PLYMOUTH MEETING, Pa.,
Sept. 17, 2019 /PRNewswire/
-- Inovio Pharmaceuticals, Inc. (NASDAQ: INO) announced today
that the company and its collaborator The Wistar Institute have
received a $4.6 million National
Institutes of Health (NIH) grant in support of innovative research
to tackle antimicrobial resistance (AMR) employing Inovio's
DNA-encoded monoclonal antibodies (dMAb®) platform.
Inovio is advancing a ground-breaking approach to combat
multidrug-resistant infections based on Inovio's dMAbs. In a recent
study, Inovio developed a targeted dMAb approach for AMR and
demonstrated that these dMAbs can effectively control
multidrug-resistant infection in animal models.
The U.S. Centers for Disease Control and Prevention estimates
that resistance to antibiotics causes 2 million illnesses and
23,000 deaths a year in the United
States. Estimates of the impact of antimicrobial resistance
on the U.S. economy include $20
billion in direct health-care costs, with additional
indirect costs as high as $25 billion
a year.
Dr. Laurent Humeau, Executive VP
and Chief Scientific Officer, said, "Antimicrobial resistance
represents an expanding global public health concern and a
tremendous market opportunity for Inovio. While
antibiotic-resistant organisms are appearing at an alarming rate,
there has been a 30-year hiatus in the development of novel classes
of effective antibiotics for combatting these infections. Our
ultimate goal is to create a paradigm shift 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. This grant from the NIH will
further this goal."
Earlier this year, Inovio initiated the first human study of its
dMAb product (INO-A002) to treat and prevent Zika virus infection.
In addition to demonstrating safety and tolerability, this Zika
study marks a major step towards the development of a broad range
of Inovio's dMAb platform targeting cancer, infectious diseases,
and inflammatory diseases. When delivered directly into the body,
the genetic instructions provided by the designed synthetic
antibody gene sequence instruct the body's cells to become the
factory which manufactures the therapeutic antibody (dMAb)
products, enabling a major leap in antibody technology. This
$4.6 million NIH grant will support
additional pre-clinical studies with the ultimate goal of
initiating clinical development for its dMAb technology against
antimicrobial-resistant infections.
Inovio and its collaborators have developed dMAb technology by
designing synthetic genetic sequences encoding functional
monoclonal antibodies into an optimized DNA platform. These gene
sequences are administered in vivo to be expressed locally
at the site of injection. The recipient receives a gene-encoded
blueprint instructing their cells to produce the encoded monoclonal
antibody specifically targeting the bacteria. Inovio's dMAbs can be
developed simply and quickly and are produced directly in the
patient, dramatically lowering production timeline and costs
associated with the manufacturing of conventional antibodies;
furthermore, DNA plasmids encoding for antibodies do not require
expensive cold chain storage and are suitable for delivery in
combinations.
Traditional monoclonal antibodies represent the largest segment
of pharmaceutical markets today, accounting for more than
$100 billion in 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 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.
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 limit
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 DNA plasmids 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 Zika virus (INO-A002) produced a high level of
expression of the antibody in the bloodstream of mice that was
protective against lethal animal challenge; earlier this year,
Inovio initiated the first human study of INO-A002. In addition to
demonstrating safety and tolerability, this Zika dMAb study marks a
major step towards the development of a broad range of Inovio's
dMAb and dBTE programs. Additional studies similarly reported data
showing that dMAb products against Ebola, 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 an innovative biotechnology company focused on the
discovery, development, and commercialization of its synthetic DNA
technology targeted against cancers and infectious diseases.
Inovio's proprietary technology platform applies antigen sequencing
and delivery to enable in vivo protein expression, which can
activate potent immune responses to targeted diseases. The
technology 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 development for the treatment of
HPV-related cervical pre-cancer. Also in development are Phase 2
immuno-oncology programs targeting HPV-related cancers and
glioblastoma, as well as externally funded platform development
programs in Zika, MERS, Lassa, and HIV. Partners and collaborators
include AstraZeneca, Regeneron, Roche/Genentech, ApolloBio
Corporation, GeneOne Life Science, The Bill & Melinda Gates
Foundation, Coalition for Epidemic Preparedness Innovations (CEPI),
Defense Advanced Research Projects Agency, National Institutes of
Health, National Institute of Allergy and Infectious Diseases,
National Cancer Institute, HIV Vaccines Trial Network, Walter Reed
Army Institute of Research, Medical CBRN Defense Consortium (MCDC),
The Wistar Institute, and the University of
Pennsylvania. For more information, visit
www.inovio.com.
This press release contains certain forward-looking
statements relating to our business, including our plans to develop
DNA-based immunotherapies, 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, 2018, our Quarterly Report on Form
10-Q for the quarter ended June 30,
2019, and other filings we make from time to time with the
Securities and Exchange Commission. 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 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.