PLYMOUTH MEETING, Pa.,
Feb. 20, 2019 /PRNewswire/
-- Inovio Pharmaceuticals, Inc. (NASDAQ: INO) in collaboration
with The Wistar Institute and the University
of Pennsylvania announced today that the first subject was
dosed as part of the first-ever human study of Inovio's DNA-encoded
monoclonal antibody (dMAb™) technology. Funded fully by the Bill
& Melinda Gates Foundation, this trial's focus is on evaluating
the dMAb's (INO-A002) ability to prevent or treat Zika virus
infection. The clinical results will also help to broadly advance
Inovio's dMAb programs in infectious diseases and cancer. When
delivered directly into the body, the genetic codes provided by the
synthetic dMAbs, instruct the body's cells to become the factory
which manufactures the therapeutic antibody products, enabling a
major leap forward in antibody technology.
Dr. J. Joseph Kim, Inovio's
President and CEO, said, "This first-in-human study could provide
important information about how DNA-encoded products may be used to
make systemically-available complex therapeutic proteins in a
consistent, dose-dependent fashion. This platform advancement, most
importantly, could lead to production of other dMAb products
targeting infectious diseases, cancer immunotherapy, inflammation,
as well as therapies for cardiovascular disease – all with
blockbuster market potential which we plan to develop with
corporate partnerships, external funding and collaborations."
Inovio recently reported successful development of optimized
dMAbs targeting the immune checkpoint molecule PD-1. This
breakthrough preclinical data demonstrated that a single injection
of synthetic designer dMAb versions of pembrolizumab or nivolumab
sequences targeting PD-1 protein can be robustly redeveloped to be
expressed directly in vivo in mice for up to several months.
Furthermore, Inovio's proprietary sequence optimization of the
molecular design of these therapeutics resulted in significantly
improved expression compared to the original PD-1 inhibitor native
sequences while maintaining identical binding capabilities.
For the Zika dMAb trial, Inovio is partnered with The Wistar
Institute with grant funding from the Bill & Melinda Gates
Foundation to support and advance this innovative program through
clinical testing. This open-label trial is a single center, dose
escalation trial that will enroll up to 24 healthy volunteers who
will receive up to four doses of INO-A002. The trial is led by
Pablo Tebas, M.D., Professor of
Medicine at the Hospital of the University of
Pennsylvania.
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 an alternative 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 produced
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.
Inovio's disruptive dMAb technology has the potential to overcome
these limitations by virtue of their simplified design, rapidity of
development, product stability, ease of manufacturing and
deployability, and cost effectiveness, thereby providing potential
new avenues for treating a range of diseases. Another significant
advancement seen in Inovio dMAb technologies is that the optimized
genes for a desired monoclonal antibody is encoded in a DNA
plasmid, which is produced using very cost effective and highly
scalable fermentation techniques. These plasmids are delivered
directly into cells of the body using electroporation and the
encoded monoclonal antibody is then directly produced by these
cells. Previously published studies show that a single
administration of a highly optimized DNA-based monoclonal antibody
targeting HIV virus produced a high level of expression of the
antibody in the bloodstream of mice; Inovio similarly reported data
showing that dMAb products against flu, Ebola, chikungunya and
dengue protected animals against lethal challenge.
About Inovio Pharmaceuticals, Inc.
Inovio is a late-stage biotechnology company focused on the
discovery, development, and commercialization of DNA-based
immunotherapies and vaccines that transform the treatment and
prevention of cancer and infectious disease. Inovio's proprietary
technology platform applies 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'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
HPV-related cancers, bladder cancer, and glioblastoma, as well as
platform development programs in hepatitis B, Zika, Ebola, MERS,
and HIV. Partners and collaborators include MedImmune, Regeneron,
Roche/Genentech, ApolloBio Corporation, The Wistar Institute, The
Bill & Melinda Gates Foundation, the University of Pennsylvania, Parker Institute for
Cancer Immunotherapy, CEPI, DARPA, GeneOne Life Science, Plumbline
Life Sciences, NIH, HIV Vaccines Trial Network, National Cancer
Institute, U.S. Military HIV Research Program, Drexel University, 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 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 we undertake no
obligation to update or revise these statements, except as may be
required by law.
CONTACTS:
Investors:
|
Ben Matone,
484-362-0076, ben.matone@inovio.com
|
Media:
|
Jeff Richardson,
267-440-4211, jrichardson@inovio.com
|
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SOURCE Inovio Pharmaceuticals, Inc.