New England Journal of Medicine Publishes Novavax’ NanoFlu Clinical Trial Data
June 13 2018 - 5:05PM
Novavax, Inc. (Nasdaq:NVAX) today announced that The New England
Journal of Medicine (NEJM) published a peer-reviewed letter to the
editor detailing the positive results from Novavax’ Phase 1/2
clinical trial in older adults comparing its Matrix- M™
adjuvanted nanoparticle seasonal influenza vaccine candidate
(NanoFlu) to the leading licensed egg-based, high-dose influenza
vaccine (IIV3-HD). The letter is available online at
www.nejm.org/doi/full/10.1056/NEJMc1803554.
“We are pleased to be able to share the detailed
data from the NanoFlu Phase 1/2 clinical trial with the broader
scientific community,” said Stanley C. Erck, President and Chief
Executive Officer of Novavax, Inc. “The low effectiveness of
seasonal influenza vaccines, and in particular the A(H3N2)
component of the vaccine, during the 2017-2018 season emphasizes
the need for a more effective vaccine. Our non-egg-based,
recombinant nanoparticle vaccine, when coupled with Matrix-M,
potentially offers broader protection against rapidly evolving
drift strain variants. We believe this addresses important public
health challenges caused by influenza and offers a significant
advantage over current influenza vaccines.”
In February 2018, Novavax reported the positive
top-line results from the NanoFlu Phase 1/2 clinical trial in older
adults. Details of the data, as published in this letter, include
that NanoFlu in comparison to IIV3-HD induced:
- Hemagglutination inhibition (HAI) immune responses that were 28
to 64% greater against the homologous and four generations of
drifted wild-type A(H3N2) influenza strains; and
- Higher HAI responses against the homologous A(H1N1) strain and
comparable responses against the homologous B/Brisbane strain.
“These results showcase the potential benefit
NanoFlu could have for older adults, a population challenged by
poor immune responses. This population faces an urgent unmet
medical need for a more effective flu vaccine, as highlighted by
the severe flu season of 2017-2018,” said Dr. Vivek Shinde,
Executive Director, Clinical Development at Novavax and lead author
of the letter. “We look forward to advancing this vaccine into the
planned Phase 2 clinical trial of quadrivalent NanoFlu in the third
quarter of 2018.”
About the Phase 1/2 Clinical Trial
Novavax, Inc. conducted a randomized,
observer-blind, comparator-controlled trial of NanoFlu (in two
trivalent formulations: 45µg or 180µg total HA) against IIV3-HD in
330 healthy adults aged 60 years or older. 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 is a recombinant hemagglutinin (HA)
protein nanoparticle influenza vaccine candidate produced by
Novavax in its SF9 insect cell baculovirus system. NanoFlu uses HA
amino acid protein sequences that are substantially the same as
wild-type circulating virus HA sequences. NanoFlu 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. is a clinical-stage biotechnology
company committed to delivering novel products to prevent
infectious diseases. Its RSV and NanoFlu vaccine candidates are
Novavax’ most advanced clinical programs and are at the forefront
of its efforts to improve global health. For more information,
please visit www.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, 2017 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:
InvestorsNovavax, Inc.Erika TrahanSenior Manager, Investor &
Public Relationsir@novavax.com240-268-2000
Westwicke PartnersJohn
Woolfordjohn.woolford@westwicke.com443-213-0506
MediaSam BrownMike Beyermikebeyer@sambrown.com312-961-2502
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