Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today announced that
post-hoc analysis of data generated from its phase 2b trial of
VGX-3100 identified immune correlates and biomarker signatures
predictive of treatment success. VGX-3100, Inovio’s lead
product now in a pivotal phase 3 trial, would be the first
non-surgical treatment for HPV-associated high grade cervical
dysplasia (squamous intraepithelial lesions or HSIL) which
frequently progresses to cancer.
Details of the new biomarker and immunologic
data are highlighted in the peer-reviewed journal Clinical Cancer
Research in the article, “Clinical and Immunologic Biomarkers for
Histologic Regression of High-grade Cervical Dysplasia and
Clearance of HPV-16 and HPV-18 after Immunotherapy,” by Inovio and
its academic collaborators.
In this paper, Inovio has identified biomarker
signatures which predicted success of VGX-3100 treatment as early
as two weeks after the completion of treatment which was a full 22
weeks prior to the formal efficacy assessment. The company believes
these biomarkers will aid physicians in guiding patient care during
VGX-3100 treatment, and is pursuing the confirmation of these
predictions in its phase 3 program. Inovio is also
researching pre-treatment biomarkers which could identify patients
most likely to respond to treatment with VGX-3100, increasing
absolute efficacy of the product.
Dr. J. Joseph Kim, President and CEO, said:
“Inovio will transform the treatment of HPV-associated disease with
the first immunotherapies to treat both pre-cancer and cancer
caused by HPV which infects more than 70% of sexually active
adults. Today’s advancement in discovering a successful treatment
biomarker moves us closer to that goal.”
Inovio previously reported that VGX-3100
eliminated high grade dysplasia in 50% of women in its phase 2b
randomized, placebo-controlled trial. In 80% of the women whose
high grade dysplasia was eliminated, the HPV infection was also
cleared by VGX-3100. Further data analysis revealed that the
combination of HPV typing and cervical cytology (Pap smear)
following dosing was predictive for both elimination of the high
grade dysplasia and clearance of HPV.
Overall, Inovio is well positioned to
comprehensively treat HPV-associated diseases across the continuum
of HPV infection, from pre-cancerous conditions through to cancer
in both women and men, with VGX-3100 -- already the most advanced
product for treating these diseases.
- Inovio’s phase 3 clinical program to evaluate the efficacy of
VGX-3100 to treat high grade cervical dysplasia caused by HPV is
enrolling as scheduled with over 35 clinical sites open. By the end
of the year, the company expects to open approximately 50 sites in
at least six countries. The pivotal data from this program will
support the licensure application of VGX-3100.
- Extending its HPV franchise, Inovio is enrolling women into a
phase 2 trial at more than 10 sites to evaluate the efficacy of
VGX-3100 in women with high-grade vulvar dysplasia, another disease
caused by HPV with a high unmet medical need.
- And, in 2018, Inovio will initiate a phase 2 “proof-of-concept”
study for the treatment of high grade anal neoplasia, also caused
by HPV with limited treatment options.
In this paper, Inovio has revealed immune
responses in the phase 2b trial that were significantly associated
with treatment success with VGX-3100 that had not been previously
reported. Analysis of data from patient blood samples showed
that when focusing on immune responses specific for the HPV type
patients were infected with, a significant increase was seen in
killer T cells that expressed perforin – a protein known to be a
key mediator in killer T cell function. These significant
increases were noted only in patients who clinically responded to
VGX-3100 and were present at week 14 of treatment, which is 22
weeks prior to the efficacy assessment. Cervical tissue
samples from these same patients also showed an influx of immune
cells that expressed perforin after treatment, further
strengthening the association between the induction of perforin by
VGX-3100 and clinical response. This understanding of the immune
mechanism of action could also aid in the advancement of Inovio’s
broader immunotherapy product pipeline.
About HPV and Cervical HSIL
HPV is the most common sexually transmitted
infection, with over 14 million new infections annually. While many
of these are transient infections, persistent high-risk infections
can cause the formation of pre-cancerous lesions. Left untreated,
women diagnosed with cervical HSIL are at increased risk of
developing cervical cancer. HPV types 16 and 18 are responsible for
70% of cervical cancers, with more than 400,000 new cases of HPV
16/18 cervical HSIL annually in the US and Europe. Cervical cancer
is a major global health problem, causing 260,000 deaths annually.
While cervical HSIL and cervical cancer are the most well-known HPV
related diseases, HPV is also a major cause of HSIL and cancer in
the entire anogenital region and oropharynx. Currently there are no
treatments available for HPV infection and surgery is the only
approved treatment for cervical HSIL. While surgery is effective at
removing lesions, it does not treat the underlying HPV infection
and it carries increased risk of cervical incompetence and pre-term
birth, which can result in fetal morbidity and mortality.
About VGX-3100
VGX-3100 is a DNA-based immunotherapy under
investigation 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 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
immunotherapies, the company is advancing a growing preclinical and
clinical stage product pipeline. Partners and collaborators include
or have included MedImmune, Regeneron, Genentech, The Wistar
Institute, University of Pennsylvania, DARPA, GeneOne Life Science,
Plumbline Life Sciences, ApolloBio Corporation, Drexel University,
National Microbiology Laboratory of the Public Health Agency of
Canada, NIH, HIV Vaccines Trial Network, NIAID, U.S. Army Medical
Research Institute of Infectious Diseases and U.S. Military HIV
Research Program. 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 the sufficiency of 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, 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 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, our Form 10-Q for the period
ended September 30, 2017, and other regulatory filings we make from
time to time. There can be no assurance that any product candidate
in Inovio's 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. In addition, the forward-looking
statements included in this press release represent Inovio’s views
as of the date hereof. Inovio anticipates that subsequent events
and developments may cause its views to change. However, while
Inovio may elect to update these forward-looking statements at some
point in the future, the company specifically disclaims any
obligation to do so, except as may be required by law. These
forward-looking statements should not be relied upon as
representing Inovio’s views as of any date subsequent to the date
of this release.
CONTACTS:
Investors/Media: Jeff Richardson, Inovio Pharmaceuticals,
267-440-4211, jrichardson@inovio.com
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