Country for PR: United States
Contributor: PR Newswire New York
Tuesday, March 05 2019 - 00:00
AsiaNet
Inovio Initiates REVEAL 2 Global Phase 3 Clinical Study For the Treatment of HPV-Related Cervical Pre-cancer
PLYMOUTH MEETING, PA., Mar. 5, 2019 /PRNewswire-AsiaNet/--

-- The second Phase 3 study initiation announcement made during the 
International HPV Awareness Day

Inovio Pharmaceuticals, Inc. (NASDAQ: INO) today announced the initiation and 
opening of sites to enroll the second portion of the company's Phase 3 program 
for VGX-3100, Inovio's DNA-based immunotherapy to treat cervical dysplasia 
caused by human papillomavirus (HPV). The study, named REVEAL 2, is the 
company's confirmatory stage Phase 3 clinical study and is designed to evaluate 
the efficacy and safety of VGX-3100. If approved after completion of the Phase 
3 clinical trials, VGX-3100 will stand as the first immunotherapy for women 
with cervical dysplasia.  The company made the announcement in concert with the 
celebration marking the 2019 International HPV Awareness Day.  The annual 
campaign encourages everyone to take action to learn about HPV, and how to 
manage the risk of HPV related cancers and precancers. (For more information on 
HPV Day visit: https://www.askabouthpv.org/)

Dr. J. Joseph Kim, Inovio's President & CEO, said, "The early initiation of our 
REVEAL 2, our second Phase 3 study, marks another milestone for our lead 
product VGX-3100. I am confident in our team's experience and expertise to 
advance the REVEAL program forward to deliver on our goal to file a BLA for 
VGX-3100 in 2021. And most importantly, we remember that patients are waiting 
and our efforts are bringing an innovative, impactful therapy to people where 
surgery is their only option.

Dr. Kim added, "Inovio is also investigating VGX-3100 in Phase 2 clinical 
trials for treating anal and vulvar dysplasia with interim results expected 
later this year." 

Inovio's Phase 3 program is assessing the efficacy of VGX-3100 to regress 
cervical HSIL (high-grade squamous intraepithelial lesions), a direct precursor 
to cervical cancer, and to eliminate the HPV infection that causes these 
lesions. The REVEAL studies are prospective, randomized (2:1), double-blind, 
placebo-controlled trials evaluating adult women with HPV 16/18 positive 
biopsy-proven cervical HSIL, otherwise known as cervical intraepithelial 
neoplasia (CIN) 2 or 3. 

The primary endpoint is regression of cervical HSIL AND virologic clearance of 
HPV-16 and/or HPV-18 in the cervix. The studies will evaluate cervical tissue 
changes at approximately 9 months after beginning a three dose regimen of 
VGX-3100 administered at months 0, 1, and 3. Secondary endpoints include 
safety; tolerability; regression of CIN 2/3 to CIN 1 or normal; virologic 
clearance of HPV; efficacy measured by non-progression to cancer; and clearance 
of HPV from non-cervical anatomic locations. For more information on these 
studies, please visit clinicaltrials.gov (search identifier NCT03185013 and 
NCT03721978 for REVEAL 1 and REVEAL 2, respectively).  

Inovio previously reported that VGX-3100 eliminated high grade dysplasia in 
almost 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 detection and cervical cytology (Pap smear) following dosing 
was predictive for both elimination of the high grade dysplasia and clearance 
of HPV.

In addition to advancing its HPV program trial enrollment, Inovio continues to 
pursue research into biomarkers with the intent of attaining the ability to 
predict clinical response to VGX-3100 that may ultimately aid in patient 
selection and physician guidance of patient care. These pre-treatment 
biomarkers could identify patients most likely to respond to treatment with 
VGX-3100, increasing absolute efficacy of the product.

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 and anus (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 a late-stage biotechnology company focused on the discovery, 
development, and commercialization of DNA-based immunotherapies and vaccines 
that transform the treatment and prevention of cancer and infectious disease. 
Inovio's proprietary technology platform 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'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 HPV-related cancers, 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 Bill and Melinda Gates Foundation, The Wistar 
Institute, the University of Pennsylvania, 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.  
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(R) 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 September 30, 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,      +1 484-362-0076, ben.matone@inovio.com
Media:     Jeff Richardson, +1-267-440-4211, jrichardson@inovio.com

SOURCE: Inovio Pharmaceuticals, Inc.
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