Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today announced that the
company is collaborating with The Wistar Institute to advance two
novel SynCon® vaccine programs against tuberculosis (TB) and
malaria, fully funded by more than $4.6 million in total grants
from the Bill & Melinda Gates Foundation and the National
Institutes of Health (NIH).
Grants from the Gates Foundation (for malaria)
and from the National Institute of Allergy & Infectious
Diseases (for TB) will fully support Inovio’s efforts to develop
new DNA vaccines employing its versatile ASPIRE (Antigen SPecific
Immune REsponses) platform that is leading the way forward for
activation immunotherapy. This one-of-a-kind platform delivers
optimized synthetic antigenic genes into cells, where it is
translated into protein antigens that activate an individual's
immune system to generate robust targeted T cell and antibody
responses.
Malaria and TB remain two of the largest global
health problems existing today. Efforts to develop better malaria
control tools have gained new urgency as drug resistance has
rendered the cheapest and most widely-used anti-malarial drugs
useless in many parts of Africa. New combination treatments for
malaria are more effective but have remained out of reach for
millions of Africans due to supply shortages and the relatively
high cost of the drugs. In 2013, there were an estimated 584,000
deaths from malaria with around 90% of these occurring in
sub-Saharan Africa, and 83% in children under the age of five in
sub-Saharan Africa. There is currently no vaccine on the market for
protection against malaria.
Dr. Laurent Humeau, Inovio’s Senior VP, Research
and Development, said, “Inovio is pleased to collaborate with The
Wistar Institute and laboratory of Inovio’s co-founder, Dr. David
B. Weiner, to develop novel, effective vaccines against the global
health threats of malaria and TB. What we learn from developing
vaccines against these infectious disease programs using our
versatile ASPIRE™ technology platform we can also apply to advance
our cancer-focused therapies. This platform is well suited to
address global health outbreaks, with its demonstrated potency and
long safety track record in the clinic as well as its rapid design,
ease of manufacturing and transportation/storage. Based on the
quality of preclinical data, Inovio and collaborators plan to
obtain additional funding to advance the vaccines into clinical
studies.”
“DNA vaccines have a significant public health
potential to rapidly impact emerging pandemics, as this technology
has conceptual safety, development, speed of production, field
stability, and deliverability advantages for vaccine and
immunotherapy development,” said Dr. David B. Weiner, Ph.D.,
executive vice president, director of the Vaccine &
Immunotherapy Center at The Wistar Institute and the W.W. Smith
Charitable Trust Professor in Cancer Research. “These synthetic DNA
approaches can be developed for important infectious diseases, and
with our collaborators, we have shown this consistently by rapidly
engineering multiple synthetic DNA vaccines and advancing them to
clinical study with positive outcomes of safety and immune
potency.”
Inovio and Wistar will also develop and evaluate
a novel SynCon vaccine against TB in non-human primates. This
research will be funded under a National Institutes of Health
(National Institute of Allergy & Infectious Diseases) grant to
Wistar. In use today is a decades-old TB vaccine (BCG) that, while
somewhat effective, has variable protective efficacy and is
unreliable in protecting against pulmonary TB, which accounts for
most of the disease burden worldwide, according to the CDC. A safe,
effective and affordable TB vaccine that covers a broad spectrum of
strains would represent a major advance in the control of the
disease, which is currently experiencing treatment ineffectiveness
due to the rise of multi-drug resistances.
The Inovio/Wistar TB program will also build on
recent clinical success by newer genetic immune modulators focused
on improved T cell and antibody induction. The program will
concentrate on increasing the breadth of coverage induced by
optimized SynCon vaccines by exploring the potential of a
multivalent DNA vaccine targeting multiple TB antigens at both
active and latent stages of infection. Furthermore, Inovio plans to
develop this collection of technologies in a simplified vaccine
scheme that has distinct clinical advantages for global testing.
Tuberculosis is one of the top ten causes of
death worldwide. In 2016, 10.4 million people fell ill with TB, and
1.7 million died from the disease. Over 95% of TB deaths occur in
low- and middle-income countries. Seven countries account for 64%
of the total, with India leading the count, followed by Indonesia,
China, Philippines, Pakistan, Nigeria, and South Africa. In 2016,
an estimated one million children became ill with TB and 250,000
children died of TB (including children with HIV-associated TB). TB
is also the leading killer of HIV-positive people: in 2016, 40% of
HIV deaths were due to TB.
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, Regeneron, Genentech, The Wistar Institute, University
of Pennsylvania, the Parker Institute for Cancer Immunotherapy,
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, including the planned initiation
and conduct of clinical trials and the availability and timing of
data from those trials, and the sufficiency of 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, 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 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, 2016, our Form 10-Q for the
period ended September 30, 2017, and other regulatory filings we
make from time to time. There can be no assurance that any product
candidate in Inovio's pipeline will be successfully developed,
manufactured or commercialized, that final results of clinical
trials 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.
Forward-looking statements speak only as of the date of this
release, and Inovio undertakes no obligation to update or revise
these statements, except as may be required by law.
CONTACTS: Investors:
Ben Matone,
Inovio, 484-362-0076, ben.matone@inovio.comMedia:
Jeff Richardson, Inovio, 267-440-4211, jrichardson@inovio.com
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