PLYMOUTH MEETING, Pa.,
May 20, 2020 /PRNewswire/
-- INOVIO (NASDAQ:INO) today announced the publication of the
preclinical study data for IN0-4800, its COVID-19 DNA vaccine,
demonstrating robust neutralizing antibody and T cell immune
responses against coronavirus SARS-CoV-2. The study was published
in the peer-reviewed journal Nature Communications titled,
"Immunogenicity of a DNA vaccine candidate for COVID-19" by INOVIO
scientists and collaborators from The Wistar Institute, the
University of Texas, Public Health
England, Fudan University, and
Advaccine.
Dr. Kate Broderick, INOVIO's
Senior Vice President of R&D and the Team Lead for COVID-19
vaccine development, said, "These
positive preclinical results from our COVID-19 DNA vaccine
(INO-4800) not only highlight the potency of our DNA medicines
platform, but also build on our previously reported positive Phase
1/2a data from our vaccine against the coronavirus that causes
MERS, which demonstrated near-100% seroconversion and
neutralization from a similarly designed vaccine INO-4700. The
potent neutralizing antibody and T cell immune responses generated
in multiple animal models are supportive of our currently on-going
INO-4800 clinical trials."
INO-4800 targets the major surface antigen Spike protein of
SARS-CoV-2 virus, which causes COVID-19 disease. The studies
demonstrated that vaccination with INO-4800 generated robust
binding and neutralizing antibody as well as T cell responses in
mice and guinea pigs. Importantly, the authors demonstrated virus
neutralizing activity using three separate neutralization assays
testing the vaccine's ability to generate antibodies which can
block virus infection by: 1) an assay using live SARS-CoV-2
viruses; 2) an assay using a pseudo-virus assay, where another
virus displays the SARS-CoV-2 Spike protein; and, 3) a novel
high-throughput surrogate neutralization assay measuring the
ability of INO-4800-induced antibodies to block SARS-CoV-2 Spike
binding to the host ACE2 receptor. Study authors also detected
these antibodies in the lungs of the vaccinated animals which could
be important in providing protection from SARS-CoV-2. In addition,
high levels of Spike-specific T cell responses were observed with
INO-4800 vaccination, which could be important in mediating
protection from the virus infection. Collectively, this preclinical
dataset demonstrates that INO-4800 is a promising COVID-19 vaccine
candidate against this emerging disease threat.
Dr. J. Joseph Kim, INOVIO's
President & CEO, said, "INOVIO and our collaborators are
working diligently to advance INO-4800 to help fight the current
pandemic. We are planning to utilize these positive preclinical
results along with our upcoming animal challenge data and safety
and immune responses data from our Phase 1 studies to support
rapidly advancing this summer to a large, randomized Phase 2/3
clinical trial."
INOVIO's swift progress in COVID-19 vaccine development is based
on the ideal suitability of its DNA medicine platform to rapidly
develop vaccines 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 in a
collaboration with GeneOne Life Science and the Walter Reed Army
Institute of Research. INO-4700 is the only MERS-CoV vaccine with
positive data from a Phase 1/2a clinical trial, 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 CEPI funding.
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 was designed using INOVIO's proprietary DNA medicine
platform rapidly after the publication of the genetic sequence of
the coronavirus that causes COVID-19. INOVIO has deep experience
working with coronaviruses and is the only company with a Phase 2a
vaccine for a related coronavirus that causes Middle East
Respiratory Syndrome (MERS).
About INOVIO's Global Coalition Advancing INO-4800
INOVIO has assembled a global coalition of collaborators,
partners and funders to rapidly advance INO-4800. R&D
collaborators to date include the Wistar Institute, the
University of Pennsylvania, the
University of Texas, Fudan University
and the Laval University. INOVIO has
partnered with Advaccine and the International Vaccine Institute to
advance clinical trials of INO-4800 in China and South
Korea, respectively. INOVIO is also assessing preclinical
efficacy of INO-4800 in several animal challenge models with Public
Health England (PHE) and Commonwealth Scientific and Industrial
Research Organization (CSIRO) in Australia. INOVIO is also working with a team
of contract manufacturers including VGXI, Inc., Richter-Helm
BioLogics, and Ology Biosciences to produce INO-4800 and seeking
additional external funding and partnerships to scale up the
manufacturing capacities to satisfy the urgent global demand for a
safe and effective vaccine. To date, the Coalition for Epidemic
Preparedness Innovations (CEPI), the Bill & Melinda Gates
Foundation, and the US Department of Defense have contributed
significant funding to the advancement and manufacturing of
INO-4800.
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). 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 intradermally or intramuscularly 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 6,000 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 protect and treat 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)/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 March 31, 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.
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SOURCE INOVIO Pharmaceuticals, Inc.