New England Journal of Medicine Publishes Novavax' NanoFlu Clinical Trial Data
13 Junho 2018 - 6:10PM
- NanoFluTM Phase
1/2 trial data published in a peer-reviewed letter to the editor
in The New England Journal of Medicine
- NanoFlu demonstrates
significantly improved immune responses against a panel of
homologous and drifted A(H3N2) influenza viruses compared to
leading licensed egg-based, high-dose flu vaccine in older
adults
- Phase 2 trial of quadrivalent
NanoFlu expected to begin in third quarter of 2018
GAITHERSBURG, Md., June 13, 2018
(GLOBE NEWSWIRE) -- 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(TM)
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(TM) and Matrix
M(TM)
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:
Investors
Novavax, Inc.
Erika Trahan
Senior Manager, Investor & Public Relations
ir@novavax.com
240-268-2000
Westwicke Partners
John Woolford
john.woolford@westwicke.com
443-213-0506
Media
Sam Brown
Mike Beyer
mikebeyer@sambrown.com
312-961-2502
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
Novavax (NASDAQ:NVAX)
Gráfico Histórico do Ativo
De Mar 2024 até Abr 2024
Novavax (NASDAQ:NVAX)
Gráfico Histórico do Ativo
De Abr 2023 até Abr 2024