Country for PR: United States
Contributor: PR Newswire New York
Monday, April 08 2019 - 23:00
AsiaNet
Inovio Achieves Third Cancer Indication Milestone for MEDI0457 Phase 2 Development
PLYMOUTH MEETING, Pennsylvania, Apr. 8, 2019 /PRNewswire-AsiaNet/--

Inovio Pharmaceuticals, Inc. (NASDAQ: INO) announced today that it achieved a 
third indication milestone from AstraZeneca resulting from dosing a patient in 
a Phase 2 combination trial evaluating MEDI0457 (formerly called INO-3112) in 
combination with durvalumab targeting cervical, anal, penile, and vulvar 
cancers associated with the human papilloma virus (HPV). The milestone 
achievement for this multi-indication trial is the third MEDI0457-related Phase 
2 milestone from AstraZeneca; two previous milestone payments resulted from 
initiating Phase 2 combination trials targeting head and neck and cervical 
cancers. Financial arrangements were not disclosed.

Dr. J. Joseph Kim, Inovio's President and Chief Executive Officer, said, "This 
Phase 2 milestone stresses the potential breadth of MEDI0457 in treating 
multiple HPV-associated cancers. Inovio's goal is to lead the HPV-treatment 
market from pre-cancers with its lead product VGX-3100 to cancers with MEDI0457 
along with our partner AstraZeneca."

In several on-going Phase 2 cancer-indication trials, AstraZeneca is evaluating 
MEDI0457 in combination with durvalumab, an anti-PD-L1 immune checkpoint 
inhibitor, in patients with HPV-associated head and neck, cervical, anal, 
penile, and vulvar cancers. Inovio is developing its HPV monotherapy VGX-3100 
for pre-cancerous indications in a Phase 3 trial for cervical dysplasia; and in 
Phase 2 trials for vulvar and anal dysplasia.

About MEDI0457 and VGX-3100

MEDI0457 (formerly called INO-3112 (VGX-3100, plus IL-12) which AstraZeneca 
in-licensed from Inovio) is under evaluation by AstraZeneca to treat 
HPV-associated cancers. Inovio is investigating VGX-3100, a DNA-based 
immunotherapy for the treatment of HPV-16 and HPV-18 infection and 
pre-cancerous lesions of the cervix (Phase 3) and vulva (Phase 2) and anal 
(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.

Under the 2015 agreement, AstraZeneca acquired exclusive rights to Inovio's 
INO-3112, now called MEDI0457. MEDI0457 targets cancers caused by HPV types 16 
and 18 which are responsible for more than 70 percent of cervical pre-cancers 
and cancers and are involved in the development of other tumors. Within the 
broader license and collaboration agreement, AstraZeneca and Inovio are 
co-developing one additional DNA-based cancer therapy product not included in 
Inovio's current product pipeline, which AstraZeneca has exclusive rights to 
develop and commercialize. Inovio will receive development, regulatory and 
commercialization milestone payments for these additional cancer vaccine 
products and will be eligible to receive royalties on worldwide net sales.

About Durvalumab 

Durvalumab, a human monoclonal antibody directed against PD-L1, blocks PD-L1 
interaction with PD-1 and CD80 on T cells, countering the tumor's 
immune-evading tactics and inducing an immune response. As part of a broad 
development program, durvalumab is being investigated as monotherapy and in 
combination with IO, small molecules, and chemotherapies across a range of 
tumors and stages of disease.

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 
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, 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,
           Inovio, +1-484-362-0076, ben.matone@inovio.com;
Media:     Jeff Richardson
           Inovio, +1-267-440-4211, jrichardson@inovio.com

SOURCE:    Inovio Pharmaceuticals, Inc. 
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