Novavax Identifies Coronavirus Vaccine Candidate; Accelerates Initiation of First-in-Human Trial to Mid-May
08 April 2020 - 12:00PM
Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company
developing next-generation vaccines for serious infectious
diseases, today announced it has identified a coronavirus vaccine
candidate, NVX-CoV2373, a stable, prefusion protein made using
Novavax’ proprietary nanoparticle technology, and will initiate a
first-in-human trial in mid-May. Novavax’ proprietary Matrix-M™
adjuvant will be incorporated with NVX-CoV2373 in order to enhance
immune responses and stimulate high levels of neutralizing
antibodies.
NVX-CoV2373 was shown to be highly immunogenic
in animal models measuring spike protein-specific antibodies,
antibodies that block the binding of the spike protein to the
receptor and wild-type virus neutralizing antibodies. High levels
of spike protein-specific antibodies with ACE-2 human receptor
binding domain blocking activity and SARS-CoV-2 wild-type virus
neutralizing antibodies were observed after a single immunization.
In addition, the already high microneutralization titers seen after
one dose increased eight fold with a second dose. High titer
microneutralizing antibodies are generally accepted evidence that a
vaccine is likely to be protective in humans.
“Our scientists identified an ideal vaccine
candidate selected from a number of constructs and, in partnership
with Dr. Matthew Frieman, demonstrated that NVX-CoV2373 produces
high levels of neutralizing antibodies against SARS-CoV-2 in animal
studies,” said Gregory Glenn, M.D., President of Research and
Development at Novavax. “In addition, we have worked closely with
our colleagues at Emergent BioSolutions to transfer our production
technology that allows the manufacture of GMP vaccine for clinical
trials. With preliminary CEPI funding, these heroic efforts,
combined with the candidate’s excellent early results, put us in
position to have preliminary human data in July.”
“We validated that NVX-CoV2373 generates high
titer neutralizing antibodies against live SARS-CoV-2 virus,” said
Matthew Frieman, Ph.D., Associate Professor at the University of
Maryland School of Medicine. “This is strong evidence that the
vaccine created by Novavax has the potential to be highly
immunogenic in humans which could lead to protection from COVID-19
and helping to control the spread of this disease.”
The NVX-CoV2373 clinical development plan
combines a Phase 1/Phase 2 approach to allow rapid advancement
during the current coronavirus pandemic. The Phase 1 clinical trial
is a placebo-controlled observer blinded study of ~130 healthy
adults and includes assessment of dosage amount and number of
vaccinations. The trial is expected to begin in mid-May with
preliminary immunogenicity and safety results in July.
As previously announced, in March, Novavax
entered into an agreement with Emergent BioSolutions to provide
contract development and manufacturing services, supplying Novavax
with GMP vaccine product for use in its clinical trials. This
agreement offers the potential to leverage Emergent’s rapid
deployment capabilities and expertise that provide Novavax
scalability and capacity to produce vaccine product. Also in March,
the Coalition for Epidemic Preparedness Innovations (CEPI) awarded
an initial funding of $4 million to support Novavax’ efforts, with
additional funding discussions ongoing.
“Because of the tireless efforts and commitment
of the Novavax team and our collaborators, we are preparing to
initiate the NVX-CoV2373 Phase 1 trial in mid-May, weeks ahead of
schedule,” said Stanley C. Erck, President and Chief Executive
Officer of Novavax. “This progress demonstrates the ability of our
recombinant nanoparticle technology to rapidly create vaccine
candidates for emerging viruses like SARS-CoV-2. In addition, the
performance of NVX-CoV2373 in multiple preclinical studies and
testing gives us increased confidence in its potential to protect
against COVID-19 disease.”
About Coronavirus
A new strain of coronavirus, SARS-CoV-2, first
appeared in late 2019 in China before beginning its rapid spread
across the globe. The disease, named COVID-19, continues to cause
severe pneumonia-like symptoms in many of those infected.
Coronaviruses, so named for their “crown-like” appearance, are a
large family of viruses that spread from animals to humans and
include diseases such as Middle East Respiratory Syndrome (MERS)
and SARS in addition to COVID-19. While much remains unknown about
the new coronavirus, it is known that the virus can spread via
human-to-human transmission before any symptoms appear.
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 and
address urgent, global health needs. Novavax recently initiated
development of a vaccine program against COVID-19, with human
results expected in July of 2020. NanoFlu™, its quadrivalent
influenza nanoparticle vaccine, met all primary objectives in its
pivotal Phase 3 clinical trial. ResVax™, its RSV vaccine for
infants via maternal immunization, is the only vaccine to
demonstrate efficacy in a Phase 3 clinical trial. Novavax is a
leading innovator of recombinant vaccines; its proprietary
recombinant technology platform combines the power and speed of
genetic engineering to efficiently produce a new class of highly
immunogenic nanoparticles addressing 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 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). 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:
InvestorsNovavax, Inc.Erika Trahanir@novavax.com
240-268-2022
WestwickeJohn
Woolfordjohn.woolford@westwicke.com 443-213-0506
MediaBrandzone/KOGS CommunicationEdna
Kaplankaplan@kogspr.com 617-974-8659
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