Novavax, Inc. (Nasdaq: NVAX), a late stage biotechnology company
developing next-generation vaccines for serious infectious
diseases, today announced that it has been selected to participate
in Operation Warp Speed (OWS), a U.S. government program that aims
to begin delivering millions of doses of a safe, effective vaccine
for COVID-19 in 2021. Novavax has been awarded $1.6 billion by the
federal government to complete late-stage clinical development,
including a pivotal Phase 3 clinical trial; establish large-scale
manufacturing; and deliver 100 million doses of NVX‑CoV2373,
Novavax’ COVID-19 vaccine candidate, as early as late 2020.
NVX‑CoV2373 consists of a stable, prefusion protein made using its
proprietary nanoparticle technology and includes Novavax’
proprietary Matrix‑M™ adjuvant.
“The pandemic has caused an unprecedented public
health crisis, making it more important than ever that industry,
government and funding entities join forces to defeat the novel
coronavirus together. We are honored to partner with Operation Warp
Speed to move our vaccine candidate forward with extraordinary
urgency in the quest to provide vital protection to our nation’s
population,” said Stanley C. Erck, President and Chief
Executive Officer of Novavax. “We are grateful to the U.S.
government for its confidence in our technology platform, and are
working tirelessly to develop and produce a vaccine for this global
health crisis.”
Under the terms of the agreement, Novavax will
demonstrate it can rapidly stand up large-scale manufacturing and
transition into ongoing production, including the capability to
stockpile and distribute large quantities of NVX-CoV2373 when
needed. The agreement will fund the late-stage clinical studies
necessary to determine the safety and efficacy of NVX-CoV2373,
including a pivotal Phase 3 clinical trial with up to 30,000
subjects beginning in the fall of 2020.
“Adding Novavax’ candidate to Operation Warp
Speed’s diverse portfolio of vaccines increases the odds that we
will have a safe, effective vaccine as soon as the end of this
year,” said U.S. Health and Human Services Secretary Alex Azar.
“Today’s $1.6 billion investment supports the Novavax candidate,
depending on success in clinical trials, all the way through to
manufacturing 100 million doses for the American people.”
Today’s agreement also allows for a follow-on
agreement with the U.S. government for additional production and
procurement to support OWS’ vaccine production goal. This latest
federal funding supports Novavax plans to file submissions for
licensure with the U.S. Food and Drug Administration (FDA).
A Phase 1/2 clinical trial of NVX-CoV2373 in 130
healthy participants 18 to 59 years of age began in Australia in
May. Preliminary immunogenicity and safety results are expected at
the end of July, and the Phase 2 portion to assess immunity,
safety, and COVID-19 disease reduction is expected to begin
thereafter. The Phase 1/2 clinical trial is being supported by an
up-to $388 million funding arrangement with the Coalition for
Epidemic Preparedness Innovations (CEPI).
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About Operation Warp Speed
Operation Warp Speed is facilitating, at an
unprecedented pace, the development, manufacturing, and
distribution of COVID-19 countermeasures, between components of
Department of Health and Human Services (HHS), including the
Centers for Disease Control and Prevention (CDC), FDA, the National
Institutes of Health (NIH), and the Biomedical Advanced Research
and Development Authority (BARDA, part of the HHS Office of the
Assistant Secretary for Preparedness and Response); the Department
of Defense. OWS is coordinate existing HHS-wide efforts, including
the NIH's ACTIV partnership for vaccine and therapeutic
development, NIH's RADx initiative for diagnostic development, and
work by BARDA.
About NVX-CoV2373
NVX‑CoV2373 is a vaccine candidate engineered
from the genetic sequence of SARS‑CoV‑2, the virus that causes
COVID-19 disease. NVX‑CoV2373 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. In
preclinical trials, NVX‑CoV2373 demonstrated indication of
antibodies that block binding of spike protein to receptors
targeted by the virus, a critical aspect for effective vaccine
protection. A Phase 1 clinical trial of NVX‑CoV2373 initiated in
May 2020, with preliminary immunogenicity and safety results
expected in July 2020. The Coalition for Epidemic Preparedness
Innovations (CEPI) is investing up to $388 million, and Department
of Defense (DoD) is investing up to $60 million of funding to
advance clinical development of NVX‑CoV2373.
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
recently initiated development of NVX-CoV2373, its vaccine
candidate against SARS-CoV-2, the virus that causes COVID-19, with
Phase 1 clinical trial results expected in July of 2020. 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.
Forward-Looking Statements
Statements herein relating to the future of
Novavax and the ongoing development of its vaccine and adjuvant
products, including statements regarding the manufacturing of
vaccine antigen dose amounts and timing, 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, as filed
with the Securities and Exchange Commission (SEC) and updated by
any Quarterly Report on Form 10-Q, particularly the risks inherent
to developing novel vaccines. We caution investors not to place
considerable reliance on the 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:InvestorsSilvia Taylor and Erika
Trahanir@novavax.com240-268-2022
MediaBrandzone/KOGS CommunicationEdna
Kaplankaplan@kogspr.com617-974-8659
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