Country for PR: United States
Contributor: PR Newswire New York
Thursday, July 30 2020 - 23:53
INOVIO's COVID-19 DNA Vaccine INO-4800 Provides Protection with Memory Immune Responses In Non-Human Primates Challenged with SARS-CoV-2 Virus
PLYMOUTH MEETING, Pa., July 30, 2020 /PRNewswire-AsiaNet/ --

- INO-4800 showed durable antibody and T cell responses in rhesus macaques for 
4 months

- INO-4800 is the only vaccine to demonstrate long-term protection in non-human 
primates challenged with SARS-CoV-2 virus 13 weeks from vaccination 

- Memory T and B cell responses resulted in reduced viral loads and faster 
viral clearance in macaques' lungs and nasal passages

- INO-4800 vaccination generated antibodies neutralizing both the earlier 
strain of virus as well as the mutant variant (D614G) that has emerged with 
greater infectivity, and now accounts for >80% of newly circulating virus

- No antibody-dependent enhanced disease events were reported

INOVIO (NASDAQ:INO), a biotechnology company focused on rapidly bringing to 
market precisely designed DNA medicines to treat and protect people from 
infectious diseases and cancer, today announced that its COVID-19 DNA vaccine 
INO-4800 targeting SARS-CoV-2 was effective in protecting non-human primates 
(NHPs; specifically rhesus macaques) from live virus challenge 13 weeks after 
the last vaccination. These protective results were mediated by memory T and B 
cell immune responses from INO-4800 vaccination. 

These results, submitted to a peer-reviewed journal and also published today on 
the non-peer reviewed online preprint site bioRxiv ( 
), demonstrate that INO-4800 reduced viral load in both the lower lungs and 
nasal passages in macaques that received two doses of INO-4800 (1 mg) four 
weeks apart and then were challenged with live virus 13 weeks after the second 
dose (study week 17). The reduced viral loads following exposure to SARS-CoV-2 
infection at this timeframe demonstrate an important durable impact mediated by 
INO-4800.  This is the first time a vaccine protection in non-human primates 
was reported from memory immune responses as previously reported monkey vaccine 
challenge studies were conducted at the time near their peak immune responses 
(1-4 weeks from their last vaccination). 

INO-4800-treated animals demonstrated seroconversion after a single 
vaccination, with protective neutralizing antibodies and T cells lasting in 
their blood more than four months after the initial dose. The antibody levels 
were similar to or greater than those seen in patients who have recovered from 
COVID-19, the infection caused by SARS-CoV-2, and the T cell responses were 
significantly higher than those from convalescent patients. 

Dr. J. Joseph Kim, President and Chief Executive Officer of INOVIO, said, "All 
other previously reported NHP vaccine protection studies actually challenged 
the animals at the peak of their immune response.  Our study demonstrates that 
INO-4800 could provide protection in a more real-world setting, where 
vaccine-generated memory immune responses protected NHPs for more than 3 months 
(13 weeks) from the last vaccination. Given the importance of protective 
antibody and T cell responses, this study gives us more confidence as we 
continue to advance INO-4800 in the clinic. We believe INO-4800 holds 
significant potential to help address this global public health crisis."

B cells are responsible for producing the antibodies that recognize SARS-CoV-2, 
while T cells play a role in killing the virally infected cells as well as 
supporting the B cell response. The published data support that immunization 
with INO-4800 limits active viral replication and has the potential to reduce 
severity of disease, as well as reduced viral shedding in the nasal cavity. In 
the study, researchers assessed the ability of INO-4800 to induce acute and 
memory T cell and B cell immune responses, including neutralizing antibody 
responses against both early virus as well as now-dominant G614 mutant 
variants. To INOVIO's knowledge, this is the first report of vaccine-induced 
responses driving immunity against G614 variants. A strong anamnestic or memory 
T and B cell responses were demonstrated following challenge with the live 

"As we eagerly anticipate initiating a Phase 2/3 efficacy trials this summer, 
an animal challenge is currently the closest thing we have to testing a 
vaccine's efficacy when confronting a live virus. We are very encouraged with 
the duration of protection that INO-4800 demonstrated in this NHP study and 
look forward to reassessing its impact on durability of response at 12 months 
out from our other ongoing non-human primate and animal challenge studies," 
said Dr. Kate Broderick, Ph.D., INOVIO's Senior Vice President, Research & 

"In addition to safety and efficacy, it is essential that any vaccine targeting 
SARS-CoV-2 generates a relevant durability of response," Dr. Broderick added. 
"A vaccine that only provides protection for a very short period of time is not 
going to realistically solve the problem of this pandemic."

A separate NHP study evaluating the durability of INO-4800 at 12 months after 
vaccination is currently under way. INO-4800 also has been selected by U.S. 
Operation Warp Speed for its COVID-19 non-human primate challenge study. 

In May, the peer-reviewed journal Nature Communications published an INOVIO 
study ("Immunogenicity of a DNA vaccine candidate for COVID-19") showing that 
vaccination with INO-4800 generated robust binding and neutralizing antibody 
and T cell responses in mice and guinea pigs. The study was funded by a grant 
from the Coalition for Epidemic Preparedness Innovations (CEPI). 

About INO-4800

INO-4800 is INOVIO's DNA vaccine candidate created to protect against the novel 
coronavirus SARS-CoV-2, which causes COVID-19. INO-4800 is currently in Phase 1 
trials in the U.S. and a Phase 2/3 trial is planned for the summer. Interim 
Phase 1 results showed a favorable safety profile and strong immunogenicity, 
including antibody and T cell responses. The Phase 1 study recently expanded to 
include adults over the age of 65 with no age limit given the propensity for 
COVID-19 to severely impact the health of older people. INO-4800 also is in 
Phase 1/2 trials for COVID-19 in South Korea and China. 

In animal studies, INO-4800 has demonstrated robust and durable T cell and B 
cell acute and memory responses in a non-human primate challenge study showing 
protective immune responses in both nasal passages and lungs. INO-4800 also was 
selected by U.S. Operation Warp Speed for its COVID-19 non-human primate 
challenge study. 

INO-4800 was designed using INOVIO's proprietary DNA medicine platform rapidly 
after the publication of the genetic sequence of SARS-CoV-2. INOVIO has 
extensive experience working with coronaviruses and is the only company with a 
Phase 2 vaccine for a related coronavirus that causes Middle East Respiratory 
Syndrome (MERS). 

INO-4800 is the only nucleic-acid based vaccine that is stable at room 
temperature for more than a year and does not need to be frozen in transport of 
storage, which are important factors when implementing mass immunizations.

About INOVIO's DNA Medicines Platform

INOVIO has 15 DNA medicine clinical programs currently in development focused 
on HPV-associated diseases, cancer, and infectious diseases, including 
coronaviruses associated with MERS and COVID-19 diseases being developed under 
grants from the Coalition for Epidemic Preparedness Innovations (CEPI) and the 
U.S. Department of Defense. 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). The CELLECTRA device uses a brief electrical pulse 
to reversibly open small pores in the cell to allow the plasmids to enter, 
overcoming a key limitation of other DNA and other nucleic acid approaches, 
such as mRNA. Once inside the cell, the DNA plasmids enable the cell to produce 
the targeted antigen. The antigen is processed naturally in the cell and 
triggers the desired T cell and antibody-mediated immune responses. 
Administration with the CELLECTRA device ensures that the DNA medicine is 
efficiently delivered directly into the body's cells, where it can go to work 
to drive 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 designed 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 7,000 applications across a range of clinical trials, INOVIO has a 
strong track record of rapidly generating DNA medicine candidates with 
potential to meet urgent global health needs.


INOVIO is a biotechnology company focused on rapidly bringing to market 
precisely designed DNA medicines to treat and protect people from infectious 
diseases, cancer, and diseases associated with HPV. 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, 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, 91% 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 
associated with MERS and COVID-19 diseases. Partners and collaborators include 
Advaccine, ApolloBio Corporation, AstraZeneca, The Bill & Melinda Gates 
Foundation, Coalition for Epidemic Preparedness Innovations (CEPI), Defense 
Advanced Research Projects Agency (DARPA)/Joint Program Executive Office for 
Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND)/Department 
of Defense (DOD), GeneOne Life Science/VGXI, HIV Vaccines Trial Network, 
International Vaccine Institute (IVI), Medical CBRN Defense Consortium (MCDC), 
National Cancer Institute, National Institutes of Health, National Institute of 
Allergy and Infectious Diseases, Ology Bioservices, the Parker Institute for 
Cancer Immunotherapy, Plumbline Life Sciences, Regeneron, Richter-Helm 
BioLogics, 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

Media: Jeff Richardson, 267-440-4211,
Investors: Ben Matone, 484-362-0076,

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, including the planned 
initiation and conduct of preclinical studies and clinical trials, and the 
availability and timing of data from those studies and 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, 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, 2019, 
our Quarterly Report on Form 10-Q for the quarter ended June 30, 2020 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.

SOURCE INOVIO Pharmaceuticals, Inc.