PLYMOUTH MEETING, Pa.,
July 30, 2020 /PRNewswire/
-- 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®. 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.
View original
content:http://www.prnewswire.com/news-releases/inovios-covid-19-dna-vaccine-ino-4800-provides-protection-with-memory-immune-responses-in-non-human-primates-challenged-with-sars-cov-2-virus-301103039.html
SOURCE INOVIO Pharmaceuticals, Inc.