Inovio Receives Milestone Payment from MedImmune as MEDI0457 and Checkpoint Inhibitor Combination Trial in Head and Neck Squa...
January 08 2018 - 8:00AM
Inovio Pharmaceuticals, Inc. (NASDAQ:INO) announced today it has
received a milestone payment from MedImmune as MEDI0457 (formerly
called INO-3112 which MedImmune in-licensed from Inovio) in
combination with durvalumab (MEDI4736) satisfactorily completed the
phase 1 safety review portion of the study and has advanced to the
phase 2 efficacy stage of the trial. As part of a $700 million 2015
license and collaboration agreement, MedImmune, the global
biologics research and development arm of AstraZeneca, is
evaluating MEDI0457 in combination with durvalumab, its PD-L1
checkpoint inhibitor, in patients with recurrent/metastatic
HPV-associated head and neck squamous cancer (HNSCC) in a clinical
trial with an estimated enrollment of 50 patients.
Under the 2015 agreement, MedImmune acquired
exclusive rights to Inovio's MEDI0457 immunotherapy. MEDI0457
targets cancers caused by human papillomavirus (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 as well such as HNSCC. Within the broader license and
collaboration agreement, MedImmune and Inovio will develop two
additional DNA-based cancer therapy products not included in
Inovio's current product pipeline, which MedImmune has 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.
Dr. Ildiko Csiki, MD, PhD, Inovio Vice
President, Clinical Development said, “We are pleased to see this
combination study advance to the efficacy portion of the trial.
Published preclinical studies suggest that treatment with HPV
targeted immunotherapeutic approach in combination with PD-1/PD-L1
inhibition may be synergistic, and potentially increase efficacy of
checkpoint inhibitors.”
Dr. J. Joseph Kim, Inovio’s President and Chief
Executive Officer, said, “Inovio’s primary goal is to become the
global leader in HPV-related disease treatment. Along with MEDI’s
development of MEDI0457 for HPV-related cancer, Inovio’s VGX-3100,
is currently being tested in global phase 3 pivotal trials for
cervical pre-cancer as well as a treatment for vulvar and anal
pre-cancers caused by HPV. Overall, these products could be
well-positioned to comprehensively treat HPV-related diseases
across the continuum of HPV infections from pre-cancerous
conditions to cancer in both women and men.”
In a phase 1 study of MEDI0457 in 22
HPV-positive patients with HNSCC, Inovio has previously
demonstrated that MEDI0457 generated robust antigen-specific CD8+
killer T cell responses in both tumor tissue and peripheral blood.
One patient in that trial who initially displayed a slight increase
in T cell immune responses developed progressive disease at 11
months into the study and subsequently received a PD-1 checkpoint
inhibitor. The patient had a sustained complete response after only
four doses of a checkpoint inhibitor, and continues on anti PD-1
therapy with no evidence of disease 18 months after initiation of
the checkpoint inhibitor.
About MEDI0457 and VGX-3100
MEDI0457 (formerly called INO-3112 (VGX-3100,
plus IL-12) which MedImmune in-licensed from Inovio) is under
evaluation by MedImmune 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). 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.
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, Regeneron, Genentech, 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, 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, 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.
Forward-looking statements speak only as of the date of this
release, and Inovio undertakes no obligation to update or revise
these statements, except as may be required by law.
CONTACTS:Investors: Ben Matone,
Inovio, 484-362-0076, ben.matone@inovio.comMedia: Jeff Richardson,
Inovio, 267-440-4211, jrichardson@inovio.com
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