Country for PR: United States
Contributor: PR Newswire New York
Thursday, March 12 2020 - 23:00
AsiaNet
INOVIO Receives New $5 Million Grant to Accelerate Scale Up of Smart Delivery Device for Its COVID-19 Vaccine
PLYMOUTH MEETING, Pennsylvania, March 12, 2020 /PRNewswire-AsiaNet/ --

INOVIO Pharmaceuticals, Inc. (NASDAQ:INO) announced today that it has received 
a new $5 million grant from the Bill & Melinda Gates Foundation to accelerate 
the testing and scale up of CELLECTRA(R) 3PSP proprietary smart device for the 
intradermal delivery of INO-4800, a DNA vaccine for COVID-19. INO-4800 is in 
preclinical studies and is planned to advance into Phase 1 clinical trials in 
the U.S. in April with up to $9 million funding from CEPI. INOVIO plans to 
accelerate the testing and scale up of the CELLECTRA 3PSP devices to support 
large scale manufacturing of INO-4800 doses by the end of 2020.

The next generation CELLECTRA 3PSP device is designed specifically for a 
COVID-19 type pandemic scenario. It is a small, portable, hand-held, 
user-friendly device that runs on readily available "AA" batteries. This allows 
for stockpiling of the device in quantity without maintenance. It is easy to 
use and is based on our current device with extensive history (over 6,000 
administrations) which has received the CE mark and has an acceptable safety 
profile. The streamlined design also allows it to be readily produced at 
reduced costs and large scale.

The device has been designed with reliability, challenging environments, user 
needs and ease of large scale manufacturing in mind. INOVIO's San Diego Device 
Manufacturing facility will build initial quantities and demonstrate the design 
and scale up of manufacturing processes which can then be transferred to 
additional contract manufacturers for increased capacity. Initial development 
of CELLECTRA 3PSP was started in 2019 with $8.1 million funding from the 
medical arm of the U.S. Defense Threat Reduction Agency (DTRA)'s Medical CBRN 
Defense Consortium. The new funding will help to accelerate the testing and 
completion of the device development and scale up to combat the COVID-19 
disease.

Dr. J. Joseph Kim, INOVIO's President & CEO, said, "INOVIO is grateful to the 
Bill & Melinda Gates Foundation for their continued investment in INOVIO's DNA 
medicines platform and for their support for DNA vaccines to potentially 
protect those at risk globally given the current COVID-19 outbreak. Our team of 
vaccine experts are working around the clock to advance INO-4800 and we look 
forward to attracting additional partnerships to expedite its development to 
meet this urgent global health need."

INOVIO aims to deliver one million doses of INO-4800 and devices to support 
them by year end with existing resources and capacity with the appropriate 
support from its funding partners. INOVIO also is working to scale up both 
INO-4800 and CELLECTRA 3PSP devices to potentially make available millions of 
doses to combat this outbreak. 

INOVIO's DNA medicine platform is ideally suited to rapidly respond against 
emerging viruses with pandemic potential. INOVIO was the first to advance its 
DNA vaccine INO-4700 against MERS-CoV, a related coronavirus, into evaluation 
in humans. INO-4700 is the only MERS-CoV vaccine in Phase 1/2a setting, and 
INOVIO is currently preparing to initiate a larger Phase 2 vaccine trial for 
INO-4700 in the Middle East where most MERS viral outbreaks have occurred. 
These efforts are supported by previous CEPI funding of up to $56 million and 
from other collaborators and partners.

About INOVIO's DNA Medicines

INOVIO has 15 DNA medicine clinical programs currently in development focused 
on HPV-associated diseases, cancer, and infectious diseases, including 
coronaviruses MERS and COVID-19 under grants from the Coalition for Epidemic 
Preparedness Innovations (CEPI). DNA medicines are composed of optimized DNA 
plasmids, which are small circles of double-stranded DNA that are synthesized 
or reorganized by a computer sequencing technology and designed to produce a 
specific immune response in the body.

INOVIO's DNA medicines deliver optimized plasmids directly into cells 
intramuscularly or intradermally using INOVIO's proprietary hand-held smart 
device called CELLECTRA(R). CELLECTRA(R) uses a brief electrical pulse to open 
small pores in the cell reversibly to allow the plasmids to enter, overcoming a 
key limitation of other DNA and mRNA approaches. Once inside the cell, the 
plasmids are used by the cell's own machinery to generate coded antigens, which 
then stimulate an immune response, thereby strengthening the body's own natural 
defense mechanisms. Administration with the CELLECTRA device ensures that the 
DNA medicine is delivered directly into the body's cells, where it can go to 
work immediately mounting an immune response. INOVIO's DNA medicines do not 
interfere with or change in any way an individual's own DNA.

The advantages of INOVIO's DNA medicine platform are how fast DNA medicines can 
be constructed and manufactured, the stability of the products which do not 
require freezing in storage and transport, and the robust immune response, 
safety profile and tolerability that have been demonstrated in clinical trials. 

With more than 2,000 patients receiving INOVIO investigational DNA medicines in 
more than 6,000 applications across a range of clinical trials, INOVIO has a 
strong track record of rapidly generating DNA medicine candidates to meet 
urgent global health needs.

About INOVIO Pharmaceuticals, Inc.

INOVIO is a biotechnology company focused on rapidly bringing to market 
precisely designed DNA medicines to treat, cure, and protect people from 
diseases associated with HPV, cancer, and infectious diseases. INOVIO is the 
first and only company to have clinically demonstrated that a DNA medicine can 
be delivered directly into cells in the body via a proprietary smart device to 
produce a robust and tolerable immune response. Specifically, INOVIO's lead 
candidate VGX-3100, currently in Phase 3 trials for precancerous cervical 
dysplasia, demonstrated it destroyed and cleared high-risk HPV 16 and 18 in a 
Phase 2b clinical trial. High-risk HPV is responsible for 70% of cervical 
cancer, 90% of anal cancer, and 69% of vulvar cancer. Also in development are 
programs targeting HPV-related cancers and a rare HPV-related disease: 
recurrent respiratory papillomatosis (RRP); non-HPV-related cancers 
glioblastoma multiforme (GBM) and prostate cancer; as well as externally funded 
infectious disease DNA vaccine development programs in Zika, Lassa fever, 
Ebola, HIV, and coronaviruses MERS and COVID-19. Partners and collaborators 
include Advaccine, ApolloBio Corporation, AstraZeneca, The Bill & Melinda Gates 
Foundation, Coalition for Epidemic Preparedness Innovations (CEPI), Defense 
Advanced Research Projects Agency, GeneOne Life Science, HIV Vaccines Trial 
Network, Medical CBRN Defense Consortium (MCDC), National Cancer Institute, 
National Institutes of Health, National Institute of Allergy and Infectious 
Diseases, Plumbline Life Sciences, Regeneron, Roche/Genentech, University of 
Pennsylvania, Walter Reed Army Institute of Research, and The Wistar Institute. 
INOVIO also is a proud recipient of 2020 Women on Boards "W" designation 
recognizing companies with more than 20% women on their board of directors. 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 medicines, our expectations 
regarding our research and development programs, as well as commercialization 
activities, including the planned initiation and conduct of clinical trials, 
the availability and timing of data from those trials and our commercialization 
strategy and tactics. 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, product development programs 
and commercialization activities and outcomes, 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 medicines, our ability to support our pipeline of DNA medicine 
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 September 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.

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