BLUE BELL, Pa., June 17, 2014 /PRNewswire/ -- Inovio
Pharmaceuticals, Inc. (NYSE MKT: INO) has expanded its existing
license agreement with the University of
Pennsylvania, adding exclusive worldwide rights to
technology and intellectual property for novel synthetic therapies
against cancer, infectious diseases and new immune activators.
Inovio has an ongoing collaborative research agreement with the
university to support fundamental research in the area of DNA-based
vaccines and immunotherapies. All newly licensed products are in
preclinical development.
These new pipeline candidates were developed using Inovio's
SynCon® design approach and were constructed and tested
in preclinical animal models for their ability to generate potent
antigen-specific T cell and antibody responses. Multiple patents
have been filed and several manuscripts are being prepared for
peer-reviewed journal publications.
Overall, this amendment broadens and strengthens the patent
protection around previously licensed oncology and infectious
disease targets by in-licensing expanded patents covering candidate
products for DNA based synthetic antibodies and those covering
dengue fever, H7N9 influenza, additional HPV serotypes as well as
certain other undisclosed cancer antigen targets.
In addition, the amended agreement provides Inovio global rights
to:
- DNA-based synthetic antibodies – DNA plasmids are able to
generate not only antigens and immune activators, but also encode
for various monoclonal antibodies. Monoclonal antibodies (mAb) 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.
mAbs have the unique ability to alert the immune system to attack
and kill specific cancer cells (as in the case of
Yervoy®) or block certain biochemical
pathways (such as those leading to rheumatoid arthritis, as in the
case of Remicade®). Monoclonal
antibodies, with their designer capabilities and potency, have
consequently become a powerful class of products against cancers,
autoimmune diseases such as rheumatoid arthritis, and neurological
diseases such as multiple sclerosis.
- Immune Activators (IL-21, IL-23 & IL-33) -- Immune
activators can play a vital role in augmenting antigen-specific
immune responses such as those generated by Inovio's DNA vaccines.
Inovio has already deployed two different DNA immune activators
(IL-12 and IL-28) in human studies. In a published clinical study,
its DNA-based IL-12 immune activator significantly enhanced
antigen-specific T cell immune responses from its HIV DNA vaccine,
PENNVAX®: 89% of the subjects who
received IL-12 DNA together with the PENNVAX® DNA vaccine delivered
with electroporation produced a vaccine specific CD4+ or CD8+ T
cell response compared to 67% who received the DNA vaccine alone
without the IL-12 DNA. Under the amended license agreement with
UPenn, Inovio also licensed additional intellectual property
covering IL-12 encoded DNA plasmids, further strengthening Inovio's
IP position on IL-12. Initial data in animal models suggests that
IL-21, IL-23 and IL-33 also have the potential to exert powerful
influences on the immune system.
- Middle East Respiratory Syndrome (MERS) -- Since the infection
was identified in 2012, 42% of MERS cases have been fatal. MERS is
similar to the SARS virus which infected 8,000 people several years
ago; but MERS is almost five times as fatal as SARS. There is
currently no vaccine or effective treatment for MERS.
- Tuberculosis – TB is second only to HIV/AIDS as the greatest
killer worldwide due to a single infectious agent. In 2012, 8.6
million people fell ill with TB and 1.3 million died from the
infection.
Dr. J. Joseph Kim, Inovio's
President and CEO, said, "Our SynCon® technology offers
the potential to treat and/or prevent a broad array of cancers and
infectious diseases, and has achieved best-in-class immune
responses in human studies. This new intellectual property from the
University of Pennsylvania expands the
development and commercialization opportunities we can pursue with
our core technology."
Under the terms of the original license agreement completed in
2007 and expanded via subsequent amendments, Inovio obtained
exclusive worldwide rights to develop multiple DNA therapies for
HIV, hepatitis B and C, HPV and related diseases, influenza,
multiple cancers, CMV (cytomegalovirus), RSV (respiratory syncytial
virus), herpes, MRSA, and multiple other infectious diseases as
well as chemokine and cytokine immune activators. In consideration,
Inovio has made upfront as well as milestone payments and will in
the future make additional milestone as well as royalty payments to
the University.
About Inovio Pharmaceuticals, Inc.
Inovio is revolutionizing vaccines to prevent and treat today's
cancers and challenging infectious diseases. Its SynCon®
vaccines, in combination with its proprietary electroporation
delivery, are generating best-in-class immune responses, with
therapeutic T-cell responses exceeding other technologies in terms
of magnitude, breadth, and response rate. Human data to date have
shown a favorable safety profile. Inovio's lead vaccine, a
therapeutic against HPV-caused pre-cancers and cancers, is in phase
II. Other phase I and preclinical programs target prostate, breast,
and lung cancers as well as HIV, influenza, malaria and hepatitis.
Partners and collaborators include Roche, the University of Pennsylvania, NIH, HIV Vaccines Trial
Network, National Cancer Institute, U.S. Military HIV Research
Program, US Dept. of Homeland Security, and University of Manitoba. More information is
available at 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 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, 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, 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, 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, 2013, our Form 10-Q for the quarter
ended March 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.
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CONTACTS:
Investors:
Bernie Hertel, Inovio
Pharmaceuticals, 858-410-3101, bhertel@inovio.com
Media:
Jeff Richardson, Inovio
Pharmaceuticals, 267-440-4211, jrichardson@inovio.com
SOURCE Inovio Pharmaceuticals, Inc.