INOVIO Reports Positive Interim Phase 2 VGX-3100 Results In Patients with HPV-associated Anal Dysplasia
PR83447
PLYMOUTH MEETING, Pennsylvania, March 26, 2020 /PRNewswire=KYODO JBN/ --
- VGX-3100 DNA medicine cleared high-risk HPV 16/18-associated precancerous
lesions in 50% of patients, and reduced the number of lesions in 75% of patients
- Data to be presented at the 2020 American Society for Colposcopy and Cervical
Pathology (ASCCP) meeting
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 (https://c212.net/c/link/?t=0&l=en&o=2761401-1&h=4055021695&u=https%3A%2F%2Fwww.cancer.gov%2FCommon%2FPopUps%2FpopDefinition.aspx%3Fid%3DCDR0000046145%26version%3DPatient%26language%3Den&a=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(TM) 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(R). CELLECTRA(R) 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, +1 267-440-4211, jrichardson@inovio.com
Investors: Ben Matone, +1 484-362-0076, ben.matone@inovio.com
SOURCE: INOVIO Pharmaceuticals, Inc.
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