Inovio Updates INO-3112 HPV Immunotherapy Development Plan
March 29 2016 - 8:00AM
Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today announced a
clinical strategy update to take its INO-3112 HPV immunotherapy
into human studies in combination with selected immunotherapy
molecules from MedImmune, the global biologics research &
development arm of AstraZeneca, which is part of an existing
partnership between the two companies.
The companies intend to advance combination
immunotherapies in populations with continued unmet need, the
potential for a registrable endpoint, and an expedient clinical
path. With these goals in mind, planned enrollment of a European
Organization for Research and Treatment of Cancer (EORTC) trial to
study cervical cancer patients with INO-3112 before and after
chemoradiation in an adjuvant setting will not go forward. The
EORTC collaboration was announced by Inovio prior to partnering
with MedImmune in August 2015.
"HPV-related cancers represent an important
unmet clinical need. We believe our combination immunotherapy
approach with MedImmune could address a missing link in the
spectrum of available and emerging treatment approaches. Following
our ongoing preparations, we expect the initiation of the first
clinical trial with this combination to be an important step for
Inovio in 2016,” said Dr. J. Joseph Kim, Inovio's President and
CEO.
INO-3112 is designed to generate antigen
specific killer T-cell responses targeting HPV 16- and 18-driven
tumors. Emerging evidence suggests the benefits from
immuno-oncology molecules, such as those in MedImmune's portfolio,
can be enhanced when used in combination with cancer vaccines that
generate tumor-specific T-cells. Under the existing strategic
cancer partnership and license agreement, MedImmune acquired from
Inovio exclusive rights to INO-3112. MedImmune paid $27.5 million
upfront, agreed to potential development and commercial
milestone payments totaling $700 million, and will fund all
development costs. Inovio is entitled to receive up to double-digit
tiered royalties on INO-3112 sales.
INO-3112 is in phase I/II clinical trials for
cervical and head and neck cancers. Inovio reported last November
interim human data showing that its INO-3112 DNA-based
immunotherapy generated robust HPV16/18 specific CD8+ T cell
responses with cytolytic function and antibodies in all 10 tested
head & neck cancer patients who received all treatments. A
total of 21 patients have been treated in this study to date;
further data will be reported in 2016.
Under the existing agreement, MedImmune and
Inovio will also co-develop up to two additional DNA-based cancer
vaccines not included in Inovio's current product pipeline, which
MedImmune will have the exclusive rights to develop and
commercialize. Inovio will receive development, regulatory and
commercialization milestone payments and will be eligible to
receive royalties on worldwide net sales for these additional
cancer vaccine products.
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, Roche, The Wistar Institute, 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 and INO-3112, 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 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, 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, 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.comMedia:
Jeff Richardson, Inovio Pharmaceuticals, 267-440-4211,
jrichardson@inovio.com
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