PLYMOUTH MEETING, Pa.,
March 26, 2020 /PRNewswire/
-- INOVIO Pharmaceuticals, Inc. (NASDAQ: INO) today announced
positive interim results from an open-label, Phase 2 study showing
its lead DNA medicine candidate VGX-3100 to be safe and effective
in treating men and women with anal dysplasia, also known as high
grade squamous intraepithelial lesion (HSIL), a precancerous
condition caused by high-risk human papillomavirus (HPV) types
16/18. Of the 20 subjects who had results at the time of data
review, 50% (10 of 20 subjects) showed clearance of HPV-16/18
associated precancerous lesions and 75% (15 of 20 subjects)
demonstrated an overall decrease in the number of lesions 6 months
after the start of treatment. No cases of anal cancer have been
observed in the trial. The results support the ability of VGX-3100
to effectively treat multiple HPV associated diseases and will be
presented in the virtual session of the annual American Society for
Colposcopy and Cervical Pathology (ASCCP) meeting titled:
Preliminary Results of an Open-label Phase 2 Study of VGX-3100 for
the Treatment of HPV16 and/or HPV-18 (HPV16/18) related Anal
HSIL.
Anal dysplasia or anal HSIL, is an orphan disease that affects
men and women in both immunocompetent and immunocompromised
populations. Fewer than 1 in 5 people with HPV 16/18-associated
precancerous dysplasia exhibit spontaneous resolution at one
year. Without adequate treatment anal HSIL could progress to
anal cancer. HPV 16/18 cause more than 90% of all anal cancer,
which is now considered one the most rapidly rising causes of
cancer incidence and mortality. According to the American Cancer
Society, anal cancer will claim the lives of more than 1,300 people
in the U.S. and 8,590 news cases (5,900 in women and 2,690 in men)
will be diagnosed in 2020 and according to a study published
November 2019 in the Journal of
the National Cancer Institute, from 2001 to 2015 the
overall incidence of anal cancer increased by 2.7%
per year and mortality jumped by 3.1% each year
Prakash Bhuyan, M.D., Ph.D.,
INOVIO's Vice President and Head of HPV Therapeutic Clinical
Development said, "These initial proof-of-concept efficacy results
show that VGX-3100 has the potential to enable the immune system to
clear HPV 16/18 HSIL that cause precancerous anal dysplasia and are
consistent with the results of our VGX-3100 Phase 2b efficacy study in high-risk HPV-associated
precancerous cervical dysplasia."
Currently, the treatments for anal dysplasia are surgical
excision, electro-cautery or laser therapy. Up to 50% of those
treated with these invasive options experience disease recurrence
within one year of treatment and nearly 70% experience recurrence
within three years. Therefore, many patients with this condition
need multiple invasive treatments.
VGX-3100 Safety and Efficacy Highlights for Anal
Dysplasia
- The first 20 subjects on VGX-3100 demonstrated safety results
consistent with the known safety profile of VGX-3100. There were no
drug-related serious adverse events.
- 75% showed an overall decrease in the number of lesions 6
months after treatment and 50% of subjects showed no HPV-16/18
associated precancerous lesions
- Results further support proof of concept for DNA medicines as
also demonstrated in prior VGX-3100 Phase 2b study in high-risk HPV-associated precancerous
cervical dysplasia
"These results are very encouraging and represent a potential
important step forward in the treatment of precancerous anal
dysplasia," said Dr. Céline Bouchard, Gynecologist/ Anoscopist at
Centre Médical Santé Femme in Québec City, Canada, former Associate Clinical Professor in
the Department of Obstetrics and Gynecology and Reproduction of
Université Laval, and Coordinating Principal Investigator for the
study. "Having a DNA medicine that can destroy and clear lesions
without the burden of repetitive, multiple, and painful surgical or
invasive treatments would change the standard of care and provide
patients with a meaningful benefit. I look forward to continuing
this research and learning more about the potential advantages of
VGX-3100."
About the Study
This open-label, multi-center Phase 2 study is designed to
evaluate the safety and efficacy of VGX-3100 in adults with
precancerous anal dysplasia caused by HPV-16 and/or HPV-18. Twenty
three subjects who are human immunodeficiency virus (HIV)
negative with histologically confirmed anal or anal/peri-anal
high-grade squamous intraepithelial lesion (HSIL) associated with
human papilloma virus (HPV)-16 and/or HPV-18 enrolled. One subject
discontinued due to an unrelated adverse event. Twenty two received
three doses of VGX-3100 administered by INOVIO's CELLECTRA™ 5PSP
smart device at Day 0, Week 4 and Week 12. Participants are
scheduled to be followed to Week 88.
About INOVIO's HPV-Associated DNA Medicines
Clinical Programs
This study builds on significant clinical benefits
demonstrated with INOVIO's HPV-associated DNA medicines in multiple
clinical trials. Specifically, VGX-3100 in a Phase 2
proof-of-concept trial for cervical dysplasia demonstrated a
complete response in 43 out of 107 patients in regression of
high-grade cervical lesions and elimination of the underlying HPV
infection. Additionally, two out of four metastatic HPV-associated
head and neck cancer patients treated with MEDI0457 and a PD-1
check point inhibitors in a Phase 1 study experienced a long-term
complete response for more two years and counting. Lastly, a pilot
study of INOVIO's DNA medicine INO-3107 in recurrent respiratory
papillomatosis (RRP) resulted in two out of two patients delaying
surgery due to lack of tumor recurrence.
About VGX-3100
VGX-3100 is a DNA medicine 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
dysplasia (HSIL). 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. It 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 dysplasia (CIN2/3 or
HSIL), treatment with VGX-3100 resulted in a statistically
significantly greater regression of cervical dysplasia and
clearance of HPV-16/18 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 Medicines
INOVIO has 15 DNA medicine clinical programs currently in
development focused on HPV-associated diseases, cancer, and
infectious diseases, including coronaviruses MERS and COVID-19
under grants from the Coalition for Epidemic Preparedness
Innovations (CEPI). DNA medicines are composed of optimized DNA
plasmids, which are small circles of double-stranded DNA that are
synthesized or reorganized by a computer sequencing technology and
designed to produce a specific immune response in the body.
INOVIO's DNA medicines deliver optimized plasmids directly into
cells intramuscularly or intradermally using INOVIO's proprietary
hand-held smart device called CELLECTRA®. CELLECTRA® uses a brief
electrical pulse to open small pores in the cell reversibly to
allow the plasmids to enter, overcoming a key limitation of other
DNA and mRNA approaches. Once inside the cell, the plasmids are
used by the cell's own machinery to generate specific coded
antigens, which then stimulate an immune response. Administration
with the CELLECTRA device ensures that the DNA medicine is
delivered directly into the body's cells, where it can go to work
immediately mounting an immune response. INOVIO's DNA medicines do
not interfere with or change in any way an individual's own DNA.
The advantages of INOVIO's DNA medicine platform are how fast DNA
medicines can be constructed and manufactured, the stability of the
products which do not require freezing in storage and transport,
and the robust immune response, safety profile and tolerability
that have been demonstrated in clinical trials.
With more than 2,000 patients receiving INOVIO investigational
DNA medicines in more than 6,000 applications across a range of
clinical trials, INOVIO has a strong track record of rapidly
generating DNA medicine candidates to meet urgent global health
needs.
About INOVIO
INOVIO is a biotechnology company focused on rapidly bringing to
market precisely designed DNA medicines to treat, cure, and protect
people from diseases associated with HPV, cancer, and infectious
diseases. INOVIO is the first and only company to have clinically
demonstrated that a DNA medicine can be delivered directly into
cells in the body via a proprietary smart device to produce a
robust and tolerable immune response. Specifically, INOVIO's lead
candidate VGX-3100, currently in Phase 3 trials for precancerous
cervical dysplasia, demonstrated it destroyed and cleared high-risk
HPV 16 and 18 in a Phase 2b clinical
trial. High-risk HPV is responsible for 70% of cervical cancer, 90%
of anal cancer, and 69% of vulvar cancer. Also in development are
programs targeting HPV-related cancers and a rare HPV-related
disease: recurrent respiratory papillomatosis (RRP);
non-HPV-related cancers glioblastoma multiforme (GBM) and prostate
cancer; as well as externally funded infectious disease DNA vaccine
development programs in Zika, Lassa fever, Ebola, HIV, and
coronaviruses MERS and COVID-19. Partners and collaborators include
Advaccine, ApolloBio Corporation, AstraZeneca, The Bill &
Melinda Gates Foundation, Coalition for Epidemic Preparedness
Innovations (CEPI), Defense Advanced Research Projects Agency,
GeneOne Life Science, HIV Vaccines Trial Network, Medical CBRN
Defense Consortium (MCDC), National Cancer Institute, National
Institutes of Health, National Institute of Allergy and Infectious
Diseases, Plumbline Life Sciences, Regeneron, Roche/Genentech,
University of Pennsylvania, Walter Reed
Army Institute of Research, and The Wistar Institute. INOVIO also
is a proud recipient of 2020 Women on Boards "W" designation
recognizing companies with more than 20% women on their board of
directors. For more information, visit www.inovio.com.
This press release contains certain forward-looking
statements relating to our business, including our plans to develop
DNA medicines, our expectations regarding our research and
development programs, as well as commercialization activities,
including the planned initiation and conduct of clinical trials,
the availability and timing of data from those trials and our
commercialization strategy and tactics. 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, product development programs and
commercialization activities and outcomes, 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 medicines, our ability to
support our pipeline of DNA medicine 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, 2019 and other
filings we make from time to time with the Securities and Exchange
Commission. 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 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:
Media:
Jeff Richardson, 267-440-4211,
jrichardson@inovio.com
Investors:
Ben Matone, 484-362-0076,
ben.matone@inovio.com
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SOURCE INOVIO Pharmaceuticals, Inc.