Two new U.S. Patents for Inovio’s dMAb
technology were issued
Inovio Pharmaceuticals, Inc. (NASDAQ:INO) announced today that it
has received the first two U.S. patents for its DNA-encoded
monoclonal antibody technology (dMAb™) from the U.S. Patent &
Trademark Office and has been awarded a $2.2 million grant from the
Bill & Melinda Gates Foundation to advance its dMAb platform
and new clinical delivery devices.
This U.S. patent protection of Inovio’s dMAb
intellectual property will provide exclusivity for the use of this
innovative technology. Additional support for Inovio’s dMAb
platform has come from the Bill & Melinda Gates Foundation
which has invested $2.2 million to advance Inovio’s dMAb platform
and to support the development of next-generation clinical DNA
delivery devices. Inovio’s dMAbs have high applicability for
rapidly responding to emerging global viral threats and addressing
critical vaccine limitations.
Inovio will employ the Gates Foundation grant to
design and test its dMAb constructs targeting priority pathogens in
preclinical studies. This funding will also help further develop
Inovio’s innovative DNA delivery technology to enhance both dMAb
expression and the ease of use in the clinic and low resource
settings.
Traditional monoclonal antibodies account for
more than $50 billion in pharmaceutical sales each year and
Inovio’s dMAb products may improve upon this class using its
synthetic design and in patient production. When delivered directly
into the body, the genetic instructions provided by the DNA plasmid
may enable the patient’s own cells to become the factory which
manufactures the therapeutic antibody products or dMAbs.
Laurent Humeau, Ph.D., Inovio’s Senior Vice
President – R&D, said, "We thank the Gates Foundation for their
investment in Inovio’s innovative technology and their
understanding of the role Inovio can play in protecting and
improving global health. We continue to see positive preclinical
data as well as growing support and funding from partners and
collaborators on our dMAb platform. We plan on advancing the first
clinical dMAb candidate into the first-in-human study in the coming
months and expect to attract additional partnerships to further
advance dMAb products targeting cancers and infectious
diseases."
While monoclonal antibody therapies have
revolutionized medicine, they are expensive and cumbersome to
produce taking them out of reach for most developing world areas.
Inovio’s dMAbs may address critical vaccine limitations because
they can be rapidly designed and scaled up in response to an
outbreak and are stable at room temperature – offering potential
advantages over traditional vaccines which require cold-chain
storage and shipping. Inovio’s dMAbs may also provide rapid
protection, unlike traditional vaccines that take days to begin
offering viral protection and they may eliminate the need for viral
culture, facilitating easy dMAb protective combinations, and
negating the need for annual vaccine antigen specificity matching –
while also decreasing cost and production restrictions associated
with traditional protein monoclonal antibodies (mAbs) as a
preventative for infectious diseases.
Inovio has been moving its cancer and infectious
disease dMAb franchise forward with several key milestones. Inovio
recently announced the successful animal testing of its dMAbs
targeting the immune checkpoint molecule CTLA-4, as reported in the
prestigious journal Cancer Research. The breakthrough preclinical
study demonstrated that highly optimized dMAbs targeting mouse
CTLA-4 protein can be robustly expressed in vivo, and shrank tumors
in mice. More importantly, Inovio’s dMAb constructs for anti-human
CTLA-4 antibodies ipilimumab (YERVOY®) and tremelimumab, achieved
high expression levels in mice (approximately 85µg/ml and 58µg/ml,
respectively). These dMAbs exhibited long-term expression with
maintenance of serum levels >15µg/ml for over a year.
A recent article in the journal Cancer
Immunology, Immunotherapy detailed how the dMAb construct against
prostate specific membrane antigen (PSMA) produced monoclonal
antibodies that shrank prostate tumors in a preclinical animal
model. This study was significant because it was the first to
report on the use of Inovio dMAb technology to develop novel
monoclonal antibody-based therapies against cancer targets. 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.
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. Inovio Ebola
dMAb™ product is being developed under a grant from the Defense
Advanced Research Projects Agency (DARPA).
About Inovio Pharmaceuticals,
Inc.
Inovio is a late-stage biotechnology company
focused on the discovery, development, and commercialization of DNA
immunotherapies that transform the treatment of cancer and
infectious diseases. Inovio’s proprietary platform technology
applies next-generation 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
is the only immunotherapy company that has reported generating T
cells whose killing capacity correlates with relevant clinical
outcomes. 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 head
and neck cancer, 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 Bill & Melinda
Gates Foundation, The Wistar Institute, University of Pennsylvania,
Parker Institute for Cancer Immunotherapy, CEPI, DARPA, GeneOne
Life Science, Plumbline Life Sciences, 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, 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 our plans and expectations regarding
partnerships. 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 June 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: |
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Investors:Media: |
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Ben Matone,
Inovio, 484-362-0076, ben.matone@inovio.comJeff Richardson, Inovio,
267-440-4211, jrichardson@inovio.com |
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