- 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(TM) (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(TM)
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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