Inovio Pharmaceuticals, Inc. (Nasdaq:INO) announced today that the
company and its academic collaborators, including the University of
Pennsylvania (UPenn), were awarded a new five-year $16 million
Integrated Preclinical/Clinical AIDS Vaccine Development Program
grant from the National Institute of Allergy and Infectious
Diseases (NIAID).
This five-year program grant was awarded based on the clinical
successes of Inovio's PENNVAX® HIV vaccine program. The grant will
fund research to expand PENNVAX coverage of HIV strains as well as
to further enhance antibody responses generated by the vaccine.
New PENNVAX envelope constructs will be designed and tested with
Inovio's DNA-based immune activator encoding novel cytokine genes
and will be studied in a prime-boost strategy with recombinant HIV
envelope proteins. The collaborators will assess different
combinations in preclinical models with the goal of generating high
levels of neutralizing antibodies mirroring the robust CD8+ T cell
responses generated by Inovio's PENNVAX-B DNA vaccine in previously
published clinical studies. The overall goal of this project is to
further build upon this important HIV vaccine approach as well to
gain fundamental insight into new technologies to improve
vaccination outcomes.
As part of this grant consortium, Inovio will couple its
expertise in constructing, developing and manufacturing HIV
vaccines with researchers from four world-leading academic
institutions (University of Pennsylvania, Emory University, Duke
University and the University of Massachusetts) along with VGXi, a
contract DNA plasmid manufacturer, and Waisman Biomanufacturing, a
contract protein manufacturer.
Dr. J. Joseph Kim, President and CEO, said, "On behalf of our
team of preeminent academic collaborators, we are honored to
receive this significant new grant from the NIAID. Having completed
the development of PENNVAX-GP under a prior $25 million NIAID
grant, we are on track to separately initiate a phase I study of
this HIV vaccine. This additional NIAID funding allows us to
immediately continue and expand the development of PENNVAX
vaccines. We have one of the most dynamic HIV programs in the world
and we look forward to pursuing any and all scientific exploration
to achieve an answer to this challenging disease using our novel
DNA immunotherapy approach."
The NIAID previously awarded Inovio a $25 million grant to
develop PENNVAX-GP. UPenn was a collaborating partner on that award
as well for the pre-clinical development activities. A phase I
study of PENNVAX-GP is expected to start in the first half of
2015.
About PENNVAX® HIV Vaccines and
Immunotherapies
Human immunodeficiency virus (HIV) is a retrovirus that causes
acquired immunodeficiency syndrome (AIDS), a condition in which
progressive failure of the immune system allows life-threatening
opportunistic infections and cancers to thrive. HIV is classified
into clades, sub-types within which the virus has genetic
similarities. The most prevalent clades are B (found mainly in
North America and Europe), A and D (found mainly in Africa), and C
(found mainly in Africa and Asia).
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® vaccine technology. In two published phase I studies,
PENNVAX-B immunization has been shown to generate high levels of
activated, antigen-specific CD8+ killer T cells with proper
functional characteristics. This ability uniquely positions PENNVAX
as an important product candidate for both preventing and treating
HIV infections.
Using a $25 million grant from the NIH, Inovio designed its
multi-clade, multi-antigen PENNVAX-GP immunotherapy targeting
viruses from clades A, B, C and D. PENNVAX-GP is Inovio's lead
preventive and therapeutic immunotherapy for HIV.
About Inovio Pharmaceuticals, Inc.
Inovio is revolutionizing the fight against cancer and
infectious diseases. Our immunotherapies uniquely activate
best-in-class immune responses to prevent and treat disease, and
have shown clinically significant efficacy 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 Roche,
MedImmune, University of Pennsylvania, DARPA, 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, 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 immune
therapy and vaccine products, our ability to advance our portfolio
of immune-oncology products independently, including INO-5150, and
to commence a phase I clinical trial for INO-5150 in the first half
of 2015, 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, 2014,
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.
CONTACT: 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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