PLYMOUTH MEETING, Pa.,
April 8, 2019 /PRNewswire/
-- Inovio Pharmaceuticals, Inc. (NASDAQ: INO) announced today
that it achieved a third indication milestone from AstraZeneca
resulting from dosing a patient in a Phase 2 combination trial
evaluating MEDI0457 (formerly called INO-3112) in combination with
durvalumab targeting cervical, anal, penile, and vulvar cancers
associated with the human papilloma virus (HPV). The milestone
achievement for this multi-indication trial is the third
MEDI0457-related Phase 2 milestone from AstraZeneca; two previous
milestone payments resulted from initiating Phase 2 combination
trials targeting head and neck and cervical cancers. Financial
arrangements were not disclosed.
Dr. J. Joseph Kim, Inovio's
President and Chief Executive Officer, said, "This Phase 2
milestone stresses the potential breadth of MEDI0457 in treating
multiple HPV-associated cancers. Inovio's goal is to lead the
HPV-treatment market from pre-cancers with its lead product
VGX-3100 to cancers with MEDI0457 along with our partner
AstraZeneca."
In several on-going Phase 2 cancer-indication trials,
AstraZeneca is evaluating MEDI0457 in combination with durvalumab,
an anti-PD-L1 immune checkpoint inhibitor, in patients with
HPV-associated head and neck, cervical, anal, penile, and vulvar
cancers. Inovio is developing its HPV monotherapy VGX-3100 for
pre-cancerous indications in a Phase 3 trial for cervical
dysplasia; and in Phase 2 trials for vulvar and anal dysplasia.
About MEDI0457 and VGX-3100
MEDI0457 (formerly called INO-3112 (VGX-3100, plus IL-12) which
AstraZeneca in-licensed from Inovio) is under evaluation by
AstraZeneca to treat HPV-associated cancers. Inovio is
investigating VGX-3100, a DNA-based immunotherapy for the treatment
of HPV-16 and HPV-18 infection and pre-cancerous lesions of the
cervix (Phase 3) and vulva (Phase 2) and anal (Phase 2). VGX-3100
has the potential to be the first approved treatment for HPV
infection of the cervix and the first non-surgical treatment for
pre-cancerous cervical lesions. VGX-3100 works by stimulating a
specific immune response to HPV-16 and HPV-18, which targets the
infection and causes destruction of pre-cancerous cells. In a
randomized, double-blind, placebo-controlled Phase 2b study in 167 adult women with histologically
documented HPV-16/18 cervical HSIL (CIN2/3), treatment with
VGX-3100 resulted in a statistically significantly greater decrease
in cervical HSIL and clearance of HPV infection vs. placebo. The
most common side effect was injection site pain, and no serious
adverse events were reported. VGX-3100 utilizes the patient's own
immune system to clear HPV-16 and HPV-18 infection and
pre-cancerous lesions without the increased risks associated with
surgery, such as loss of reproductive health and negative
psychosocial impacts.
Under the 2015 agreement, AstraZeneca acquired exclusive rights
to Inovio's INO-3112, now called MEDI0457. MEDI0457 targets cancers
caused by HPV types 16 and 18 which are responsible for more than
70 percent of cervical pre-cancers and cancers and are involved in
the development of other tumors. Within the broader license and
collaboration agreement, AstraZeneca and Inovio are co-developing
one additional DNA-based cancer therapy product not included in
Inovio's current product pipeline, which AstraZeneca has exclusive
rights to develop and commercialize. Inovio will receive
development, regulatory and commercialization milestone payments
for these additional cancer vaccine products and will be eligible
to receive royalties on worldwide net sales.
About Durvalumab
Durvalumab, a human monoclonal antibody directed against PD-L1,
blocks PD-L1 interaction with PD-1 and CD80 on T cells, countering
the tumor's immune-evading tactics and inducing an immune response.
As part of a broad development program, durvalumab is being
investigated as monotherapy and in combination with IO, small
molecules, and chemotherapies across a range of tumors and stages
of disease.
About Inovio Pharmaceuticals, Inc.
Inovio is a late-stage biotechnology company focused on the
discovery, development, and commercialization of DNA-based
immunotherapies and vaccines that transform the treatment and
prevention of cancer and infectious disease. Inovio's
proprietary technology platform applies antigen sequencing and DNA
delivery to activate potent immune responses to targeted
diseases. The technology functions exclusively in vivo,
and has been demonstrated to consistently activate robust and fully
functional T cell and antibody responses against targeted cancers
and pathogens. Inovio's most advanced clinical program, VGX-3100,
is in Phase 3 for the treatment of HPV-related cervical
pre-cancer. Also in development are Phase 2 immuno-oncology
programs targeting HPV-related cancers, bladder cancer, and
glioblastoma, as well as platform development programs in hepatitis
B, Zika, Ebola, MERS, and HIV. Partners and collaborators
include AstraZeneca, Regeneron, Roche/Genentech, ApolloBio
Corporation, The Wistar Institute, The Bill & Melinda Gates
Foundation, the University of
Pennsylvania, Parker Institute for Cancer Immunotherapy,
CEPI, DARPA, GeneOne Life Science, Plumbline Life Sciences, NIH,
HIV Vaccines Trial Network, National Cancer Institute, Walter Reed
Army Institute of Research, Drexel
University, 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, including the planned initiation and conduct of clinical
trials and the availability and timing of data from those trials.
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, 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
us or our collaborators, including alternatives that may be more
efficacious or cost effective than any therapy or treatment that we
and our collaborators hope to develop, issues involving product
liability, issues involving patents and whether they or licenses to
them will provide us 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
we can finance or devote other significant resources that may be
necessary to prosecute, protect or defend them, the level of
corporate expenditures, assessments of our 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, 2018 and other
regulatory filings we make from time to time. There can be no
assurance that any product candidate in our 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. Forward-looking statements speak only as of the date of
this release, and we undertake no obligation to update or revise
these statements, except as may be required by law.
CONTACTS:
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Investors:
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Ben Matone, Inovio,
484-362-0076, ben.matone@inovio.com
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Media:
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Jeff Richardson,
Inovio, 267-440-4211, jrichardson@inovio.com
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SOURCE Inovio Pharmaceuticals, Inc.