Inovio Pharmaceuticals HPV Immunotherapy Activates Robust In Vivo T Cell Responses in Head & Neck Cancer Patients
April 09 2015 - 8:00AM
Inovio Pharmaceuticals, Inc. (Nasdaq:INO) announced today
preliminary data showing that its INO-3112 DNA-based
immunotherapy generated strong CD8+ T cell responses in 3 of 4
patients with head and neck cancer associated with human
papillomavirus (HPV) types 16 and 18. INO-3112, an active
immunotherapy that targets HPV 16 and 18 and simultaneously
expresses IL-12, is designed to activate in vivo (in the body)
immune responses to antigens from high risk HPV types and eliminate
precancerous and cancerous cells displaying these antigens. The
data, which are T cell measurements from the first four treated
patients of this phase I/IIa study, are being presented today at
the World Vaccine Congress 2015 by Inovio's COO, Dr. Niranjan Y.
Sardesai.
These positive results represent the first study and first
report of T cell immune responses generated in cancer patients
after treatment with an Inovio DNA immunotherapy. The magnitude and
characteristics of these interim immune response data mirror immune
responses previously observed in human studies of VGX-3100 for
HPV-associated cervical dysplasia; in a placebo-controlled phase II
study, strong T cell immune responses were positively correlated
with achievement of primary and secondary efficacy endpoints.
Dr. J. Joseph Kim, Inovio's President and CEO, said, "This
initial data set from Inovio's first cancer study provides
encouraging evidence that we are on an important path to better
optimized immunotherapy products. Regardless of whether it is an
infectious disease, a precancer, or a cancer: the immune system
uses the same mechanism to eliminate infected or mutated cells. In
immune-oncology, it's all about the T cells. Here we show in cancer
patients that we can generate antigen-specific CD8+ killer T cell
responses, which are essential to an effective immunotherapy.
"We look forward to completing our currently enrolling studies
for HPV-associated head & neck and cervical cancers, completing
the preparations for our planned phase III study for cervical
precancer, and launching new studies for hepatitis B and prostate
cancer that all rely on the same targeted T-cell-based killing
activity."
This open label study of HPV-caused head and neck cancer is
intended to assess the safety, tolerability, and immunogenicity of
INO-3112 in up to twenty adults with HPV-positive head and neck
squamous cell carcinoma. The study (NCT02163057) includes patients
who are being treated with INO-3112 before and after resection of
their tumor as well as patients being treated with INO-3112 after
completion of chemotherapy and radiation therapy.
About HPV-Caused Head & Neck Cancer
Human papillomavirus (HPV) is the most common sexually
transmitted disease in the United States, infecting 79 million
Americans. HPV is known to play a major role in the development of
head and neck cancers, which include cancers of the oral cavity,
oropharynx, nose/nasal passages and larynx. Head and neck cancers
associated with HPV account for nearly 3 percent of all cancers in
the United States and are twice as prevalent in men as in women.
Incidence rates of HPV-caused head and neck cancers have been on
the rise, especially HPV-associated oropharyngeal cancer in men,
and are expected to continue growing. By 2025, researchers believe
that HPV will be the causative factor of 90% of all head/neck
cancers.
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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