Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today announced that its
novel DNA-based monoclonal antibody technology will be deployed to
develop products which could be used alone and in combination with
other immunotherapies in the pursuit of new ways to treat and
potentially cure infection from the HIV virus.
In a recently published article, Inovio
demonstrated that a single administration in mice of a highly
optimized dMAb® DNA, which targets HIV, generated antibody
molecules in the bloodstream that possessed desirable functional
activity including high antigen-binding and HIV-neutralization
capabilities against diverse strains of HIV viruses.
Funding for Inovio’s effort to treat and
potentially cure HIV is part of a $23 million grant from the
National Institutes of Health to The Wistar Institute, an Inovio
collaborator. This grant brings together Inovio and more than 30 of
the nation's leading HIV investigators to work on finding a cure
for the virus. The grant, called BEAT-HIV: Delaney Collaboratory to
Cure HIV-1 Infection by Combination Immunotherapy, is one of six
awarded by the NIH as part of the Martin Delaney Collaboratories
for HIV Cure Research.
“A simple, safe and scalable cure for HIV would
accelerate progress toward ending the HIV/AIDS pandemic,” said
National Institute of Allergy and Infectious Disease (NIAID)
Director Anthony S. Fauci, M.D. “Through the leadership of talented
investigators with a diversity of expertise, the Martin Delaney
Collaboratory program will accelerate progress in this key research
endeavor.”
Dr. J. Joseph Kim, Inovio’s President & CEO,
said, “With 37 million people infected with HIV still awaiting a
cure to HIV, we are pleased that our new HIV dMAb products are
expanding our initiative alongside our breakthrough DNA vaccine
products to potentially help these patients.”
Inovio has demonstrated experience in advancing
HIV product candidates. Inovio completed initial clinical studies
of its HIV immunotherapy PENNVAX®-B, targeting clade B viruses, to
achieve proof of principle in generating potent immune responses
using its SynCon® immunotherapy technology. In two published phase
I studies, PENNVAX-B immunization generated high levels of
activated, antigen-specific CD8+ killer T cells with proper
functional characteristics. This ability uniquely positioned
PENNVAX as an important vaccine candidate to prevent and treat HIV
infections.
Using a $25 million grant from the NIAID, Inovio
designed its universal, multi-antigen PENNVAX-GP vaccine targeting
the env, gag and pol antigens to provide global coverage against
all major HIV-1 clades. PENNVAX-GP is Inovio's lead preventive and
therapeutic immunotherapy for HIV and is being evaluated in a phase
I clinical study (HVTN-098) involving 94 healthy subjects as a
preventive vaccine.
About Inovio’s
dMAbs
Monoclonal antibodies (mAb) were a
transformational scientific innovation designed to enhance the
immune system's ability to regulate cell functions. They are
designed to bind to a very specific epitope (area) of an antigen or
cell surface target and can bind to almost any selected target.
The paradigm shift of Inovio's technology is
that the DNA for a monoclonal antibody is encoded in a DNA plasmid,
delivered directly into cells of the body using electroporation,
and the mAbs are "manufactured" by these cells. Using this newly
patented approach, Inovio published that a single administration of
a highly optimized DNA-based monoclonal antibody targeting HIV
virus in mice generated antibody molecules in the bloodstream
possessing desirable functional activity including high
antigen-binding and HIV-neutralization capabilities against diverse
strains of HIV viruses. The potential of this technology was
further demonstrated in two additional published studies where dMAb
products for Chikungunya and dengue viruses were able to completely
protect the treated mice from lethal exposure to these viruses.
All of these feats were not previously
achievable with other DNA-based or viral delivery technologies.
Inovio's transformational approach could be applied to develop
active monoclonal antibody products against multiple
therapeutically important diseases including cancers as well as
inflammatory and infectious diseases. Combined with favorable
pharmacokinetic characteristics and cost structure compared to
conventional monoclonal antibody technology, Inovio's active
in-body generation of functional monoclonal antibodies in humans
has the potential to significantly expand the range of targetable
diseases.
Monoclonal antibodies as a product class have
become one of the most valuable therapeutic technologies of recent
years. In 2012, global sales value of monoclonal antibodies
exceeded $50 billion. Among the top 10 best-selling drugs in 2012,
six of them were monoclonal antibodies, each with annual sales
exceeding $5 billion.
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, Roche, The Wistar Institute, University of Pennsylvania,
DARPA, GeneOne Life Science, Plumbline Life Sciences, Drexel
University, NIH, HIV Vaccines Trial Network, National Cancer
Institute, U.S. Military HIV Research Program, and University of
Manitoba. 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 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, but not limited to, the fact that
pre-clinical and clinical results referenced in this release may
not be indicative of results achievable in other trials or for
other indications, that the studies or trials may not be successful
or achieve the results desired, including safety and efficacy for
VGX-3100 and INO-3112, that pre-clinical studies and clinical
trials may not commence or be completed in the time periods
anticipated, that results from one study may not necessarily be
reflected or supported by the results of other similar studies and
that results from an animal study may not be indicative of results
achievable in human studies), 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, our ability to advance our portfolio of immuno-oncology
products independently, 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, our ability to enter into
partnerships in conjunction with our research and development
programs, evaluation of potential opportunities, 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, 2015,
our Form 10-Q for the quarter ended March 31, 2016, 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.
CONTACTS:
Investors: Bernie Hertel, Inovio Pharmaceuticals, 858-410-3101, bhertel@inovio.com
Media: Jeff Richardson, Inovio Pharmaceuticals, 267-440-4211, jrichardson@inovio.com
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