Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today announced
MedImmune, AstraZeneca’s global biologics research and development
arm, will start a new clinical trial investigating the combination
of MEDI0457, an immunotherapy designed to generate antigen specific
killer T cell responses targeting HPV-associated tumors, and
durvalumab, an investigational PD-L1 checkpoint inhibitor. The
combination trial will enroll patients with metastatic
HPV-associated squamous cell carcinoma of the head & neck
(SCCHN) with persistent or recurrent disease after chemotherapy
treatment.
The open-label study is designed to evaluate the
safety and efficacy of the combination therapy in approximately 50
subjects at multiple U.S. sites. Subjects will receive multiple
doses of MEDI0457 (previously known as INO-3112) and durvalumab.
The primary endpoints of the study are safety and objective
response rate. The study will also evaluate immunological impact,
progression-free survival and overall survival.
Dr. J. Joseph Kim, Inovio's President and CEO,
said, "This study marks a significant moment for Inovio as we
transition into a late-stage biotechnology company. MedImmune is
investigating the possibility of elevating the response rate of
checkpoint inhibitors by using durvalumab in combination with a DNA
plasmid vaccine originally from Inovio which has shown the ability
to generate killer T cells. I’m a strong believer in this
combination regimen strategy against cancer: utilize Inovio’s
cancer vaccine to generate significant levels of antigen-specific
killer T cells, have them infiltrate into tumors -- or what is
being referenced as turning a tumor from “cold” to “hot” -- then
suppress the cancer cells’ defensive mechanisms utilizing a
checkpoint inhibitor. We think that powerful combination can be
effective in treating multiple tumors going forward.”
Increasing evidence suggests that response rates
from checkpoint inhibitors such as MedImmune’s durvalumab 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.
In 2015, MedImmune acquired exclusive rights to
Inovio's INO-3112 immunotherapy for all HPV-associated cancers.
MedImmune provided an upfront payment of $27.5 million to Inovio as
well as potential future payments upon reaching development and
commercial milestones totaling up to $700 million. MedImmune will
fund all development costs. Inovio is entitled to receive up to
double-digit tiered royalties on INO-3112 product sales.
About HPV-associated Head & Neck
CancerHead and neck cancer is the sixth most common cancer
worldwide. Human papillomavirus (HPV), the most common
sexually transmitted disease in the US, 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. New cases of HPV-associated squamous cell carcinoma of the
head & neck (SCCHN) are growing fastest in developed countries
like the US. There are approximately 16,000 new cases of
HPV-associated SCCHN per year in the US alone. In contrast, the
rate of smoking and alcohol-related SCCHN has been steadily
declining. Men are four times more likely than women to be
diagnosed with this disease. Patients with HPV-associated
SCCHN tend to be diagnosed at a younger age than those with smoking
and alcohol related disease.
Head and neck cancers are currently treated by
surgical removal of the cancer and lymph nodes, often followed by
radiation and chemotherapy based on the extent of the
disease. While patients may achieve good long-term survival,
standard treatments can change their physical appearance and are
associated with significant short and long-term toxicities which
may interfere with salivary gland function, taste, smell, and the
ability to swallow. The biology and natural history of
oropharyngeal HPV infection and the best clinical management of
patients with HPV-associated SCCHN are not well understood.
About MEDI0457
(INO-3112)Inovio's DNA-based immunotherapies help the
immune system activate disease-specific killer T cells to fight a
targeted disease. INO-3112 targets disease associated with the
high-risk HPV types 16 and 18, which are responsible for over 70%
of cervical pre-cancers and cancers and 60% of head and neck
cancers. INO-3112 combines Inovio's VGX-3100, its immunotherapy
targeting HPV-associated diseases, with its DNA-based immune
activator encoding IL-12.
About DurvalumabDurvalumab,
previously known as MEDI4736, a human monoclonal antibody directed
against PD-L1, blocks PD-L1 interaction with PD-1 and CD80 on T
cells, countering the tumour's immune-evading tactics and inducing
an immune response. Additional clinical trials are ongoing to
investigate durvalumab as monotherapy or in combination with
tremelimumab in non-small cell lung cancer, head and neck squamous
cell carcinoma, bladder, hepatocellular carcinoma and blood
cancers.
About MedImmuneMedImmune is the
global biologics research and development arm of AstraZeneca, a
global, innovation-driven biopharmaceutical business that focuses
on the discovery, development and commercialization of small
molecule and biologic prescription medicines. MedImmune is
pioneering innovative research and exploring novel pathways across
Oncology; Respiratory, Cardiovascular & Metabolic Diseases; and
Infection and Vaccines. The MedImmune headquarters is located in
Gaithersburg, MD., one of AstraZeneca’s three global R&D
centers, with additional sites in Cambridge, UK, and Mountain View,
CA. For more information, please visit www.medimmune.com.
About AstraZenecaAstraZeneca is
a global, science-led biopharmaceutical company that focuses on the
discovery, development and commercialization of prescription
medicines, primarily for the treatment of diseases in three main
therapy areas - Oncology, Cardiovascular & Metabolic Diseases
and Respiratory. The Company also is selectively active in the
areas of autoimmunity, neuroscience and infection. AstraZeneca
operates in over 100 countries and its innovative medicines are
used by millions of patients worldwide. For more information,
please visit www.astrazeneca.com and follow us on Twitter
@AstraZeneca.
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, 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 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 the cancer immunotherapy INO-3112,
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 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,
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.com
Media: Jeff Richardson, Inovio Pharmaceuticals, 267-440-4211, jrichardson@inovio.com
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