Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today announced that the
development of its DNA-based monoclonal antibody program received a
boost from two peer-reviewed scientific papers that demonstrate
their impact on prostate tumors and in preventing infection from a
pneumonia-causing bacteria in preclinical studies.
Dr. J. Joseph Kim, Inovio's President and CEO,
said, “Many of the top-selling drugs on the market today are
monoclonal antibodies; our dMAb products may improve upon this
class using our synthetic design and in vivo production. In
fact, we are advancing our first dMAb product – our therapeutic
Ebola product funded by DARPA – into human testing next year,
opening the path for commercializing these new products to treat
cancer and infection. These two newly published studies further
support that Inovio’s potent dMAb platform could be expanded to
target cancer and bacterial diseases along with viral infectious
diseases. Our dMAb program represents a new application of
our potent DNA technology platform to develop valuable new
treatments for cancers and infection.”
An article in the journal Cancer Immunology,
Immunotherapy detailed how the dMAbTM construct against prostate
specific membrane antigen (PSMA) produced monoclonal antibodies
that shrank prostate tumors in a preclinical animal model.
The article is entitled, “Novel cancer immunotherapy with
DNA-encoded anti‑prostate‑specific membrane antigen monoclonal
antibody,” by Inovio researchers and collaborators.
This research publication is significant because
it is the first to report on the use of Inovio dMAb technology to
develop novel monoclonal antibody-based therapies against cancer
targets. This new dMAb construct utilizes engineered synthetic DNA
to encode therapeutic monoclonal antibodies targeted to bind PSMA.
When delivered directly into the body, the genetic instructions
provided from the dMAb construct enable the patient’s own cells to
become the factory which manufactures the therapeutic monoclonal
antibody products. The PSMA dMAb antibody was expressed in high
levels directly in mice and successfully regressed human prostate
cancer cells grown in transgenic mice. Inovio has previously
published several papers demonstrating its dMAb product candidate’s
ability to treat multiple virus targets such as flu, dengue,
chikungunya, and HIV.
The anti-cancer dMAb products work by binding
the antigens on the cancer cells and killing them by an antibody
dependent cytotoxicity (ADCC) mechanism in conjunction with natural
killer (NK) cells. These results indicate the potential clinical
utility of the dMAb therapeutic strategy against prostate cancer as
well as other cancers. The data is especially interesting since the
anti-cancer dMAb products utilize an NK cell-killing mechanism
which is distinct from the killer T cell mechanisms generated by
Inovio’s cancer vaccine products like INO-5150 and
INO-5401.
In another first, Inovio also published results
showing its dMAb constructs targeting antibiotic-resistant bacteria
protected mice when challenged with a lethal dose of drug-resistant
pseudomonas -- a pneumonia-causing bacteria. Pseudomonas infections
usually occur in people in the hospital or with weakened immune
systems. The CDC reports each year that more than two million
Americans acquire antibiotic-resistant infections that are becoming
increasingly more difficult and costly to treat. The bacteria can
cause infections of the blood, pneumonia, and infections following
surgery that can lead to severe illness and death.
To design an effective treatment, Inovio
engineered dMAb constructs encoding two pseudomonas antigens. The
constructs were protective against lethal pneumonia, prevented
severe lung pathology and even exhibited enhanced protective
activity when combined with antibiotics. This paper is also
significant for Inovio to demonstrate that dMAb constructs could be
successfully designed to generate bispecific monoclonal antibodies.
Bispecific monoclonal antibodies are engineered synthetic
antibodies which could simultaneously bind two different antigens,
and this technique is very difficult to achieve using traditional
protein-based monoclonal technology. These results further support
the sophisticated capabilities built into Inovio dMAbTM
technology. Results from this study were published in Nature
Communications, in an article entitled, “DNA-delivery of mono- and
engineered bispecific monoclonal antibodies protect against
multidrug resistant Pseudomonas aeruginosa,” authored by Inovio and
its collaborators at The Wistar Institute and MedImmune,
AstraZeneca’s global biologics research and development arm.
Funded with over $60 million in R&D support
from top agencies like DARPA, NIH, and the Gates Foundation, Inovio
dMAb products could extend the medical benefits that marketed
monoclonal antibodies have already achieved, and even potentially
address diseases that conventional monoclonal antibodies cannot.
For instance in immuno-oncology, Inovio is already developing
PD-1/PD-L1 as well as other checkpoint inhibitors in its cancer
dMAb portfolio.
Even though conventional monoclonal antibodies
represent one of the most successful segments of the biotechnology
market, accounting for over $50 billion in sales today, they are
still costly and time consuming to develop, produce and study. They
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 deplorability, and cost effectiveness, thereby
providing potential new avenues for treating a range of
diseases.
About Inovio’s DNA-based Monoclonal
Antibody Platform
Funded by over $60 million in R&D support in
the last 3 years, Inovio has rapidly advanced this transformative
approach in a systemic way. Earlier this year Inovio reported its
influenza dMAb produced broadly cross-reactive antibodies that
provided complete protection from a lethal challenge with multiple
viruses from both influenza A and B types. The flu dMAb paper
expanded on similar data from our dMAb products for other viral
targets including HIV, dengue, and chikungunya. Together with the
two new published studies demonstrating the potential of Inovio
dMAb platform to cancer and bacterial diseases, these results fully
demonstrate the potential of this platform to target multiple
medical markets.
The 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. Inovio 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 dMAbTM products, 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
development of Inovio dMAb products, 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 June 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. 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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