that are substantially the same as wild-type
circulating virus HA sequences. NanoFlu vaccine contains Novavax’
patented saponin-based Matrix-M adjuvant, which has demonstrated a
potent and well-tolerated effect by stimulating the entry of
antigen-presenting cells into the injection site and enhancing
antigen presentation in local lymph nodes.
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.
References
1. Morbidity and Mortality Weekly Report (MMWR), February 16,
2018 / 67(6);169–179, Centers for Disease Control and Prevention.
[86.4% influenza hospitalizations were Type-A flu viruses and 86.1%
of these were A(H3N2) subtype.] 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 Quarterly Report on Form
10-Q for the period ended September 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:
InvestorsWestwicke PartnersJohn
Woolfordjohn.woolford@westwicke.com 443-213-0506
MediaSam BrownMike Beyermikebeyer@sambrown.com312-961-2502
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