Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today announced that two
of its cancer immunotherapies demonstrated antigen-specific T-cell
stimulation in phase 1 studies. INO-3112 (now called MEDI0457), an
investigational T-cell activation immunotherapy that targets
cancers caused by human papillomavirus (HPV) types 16 and 18 and
licensed to MedImmune, the global Research and Development arm of
AstraZeneca, also led to a head and neck cancer patient’s complete
response when matched with a PD-1 checkpoint inhibitor. In
addition, INO-1400, Inovio’s investigational cancer immunotherapy
targeting hTERT, which is over-expressed in a majority of cancers,
generated hTERT-specific IFN-γ secreting T cells, suggesting an
ability to break immune tolerance. These results were revealed at
poster presentations at the Society for Immunotherapy of Cancer
(SITC) 32nd Annual Meeting starting today at National Harbor, Md.
Dr. J. Joseph Kim, Inovio’s President and CEO,
said, “This study of MEDI0457 shows efficacy signals that Inovio’s
activation immunotherapy coupled with checkpoint inhibitor could
have meaningful therapeutic impact, given an unusual complete
response in one patient. Separately, we are evaluating our hTERT
therapy, INO-1400, in nine different solid tumors including breast,
lung and pancreatic cancers in a clinical study. Any success
we see in our hTERT therapy gives us added confidence in our
recently initiated efficacy studies combining PD-1/PD-L1 inhibitors
and INO-5401, which includes three of Inovio’s top SynCon® cancer
antigens – hTERT, WT1, and PSMA, which are over-expressed in
multiple tumor types. We look forward to sharing further data on
our immunotherapies as studies progress.”
In a phase 1 study of MEDI0457 in 22
HPV-positive patients with squamous cell carcinoma of the head and
neck, Inovio has previously demonstrated that this cancer
immunotherapy generated robust antigen-specific CD8+ killer T cell
responses in both tumor tissue and peripheral blood. One patient
which initially displayed a slight increase in T cell immune
responses developed progressive disease at 11 months into the study
and received nivolumab, a PD-1 checkpoint inhibitor. Subsequently,
the patient had a sustained complete response after only four
doses, and continues on therapy with no evidence of disease, 16
months after initiation of nivolumab.
Detailed immune analyses found that MEDI0457 had
activated HPV16-specific CD8+ T cells in the patient and the
subsequent treatment with nivolumab helped to unleash the expansion
of these killer T cells, which is contributing to the sustained
complete response observed in this patient. Medimmune is conducting
a separate phase 1/2 trial combining its PD-L1 inhibitor
(durvalumab) with MEDI0457 in HPV-associated head and neck cancer
patients to evaluate the clinical efficacy of the combination
treatment.
Dr. Charu Aggarwal, MD, MPH, medical oncologist
and assistant professor of medicine at the hospital of the
University of Pennsylvania and the principal investigator of this
study, said “This observation suggests that treatment with MEDI0457
prior to PD-1 inhibition can be synergistic, and increase efficacy
of checkpoint inhibitors.”
In Inovio’s phase 1 dose-escalation study of its
synthetic optimized DNA plasmids that target hTERT, the
immunotherapies were administered via Inovio’s CELLECTRA® delivery
device to assess the safety, tolerability, and immune effects of
INO-1400 or INO-1401 (two different versions of HTERT constructs),
alone or co-administered with a plasmid encoding for IL-12
(INO-9012), in 90 patients with 9 different solid tumors. Interim
results presented at the conference show positive safety and
tolerability data as well as the generation of hTERT-specific IFN-γ
secreting T cells, suggestive of an ability to break immune
tolerance.
Dr. Robert Vonderheide, MD, DPhil, Director of
the Abramson Cancer Center of the University of Pennsylvania and a
principal investigator for the study, said: "If successful, this
vaccine platform could represent not only a novel type of immune
therapy for cancer patients, but also one day offer an opportunity
for immune prevention of cancer."
High levels of human telomerase reverse
transcriptase (hTERT) have been reported in many tumor types such
as breast, lung, and pancreas. Inovio’s hTERT therapy may prove to
be a promising immuno-oncology target for the treatment of these
cancers. In 2017, over 530,000 new cases of breast, lung, or
pancreatic cancers were reported in the United States and over
240,000 people died from these cancers. Despite available
treatments, mortality rates remain unacceptably high in these tumor
types. In addition, many existing treatment modalities are
associated with significant adverse events.
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
immunotherapies, the company is advancing a growing preclinical and
clinical stage product pipeline. Partners and collaborators include
or have included MedImmune, Regeneron, Genentech, The Wistar
Institute, University of Pennsylvania, DARPA, GeneOne Life Science,
Plumbline Life Sciences, ApolloBio Corporation, Drexel University,
National Microbiology Laboratory of the Public Health Agency of
Canada, NIH, HIV Vaccines Trial Network, NIAID, U.S. Army Medical
Research Institute of Infectious Diseases and U.S. Military HIV
Research Program. 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, including the planned initiation
and conduct of clinical trials and the availability and timing of
data from those trials, and the sufficiency of 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, 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 including
INO-1400 and INO-9012, our ability to support our 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, 2016,
our Form 10-Q for the period ended September 30, 2017, and
other regulatory filings we make from time to time. There can be no
assurance that any product candidate in Inovio's pipeline will be
successfully developed, manufactured or commercialized, that final
results of clinical trials 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. In addition, the forward-looking statements included in
this press release represent Inovio’s views as of the date hereof.
Inovio anticipates that subsequent events and developments may
cause its views to change. However, while Inovio may elect to
update these forward-looking statements at some point in the
future, the company specifically disclaims any obligation to do so,
except as may be required by law. These forward-looking statements
should not be relied upon as representing Inovio’s views as of any
date subsequent to the date of this release.
CONTACTS:
Investors/Media: Jeff Richardson, Inovio Pharmaceuticals,
267-440-4211, jrichardson@inovio.com
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