GAITHERSBURG, Md., Dec. 30,
2022 /PRNewswire/ -- Novavax, Inc. (Nasdaq:
NVAX), a biotechnology company dedicated to developing and
commercializing next-generation vaccines for serious infectious
diseases, today announced the initiation of a Phase 2 trial for its
COVID-19-Influenza Combination (CIC) and influenza stand-alone
vaccine candidates. The dose-confirming trial will evaluate the
safety and effectiveness (immunogenicity) of different formulations
of the CIC and influenza vaccine candidates in adults aged 50
through 80.
"We're encouraged by the initiation of this trial given the
positive results shared earlier this year from our Phase 1/2 trial,
the first of its kind to evaluate a combined COVID-19 and influenza
vaccine," said Stanley C. Erck,
President and Chief Executive Officer, Novavax. "We believe that
like influenza, COVID-19 will also be seasonal moving forward, and
that there is room in the market for new alternatives to provide
better protection against the impact of influenza, particularly in
older adults, and to explore the potential to combine this with
protection from COVID."
The randomized, observer-blinded trial will assess a combination
of Novavax' recombinant protein-based COVID-19 vaccine
(NVX-CoV2373), 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 and influenza
vaccine candidates. The Phase 2 dose-confirmation trial will be
conducted in two parts and seek to enroll a total of approximately
2,300 participants across multiple sites located in Australia and New
Zealand.
Initial results of the trial are expected mid-year 2023. These
data will inform the Phase 3 trials for both influenza stand-alone
and COVID-19-influenza combination candidates.
About NVX-CoV2373
NVX-CoV2373 is a protein-based
vaccine engineered from the genetic sequence of the first strain of
SARS-CoV-2, the virus that causes COVID-19 disease. The vaccine was
created using Novavax' recombinant nanoparticle technology to
generate antigen derived from the coronavirus spike protein and is
formulated with Novavax' patented saponin-based Matrix-M™ adjuvant
to enhance the immune response and stimulate high levels of
neutralizing antibodies. NVX-CoV2373 contains purified protein
antigen and can neither replicate, nor can it cause COVID-19.
The vaccine is packaged as a ready-to-use liquid formulation and
is stored at 2°- 8° Celsius, enabling the use of existing vaccine
supply and cold chain channels. Use of the vaccine should be in
accordance with official recommendations.
Novavax has established partnerships for the manufacture,
commercialization, and distribution of NVX-CoV2373 worldwide.
Existing authorizations leverage Novavax' manufacturing partnership
with Serum Institute of India, the
world's largest vaccine manufacturer by volume. They will later be
supplemented with data from additional manufacturing sites
throughout Novavax' global supply chain.
About Matrix-M™ Adjuvant
Novavax' patented
saponin-based Matrix-M 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 harnesses the
power and speed of genetic engineering to efficiently produce
highly immunogenic nanoparticles designed to address urgent global
health needs. The Novavax COVID-19 vaccine, has received
authorization from multiple regulatory authorities globally,
including the U.S. FDA, the European Commission, and the World
Health Organization. The vaccine is currently under review by
multiple regulatory agencies worldwide, including for additional
indications and populations such as adolescents and as a booster.
In addition to its COVID-19 vaccine, Novavax is also currently
evaluating its COVID-19-Influenza Combination (CIC) vaccine
candidate in a Phase 1/2 clinical trial, its quadrivalent influenza
investigational vaccine candidate, and an Omicron strain-based
vaccine (NVX-CoV2515) as well as a bivalent format Omicron-based /
original strain-based vaccine. These vaccine candidates incorporate
Novavax' proprietary saponin-based Matrix-M 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 LinkedIn.
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, NVX-CoV2515 and a bivalent
Omicron-based / original strain based vaccine, the CIC vaccine
candidate, including Novavax' plans to initiate a Phase 3 study in
2024, a quadrivalent influenza investigational vaccine candidate,
the scope, timing and outcome of future regulatory filings and
actions, including Novavax' plans to supplement existing
authorizations with data from the additional manufacturing sites in
Novavax' global supply chain, additional worldwide authorizations
of NVX-CoV2373 for use in adults and adolescents, and as a booster,
the potential impact and reach of Novavax and NVX-CoV2373 in
addressing vaccine access, increasing vaccination rates,
controlling the pandemic, and protecting populations, the efficacy,
safety, intended utilization, and expected administration of
NVX-CoV2373 and the CIC vaccine candidate 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; 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, 2021 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
Erika Schultz | 240-268-2022
ir@novavax.com
Media
Ali Chartan or Giovanna Chandler | 202-709-5563
media@novavax.com
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SOURCE Novavax, Inc.