Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today announced that it
has entered into a partnership with the AIDS Malignancy Consortium
(AMC) to evaluate VGX-3100, Inovio’s immunotherapy for treating
HPV-associated precancerous conditions in HIV-positive adult men
and women. AMC will fund a Phase 2 clinical trial to evaluate the
efficacy of VGX-3100 in adult men and women with human
papillomavirus (HPV)-related high-grade anal dysplasia or squamous
intraepithelial lesions (ASIL) and HIV. Recruitment is already
ongoing for patients who are HIV-positive with histologically
confirmed anal high-grade squamous intraepithelial lesions (HSIL)
associated with HPV-16 and/or HPV-18. The multi-site Phase 2 study
is planning to enroll approximately 75 patients who will receive
four doses of VGX-3100. Financial details of the agreement were not
disclosed.
Joel M. Palefsky, MD, Professor of Medicine,
Division of Infectious Diseases, UCSF, and founder and chair of the
HPV Working Group of the NCI AIDS Malignancy Consortium, said, “The
incidence of anal cancer among HIV-positive men and women is
unacceptably high. Better methods to treat the anal cancer
precursor, known as anal high-grade squamous intraepithelial
lesions (HSIL), are needed in an effort to prevent progression from
HSIL to cancer. Given the encouraging results with VGX-3100 in
treatment of cervical HSIL, the AMC looks forward to testing the
immunotherapy for treatment of anal HSIL in this population.”
Dr. J. Joseph Kim, Inovio's President and CEO,
said, “Expanding VGX-3100 to treat anal dysplasia represents a
significant increase in commercial potential for our lead product.
We thank the AMC for partnering with us to test the efficacy of
VGX-3100 in a patient community where there is a great unmet need
for a successful therapy. For these patients and others, Inovio is
moving forward to become the ‘go-to’ immunotherapeutic solution
provider for all major diseases caused by HPV, including cervical,
vulvar and anal precancers.”
This open-label, multi-center Phase 2 study is
designed to evaluate the safety and efficacy of VGX-3100
administered by intramuscular (IM) injection with CELLECTRA®
delivery system in adult men and women who are HIV-positive with
anal HSIL associated with HPV-16 and/or HPV-18. For additional
information about the study, please visit www.clinicaltrials.gov
(search identifier NCT03603808).
Separately, Inovio has already initiated a
multi-center Phase 2 study designed to evaluate the safety and
efficacy of VGX-3100 in 24 HIV-negative patients with anal HSIL
associated with HPV-16 and/or HPV-18. The first patient was dosed
in July.
Anal HSIL can lead to HPV-associated squamous
cell carcinoma of the anus (SCCA). Anal cancer is uncommon in the
general population, but its incidence is considerably increasing
and is higher among HIV-positive men and women than in HIV-negative
persons. The risk of SCCA among HIV-positive men has continued to
increase even after the introduction of highly active
antiretroviral therapy. Currently, rates of SCCA in HIV-positive
men are higher than cervical cancer reported anywhere in the world.
This trend is likely to continue with the aging of the HIV-positive
population.
Anal cancer is estimated to have nearly 8,600
new cases diagnosed and cause more than 1,100 deaths in the United
States in 2018. Currently, the only treatments for anal dysplasia
consist of surgical excision, electro-cautery or laser therapy, but
more than 50% of those treated with these current treatments
experience recurrence of the disease. The HIV population has a
significant burden of existing disease which cannot be addressed by
current prophylactic approaches.
About the AIDS Malignancy
Consortium
The AIDS Malignancy Consortium (AMC) is a
National Cancer Institute-supported clinical trials group founded
in 1995 to support innovative trials for AIDS-related cancers. The
AMC is composed of 36 Clinical Trials Sites worldwide, five Working
Groups, an Administrative Office, a Statistical Office, and an
Operations and Data Management Office. Collectively, these
components develop and oversee the scientific agenda, manage the
groups’ portfolio of clinical trials and other scientific-based
studies, and help to develop new protocols. The AMC mission is to
investigate new treatment and prevention interventions for
malignancies in people living with HIV and to study the
pathobiology of these tumors in the context of clinical trials.
About VGX-3100
VGX-3100 is a DNA-based immunotherapy under
Phase 3 investigation for the treatment of HPV-16 and HPV-18
infection and precancerous lesions of the cervix. Inovio has also
initiated open-label Phase 2 clinical trials evaluating its
efficacy for treating HPV-related vulvar and anal precancers.
VGX-3100 has the potential to be the first approved treatment for
HPV infection of the cervix and the first non-surgical treatment
for precancerous 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 precancerous 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 precancerous lesions without the increased
risks associated with surgery, such as loss of reproductive health
and negative psychosocial impacts.
About Inovio’s DNA Immunotherapy
Technology Platform
Inovio is advancing the medical potential of a
unique class of immunotherapy technology. Its DNA-based platform,
which is the foundation for all of Inovio’s products, including
VGX-3100, is unique in its ability to leverage the body’s naturally
existing mechanisms to generate robust, highly targeted immune
responses to prevent and treat disease – and to do so in the body
without harmful side effects. Its SynCon® immunotherapy design and
CELLECTRA® delivery transform novel genetic blueprints into
functional antibody and killer T cell responses. Inovio was the
first to report the activation – in the body – of significant,
antigen-specific functional T cells correlated to statistically
significant efficacy in a placebo-controlled, randomized,
double-blind Phase 2b clinical trial (HPV-related precancer), with
a very favorable safety profile. These data were published in The
Lancet and independently described as a “major breakthrough” in the
field by U.S. National Cancer Institute scientists. Inovio has
achieved significant antigen-specific immune responses against
multiple diseases and is advancing a growing pipeline of cancer and
infectious disease immunotherapies and vaccines.
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. The ASPIRE (Antigen Specific Immune Responses)
technology platform is designed to activate an individual’s immune
system to generate a robust, targeted T cell and antibody response
against targeted diseases. Inovio is the only
immunotherapy company that has reported generating T cells
entirely in vivo in high quantity that are fully functional
and whose killing capacity correlates with relevant clinical
outcomes with a favorable safety profile. Inovio’s most advanced
clinical program, VGX-3100, is in Phase 3 for the treatment of
HPV-related cervical precancer. 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, the Parker Institute for Cancer Immunotherapy, DARPA,
GeneOne Life Science, Plumbline Life Sciences, Drexel University,
National Institute of Allergy and Infectious Diseases, U.S. Army
Medical Research Institute of Infectious Diseases, NIH, HIV
Vaccines Trial Network, U.S. Military HIV Research Program and
CEPI. 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, our plans and expectations regarding
partnerships and the plans of GENEOS Therapeutics, Inc. to raise
capital. 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 March 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:Investors: Ben Matone,
Inovio, 484-362-0076, ben.matone@inovio.comMedia: Jeff Richardson,
Inovio, 267-440-4211, jrichardson@inovio.com
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