Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today announced that it
has commenced a Phase 2 clinical trial to evaluate the
efficacy of VGX-3100 in adult men and women with human papilloma
virus (HPV)-related anal dysplasia. Recruitment is ongoing for
patients who are HIV-negative with histologically confirmed anal or
perianal high-grade squamous intraepithelial lesions (HSIL)
associated with HPV-16 and/or HPV-18. The study is planning to
enroll approximately 24 patients and will administer at least three
doses of VGX-3100.
Anal HSIL or dysplasia is the precursor to anal
cancer, which is estimated to 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.
Dr. Céline Bouchard, FRCSC, gynecologist, colposcopist and
Coordinating Principal Investigator, said, “The large burden of
disease rests in the general population. As more than 70% of anal
cancers in the United States occur among HIV-negative men and
women, a non-surgical immunotherapy to eradicate precancerous
perianal and/or anal lesions caused by HPV types 16 or 18 infection
would represent a major breakthrough for the treatment of this
disease and the prevention of anal cancer.”
Dr. J. Joseph Kim, Inovio's President and CEO,
said, “Inovio is boldly targeting the world’s No. 1 sexually
transmitted disease – the HPV virus – across the continuum of
conditions with our treatment that has demonstrated efficacy
eliminating disease and clearing the underlying HPV infection. This
compact Phase 2 efficacy trial represents an important step towards
Inovio’s aim to develop a comprehensive immunotherapeutic solution
to HPV-related diseases, especially given that anal dysplasia
remains an underdiagnosed condition which needs better treatment
options. Inovio is rapidly moving on a path to become the ‘go-to’
immunotherapeutic solution provider for all diseases caused by HPV,
including cervical, vulvar and anal precancers and with our partner
MedImmune/AstraZeneca for HPV-related cancers.”
This open-label, multi-center Phase 2 study is
designed to evaluate the safety and efficacy of VGX-3100
administered by intramuscular (IM) injection w CELLECTRA® delivery
system in adult men and women who are human immunodeficiency virus
(HIV) negative with HSIL associated with HPV-16 and/or HPV-18.
Prior study results utilizing Inovio’s VGX-3100 immunotherapy,
which is also in a Phase 3 trial evaluating treatment for cervical
dysplasia, supported expanding treatment indications for patients
associated with HPV-16 and/or HPV-18. In a Phase 2 trial for
cervical dysplasia, VGX-3100 demonstrated a systemic response (vs.
localized surgery) and clearance of cervical lesions and
eliminating the underlying HPV infection in many patients. For
additional information about the study, please
visit www.clinicaltrials.gov (search
identifier NCT03499795).
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 is in
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. Inovio’s proprietary platform technology,
ASPIRE, 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 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, 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 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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