Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today announced that its
SynCon® WT1 cancer immunotherapy was capable of breaking immune
tolerance and inducing neo-antigen-like T cell responses to cause
tumor regression in pre-clinical studies. Breaking tolerance has
been a major challenge for developing a potent cancer therapy;
researchers have tried many other methods and been unsuccessful for
decades. Notably, the WT1 antigen is over-expressed in multiple
cancer types but not found in most normal tissue, giving it
potential to be used as part of a universal cancer vaccine against
multiple tumor types.
Results of these pre-clinical studies appear in
the online edition of Molecular Therapy in a paper entitled, “A
novel DNA vaccine platform enhances neo-antigen-like T-cell
responses against WT1 to break tolerance and induce anti-tumor
immunity,” authored by Inovio and its collaborators at The Wistar
Institute.
Study results revealed that while mice did not
mount an immune response to native mouse WT1 antigens, mice
immunized with Inovio’s SynCon WT1 antigen broke tolerance and
generated robust neo-antigen-like T cells. Furthermore, the
immunized mice exhibited smaller tumors and prolonged survival in a
tumor challenge study. SynCon WT1 DNA vaccination also broke
tolerance and generated neo-antigen-like T cell immune responses in
Rhesus monkeys, a species whose immune system closely resembles
that of humans. Inovio’s ability to overcome the immune system’s
usual tolerance of WT1 antigen suggests the potential of its SynCon
WT1 antigen to tackle any WT1-expressing cancer in humans, which
include pancreatic, brain, lung, thyroid, breast, testicular,
ovarian, and melanoma.
Dr. J. Joseph Kim, Inovio's President and CEO,
said, "Our SynCon antigens’ ability to overcome the immune system’s
inability to recognize tumor self-antigens is unique and powerful.
While we systematically and synthetically mimic the body’s natural
process of creating tumor neo-antigens, which possess
differentiated but individualized genetic sequences that may then
induce an immune response, our ability to break tolerance with
broadly prevalent antigens makes our approach more universal across
populations. We are pleased to again show such results with an
important cancer antigen – in this case, WT1 – and continue to add
to our array of promising universal cancer antigens in Inovio’s
product development strategy.
“To expand on our capabilities and strategy, the
power of our differentiated antigens dovetails with our ability to
turn cancer tumors from cold to hot by creating a significant
presence of antigen-specific CD8+ killer T cells in a target lesion
or tumor microenvironment, which we have shown via biopsies in two
human studies. These are critical outcomes: although checkpoint
inhibitors have raised the bar for treating cancers by neutralizing
cancer cells’ inherent ability to switch off T cells that are
hunting them, they do not actually generate the antigen-specific
killer T cells required to destroy cancer cells. We believe our
DNA-based SynCon immunotherapies are the missing link to take
immuno-oncology to the next level.”
“With these accomplishments we could not be more
enthusiastic about two immuno-oncology combination human studies to
start in the first half of 2017. MedImmune will combine INO-3112
(also named MEDI0457) with their checkpoint inhibitor molecule in
an upcoming clinical study. Inovio is also planning to conduct a
combination study for INO-5401 with a checkpoint inhibitor in
cancer patients. We previously noted that INO-5401 will include our
hTERT SynCon antigen. I am pleased to say that INO-5401 will also
include our SynCon antigens for WT1 and PSMA. We believe this
product has the potential to be a very powerful universal cancer
immunotherapy in combination with different checkpoint
inhibitors.”
The National Cancer Institute previously
highlighted WT1, hTERT and PSMA among a list of attractive cancer
antigens, designating them as high priorities for cancer
immunotherapy development. WT1 was at the top of the list. The
hTERT antigen relates to 85% of cancers and WT1 and PSMA antigens
are also widely prevalent in many cancers.
Inovio’s synthetically designed antigens use a
consensus of human and multiple animal genetic sequences for the
same antigen to create a differentiated SynCon® antigen that can be
more readily recognized as “foreign” by immune sentries in the
patients. This recognition may help overcome the immune system’s
tolerance of tumor cells displaying the native or self-antigens
generated by the body. Once a significant antigen-specific T cell
response is activated, these T cells may then also seek throughout
the body and destroy cancer cells expressing the pre-existing
natural or native tumor antigens.
There are multiple lines of evidence pointing to
the potential of INO-5401 in immuno-oncology. Inovio previously
reported preclinical data indicating the ability of its PSMA and
hTERT tumor-associated SynCon antigens to generate significant
antigen-specific killer T cell responses. Inovio is also running an
ongoing phase I study of its SynCon hTERT antigen (INO-1400) to
assess safety and immunogenicity in over fifty patients with at
least one of nine different hTERT-expressing cancers. Our SynCon
PSMA antigen is one of two components (along with SynCon PSA)
making up INO-5150, which is currently in a phase I study of sixty
biochemical-relapse prostate cancer patients. Interim immune
responses and safety data from both INO-1400 and INO-5150 studies
will be presented at cancer conferences in 2017.
Importantly, Inovio has already reported human
data characterizing the activation of significant antigen-specific
CD8+ killer T cells in patients and their infiltration into lesions
and tumors displaying target antigens. These studies of HPV-related
precancer (VGX-3100) and cancer (INO-3112) showed a significant
presence of activated T cells based on pre and post immunization
biopsies. In a controlled phase 2b study for VGX-3100, Inovio also
showed statistically significant efficacy in regressing HPV-related
cervical dysplasia.
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, ApolloBio
Corporation, 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 the cancer immunotherapy INO-5401,
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
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