PLYMOUTH MEETING, Pa.,
April 18, 2019 /PRNewswire/ -- Inovio
Pharmaceuticals, Inc. (NASDAQ: INO) announced today the company's
novel DNA-encoded Bi-specific T Cell Engagers (dBiTEs) generated
potent anti-tumor activities and cleared established tumors in
preclinical studies. Inovio's dBiTE results were published in a
JCI Insight article entitled, "DNA-encoded bi-specific T
cell engagers and antibodies present long-term antitumor activity,"
by Inovio and its collaborators at The Wistar Institute. JCI
Insight is a peer-reviewed journal published by the American
Society for Clinical Investigation dedicated to well-executed
preclinical and clinical research studies.
For this study, Inovio developed a novel dBiTE targeting the
HER2 molecule which was tested in therapeutic models for the
treatment of ovarian and breast cancers. Importantly, just a single
dose of Inovio's HER2 dBiTE resulted in high levels of
corresponding BiTE in mice for up to four months, exceeding what is
typically displayed with the currently approved BiTE's short
half-life of only a few hours. The HER2 dBiTE treatment effectively
killed HER2-expressing tumor cells resulting in a near-complete
tumor clearance.
Dr. J. Joseph Kim, Inovio's
President and CEO, said, "Inovio's dBiTEs represent game-changing
advancements in immuno-oncology. Leveraging Inovio's in vivo
synthetic nucleic expression platform, we have shown that just one
dose of Inovio's dBiTE could generate corresponding BiTEs at high
levels for several months, demonstrating a dramatic advantage over
conventional BiTEs. Our dBiTE technology could be utilized to
overcome the greatest shortcomings of traditional BiTEs,
particularly its incredibly short half-life. Based on these
promising preclinical results, we plan to rapidly advance our first
dBiTE candidate into clinical testing, as well as develop more
cancer tumor-targeting dBiTEs as partnering candidates."
BiTEs are a class of artificial bi-specific monoclonal
antibodies that has the potential to transform the immunotherapy
landscape for cancer. They direct a host's immune system, more
specifically the T cells' cytotoxic activity, against cancer cells.
In layman's terms, BiTEs are like a double-sided tape that binds to
a tumor and to a cancer-killing T cell. One domain of the BiTE
binds to the targeted tumor (like HER2 or CD19 expressing cells)
while the other engages the immune system by binding directly to
CD3 molecules on T cells. This double-binding activity drives T
cell activation directly at the tumor resulting in a killing
function and tumor destruction.
The biggest drawback of conventional protein-based BiTEs is
their short half-life. The BiTEs have a half-life of only two
hours, which requires patients to undergo continuous intravenous
infusion for several weeks to maintain therapeutic levels, making
treatment adherence more difficult and resulting in high levels of
infusion-associated adverse events. In addition, just like other
traditional monoclonal antibodies, conventional BiTEs are also
manufactured in bioreactors, typically requiring costly large-scale
manufacturing facility development and laborious production as well
as having to deal with improper product folding and stability. They
must also be kept and distributed frozen at all times. These
difficulties collectively have limited the development and
commercialization of conventional BiTEs as only one licensed
product is currently on the market (BLINCYTO®
(blinatumomab)).
Inovio's dBiTE is a new transformative application of Inovio's
dMAb™ platform. The dBiTEs share many advantages of
Inovio's dMAbs as they both are composed of engineered DNA
sequences which encode antibody fragments. When administered by
Inovio's CELLECTRA® delivery device, the patient's own
cells become the factory to manufacture functional BiTES encoded by
the delivered dBiTE sequences. Inovio's dBiTEs are developed with
novel syntheic nucleics design using plasmid vectors and unique
formulations allowing for rapidity of development, long-term
product stability at refrigeration, ease of validated and scalable
manufacturing and deployability.
About Inovio's dBiTE program
Inovio's dBiTEs are able to target the cytotoxic T cells to
tumors by engaging proteins expressed in the tumor surface. The
current preclinical models have shown proof that DNA technologies
are in an advantageous position to launch a more ambitious BiTE
program. The tumor-binding domain can be modified to engage
multiple targets, of which preclinical data targeting HER2 and CD19
has been presented. Of these, the CD19dBiTE can be used to target B
cell cancers and the HER2dBiTE can be used to treat advanced
breast, ovarian, gastric, esophageal and endometrioid cancers.
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 AstraZeneca, 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, Walter Reed
Army Institute of Research, 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, 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:
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Investors:
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Ben Matone,
484-362-0076, ben.matone@inovio.com
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Media:
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Jeff Richardson,
267-440-4211, jrichardson@inovio.com
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SOURCE Inovio Pharmaceuticals, Inc.