- This Phase 2 trial is evaluating three vaccine candidates:
COVID-Influenza Combination, stand-alone influenza and high-dose
COVID
- Preliminary topline immune responses for all three vaccine
candidates were robust versus authorized comparators
- For the stand-alone influenza vaccine candidate, HAI
responses were 31 to 56% higher for all four influenza strains
compared to Fluad®, and were 44 to 89% higher for
A strains compared to Fluzone HD®
- For the COVID-Influenza Combination vaccine candidate,
anti-S IgG and neutralization responses achieved levels seen in
Phase 3 trial with Novavax's prototype vaccine, with HAI responses
generally consistent with Fluad® and Fluzone
HD®
- All three vaccine candidates were well-tolerated and
demonstrated a reassuring preliminary safety profile, with
reactogenicity comparable to authorized comparators
- These Phase 2 results support continued development for all
three vaccine candidates
GAITHERSBURG, Md., May 9, 2023
/CNW/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing
protein-based vaccines with its novel Matrix-M™
adjuvant, today announced that its COVID-Influenza Combination
(CIC), stand-alone influenza and high-dose COVID vaccine candidates
all showed a reassuring preliminary safety profile as well as
comparable reactogenicity to individual Novavax influenza and COVID
vaccine candidates or authorized influenza vaccine comparators.
Additionally, all three vaccines demonstrated preliminary robust
immune responses.
The primary endpoint evaluated the safety of different
formulations of the CIC vaccine candidate and the quadrivalent
influenza vaccine candidate compared to Fluad®* and
Fluzone High-Dose Quadrivalent®** (Fluzone HD), as well
as a high-dose COVID vaccine candidate in adults aged 50 through
80. All three vaccine candidates contained Novavax's patented
Matrix-M adjuvant and showed reassuring preliminary safety profiles
and reactogenicity that was comparable to Fluad and Fluzone HD. The
reactogenicity profile remained consistent as the adjuvant or
antigen dose was increased.
In all groups there were no adverse events (AE) of special
interest, no potentially immune mediated medical conditions and no
treatment-related serious AEs. Unsolicited AEs occurred in 25% or
fewer of any group and were consistent with diagnoses in the older
adult population. Local and systemic symptoms were mostly mild and
moderate and occurred at rates comparable to Fluad and Fluzone
HD.
"The reactogenicity results support our previous observations
that this technology is well suited for combination vaccines
because large amounts of antigen can be incorporated without
impacting tolerability," said Filip
Dubovsky President, Research and Development, Novavax. "The
immune responses we observed were robust, and the data we have
shared today significantly increase the probability of Phase 3
success."
The CIC vaccine candidate achieved both immunoglobulin G (IgG)
and neutralizing levels comparable to Novavax's prototype COVID
vaccine (NVX-CoV2373). In addition, several of the combination
formulations achieved responses to both SARS-CoV-2 and to the four
homologous influenza strains that were comparable to the reference
comparators, supporting their prioritization for advanced
development. The stand-alone influenza vaccine candidate achieved
statistically significant hemagglutination inhibition (HAI)
antibody responses 31 to 56% higher for all four strains compared
to Fluad. Titers were 44 (H1N1) to 89% (H3N2) higher for A strains
and statistically non-inferior for B-strains compared to Fluzone
HD.
The highest dose stand-alone COVID vaccine candidate achieved
statistically significant anti-S IgG and neutralization
responses approximately 30% higher than Novavax's prototype COVID
vaccine while maintaining comparable safety and reactogenicity to
currently authorized dose level of Nuvaxovid.
"Today's positive data are encouraging and further validate the
value of our technology platform and its potential to improve
global public health," said John C.
Jacobs, President and Chief Executive Officer, Novavax.
"This is an important milestone in our journey to create additional
value and diversify our portfolio of vaccines."
About the Phase 2 Trial for CIC, Stand-alone Influenza and
High-Dose COVID Vaccine Candidates
The Phase 2 Trial is a
dose-confirming, randomized, observer-blinded trial evaluating the
safety and effectiveness (immunogenicity) of different formulations
of the CIC and influenza vaccine candidates, and higher doses of
Novavax's COVID vaccine in adults aged 50 through 80. The trial is
assessing a CIC vaccine candidate comprised of Novavax's
recombinant protein-based COVID vaccine, quadrivalent influenza
vaccine candidate and patented saponin-based Matrix-M adjuvant.
Primary and secondary objectives of the study are to assess the
safety, tolerability and immune responses to various formulations
of the CIC, influenza and high-dose COVID vaccine candidates. The
Phase 2 dose-confirmation trial is being conducted in two
parts.
About NVX-CoV2373
NVX-CoV2373 is a protein-based
vaccine made by creating copies of the surface spike protein of
SARS-CoV-2 that causes COVID. With Novavax's unique recombinant
nanoparticle technology, the non-infectious spike protein serves as
the antigen that primes the immune system to recognize the virus,
while Novavax's Matrix-M adjuvant enhances and broadens the immune
response. The vaccine is packaged as a ready-to-use liquid
formulation and is stored at 2° to 8°C, enabling the use of
existing vaccine supply and cold chain channels.
About Matrix-M™ Adjuvant
When added to vaccines,
Novavax's patented saponin-based Matrix-M adjuvant enhances the
immune system response, making it broader, and more durable. The
Matrix-M adjuvant stimulates the entry of antigen-presenting cells
at the injection site and enhances antigen presentation in local
lymph nodes.
About Novavax
Novavax, Inc. (Nasdaq: NVAX) promotes
improved health by discovering, developing and commercializing
innovative vaccines to protect against serious infectious diseases.
Novavax, a global company based in Gaithersburg, Md., U.S., offers a
differentiated vaccine platform that combines a recombinant protein
approach, innovative nanoparticle technology and Novavax's patented
Matrix-M adjuvant to enhance the immune response. Focused on the
world's most urgent health challenges, Novavax is currently
evaluating vaccines for COVID, influenza, and COVID and influenza
combined. Please visit novavax.com and LinkedIn for more
information.
Forward-Looking Statements
Statements herein relating
to the future of Novavax, its operating plans and prospects, its
partnerships, the timing of clinical trial results, the ongoing
development of NVX-CoV2373, the CIC, the high-dose COVID vaccine
candidates, the quadrivalent influenza investigational vaccine
candidate, the potential impact and reach of Novavax and
NVX-CoV2373 in improving public health, the efficacy, safety
intended utilization, and the expected administration of
NVX-CoV2373 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, without limitation, 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; unanticipated challenges or
delays in conducting clinical trials; challenges meeting
contractual requirements under agreements with multiple commercial,
governmental, and other entities; challenges in implementing our
global restructuring and cost reduction plan; challenges in
obtaining commercial adoption of NVX-CoV2373 or a COVID-19 variant
strain-containing formulation; 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's Annual Report on Form 10-K for the year ended
December 31, 2022 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.
*Fluad® is a registered trademark of Seqirus UK
Limited
**Fluzone High-Dose Quadrivalent®* is a registered
trademark of Sanofi Pasteur Inc.
Contacts:
Investors
Erika Schultz
240-268-2022
ir@novavax.com
Media
Ali Chartan
240-720-7804
media@novavax.com
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SOURCE Novavax, Inc.