PLYMOUTH MEETING, Pa.,
Jan. 7, 2019 /PRNewswire/
-- Inovio Pharmaceuticals, Inc. (NASDAQ: INO) in collaboration
with The Wistar Institute and the University
of Pennsylvania announced today the initiation of the first
human study of its DNA-encoded monoclonal antibody
(dMAb™) technology to prevent Zika virus infection. In
addition to demonstrating safety and tolerability, starting at
lower and then increasing doses in this Phase 1 dose-escalation
study of INO-A002. When delivered directly into the body, the
genetic instructions provided by the designed synthetic dMAbs,
instruct the body's cells to become the factory which manufactures
the therapeutic antibody products, enabling a major leap in
antibody technology.
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Dr. J. Joseph Kim, Inovio's
President and CEO, said, "Initiating this first human trial is a
milestone for Inovio and a major potential advancement for a
potentially breakthrough class of medicines – DNA-encoded
monoclonal antibodies – produced directly in the human body via the
dMAb technology, pioneered by Inovio and our collaborators. While
this trial targets Zika virus infection, we will gain important
data from this study towards development of a broad range of our
dMAb programs targeting infectious diseases, cancer immunotherapy,
inflammation, as well as therapies for cardiovascular disease. Our
goal was to create a new improved approach to monoclonal antibody
technology that results in a pipeline of high impact dMAb products,
which can be developed with corporate partnerships, external
funding and collaborations."
The Wistar Institute was awarded funding via a grant from the
Bill & Melinda Gates Foundation to support and advance this
innovative research into the clinic. David
B. Weiner, Ph.D., executive vice president, director of
Wistar's Vaccine & Immunotherapy Center, and the W.W. Smith
Charitable Trust Professor in Cancer Research at Wistar, led the
research efforts and is working with partners to advance this
new generation of DNA-based technologies. This open-label trial is
a single center, dose escalation trial will enroll up to 24 healthy
volunteers who will receive up to four doses of INO-A002. The trial
will be led by Pablo Tebas, M.D.,
Professor of Medicine at the Hospital of the University of Pennsylvania.
"Through detailed preclinical studies developing this new
platform, the team has demonstrated the in vivo production by
synthetic DNA technology of dMAbs using the CELLECTRA®
delivery system," said Weiner. "These antibodies (produced in the
body) can display improved kinetics with simple stable formulations
providing disease protection in animal challenge models. We are
very excited to have contributed to the conception and development
of this technology and to participate in this first human trial of
a synthetic DNA-encoded monoclonal antibody. This approach
represents the potential for major advancement over traditional MAb
approaches and may broaden therapeutic strategies and open new
patient markets to the benefits of antibody-based therapies for
disease prevention or treatment."
Traditional monoclonal antibodies represent the largest segment
of pharmaceutical markets today, accounting for more than
$100 billion in pharmaceutical sales
each year, with treatments spanning cancer, infectious diseases,
inflammation and cardiovascular diseases. With its synthetic design
and in-patient production, dMAb products represent a disruptive
entrant to this important class of pharmaceuticals. Inovio and its
collaborators have already received over $60
million in non-dilutive grant funding to advance its dMAb
platform in the last few years. There is a significant interest in
dMAb's as a disruptive entrant to a highly valuable overall
monoclonal antibody market as well as its unique applicability for
rapid responses against emerging global infectious disease threats
and for addressing critical vaccine limitations.
In just the past few years, Inovio and collaborators have
published multiple impactful papers consistently demonstrating
potent preclinical data from the dMAb platform, with therapeutic
displays spanning protection against deadly infections to
eliminating cancers and lowering life-threatening levels of
cholesterol. In this regard dMAbs offer unique features for rapid
production, deployment and advancement of new MAb-like biologics,
with much increased efficiency. In addition, the dMAb's
constructed in vivo likely may have additional advantages such as
expression profiles, as well as glycosylation, and unlike
traditional MAb approaches, there is no reliance on in vivo tissue
culture and costly or time-consuming production systems.
Studies such as INO-002 are important to provide the initial data
for expanding this valuable platform. In addition,
Inovio collaborative studies have recently reported on the
development of several dMAb checkpoint inhibitors which in animal
studies reproduce faithfully the anti-cancer effects of the
biologic molecules. Inovio directly and through their
sponsored research has established a significant patent estate in
this area.
About Inovio's DNA-based Monoclonal Antibody
Platform
Traditional monoclonal antibodies are manufactured outside the
body in bioreactors, typically requiring costly large-scale
manufacturing facility development and laborious production.
In addition, post production storage and formulation stability
limits the reach of some of these products. Inovio's disruptive
dMAb technology has the potential to overcome these limitations by
virtue of their simplified design using novel plasmid vectors and
unique formulations allowing for rapidity of development, improved
product stability, ease of manufacturing and deployability,
ultimately all resulting in increases in cost effectiveness and
reach, providing potential new avenues for treating a range of
diseases. The dMAbs are delivered directly into cells of the body
and the encoded monoclonal antibody is then produced by the locally
transfected cells. Previously published studies show that a single
administration of a highly optimized DNA-based monoclonal antibody
targeting Ebola virus produced a high level of expression of the
antibody in the bloodstream of mice that was protective against
lethal animal challenge; Additional studies similarly reported data
showing that dMAb products against flu, chikungunya, Lyme, and
dengue protected animals against lethal or pathogenic challenge. In
addition, the team has reported delivery of dMAbs that impact
prostate as well as breast and ovarian cancers in
animals.
About Inovio Pharmaceuticals, Inc.
Inovio is a biotechnology company focused on the discovery,
development, and commercialization of DNA immunotherapies that
transform the treatment of cancer and infectious diseases. Inovio's
proprietary platform technology applies next-generation antigen
sequencing and DNA delivery to activate potent immune responses to
targeted diseases. The technology functions exclusively in
vivo, and has been demonstrated to consistently activate robust and
fully functional T cell and antibody responses against targeted
cancers and pathogens. Inovio is the only immunotherapy
company that has reported generating T cells whose killing capacity
correlates with relevant clinical outcomes. Inovio's most
advanced clinical program, VGX-3100, is in Phase 3 for the
treatment of HPV-related cervical pre-cancer. Also, in
development are Phase 2 immuno-oncology programs targeting head and
neck cancer, bladder cancer, and glioblastoma, as well as platform
development programs for hepatitis B, Zika, Ebola, MERS, and HIV.
Partners and collaborators include MedImmune, Regeneron,
Roche/Genentech, ApolloBio Corporation, The Bill & Melinda
Gates Foundation, The Wistar Institute, University of Pennsylvania, Parker Institute for
Cancer Immunotherapy, CEPI, DARPA, GeneOne Life Science, Plumbline
Life Sciences, 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.
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 us or our collaborators, including
alternatives that may be more efficacious or cost effective than
any therapy or treatment that we and our collaborators hope to
develop, issues involving product liability, issues involving
patents and whether they or licenses to them will provide us 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 we can finance or devote other
significant resources that may be necessary to prosecute, protect
or defend them, the level of corporate expenditures, assessments of
our 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, 2017, our Quarterly Report on Form
10-Q for the quarter ended September 30,
2018 and other regulatory filings we make from time to time.
There can be no assurance that any product candidate in our
pipeline will be successfully developed, manufactured or
commercialized, that 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 we undertake no obligation to update
or revise these statements, except as may be required by
law.
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SOURCE Inovio Pharmaceuticals, Inc.