Inovio’s Cancer Immunotherapy (INO-3112) Generates T Cell Immune Responses in Tumor Tissue and Peripheral Blood in Patients...
14 November 2016 - 11:00PM
Inovio Pharmaceuticals, Inc. (NASDAQ:INO), today announced an
interim data analysis showing that its INO-3112 cancer
immunotherapy product generated antigen-specific CD8+ killer T cell
responses measured both in tumor tissue and in peripheral blood
from subjects with head and neck cancer associated with human
papillomavirus (HPV). The immunology results show that INO-3112
treatment generated robust HPV16/18 specific CD8+ T cell responses
in peripheral blood in four of five subjects who also showed
increased T cell activation in resected tumor tissue samples. These
four subjects remained disease free in continuing follow-up that
ranged from nine to 24 months at the time of analysis. One subject
with only minimal increases in T cell immune responses developed
progressive disease at 11 months post start of the study. These
results were presented November 12th at the 2016 Annual Meeting of
the Society for Immunotherapy of Cancer (SITC) in National Harbor,
Maryland.
Dr. J. Joseph Kim, Inovio's President and CEO, said, "In
immuno-oncology, it's all about the T cells. We now have evidence
in cancer patients that our immunotherapy product can generate
antigen-specific CD8+ killer T cell responses in the tumor, a major
step forward towards an effective immunotherapy. This study gives
us an important opportunity to evaluate a novel treatment approach
using a DNA vaccine platform to increase immune activation by
generating a robust in-vivo T cell response, especially in the
tumor, and potentially decreasing tumor recurrence in HPV positive
head and neck cancer patients.”
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 patients’ immune responses to specifically
target and kill HPV associated tumors. This open label phase I/IIa
study has fully enrolled twenty-two subjects with HPV-positive head
and neck squamous cell carcinoma and is intended to assess the
safety, tolerability, and immunogenicity of INO-3112 in two
treatment groups. Additionally, the study is evaluating the
anti-tumor response and progression free survival of patients. The
first group enrolled six subjects who were treated with INO-3112
before and after resection of their tumor. One subject withdrew
consent after surgery, leaving five evaluable subjects in this
group. All of these subjects received one dose of INO-3112
(averaging 14 days and ranging 7 to 28 days) prior to definitive
surgery plus three additional doses post-surgery. The second group
enrolled sixteen subjects who received four doses of INO-3112 after
at least two months following completion of definitive
chemoradiation or surgery and adjuvant chemoradiation therapy.
This poster presentation provided immune
response and disease free survival data from the first treatment
group. CD8+ and FoxP3 T cell expression were evaluated in tumor
samples obtained before and after surgery. In addition, ELISpot
analysis was performed to determine the number of T cells capable
of secreting IFN-γ in response to HPV antigen stimulation. Four of
five subjects had robust T cell response as measured by blood
ELISpot assay and the same four subjects also showed an average
increase of 60% of CD8+ to FoxP3 ratio measured by
immunohistochemistry post vaccination, demonstrating increased
infiltration of CD8+ T cells as well as reduction of regulatory T
cells measured by FoxP3 expression in tumor tissue. These four
subjects remained disease free with follow-up ranging from nine to
24 months to date. One subject with only a marginal increase in
ELISpot response magnitude to HPV and no increase in CD8+/FoxP3
ratio in tumor tissue post INO-3112 developed progressive disease
at 11 months post-treatment.
Overall the characteristics of these immune
response data mirrored those previously observed in a phase IIb
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. 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.
Inovio is continuing subject monitoring and
comprehensive immune analyses for both cohorts of this study and
expects multiple reports of additional data throughout 2017.
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, currently
infecting about 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. In 2016 an estimated 48,330 persons will get oral cavity or
oropharyngeal cancer in the U.S. New cases of head and neck cancer
occur nearly three times more often in men as in women. Incidence
rates of head and neck cancers have been on the rise, especially
HPV-associated oropharyngeal cancer in men, and are expected to
continue growing.
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, The Wistar Institute, University of Pennsylvania, DARPA,
GeneOne Life Science, Plumbline Life Sciences, Drexel University,
NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S.
Military HIV Research Program, and Laval University. 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 INO-3112, 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 immunotherapy and
vaccine products, 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, 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, our Form 10-Q for the quarter
ended September 30, 2016, 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
Inovio Pharmaceuticals (NASDAQ:INO)
Historical Stock Chart
From Apr 2024 to May 2024
Inovio Pharmaceuticals (NASDAQ:INO)
Historical Stock Chart
From May 2023 to May 2024