Country for PR: United States
Contributor: PR Newswire New York
Tuesday, September 17 2019 - 23:00
AsiaNet
Inovio Receives NIH Funding to Target its dMAb(R) Technology Against Antimicrobial-Resistant Infection
PLYMOUTH MEETING, Pennsylvania, Sept. 17, 2019 /PRNewswire-AsiaNet/ --

Inovio Pharmaceuticals, Inc. (NASDAQ: INO) announced today that the company and 
its collaborator The Wistar Institute have received a $4.6 million National 
Institutes of Health (NIH) grant in support of innovative research to tackle 
antimicrobial resistance (AMR) employing Inovio's DNA-encoded monoclonal 
antibodies (dMAb(R)) platform. Inovio is advancing a ground-breaking approach 
to combat multidrug-resistant infections based on Inovio's dMAbs. In a recent 
study, Inovio developed a targeted dMAb approach for AMR and demonstrated that 
these dMAbs can effectively control multidrug-resistant infection in animal 
models.

The U.S. Centers for Disease Control and Prevention estimates that resistance 
to antibiotics causes 2 million illnesses and 23,000 deaths a year in the 
United States. Estimates of the impact of antimicrobial resistance on the U.S. 
economy include $20 billion in direct health-care costs, with additional 
indirect costs as high as $25 billion a year.

Dr. Laurent Humeau, Executive VP and Chief Scientific Officer, said, 
"Antimicrobial resistance represents an expanding global public health concern 
and a tremendous market opportunity for Inovio. While antibiotic-resistant 
organisms are appearing at an alarming rate, there has been a 30-year hiatus in 
the development of novel classes of effective antibiotics for combatting these 
infections. Our ultimate goal is to create a paradigm shift approach to 
monoclonal antibody technology that results in a pipeline of high impact dMAb 
products, which can be developed with corporate partnerships, external funding, 
and collaborations. This grant from the NIH will further this goal."

Earlier this year, Inovio initiated the first human study of its dMAb product 
(INO-A002) to treat and prevent Zika virus infection. In addition to 
demonstrating safety and tolerability, this Zika study marks a major step 
towards the development of a broad range of Inovio's dMAb platform targeting 
cancer, infectious diseases, and inflammatory diseases. When delivered directly 
into the body, the genetic instructions provided by the designed synthetic 
antibody gene sequence instruct the body's cells to become the factory which 
manufactures the therapeutic antibody (dMAb) products, enabling a major leap in 
antibody technology. This $4.6 million NIH grant will support additional 
pre-clinical studies with the ultimate goal of initiating clinical development 
for its dMAb technology against antimicrobial-resistant infections.

Inovio and its collaborators have developed dMAb technology by designing 
synthetic genetic sequences encoding functional monoclonal antibodies into an 
optimized DNA platform. These gene sequences are administered in vivo to be 
expressed locally at the site of injection. The recipient receives a 
gene-encoded blueprint instructing their cells to produce the encoded 
monoclonal antibody specifically targeting the bacteria. Inovio's dMAbs can be 
developed simply and quickly and are produced directly in the patient, 
dramatically lowering production timeline and costs associated with the 
manufacturing of conventional antibodies; furthermore, DNA plasmids encoding 
for antibodies do not require expensive cold chain storage and are suitable for 
delivery in combinations.

Traditional monoclonal antibodies represent the largest segment of 
pharmaceutical markets today, accounting for more than $100 billion in sales 
each year, with treatments spanning cancer, infectious diseases, inflammation, 
and cardiovascular diseases. With its synthetic design and in-patient 
production, dMAb products represent a disruptive entrant to this important 
class of pharmaceuticals. Inovio and its collaborators have already received 
over $60 million in non-dilutive grant funding to advance its dMAb platform in 
the last few years. There is a significant interest in dMAb as a disruptive 
entrant to a highly valuable overall monoclonal antibody market as well as its 
unique applicability for rapid responses against emerging global infectious 
disease threats.

About Inovio's DNA-based Monoclonal Antibody Platform

Traditional monoclonal antibodies are manufactured outside the body in 
bioreactors, typically requiring costly large-scale manufacturing facility 
development and laborious production. In addition, post-production storage and 
formulation stability limit the reach of some of these products. Inovio's 
disruptive dMAb technology has the potential to overcome these limitations by 
virtue of their simplified design using novel plasmid vectors and unique 
formulations allowing for rapidity of development, improved product stability, 
ease of manufacturing and deployability, ultimately all resulting in increases 
in cost-effectiveness and reach, providing potential new avenues for treating a 
range of diseases. The DNA plasmids are delivered directly into cells of the 
body and the encoded monoclonal antibody is then produced by the locally 
transfected cells. Previously published studies show that a single 
administration of a highly optimized DNA-based monoclonal antibody targeting 
Zika virus (INO-A002) produced a high level of expression of the antibody in 
the bloodstream of mice that was protective against lethal animal challenge; 
earlier this year, Inovio initiated the first human study of INO-A002. In 
addition to demonstrating safety and tolerability, this Zika dMAb study marks a 
major step towards the development of a broad range of Inovio's dMAb and dBTE 
programs. Additional studies similarly reported data showing that dMAb products 
against Ebola, flu, chikungunya, Lyme, and dengue protected animals against 
lethal or pathogenic challenge. In addition, the team has reported delivery of 
dMAbs that impact prostate as well as breast and ovarian cancers in animals.

About Inovio Pharmaceuticals, Inc.

Inovio is an innovative biotechnology company focused on the discovery, 
development, and commercialization of its synthetic DNA technology targeted 
against cancers and infectious diseases. Inovio's proprietary technology 
platform applies antigen sequencing and delivery to enable in vivo protein 
expression, which can activate potent immune responses to targeted diseases. 
The technology 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 
development for the treatment of HPV-related cervical pre-cancer. Also in 
development are Phase 2 immuno-oncology programs targeting HPV-related cancers 
and glioblastoma, as well as externally funded platform development programs in 
Zika, MERS, Lassa, 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 (CEPI), 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, Medical CBRN Defense Consortium (MCDC), 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 
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, our Quarterly Report 
on Form 10-Q for the quarter ended June 30, 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.

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.
Translations

Japanese