Novavax Awarded Department of Defense Contract for COVID-19 Vaccine
04 Junho 2020 - 9:04PM
Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company
developing next-generation vaccines for serious infectious
diseases, today announced that the company has been awarded a
contract by the U.S. Department of Defense (DoD) for the
manufacturing of NVX‑CoV2373, Novavax’ COVID-19 vaccine candidate.
NVX‑CoV2373 consists of a stable, prefusion protein antigen made
using its proprietary nanoparticle technology and includes Novavax’
proprietary Matrix‑M™ adjuvant.
JPEO-CRBND-EB through funding provided by the
Defense Health Program, has agreed to fund up to $60 million to
support Novavax in its production of several components of the
vaccine that will be manufactured in the U.S. The agreement
includes a 2020 delivery of 10 million doses of NVX‑CoV2373 for DoD
that could be used in Phase 2/3 clinical trials or under an
Emergency Use Authorization (EUA) if approved by the U.S. FDA.
“We are genuinely honored at the opportunity to
protect our military personnel and their families who have devoted
themselves to the needs of U.S. citizens and others worldwide,”
said Stanley C. Erck, President and Chief Executive Officer of
Novavax. “Importantly, this award will allow Novavax to
significantly expand its U.S. production capacity of NVX-CoV2373, a
critical step in our ability to provide vaccine support to the
COVID-19 pandemic.”
As part of the contract, Novavax will work with
a U.S.-based biologics contract development manufacturing
organization (CDMO) to manufacture the antigen component of
NVX-CoV2373 for at least 10 million doses of vaccine. Novavax will
also collaborate with U.S.-based CDMOs to scale up production and
manufacture of the Matrix-M adjuvant component of the vaccine.
About the JPEO-CBRND
The Joint Program Executive Office for Chemical,
Biological, Radiological and Nuclear Defense is the Joint Service's
lead for development, acquisition, fielding and life-cycle support
of chemical, biological, radiological and nuclear defense equipment
and medical countermeasures. As an effective acquisition program,
we put capable and supportable systems in the hands of the service
members and first responders, when and where it is needed, at an
affordable price. Our vision is a resilient Joint Force enabled to
fight and win unencumbered by a chemical, biological, radiological,
or nuclear environment; championed by innovative and
state-of-the-art solutions. JPEO Enabling Biotechnologies (EB) is
an organization established for the purpose of providing medical
solutions, during a crisis, against future threats.
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 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:
Investors Novavax, Inc. Erika Trahan ir@novavax.com
240-268-2022
Westwicke John Woolford john.woolford@westwicke.com
443-213-0506
Media Brandzone/KOGS Communication Edna Kaplan kaplan@kogspr.com
617-974-8659
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