Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today announced its
DNA-based monoclonal antibody product for flu produced broadly
cross-reactive antibodies that provided complete protection from a
lethal challenge with multiple viruses from both influenza A and B
types in a preclinical study. Results of this study in mice were
published in the journal npj Vaccines in an article entitled “DNA
Inoculation of Synthetic Cross-Reactive Antibodies Protects Against
Lethal Influenza A and B Infections,” authored by Inovio and its
collaborators.
Following on previously reported similar data
from its dMAb® products for HIV, dengue, and Chikungunya, this
study further validates the ability of Inovio’s dMAb technology
platform to use encoded DNA plasmids to enable in vivo production
of monoclonal antibodies and induce protective immune responses.
The goal for this platform is to rapidly generate therapeutic
monoclonal antibodies directly in the recipients. Such benefits are
complementary to Inovio’s antigen-generating platform in terms of
immune mechanism and short response times, and advantages that
overcome conventional monoclonal antibodies’ long development lead
times and complex manufacturing processes and costs.
Inovio’s dMAb products deliver DNA sequences
that encode and directly result in the in vivo production of
protective antibodies, unlike its DNA vaccines which attempt to
incite the production of antibodies through the immune system. In
the case of influenza and other infectious disease, a dMAb product
may provide immediate and short term protection while a DNA vaccine
may provide long term immune memory and protection. Both products
can be encoded to provide cross-strain protection. Inovio’s
influenza dMAb product was designed to provide cross-strain
protection across two major sub-types of influenza, A and B. This
approach would bypass the burdensome design and manufacturing
approach for conventional monoclonal antibodies that make them less
ideal for pandemic situations and would be desirable in their
potential ability to offer prevention against unexpected changes of
seasonal influenza strains.
“The annual flu vaccine matching process is not
a perfect science, therefore in some flu seasons the vaccine
available in the fall is much less effective,” said Dr. David B.
Weiner, Executive Vice President and Director of the Vaccine and
Immune Therapy Center at The Wistar Institute and the lead author
of the study. “Flu occasionally can dramatically shift strains,
resulting in a pandemic strain that requires a new strategy for
developing a vaccine and leaving populations at risk of major
health consequences. Furthermore, some vulnerable people may not
respond well to vaccines and this new approach that is simple,
rapid and can broadly protect against influenza would be a major
step forward,” said Dr. Weiner, who is also a member of the Inovio
board and a scientific adviser.
Dr. J. Joseph Kim, Inovio's President and CEO,
said, “Inovio’s dMAb products represent a new class of products we
are developing to treat cancers and infectious diseases using our
potent platform. Funded by over $60 million in grants from DARPA,
NIH, and the Gates Foundation, these dMAb products can extend the
medical benefits that marketed monoclonal antibodies have already
achieved and potentially address diseases that conventional
monoclonal antibodies cannot. With respect to influenza, our dMAb
product offers a new game-changing model to address seasonal and
pandemic influenza with a single dose. We look forward to advancing
the first dMAb product – our therapeutic Ebola product funded by
DARPA – into human testing in 2018.”
While Inovio is advancing its dMAb technology
against infectious disease targets, this platform is applicable
beyond these diseases. Conventional monoclonal antibodies are
costly and time consuming to develop, produce and study. They are
manufactured outside the body, typically requiring costly
large-scale manufacturing facility development and laborious
production. Inovio’s DNA-based monoclonal antibodies have the
potential to overcome these limitations by virtue of their
simplified design, rapidity of development, product stability, ease
of manufacturing and deployablity, and cost effectiveness, thereby
providing potential new avenues for treating a range of
diseases.
This published study was supported by grants
from DARPA and the National Institutes of Health for a
collaborative study that, in addition to Inovio, includes
scientists from The Wistar Institute and MedImmune, AstraZeneca’s
global biologics research and development arm.
About Inovio’s DNA-based Monoclonal
Antibody Platform
The significant advancement seen in Inovio’s
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 Ebola,
chikungunya and dengue protected animals against lethal challenge.
Inovio’s Ebola dMAb® product is being developed under a grant from
the Defense Advanced Research projects Agency (DARPA).
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, 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 and dMAb® products, 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 its dMAb®
technology, 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, 2016,
our Form 10-Q for the quarter ended March 31, 2017, 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.
In addition, the forward-looking statements
included in this press release represent Inovio’s views as of the
date hereof. Inovio anticipates that subsequent events and
developments may cause its views to change. However, while Inovio
may elect to update these forward-looking statements at some point
in the future, the company specifically disclaims any obligation to
do so, except as may be required by law. These forward-looking
statements should not be relied upon as representing Inovio’s views
as of any date subsequent to the date of this release.
CONTACTS:
Investors/Media: Jeff Richardson, Inovio Pharmaceuticals, 267-440-4211, jrichardson@inovio.com
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