Results from Novavax NanoFlu Influenza Vaccine Phase 3 Clinical Trial Published in The Lancet Infectious Diseases
PR91892
GAITHERSBURG, Md., Sept. 24, 2021 /PRNewswire=KYODO JBN/ --
- Pivotal Phase 3 trial achieved all primary endpoints, demonstrating
non-inferiority to a leading U.S.-licensed quadrivalent influenza vaccine
- NanoFlu(TM) vaccine candidate induced significantly enhanced cell-mediated
immune responses
- NanoFlu was well-tolerated with a comparable safety profile
Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing
and commercializing next-generation vaccines for serious infectious diseases,
today announced publication of complete results from a pivotal Phase 3 clinical
trial of NanoFlu(TM), its recombinant quadrivalent seasonal influenza vaccine
candidate with Matrix-M(TM) adjuvant, in The Lancet Infectious Diseases (Lancet
ID).
The trial evaluated the immunogenicity and safety of NanoFlu in older adults
compared to a leading U.S.-licensed quadrivalent influenza vaccine. In the
complete analysis, NanoFlu was well-tolerated and produced significantly
enhanced humoral and cellular immune responses versus the comparator vaccine.
"Despite high vaccination rates, limitations in the effectiveness of existing
influenza vaccines leave significant disease burden unaddressed, particularly
in older adults," said Stanley C. Erck, President and Chief Executive Officer,
Novavax. "These encouraging results reflect NanoFlu's promise, especially as we
currently have a combination COVID-19-influenza vaccine under evaluation (
) for protection against two life-threatening diseases simultaneously."
Novavax previously announced that NanoFlu achieved (
) the trial's primary endpoints, demonstrating non-inferior immunogenicity to
Fluzone(R) Quadrivalent against all four influenza virus strains included in
the vaccine, while also showing both enhanced wild-type
hemagglutination-inhibiting antibody responses against homologous strains
(22-66% increased) and six heterologous A/H3N2 strains (34-46% increased) as
compared to Fluzone Quadrivalent.
Additionally, NanoFlu showed potent induction of polyfunctional
antigen-specific CD4+ T-cells against A/H3N2 and B/Victoria strains, with a
126–189% increase in various post-vaccination cell-mediated immunity markers as
compared to Fluzone Quadrivalent.
The paper, 'Comparison of the safety and immunogenicity of a novel
Matrix-M-adjuvanted nanoparticle influenza vaccine with a quadrivalent seasonal
influenza vaccine in older adults: a phase 3 randomised controlled trial,' may
be accessed here (
https://c212.net/c/link/?t=0&l=en&o=3301698-1&h=73356929&u=https%3A%2F%2Fwww.thelancet.com%2Fjournals%2Flaninf%2Farticle%2FPIIS1473-3099(21)00192-4%2Ffulltext&a=here
). The manuscript was previously posted to the medRxiv (
) preprint server in August 2020.
About NanoFlu(TM)
NanoFlu(TM) is a quadrivalent recombinant hemagglutinin (HA) protein
nanoparticle influenza vaccine produced in Novavax' SF9 insect cell baculovirus
system. NanoFlu uses HA amino acid protein sequences that are the same as the
recommended wild-type circulating virus HA sequences and contains Novavax'
patented saponin-based Matrix-M(TM) adjuvant.
About Matrix-M(TM) Adjuvant
Novavax' patented saponin-based Matrix-M(TM) adjuvant 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, boosting immune response.
About Novavax
Novavax, Inc. (Nasdaq: NVAX) is a biotechnology company that promotes improved
health globally through the discovery, development and commercialization of
innovative vaccines to prevent serious infectious diseases. The company's
proprietary recombinant technology platform combines the power and speed of
genetic engineering to efficiently produce highly immunogenic nanoparticles
designed to address urgent global health needs. Novavax is conducting
late-stage clinical trials for NVX-CoV2373, its vaccine candidate against
SARS-CoV-2, the virus that causes COVID-19. NanoFlu(TM), its quadrivalent
influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase
3 clinical trial in older adults. Both vaccine candidates incorporate Novavax'
proprietary saponin-based Matrix-M(TM) adjuvant to enhance the immune response
and stimulate high levels of neutralizing antibodies.
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, its operating plans and
prospects, the ongoing development of NanoFlu(TM) and its partnerships, and
other Novavax vaccine product candidates, the efficacy, safety and intended
utilization of our product candidates, the timing of results from clinical
trials, and the potential for a combination NanoFlu(TM) and NVX-CoV2373 vaccine
to lead to greater efficiencies for the healthcare system and achieve high
levels of protection against COVID-19 and influenza are forward looking
statements. Novavax cautions that these forward-looking statements are subject
to numerous risks and uncertainties that could cause actual results to differ
materially from those expressed or implied by such statements. These risks and
uncertainties include challenges satisfying, alone or together with partners,
various safety, efficacy, and product characterization requirements, including
those related to process qualification and assay validation, necessary to
satisfy applicable regulatory authorities; difficulty obtaining scarce raw
materials and supplies; resource constraints, including human capital and
manufacturing capacity, on the ability of Novavax to pursue planned regulatory
pathways; challenges meeting contractual requirements under agreements with
multiple commercial, governmental, and other entities; and those other risk
factors identified in the "Risk Factors" and "Management's Discussion and
Analysis of Financial Condition and Results of Operations" sections of Novavax'
Annual Report on Form 10-K for the year ended December 31, 2020 and subsequent
Quarterly Reports on Form 10-Q, as filed with the Securities and Exchange
Commission (SEC). We caution investors not to place considerable reliance on
forward-looking statements contained in this press release. You are encouraged
to read our filings with the SEC, available at www.sec.gov and www.novavax.com,
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:
Investors
Novavax, Inc.
Erika Schultz | +1-240-268-2022
ir@novavax.com
Solebury Trout
Alexandra Roy | +1-617-221-9197
aroy@soleburytrout.com
Media
Ali Chartan | +1-240-720-7804
Laura Keenan Lindsey | +1-202-709-7521
media@novavax.com
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SOURCE Novavax, Inc.
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