Inovio Pharmaceuticals, Inc. (NASDAQ:INO) announced today an
interim data analysis showing that its INO-3112 DNA-based
immunotherapy generated specific T-cell responses and was well
tolerated in all evaluable patients with head and neck cancer
associated with human papillomavirus (HPV) types 16 and 18.
The immunology results show that INO-3112
generated robust HPV16/18 specific CD8+ T cell responses and
antibodies against HPV16/18 in all 10 tested patients who received
all treatments. These results will be presented today and tomorrow
at the 30th Anniversary Annual Meeting of the Society for
Immunotherapy of Cancer in National Harbor, MD and on Nov 20-22 at
the European Society for Medical Oncology Symposium on
Immuno-Oncology in Lausanne, Switzerland.
INO-3112, an active immunotherapy targeting HPV
16/18 combined with a DNA plasmid for IL-12 as an immune activator,
is designed to activate patient’s immune responses to specifically
kill HPV associated tumors. In this phase I/IIa study, patients
with HPV positive head and neck cancer received INO-3112 once every
three weeks for a total of four injections.
The characteristics of these immune response
data mirror those previously observed in a phase II clinical study
of VGX-3100 for HPV-associated cervical dysplasia. In that study,
strong CD8+ T cell immune responses were positively correlated with
achievement of primary and secondary efficacy endpoints. Data from
that trial was recently published in a peer-reviewed article in The
Lancet. This publication details that VGX-3100 is the first therapy
to demonstrate that activated killer T cells induced in the body
have the power to clear neoplastic lesions as well as the virus
which caused the disease.
Dr. Charu Aggarwal, MD, MPH, Assistant Professor
of Medicine, Medical Oncologist at Abramson Cancer Center,
University of Pennsylvania, Philadelphia and the principal
investigator of this study said, “These results are in line with
our hypothesis that DNA immunotherapy would lead to activation of
the immune system. We are excited to follow these patients and
learn about long-term results with this immunotherapy.”
Dr. J. Joseph Kim, Inovio's President and CEO,
said, "These results demonstrate we’re on the right path using our
DNA immunotherapies to fight cancer. In immuno-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.”
This open label study is intended to assess the
safety, tolerability, and immunogenicity of INO-3112 in up to
twenty five 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. This study currently continues
patient enrollment at Abramson Cancer Center of University of
Pennsylvania in Philadelphia. In August 2015, Inovio licensed
INO-3112 to MedImmune, the global biologics research and
development arm of AstraZeneca, for an upfront payment of $27.5
million, $700 million in potential development and commercial
milestone payments, and royalties on INO-3112 product sales.
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 and neck cancers.
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 is generating T cells, in vivo, in
high quantity that are fully functional whose killing capacity
correlates with relevant clinical outcomes with a favorable safety
profile. With an expanding portfolio of immunotherapies, the
company is advancing a growing preclinical and clinical stage
product pipeline. Partners and collaborators include MedImmune,
Roche, 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, 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 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,
our Form 10-Q for the quarter ended June 30, 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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