Phase 2 cancer study will evaluate T
cell-activating immunotherapy MEDI0457 with
MedImmune’s durvalumab targeting several HPV-related
cancers
Inovio Pharmaceuticals, Inc. (NASDAQ:INO) announced today the
dosing of the first patient in a Phase 2 combination trial to
evaluate MedImmune’s MEDI0457 (formerly called INO-3112 which
MedImmune in-licensed from Inovio) in combination with durvalumab
targeting a broad array of cancers associated with the human
papilloma virus (HPV).
This open-label trial funded by MedImmune, the
global biologics research and development arm of AstraZeneca, is
sponsored by noted cancer researcher Dr. Michael Frumovitz, MD,
MPH, of the MD Anderson Cancer Center in Houston, Texas, where the
trial will be conducted as part of MD Anderson’s “Moon Shot” cancer
initiative. MedImmune is evaluating MEDI0457 in combination with
durvalumab, an anti-PD-L1 immune checkpoint inhibitor, in patients
with HPV-associated cervical, anal, penile, and vulvar cancers in
arms of a clinical trial with an estimated total enrollment of 77
patients. For additional information about the study, please visit
www.clinicaltrials.gov (search identifier NCT03439085).
The opening of this trial will result in a
milestone payment from MedImmune to Inovio. Financial arrangements
were not disclosed.
Dr. Frumovitz said, “This is the first Phase 2
clinical trial at MD Anderson that is focused not on the site of
disease origin, but instead on the cause of a cancer -- in this
case exposure to HPV 16 or 18. The HPV Moon Shot at MD Anderson has
developed an entire research program with this philosophy in mind —
that HPV-associated cancers behave similarly, regardless of site of
origin, and should be studied as a whole, not as individual
cancers. This study will be “site agnostic”, meaning any patient
with an HPV 16/18 associated cancer, regardless of primary site,
will be eligible. Another truly unique aspect of this study is a
separate cohort for patients who are HIV positive with an HPV 16/18
associated cancer.”
Dr. J. Joseph Kim, Inovio’s President and Chief
Executive Officer, said, “We are pleased to see Inovio’s
cancer-fighting immunotherapy, in MEDI0457, expand to new cancer
indications. Such expansion is great for patients and the oncology
community. For Inovio, amplification of HPV cancer targets holds
the potential to bring about additional milestone and royalty
payments.”
An article in the online edition of Clinical
Cancer Research highlights a recent Phase 1 study of MEDI0457 as a
monotherapy in 22 HPV-positive patients with HPV-associated head
and neck cancer that demonstrated MEDI0457 generated robust
HPV16/18 specific CD8+ T cell responses in peripheral blood and
increased CD8+ T cell infiltration in resected tumor tissue. 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 achieved a complete response, which has
sustained for over two years and counting. Increasing evidence
suggests that response rates from checkpoint inhibitors can be
enhanced when used in combination with cancer vaccines like
MEDI0457 that generate tumor-specific T cells.
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) 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, MedImmune 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, MedImmune and
Inovio are co-developing one additional DNA-based cancer therapy
product 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 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
immunotherapies that transform the treatment of cancer and
infectious diseases. Inovio’s proprietary platform technology
applies next-generation 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
is the only immunotherapy company that has reported generating T
cells whose killing capacity correlates with relevant clinical
outcomes. 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 head
and neck cancer, bladder cancer, and glioblastoma, as well as
platform development programs in hepatitis B, Zika, Ebola, MERS,
and HIV. Partners and collaborators include MedImmune, Regeneron,
Roche/Genentech, ApolloBio Corporation, The Wistar Institute,
University of Pennsylvania, Parker Institute for Cancer
Immunotherapy, CEPI, DARPA, GeneOne Life Science, Plumbline Life
Sciences, 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 our plans and expectations regarding
partnerships. 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, 2017, our
Quarterly Report on Form 10-Q for the quarter ended September 30,
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:
Investors: Ben Matone, Inovio, 484-362-0076,
ben.matone@inovio.comMedia: Jeff Richardson, Inovio, 267-440-4211,
jrichardson@inovio.com
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