INOVIO's COVID-19 DNA Vaccine INO-4800 Provides Protection with Memory Immune Responses In Non-Human Primates Challenged with SARS-CoV-2 Virus
PR84972
PLYMOUTH MEETING, Pa., July 30, 2020 /PRNewswire=KYODO JBN/ --
- 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
virus.
"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 &
Development.
"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.
About INOVIO
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
www.inovio.com.
CONTACTS:
Media: Jeff Richardson, 267-440-4211, jrichardson@inovio.com
Investors: Ben Matone, 484-362-0076, ben.matone@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, 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.
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