Inovio Pharmaceuticals, Inc. (NASDAQ:INO) announced today that its
immunotherapy to treat cervical dysplasia (VGX-3100) was recognized
as "Best Therapeutic Vaccine" by the World Vaccine Congress held
this week in Washington, D.C. The Vaccine Industry Excellence (ViE)
Awards honor outstanding vaccine advancements and achievements of
therapeutic and preventive vaccine developers across the worldwide
industry as judged by a panel of global biotech industry
stakeholders.
Inovio was recognized by industry peers for
"Best Therapeutic Vaccine" for its DNA-based immunotherapy,
VGX-3100, a first-in-class product for treating high grade cervical
neoplasia associated with human papillomavirus (HPV). Medical
researchers have previously tried to stimulate therapeutic immune
responses against HPV and cervical lesions with little success.
Inovio’s phase II data from this immunotherapy demonstrated that
robust CD8+ killer T cells activated in the body by VGX-3100 were
correlated to the clearance of neoplastic cervical lesions as well
as the virus which caused the disease. These results were
statistically significant and clinically relevant, and were
published last year in a peer-reviewed article in The Lancet, one
of the world's leading medical journals. Inovio will take VGX-3100
into a phase III trial later this year.
Each year, the ViE award recognizes the
therapeutic vaccine that addresses an unmet medical need and holds
significant potential for vast geographical and market reach. This
is the fourth consecutive year that Inovio's lead product has won
this designation.
Dr. J. Joseph Kim, President and CEO, said,
"Women around the world with HPV-related cervical pre-cancers would
ideally have access to an effective non-surgical treatment to
prevent progression to cancer. We greatly appreciate the World
Vaccine Congress' recognition of the potential of Inovio's VGX-3100
to address this opportunity.”
About VGX-3100
Inovio's VGX-3100 is an immunotherapy designed
to activate − in the body − functional antigen-specific CD8+ killer
T cells capable of clearing cells displaying the E6 and E7 antigens
of HPV types 16 and 18. The E6 and E7 antigens are oncogenes
responsible for transforming HPV-infected cells into pre-cancerous
and cancerous cells. VGX-3100 met primary and secondary endpoints
in a double-blind, placebo-controlled, randomized phase II clinical
trial.
About HPV and Cervical
Dysplasia
Human papillomavirus (HPV) is the most common
sexually transmitted disease, infecting over 12% of women
worldwide. Persistent HPV infection can lead to dysplasia, or
premalignant changes, in cervical cells; left untreated dysplasia
can advance to cervical cancer. Approximately 350,000 women are
diagnosed with cervical dysplasia each year in the U.S. Cervical
dysplasia most often occurs in younger women (aged 25 to 35 years)
and is divided into three progressive stages (CIN1, CIN2, and
CIN3).
HPV 16 and HPV 18 are the two genotypes most
likely to cause high-grade CIN (2/3) and are estimated to cause
approximately 70% of all cervical cancers in the U.S. and
worldwide. Although effective prophylactic vaccines for HPV
have been available for several years, only 40% of eligible
adolescent females (aged 13 to 17 years) in the U.S. received all
three doses of the regimen in 2014. Well-known preventive measures
are not practiced universally and it is expected that high-risk HPV
infections, high-grade CIN, and cervical cancer will continue to be
a substantial public health problem for years to come.
The primary treatment today for high grade
cervical dysplasia is the LEEP procedure, which is associated with
pre-term birthing, infertility, heavy bleeding and other side
effects. Recurrences occur in 10 – 16% of women treated by
LEEP.
About the ViE Awards
The World Vaccine Congress & Expo, now in
its 16th year, is the largest and most comprehensive event in the
industry. Covering everything from the latest R&D to
manufacturing to corporate development strategies, the Congress
hosts the only awards ceremony dedicated to the vaccine industry.
The ViE Awards honor individuals, organizations and initiatives
which have made significant contributions over the past 12 months
to innovation in the field of vaccines.
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, 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 immune therapy and vaccine products, our ability to
advance our portfolio of immune-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, 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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