PLYMOUTH MEETING, Pa.,
Nov. 17, 2014 /PRNewswire/
-- Inovio Pharmaceuticals, Inc. (NASDAQ: INO) announced today
the company and Roche have terminated their 2013 collaboration,
option, and license agreement to co-develop INO-5150, Inovio's DNA
immunotherapy targeting prostate cancer, as well as their research
collaboration in prostate cancer. All of Roche's rights to
INO-5150, including the right to license the product to other
parties, will be returned to Inovio. Inovio plans to
independently advance INO-5150 into a phase I clinical trial in the
first half of 2015.
Inovio and Roche will continue to collaborate and co-develop
Inovio's DNA immunotherapy (INO-1800) against hepatitis B virus
under their existing license agreement. The partnership is on track
to move INO-1800 collaboratively into a phase I study in 2015.
Dr. J. Joseph Kim, Inovio's
president & CEO, said, "The Inovio/Roche partnership will
continue to thrive focusing on the development of INO-1800 for the
treatment of hepatitis B. In addition to recently demonstrating
clinical efficacy and the ability to induce potent antigen specific
CD8+ T cell responses in our VGX-3100 phase II study, Inovio will
be moving a broad portfolio of immuno-oncology products through
development, including INO-3112 (head/neck and cervical cancers),
INO-1400 (breast, lung and pancreatic cancers) and INO-5150
(prostate cancer). We believe that these products along with
pre-phase III VGX-3100 will further our growth and represent
opportunities for additional value-adding partnerships."
About INO-5150 for Prostate Cancer
Inovio's
dual-antigen synthetic DNA immunotherapy (INO-5150) targets
prostate-specific membrane antigen (PSMA) and prostate-specific
antigen (PSA). A study in monkeys showed that vaccination with
INO-5150 generated strong and robust T-cell immune responses that
were the highest generated by a PSA-targeting immunotherapy in
animal studies and were similar to the immune responses generated
by VGX-3100, Inovio's phase II-completed HPV immunotherapy that
generated best-in-class T-cell responses.
Inovio's SynCon® DNA vaccine for prostate cancer was designed
with PSA and PSMA synthetic consensus immunogens based on human and
macaque sequences, resulting in amino acid sequences that differ
slightly from the native human protein. In humans, this novel
approach is utilized to help the body's immune system recognize
cancerous cells created in the body as 'foreign', overcoming the
body's self-tolerance of these cells and mounting an immune
response to clear them.
About INO-1800 for Hepatitis B
Inovio has reported
preclinical data showing its hepatitis B vaccine (INO-1800)
generated strong T-cell and antibody responses that led to the
elimination of targeted liver cells in mice. These results indicate
this DNA immunotherapy's potential to treat hepatitis B infection
and prevent further development of the infection into liver cancer
in humans.
In a preclinical study, researchers found the vaccine-specific
T-cells exhibited a killing function, and could migrate to and stay
in the liver and cause clearance of target cells without evidence
of liver injury. This was the first study to provide evidence that
intramuscular immunization can induce killer T-cells that can
migrate to the liver and eliminate target cells.
About Inovio
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 cancer immunotherapies and
clinical studies, the company is advancing a growing product
pipeline. Partners and collaborators include Roche, MedImmune,
the University of Pennsylvania, DARPA, Drexel University, NIH, HIV Vaccines Trial
Network, National Cancer Institute, U.S. Military HIV Research
Program, US Dept. of Homeland Security, 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, 2013, our Form 10-Q for the quarter
ended September 30, 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.
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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SOURCE Inovio Pharmaceuticals, Inc.