Country for PR: United States
Contributor: PR Newswire New York
Monday, May 06 2019 - 23:00
Inovio Receives European Medicines Agency Certification For Quality and Non-Clinical Data for Its Phase 3 Product, VGX-3100
PLYMOUTH MEETING, PA., May 7, 2019 /PRNewswire-AsiaNet/--

Inovio Pharmaceuticals, Inc. (NASDAQ: INO) today announced that its lead Phase 
3 product candidate, VGX-3100, has been granted an Advanced Therapy Medicinal 
Product Certificate for quality and non-clinical data. The procedure of 
certification of quality and non-clinical data involves an assessment of the 
available data in view of future registration and the related European 
Scientific Data Requirements, not including any clinical data or benefit-risk 
assessment. The granted EMA's certificate confirms that Inovio's chemistry, 
manufacturing and controls (CMC) data and nonclinical results available to date 
overall comply with the scientific and technical standards for evaluating an EU 
Marketing Authorization.

Dr. Ami Shah Brown, Inovio's Senior Vice President of Regulatory Affairs, said, 
"We are extremely pleased that the current CMC, coupled with the nonclinical 
data supporting our lead product, VGX-3100, meets stringent EMA requirements. 
This certification is a testament to Inovio's technical excellence, 
cross-functional development expertise, and high quality standards as applied 
for VGX-3100 and indirectly for Inovio's technology."

VGX-3100 is currently being tested in a pivotal, global Phase 3 program, which 
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. In parallel, the 
final commercial manufacturing process will be validated yielding additional 
quality data by time of the EU filing.

About VGX-3100

VGX-3100 is a DNA-based immunotherapy under investigation for the treatment of 
HPV 16 and HPV 18 infection and precancerous 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 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 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 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 
pre-cancer. 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 AstraZeneca, Regeneron, Roche/Genentech, ApolloBio 
Corporation, The Wistar Institute, The Bill & Melinda Gates Foundation, the 
University of Pennsylvania, Parker Institute for Cancer Immunotherapy, CEPI, 
DARPA, GeneOne Life Science, Plumbline Life Sciences, NIH, HIV Vaccines Trial 
Network, National Cancer Institute, Walter Reed Army Institute of Research, 
Drexel University, and Laval University. For more information, visit:

                                  * * * *

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, 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.

Ben Matone

Jeff Richardson

SOURCE: Inovio Pharmaceuticals, Inc.