Significant immune responses observed in
100% of Zika-vaccinated subjects and 98% of MERS-vaccinated human
subjects in separate phase I studies
Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today announced that Dr.
David B. Weiner, Inovio’s co-founder, presented positive clinical
data on Inovio’s DNA-based vaccines against MERS (Middle East
Respiratory Syndrome) (GLS-5300) and Zika (GLS-5700) at the
Coalition for Epidemic Preparedness Innovation (CEPI)’s 1st
Scientific Meeting on “Vaccines Against Emerging Infections - A
Global Insurance” in Paris, France.
Dr. J. Joseph Kim, Inovio’s CEO, said:
“Advancing DNA vaccine technology for broadly applicable, rapid
response against infectious diseases of epidemic potential is one
of Inovio’s priorities. We quickly designed and manufactured
vaccines for two recent emerging infectious pathogens, MERS CoV and
Zika, and these products join our Ebola program in generating
significant immune responses with a favorable safety profile in
phase I studies. We are pleased to see CEPI moving forward on its
vision for proactive and accelerated vaccine development for
epidemic threats and to contribute to their first scientific
meeting.”
Officially launched at the World Economic Forum
in Davos in January, 2017, CEPI received an initial $460 million
from the governments of Germany, Japan and Norway, plus the Bill
& Melinda Gates Foundation and Wellcome Trust, as part of a
drive to bring together a total of $1 billion to fund and support
its goal of stimulating, financing and coordinating the advancement
of safe, effective and affordable vaccines.
MERS Vaccine Results
Dr. Weiner noted that in a phase I MERS study,
after a three dose vaccine regimen with GLS-5300, high levels of
binding antibodies were measured (ELISA) in 92% (57 of 62) of
evaluated subjects. Even two doses or a single dose of vaccine
generated a robust antibody response in 84% (52 of 62) or 44% (27
of 62) of evaluated subjects, respectively.
Significant antigen-specific cytotoxic
T-lymphocyte (CTL) responses were also observed. Importantly, all
but one evaluated vaccinated subject or 98% (61 of 62) generated an
antibody and/or T cell response against the MERS vaccine.
Generation of MERS antigen-specific antibody and T cell responses
is believed to be important for generating immediate and
long-lasting protection against the disease. The vaccine was well
tolerated and no significant safety concerns were noted to
date.
These interim data from the first set of
evaluated subjects were from a fully enrolled phase I study of 75
healthy volunteers. Inovio and GeneOne Life Science Inc. (KSE:
011000) are co-developing Inovio’s GLS-5300 in partnership with the
Walter Reed Army Institute of Research in Maryland, where the trial
was conducted. This trial represents the first and still only MERS
vaccine to be tested in humans for this disease that has no
approved vaccines or treatments.
In preclinical studies of GLS-5300 (data
published in the peer reviewed journal Science Translational
Medicine, 2015), 100% of vaccinated Rhesus macaques were protected
from symptoms of MERS when exposed to the live MERS virus. The
animals also generated strong antibody and T-cell responses.
Since the virus was first identified in Saudi
Arabia in 2012, the World Health Organization has reported almost
2,000 MERS infections and nearly 700 deaths worldwide. Twenty seven
countries have reported cases, including Korea where an outbreak in
the summer of 2015 resulted in 186 cases and 38 deaths. While the
SARS epidemic in 2003 killed 10% of those infected, SARS-related
MERS has killed about 36% of people who contracted this
communicable virus.
Zika Vaccine results
Dr. Weiner also highlighted that in a phase I
Zika study, after a three dose vaccine regimen with GLS-5700, high
levels of binding antibodies were measured (ELISA) in 100% (39 of
39) of evaluated subjects. Moreover, two doses or a single dose of
vaccine generated a robust antibody response in 82% (32 of 39) or
40% (16 of 40) of evaluated subjects, respectively.
T cell immune responses are currently being
evaluated. The vaccine was well tolerated and no significant safety
concerns were noted. These preliminary data are from a fully
enrolled phase I study of 40 healthy volunteers. Inovio and GeneOne
are co-developing GLS-5700. This trial represents the first Zika
vaccine to be tested in humans for this disease that has no
approved vaccines or treatments and also the first human clinical
data reported with a Zika vaccine documenting the induction of
immune responses following vaccination.
Preclinical data published in the peer-reviewed
journal npg Vaccines (2016) showed that GLS-5700 generated
single-dose protection in 100% of animals against neurologic or
testicular effects of the Zika virus.
Dr. Scott White, Inovio’s Vice
President of Infectious Disease Clinical Development, will also
present this Zika data on Friday, February 24th at the “First
International Conference on Zika Virus,” a worldwide forum
sponsored by the American Society of Tropical Medicine and Hygiene
in Washington, D.C.
About Inovio Pharmaceuticals,
Inc.
Inovio is taking immunotherapy to the next level
in the fight against cancer and infectious diseases. We are the
only immunotherapy company that has reported generating T cells in
vivo in high quantity that are fully functional and whose killing
capacity correlates with relevant clinical outcomes with a
favorable safety profile. With an expanding portfolio of immune
therapies, the company is advancing a growing preclinical and
clinical stage product pipeline. Partners and collaborators include
MedImmune, The Wistar Institute, University of Pennsylvania, DARPA,
GeneOne Life Science, Plumbline Life Sciences, ApolloBio
Corporation, Drexel University, NIH, HIV Vaccines Trial Network,
National Cancer Institute, U.S. Military HIV Research Program, and
Laval University. For more information, visit www.inovio.com.
This press release contains certain
forward-looking statements relating to our business, including our
plans to develop electroporation-based drug and gene delivery
technologies and DNA vaccines, our expectations regarding our
research and development programs and our capital resources. Actual
events or results may differ from the expectations set forth herein
as a result of a number of factors, including uncertainties
inherent in pre-clinical studies, clinical trials and product
development programs, including the MERS vaccine GLS-5300 or Zika
vaccine GLS-5700, the availability of funding to support continuing
research and studies in an effort to prove safety and efficacy of
electroporation technology as a delivery mechanism or develop
viable DNA vaccines, our ability to support our broad pipeline of
SynCon® active immunotherapy and vaccine products, the ability of
our collaborators to attain development and commercial milestones
for products we license and product sales that will enable us to
receive future payments and royalties, the adequacy of our capital
resources, the availability or potential availability of
alternative therapies or treatments for the conditions targeted by
the company or its collaborators, including alternatives that may
be more efficacious or cost effective than any therapy or treatment
that the company and its collaborators hope to develop, issues
involving product liability, issues involving patents and whether
they or licenses to them will provide the company with meaningful
protection from others using the covered technologies, whether such
proprietary rights are enforceable or defensible or infringe or
allegedly infringe on rights of others or can withstand claims of
invalidity and whether the company can finance or devote other
significant resources that may be necessary to prosecute, protect
or defend them, the level of corporate expenditures, assessments of
the company's technology by potential corporate or other partners
or collaborators, capital market conditions, the impact of
government healthcare proposals and other factors set forth in our
Annual Report on Form 10-K for the year ended December 31, 2015,
our Form 10-Q for the quarter ended September 30,
2016, and other regulatory filings from time to time. There
can be no assurance that any product in Inovio's pipeline will be
successfully developed or manufactured, that final results of
clinical studies will be supportive of regulatory approvals
required to market licensed products, or that any of the
forward-looking information provided herein will be proven
accurate.
CONTACTS:
Investors: Bernie Hertel, Inovio Pharmaceuticals, 858-410-3101, bhertel@inovio.com
Media: Jeff Richardson, Inovio Pharmaceuticals, 267-440-4211, jrichardson@inovio.com
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