--Biotech company will report interim data later this year

Inovio Pharmaceuticals, Inc. (NASDAQ:INO) announced today that it has completed 
enrollment in its Phase 2 trial with VGX-3100 in patients with precancerous 
lesions of the vulva or vulvar intraepithelial neoplasia (VIN). VGX-3100 is an 
immunotherapy that targets human papillomavirus (HPV) 16 and 18 and is being 
studied for the treatment of HPV-related precancerous lesions and the HPV 
infection that causes these lesions. Inovio is already evaluating VGX-3100 in 
two Phase 3 registration trials (REVEAL 1 and REVEAL 2) to treat cervical 
dysplasia caused by HPV.

This randomized, open-label Phase 2 study will assess the efficacy of VGX-3100 
in 33 women with high-grade HPV-related vulvar lesions. The immunotherapy is 
administered with Inovio's CELLECTRA(R) device. The primary endpoint of the 
study is histologic clearance of high-grade lesions and virologic clearance of 
the HPV virus in vulvar tissue samples. The study will also evaluate safety and 
tolerability of VGX-3100. The company intends to report interim clinical data 
from this study before year's end. 

Dr. Prakash Bhuyan, MD PhD, VP, Clinical Development and the Lead for the 
VGX-3100 Program, said, "Inovio is developing VGX-3100 to be the first, 
comprehensive non-surgical treatment option for HPV-related precancer.  
Surgical treatment of VIN is often disfiguring, and recurrence occurs in 
approximately one third of women.  The enrollment of our US-based Phase 2 study 
of VIN exemplifies the outstanding commitment of our Investigators and their 
patients to making it possible to improve the current standard of care for VIN 
and ultimately reduce the occurrence of vulvar cancer." 

VIN has a very low rate of spontaneous, or natural, regression − below 
5%. Currently there are no FDA-approved non-surgical treatments for 
precancerous lesions of the vulva. Surgery, the most common treatment, is 
associated with high rates of disease recurrence and can cause disfigurement, 
long-term pain, and psychological distress for the women who undergo the 
procedure. VIN recurs in approximately one of every two patients who undergo 
surgical treatment.

Inovio's immunotherapy aims to address the unmet medical need for VIN by 
providing a non-surgical option for women with this disease. In a previously 
conducted Phase 2b randomized, placebo-controlled study of 167 women with 
HPV-associated cervical pre-cancer, VGX-3100 led to a significantly higher rate 
of lesion regression and clearance of the underlying HPV viral infection. 
Inovio is currently conducting a Phase 3 study of VGX-3100 as a treatment for 
high grade cervical dysplasia, and the treatment of VIN represents an important 
additional indication for the lead product.

About Vulvar Pre-Cancers
If left untreated vulvar pre-cancers can progress to invasive cancer of the 
vulva. Approximately 27,000 cases of HPV-related vulvar pre-cancers occur in 
the U.S. each year with a similar number of estimated cases in Europe each 
year. HPV-16 and/or HPV-18 are involved in about 80% of HPV-related vulvar 
pre-cancers cases in the U.S. and Europe. Once vulvar pre-cancers develop, 
spontaneous regression (i.e. natural disappearance of the lesion) is rare and 
occurs in 1.5% to 5% of cases. An estimated 6,000 new cases of vulvar cancer 
occur in the U.S. each year with about 50% to 80% of those being 
HPV-associated. About 1,110 deaths occur annually due to vulvar cancer in the 
U.S. Standard of care treatment of vulvar pre-cancer usually involves surgery, 
which has significant physical and psychosocial impacts in women (e.g. severe 
pain, disfigurement, sexual dysfunction), and the success of such surgery is 
marginal, as the recurrence rate of high grade vulvar pre-cancer is extremely 
high, i.e. about 30 to 50% three years post-treatment.

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 an innovative biotechnology company focused on the discovery, 
development, and commercialization of its synthetic nucleic technology targeted 
against cancers and infectious diseases. Inovio's proprietary technology 
platform applies antigen sequencing and 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, GeneOne Life Science, The 
Bill & Melinda Gates Foundation, Coalition for Epidemic Preparedness 
Innovations, Defense Advanced Research Projects Agency, National Institutes of 
Health, National Institute of Allergy and Infectious Diseases, National Cancer 
Institute, HIV Vaccines Trial Network, Walter Reed Army Institute of Research, 
The Wistar Institute, and the University of Pennsylvania. 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-based immunotherapies, 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 
immunotherapies, 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 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, 
our Quarterly Report on Form 10-Q for the quarter ended March 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.

Inovio Pharmaceuticals Inc.
Investors                         	Media               
Ben Matone                        	Jeffrey C. Richardson
1-484-362-0076                    	1-267-440-4211
ben.matone@inovio.com            	jrichardson@inovio.com

                   

SOURCE: Inovio Pharmaceuticals, Inc.