- Trial is the first of its kind to evaluate a combined
COVID-19 and influenza vaccine
- Dose insights from Phase 1/2 trial will inform Phase
2 confirmation trial to begin in late 2022
GAITHERSBURG, Md., Oct. 13,
2022 /PRNewswire/ -- Novavax, Inc. (Nasdaq:
NVAX), a biotechnology company dedicated to developing and
commercializing next-generation vaccines for serious infectious
diseases, today announced positive results from the Phase 1/2
clinical trial of its COVID-19-Influenza Combination (CIC) vaccine
candidate. Data demonstrated the CIC vaccine's ability to
generate immune responses, including both antibody and
polyfunctional CD4+ T-cell (lymphocytes that help coordinate the
immune response) responses against severe acute respiratory
syndrome coronavirus 2 (SARS-CoV-2) and homologous and heterologous
influenza strains. The CIC combines Novavax' COVID-19 vaccine
(NVX-CoV2373) and its quadrivalent influenza vaccine candidate.
The CIC vaccine formulations demonstrated induction of
polyfunctional CD4+ T-cell responses against both SARS-CoV-2 and
homologous and heterologous influenza strains at levels comparable
to stand-alone NVX-CoV2373 and quadrivalent influenza vaccine
candidate reference formulations. NVX-CoV2373 has previously been
shown to induce functional SARS-CoV-2–specific CD4+ and CD8+ T-cell
responses, and Novavax' quadrivalent influenza vaccine candidate
has previously been shown to induce cross-reactive polyfunctional
CD4+ T-cell responses. T-cell responses are thought to play an
important role in the immune system's control of SARS-CoV-2 and
influenza virus infections (e.g., by limiting disease severity and
clearing infection), and in increasing the breadth of immunity.
The CIC vaccine formulations generated robust antibody responses
against both SARS-CoV-2 and influenza antigens, and antibody
responses were modelled using a Design of Experiments (DoE)
approach to help optimize future dose selection.
The safety and tolerability profile of the CIC vaccine was
consistent with the stand-alone NVX-CoV2373 prototype vaccine and
quadrivalent influenza vaccine candidate reference formulations in
the trial. The CIC vaccine was found to be generally well
tolerated. Serious adverse events were rare, and none were assessed
as being related to the vaccine.
"Today's results demonstrate that our COVID-19-Influenza
Combination vaccine candidate is feasible, well-tolerated, and
immunogenic, inducing both antibody and T-cell responses," said
Gregory M. Glenn, M.D., President of
Research and Development, Novavax. "As we transition from a
SARS-CoV-2 pandemic to endemic circulation, we believe our
protein-based combination vaccine candidate can help address two
global public health threats with one vaccine."
"The DoE modeling approach in the trial enabled assessment of
the optimal dose of both the COVID-19 and influenza antigens for
further development of the COVID-19-Influenza Combination vaccine
candidate," said Vivek Shinde, M.D.,
MPH, Vice President, Clinical Development Lead, Older Adult CIC,
Influenza & RSV Vaccines, Novavax, who presented the results.
"These preliminary results provide important insights on dose
regimens that can be applied as we look to the Phase 2 confirmation
trial later this year."
The DoE modeling-based approach used to design the trial enabled
more powerful fine-tuning of dose selection of both the COVID-19
and influenza antigens for further development compared to
traditional approaches. These dose insights will inform the Phase 2
confirmation trial to begin by the end of 2022.
Both protein-based vaccines used in the trial were formulated
with Novavax' patented saponin-based Matrix-M™ adjuvant, which is
designed to enhance the immune response and stimulate high levels
of neutralizing antibodies.
Trial results were presented today at the World Vaccine Congress
(WVC) Europe 2022. Previous
initial trial results were presented at WVC in April 2022.
About the COVID-19-Influenza Combination Vaccine Candidate
Phase 1/2 trial
The Phase 1/2 CIC vaccine trial
evaluated a combination of Novavax' recombinant protein-based
NVX-CoV2373, influenza vaccine candidate, and patented
saponin-based Matrix-M adjuvant in a single formulation. The trial
evaluated the safety, tolerability, and immune response to the CIC
in 642 healthy adults aged 50 to 70. Participants were either
previously infected with the SARS-CoV-2 virus that causes COVID-19
or vaccinated with an authorized vaccine at least eight weeks prior
to enrollment. All participants were randomly assigned to cohorts
to evaluate multiple formulations and were dosed on Day 0 and again
at Day 56. The trial was conducted in Australia at 10
sites.
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 in
a vial containing ten doses. The vaccination regimen calls for two
0.5 ml doses (5 mcg antigen and 50 mcg Matrix-M adjuvant) given
intramuscularly 21 days apart. The vaccine 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 the vaccine 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. Food and Drug Administration, the European
Commission, and the WHO. The vaccine is currently under review by
multiple regulatory agencies worldwide, including for additional
populations and indications such as adolescents and as a booster.
In addition to its COVID-19 vaccine, Novavax is also currently
evaluating its 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, including
NVX-CoV2515 and bivalent Omicron-based / original strain based
vaccine, the CIC investigational vaccine candidate, its
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, controlling the pandemic and protecting
populations, the efficacy, safety and intended utilization and
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; unanticipated challenges or delays in conducting
clinical trials; 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, 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.