Country for PR: United States
Contributor: PR Newswire New York
Monday, April 01 2019 - 22:45
AsiaNet
Inovio Completes Enrollment Ahead of Schedule In Immuno-Oncology Study for Glioblastoma (GBM) with INO-5401 in Combination with Regeneron's PD-1 Inhibitor
PLYMOUTH MEETING, Pa., April 1, 2019 /PRNewswire-AsiaNet/ --

Inovio Pharmaceuticals, Inc. (NASDAQ: INO) announced today that its Phase 1/2 
immuno-oncology trial in patients with newly diagnosed glioblastoma (GBM) has 
completed its enrollment three months ahead of schedule. The 52-patient trial 
is designed to evaluate Inovio's INO-5401 T cell activating immunotherapy 
encoding multiple antigens expressed by GBM and INO-9012, an immune activator 
encoding IL-12, in combination with cemiplimab-rwlc (also known as Libtayo(R) 
or REGN2810), a PD-1 inhibitor developed by Regeneron Pharmaceuticals in 
collaboration with Sanofi. This trial information will be presented today at 
Phase I-III Trials in Progress session at the Annual Meeting of the American 
Association for Cancer Research being held in Atlanta.

Inovio expects to report interim results from this study before the end of this 
year evaluating safety, immunological impact, progression-free survival and 
overall survival (see www.clinicaltrials.gov, identifier NCT03491683). 

Dr. J. Joseph Kim, Inovio's President and Chief Executive Officer, said, "We 
sincerely thank the patients and their doctors for participating in our 
innovative combination trial. This is an important step for Inovio's cancer 
combination strategy using our T cell-generating therapies in combination with 
PD-1/PD-L1 inhibitors for GBM and for multiple other cancers to improve overall 
efficacy of immunotherapy. We have previously shown in a Phase 1 head and neck 
cancer clinical study, combining Inovio's T cell-generating immunotherapy 
MEDI0457 along with checkpoint inhibitors have resulted in two complete 
responders who remain cancer free for over two years.  In this GBM trial, our 
goal is to increase the overall survival of patients facing a disease where 
neither the standard of care, nor clinical outcomes have changed in a 
clinically significant way in more than a decade."

Inovio holds clinical partnerships with AstraZeneca for MEDI0457 (in 
HPV-related cancers) and collaborations with Roche/Genentech and Regeneron for 
INO-5401 (in bladder cancer and GBM), each providing for clinical evaluation of 
Inovio immunotherapies combined with checkpoint inhibitors. In particular, the 
INO-5401 collaborations are based on a strong scientific rationale to combine 
two immunotherapies: INO-5401, which generates antigen-specific killer T cells, 
and a checkpoint inhibitor, which augments T cell activity.

About Glioblastoma 

Glioblastoma (GBM) is the most common and aggressive type of brain cancer and 
remains a devastating disease for both patients and caregivers. Its prognosis 
is extremely poor, despite a limited number of new therapies approved over the 
last 10 years. The median overall survival for patients receiving standard of 
care therapy is approximately 15 months and the average five-year survival rate 
is less than five percent.

About INO-5401 

INO-5401 includes Inovio's SynCon(R) antigens for hTERT, WT1, and PSMA, and has 
the potential to be a powerful cancer immunotherapy in combination with 
checkpoint inhibitors. The National Cancer Institute previously highlighted 
hTERT, WT1, and PSMA among a list of important cancer antigens, designating 
them as high priorities for cancer immunotherapy development. These three 
antigens are known to be over-expressed, and often mutated, in a variety of 
human cancers, and targeting these antigens may prove efficacious in the 
treatment of patients with cancer.

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

SOURCE: Inovio Pharmaceuticals, Inc. 
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