Novavax Announces Initiation of Ebola Vaccine Phase 1 Clinical Trial Supported by Non-Human Primate Challenge Data and Docume...
February 12 2015 - 8:30AM
- Initiation of Enrollment of Phase 1 Clinical Trial of Ebola GP
Vaccine
- Non-Human Primate Challenge Data Signal Breakthrough in Ebola
Vaccine Development
- Rapid Manufacturing Process of Ebola GP Vaccine Published in
BioProcessing Journal
GAITHERSBURG, Md., Feb. 12, 2015 (GLOBE NEWSWIRE)
-- Novavax, Inc. (Nasdaq:NVAX), a
clinical-stage vaccine company focused on the discovery,
development and commercialization of recombinant nanoparticle
vaccines and adjuvants, today announced that enrollment has begun
in a Phase 1 clinical trial of its Ebola virus glycoprotein (GP)
recombinant nanoparticle vaccine candidate adjuvanted with
Matrix-M™ (Ebola GP Vaccine) in healthy subjects. Novavax initiated
the development of its Ebola GP Vaccine shortly after the
publication of the genetic sequence of the 2014 Ebola Makona strain
(previously referred to as the 2014 Ebola Guinea strain), which is
responsible for the current Ebola epidemic in West Africa. In an
expedited time-frame, from the publication of the Makona sequence
in September 2014, Novavax has developed the vaccine, scaled-up GMP
manufacturing, delivered positive results from multiple relevant
animal models, including a non-human primate challenge study, and
today initiated a Phase 1 clinical trial.
Stanley C. Erck, President and CEO said, "In less than 5 months,
Novavax has validated its Ebola GP Vaccine with compelling animal
data, including complete protection against a lethal Ebola
challenge in non-human primates, leading to the initiation of this
Phase 1 clinical trial. With our ongoing efforts to develop our
vaccine against the A/H7N9 influenza strain, this is the second
novel strain of an emerging virus with pandemic potential, for
which Novavax has been able to construct and produce a vaccine,
subsequently demonstrate immunogenicity in one or more relevant
animal models, and initiate a clinical trial. Additionally, like
our other recombinant vaccine candidates, our Ebola GP Vaccine can
be rapidly scaled-up to produce millions of doses. Creating new
vaccines in such an expeditious manner exemplifies Novavax' ability
to respond to a variety of global infectious disease threats."
The Ebola GP Vaccine clinical trial, which is being conducted in
Australia, is a randomized, observer-blinded, dose-ranging Phase 1
study to evaluate the safety and immunogenicity of the vaccine,
with and without Matrix-M adjuvant, in 230 healthy adult subjects
between 18 and 50 years of age. Each subject will receive two
intramuscular injections, one each on study days 0 and 21. In
addition to the trial's primary goal of evaluating safety in this
population, the study will also evaluate immunogenicity as measured
by concentrations of serum IgG antibodies to the Ebola Makona
strain glycoprotein. Secondary study endpoints include
epitope-specific immune responses to the Ebola GP antigen as
measured by serum titers in a competitive ELISA assay using
known-neutralizing monoclonal antibodies, as well as serum Ebola
virus neutralizing antibody reciprocal titers.
The Phase 1 clinical trial initiation is supported by
significant immunogenicity and efficacy data demonstrating that the
Ebola GP Vaccine is the first subunit Ebola GP-based vaccine to
provide protection in non-human primates. Non-human primates
received two injections of a 5µg dose of the Ebola GP Vaccine with
the Matrix-M adjuvant, and were challenged with a lethal dose of
Ebola virus. As expected, the challenge was lethal for the control
animal whereas, in sharp contrast, 100% of the immunized animals
were protected. Additionally, the Ebola GP Vaccine induced Ebola
Makona strain GP antibody titers of 106 (ELISA EC90) after two
doses and 104, after a single dose, both results well above the
range reported to provide protection in non-human primate models
and reported in recent Ebola Phase 1 clinical trials.
"The strong immune responses observed in our animal
immunogenicity models and the protection observed in the non-human
primate challenge models, confirm that our Ebola GP Vaccine is an
important candidate for consideration. The use of a sequence
reflecting the current circulating Makona strain of Ebola virus,
along with the observed dose-sparing and enhanced antibody quality
by the addition of our Matrix-M adjuvant, compelled the company to
move to clinical testing," said Gregory Glenn, M.D., Senior Vice
President, Research and Development. "Because of the unprecedented
ongoing Ebola epidemic, and with more than 20 historical outbreaks
of Ebola virus, Novavax believes there is an urgent need for a safe
and effective licensed vaccine. Combined with the very promising
recent data on our Ebola GP Vaccine, there is a clear rationale for
moving this program forward."
The rapid progression to a Phase I clinical trial is further
supported by Novavax' GMP manufacturing process, as documented in
the February 10, 2015 online publication of BioProcessing Journal
(available at novavax.com under "Publications &
Presentations"). The article titled "Rapid Manufacture and Release
of a GMP Batch of Zaire Ebolavirus Glycoprotein Vaccine Made Using
Recombinant Baculovirus-Sf9 Insect Cell Culture Technology" details
Novavax' manufacturing development process from genetic engineering
of the 2014 Makona strain gene sequence through master seed
preparation, qualification of analytical methods, and ultimately
GMP manufacture with product release three months after project
initiation.
About Ebola
Ebola virus, formerly known as Ebola hemorrhagic fever, is a
severe, often fatal illness in humans. Five strains of Ebola virus
have been identified, the most recent of which, the 2014 Makona
strain, is associated with a case fatality rate of between 50 and
90%. There are currently no licensed immunological or therapeutic
treatments proven to neutralize the virus, although a range of
blood, immunological vaccine and drug therapies are under
development.
About Novavax
Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage vaccine company
committed to delivering novel products to prevent a broad range of
infectious diseases. Our recombinant nanoparticles and Matrix-M™
adjuvant technology are the foundation for groundbreaking
innovation that improves global health through safe and effective
vaccines. Additional information about Novavax is available on the
company's website, novavax.com.
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, 2013, 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.
CONTACT: Barclay A. Phillips
SVP, Chief Financial Officer and Treasurer
Novavax, Inc.
240-268-2000
David Schull or Andrea Flynn, Ph.D.
Russo Partners, LLC
212-845-4271
David.schull@russopartnersllc.com
Andrea.flynn@russopartnersllc.com
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