Inovio Pharmaceuticals, Inc. (NASDAQ:INO) announced today a paper
published in a major cancer journal detailed results of a patient
with head and neck cancer treated with MEDI0457 achieved a
sustained complete response (full remission) on treatment with a
subsequent PD-1 checkpoint inhibitor. In the Inovio-sponsored study
of 22 patients with head and neck squamous cell carcinoma the
company reported 91% (20/22) showed T cell activity in the blood or
tissue. MEDI0457 – formerly called INO-3112 – was in 2015
licensed to MedImmune, the global biologics research and
development arm of AstraZeneca. These immune data as well as the
financial terms of the license agreement have been previously
reported by Inovio.
Dr. J. Joseph Kim, Inovio's President and CEO,
said, "We are buoyed by the study as it lends support to all of our
HPV and oncology programs. These data demonstrated that Inovio’s
technology based in MEDI0457 can generate durable HPV16/18
antigen-specific peripheral and tumor immune responses. The study
supports our belief that this approach may be used as a
complementary strategy to PD-1/PD-L1 inhibition in HPV-associated
head and neck and other types of cancer to improve therapeutic
outcomes. Inovio is collaborating with MedImmune (w/ MEDI0457) as
well as Genentech and Regeneron (w/ INO-5401) in efficacy trials
coupling Inovio’s DNA-based cancer immunotherapies with checkpoint
inhibitors designed to increase response rates with data expected
in 2019.”
An article in the most recent edition of
Clinical Cancer Research highlights data from an Inovio-sponsored
trial that demonstrated that after a cancer progressed a patient
was subsequently given 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. Interim data from a MEDI0457 monotherapy
study of head and neck cancer patients demonstrated that MEDI0457
generated robust HPV16/18 specific CD8+ T cell responses in
peripheral blood and increased CD8+ T cell infiltration in resected
tumor tissue samples. Charu Aggarwal,
MD, MPH, the study’s principal investigator and an assistant
professor of Hematology-Oncology at the University of
Pennsylvania’s Perelman School of Medicine, said, “We wanted to
know if this vaccine (MEDI0457) can boost the immune systems of
patients with HPV-related head and neck cancer, potentially opening
the door for better response rates to other existing therapies, and
our findings show that we can.”
The article notes that researchers administered
four doses of MEDI0457 to 21 patients separated into two different
groups. One group received a dose before surgery, followed by three
doses after surgery. The second group received four doses following
chemotherapy and radiation. Eighteen out of the 21 patients showed
elevated T cell activity that lasted at least three months after
the final vaccine dose, meaning the immune effect persisted for at
least six months from the start of immunotherapy. Five tumors were
biopsied both before and after one dose of the vaccine, and there
was evidence of T cells infiltrating into tumors and expressing
proteins associated with cell killing potential.
“We have not seen that kind of T cell
infiltration with just one dose of a vaccine before,” Dr. Aggarwal
added. “These findings open the door for utilizing targeted
immunotherapy approaches against specific cancer-causing targets
like HPV.”
Overall the characteristics of these immune
response data mirrored those previously observed in a Phase 2b
clinical study of VGX-3100 for HPV-associated cervical dysplasia.
In that study, strong CD8+ T cell immune responses were positively
correlated with achievement of primary and secondary efficacy
endpoints. VGX-3100, which is currently in global REVEAL 1 Phase 3
trial, is the first therapy to demonstrate that activated killer T
cells induced in the body have the power to clear neoplastic
lesions as well as the virus which caused the disease.
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 HPV-Caused Head & Neck
Cancer
Human papillomavirus (HPV) is the most common
sexually transmitted disease in the United States, currently
infecting about 79 million Americans. HPV is known to play a major
role in the development of head and neck cancers, which include
cancers of the oral cavity, oropharynx, nose/nasal passages and
larynx. In 2018 an estimated 48,330 persons will get oral cavity or
oropharyngeal cancer in the U.S. New cases of head and neck cancer
occur nearly three times more often in men as in women. Incidence
rates of head and neck cancers have been on the rise, especially
HPV-associated oropharyngeal cancer in men, and are expected to
continue growing.
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 June 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.com |
Media: |
Jeff Richardson,
Inovio, 267-440-4211, jrichardson@inovio.com |
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