Novavax, Inc. (Nasdaq: NVAX), a late stage biotechnology company
developing next-generation vaccines for serious infectious
diseases, today announced that it has initiated its first Phase 3
study to evaluate the efficacy, safety and immunogenicity of
NVX-CoV2373, Novavax’ COVID-19 vaccine candidate. The trial is
being conducted in the United Kingdom (UK), in partnership with the
UK Government’s Vaccines Taskforce, and is expected to enroll and
immunize up to 10,000 individuals between 18-84 (inclusive) years
of age, with and without relevant comorbidities, over the next four
to six weeks.
“With a high level of SARS-CoV-2 transmission
observed and expected to continue in the UK, we are optimistic that
this pivotal Phase 3 clinical trial will enroll quickly and provide
a near-term view of NVX-CoV2373’s efficacy,” said Gregory M. Glenn,
M.D., President, Research and Development at Novavax. “The data
from this trial is expected to support regulatory submissions for
licensure in the UK, EU and other countries. We are grateful for
the support of the UK Government, including from its Department of
Health and Social Care and National Institute for Health Research,
to advance this important research.”
NVX-CoV2373 is a stable, prefusion protein made
using Novavax’ recombinant protein nanoparticle technology that
includes Novavax’ proprietary MatrixM™ adjuvant. The vaccine has a
favorable product profile that will allow handling in an unfrozen,
liquid formulation that can be stored at 2°C to 8°C, allowing for
distribution using standard vaccine channels.
Novavax has continued to scale-up its
manufacturing capacity, currently at up to 2 billion annualized
doses, once all capacity has been brought online by mid-2021.
About the Phase 3 Study
Consistent with its long-standing commitment to
transparency and in order to enhance information-sharing during the
worldwide pandemic, Novavax will be publishing its UK study
protocol in the coming days.
The UK Phase 3 clinical trial is a randomized,
placebo-controlled, observer-blinded study to evaluate the
efficacy, safety and immunogenicity of NVX-CoV2373 with Matrix-M in
up to 10,000 subjects aged 18 to 84 years. Half the participants
will receive two intramuscular injections of vaccine comprising 5
µg of protein antigen with 50 µg Matrix‑M adjuvant, administered 21
days apart, while half of the trial participants will receive
placebo.
The trial is designed to enroll at least 25
percent of participants over the age of 65 as well as to prioritize
groups that are most affected by COVID-19, including racial and
ethnic minorities. Additionally, up to 400 participants will also
receive a licensed seasonal influenza vaccine as part of a
co-administration sub-study.
The trial has two primary endpoints. The first
primary endpoint is first occurrence of PCR-confirmed symptomatic
COVID-19 with onset at least 7 days after the second study
vaccination in volunteers who have not been previously infected
with SARS-CoV-2. The second primary endpoint is first occurrence of
PCR-confirmed symptomatic moderate or severe COVID-19 with onset at
least 7 days after the second study vaccination in volunteers who
have not been previously infected with SARS-CoV-2. The primary
efficacy analysis will be an event-driven analysis based on the
number of participants with symptomatic or moderate/severe COVID-19
disease. An interim analysis will be performed when 67% of the
desired number of these cases has been reached.
For further information, including media-ready
images, b-roll, downloadable resources and more, click here.
About NVX-CoV2373
NVXCoV2373 is a vaccine candidate engineered
from the genetic sequence of SARSCoV2, the virus that causes
COVID-19 disease. NVXCoV2373 was created using Novavax’ recombinant
nanoparticle technology to generate antigen derived from the
coronavirus spike (S) protein and contains Novavax’ patented
saponin-based Matrix-M™ adjuvant to enhance the immune response and
stimulate high levels of neutralizing antibodies. NVX-CoV2373
contains purified protein antigens and cannot replicate, nor can it
cause COVID-19. In preclinical trials, NVXCoV2373 demonstrated
indication of antibodies that block binding of spike protein to
receptors targeted by the virus, a critical aspect for effective
vaccine protection. In its the Phase 1 portion of its Phase 1/2
clinical trial, NVXCoV2373 was generally well-tolerated and
elicited robust antibody responses numerically superior to that
seen in human convalescent sera. NVX-CoV2373 is also being
evaluated in two ongoing Phase 2 studies, which began in August; a
Phase 2b trial in South Africa, and a Phase 1/2 continuation in the
U.S. and Australia. Novavax has secured $2
billion in funding for its global coronavirus vaccine program,
including up to $388 million in funding from
the Coalition for Epidemic Preparedness
Innovations (CEPI).
About Matrix-M™
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 late-stage
biotechnology company that promotes improved health globally
through the discovery, development, and commercialization of
innovative vaccines to prevent serious infectious
diseases. Novavax is undergoing clinical trials for
NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus
that causes COVID-19. NanoFlu™, 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™ adjuvant
in order to enhance the immune response and stimulate high levels
of neutralizing antibodies. Novavax is a leading
innovator of recombinant vaccines; its proprietary recombinant
technology platform combines the power and speed of genetic
engineering to efficiently produce highly immunogenic nanoparticles
in order to address urgent global health needs.
For more information, visit www.novavax.com and
connect with us on Twitter and LinkedIn.
Novavax 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, 2019, and Quarterly Report on Form 8-K for
the period ended June 30, 2020, 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 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.
Contacts:
Novavax
InvestorsSilvia Taylor and Erika
Trahanir@novavax.com240-268-2022
MediaBrandzone/KOGS CommunicationEdna
Kaplankaplan@kogspr.com617-974-8659
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