PLYMOUTH MEETING, Pa.,
Aug. 4, 2021 /PRNewswire/
-- INOVIO (NASDAQ: INO), a biotechnology company bringing to
market precisely designed DNA medicines to treat and protect people
from infectious diseases, cancer, and HPV-associated diseases,
today announced that the company has dosed the first Phase 2 trial
subject in its quest to develop the first vaccine against the
Middle East Respiratory Syndrome (MERS). INOVIO's Phase 2 trial is
designed to evaluate INO-4700, its DNA vaccine candidate for the
prevention of MERS, a disease in the coronavirus family for which
there are no approved vaccines.
The multi-center Phase 2 trial is a randomized, double-blinded,
placebo-controlled study designed to evaluate the safety,
tolerability, and immunogenicity of INO-4700 administered with
INOVIO's smart device, the CELLECTRA® 2000, in
approximately 500 healthy adult volunteers. The study, which is
sponsored by INOVIO and fully funded by the Coalition for Epidemic
Preparedness Innovations (CEPI), is being conducted at sites in
Jordan and Lebanon where MERS cases have been
reported.
This trial builds on the positive results of the Phase 1 trial,
which were published in a peer-reviewed article in The
Lancet Infectious Diseases entitled, "Safety and immunogenicity
of an anti-Middle East respiratory
syndrome coronavirus DNA vaccine: A phase 1, open-label,
single-arm, dose-escalation trial." Results from this
first-in-human Phase 1 trial found high levels of binding
antibodies in 92% (57 of 62) of evaluated subjects. Significant
antigen-specific cytotoxic T-lymphocyte (CTL) responses were also
observed. Importantly, 98% (61 of 62) of vaccinated subjects
generated an antibody and/or T cell response against the MERS
vaccine.
Dr. J. Joseph Kim, President and
CEO of INOVIO, said, "We are pleased to collaborate with CEPI to
combat one of the most virulent pathogens of the coronavirus family
for which there is no approved vaccine. This advancement not only
complements our late-stage efforts with COVID-19, but it also
represents an important milestone for INOVIO's infectious disease
platform. We look forward to continuing our collaboration with CEPI
and moving another step closer to providing patients with a safe
and effective preventive vaccine against MERS."
INOVIO's pursuit of a MERS vaccine is funded by a previously
announced $56 million grant from CEPI
under which INOVIO is advancing two vaccine candidates through
Phase 2 field trials against MERS and Lassa fever, respectively.
INOVIO and CEPI plan to make a stockpile of these vaccines
available for emergency use as soon as possible following Phase 2
testing.
Richard Hatchett, CEO of CEPI,
said, "I'm delighted to see the progress made by INOVIO in its MERS
vaccine program. As we've seen with COVID-19, coronaviruses pose a
significant threat to global health. Prior to the COVID-19
pandemic, CEPI had identified the MERS coronavirus, in particular,
as an epidemic threat and partnered with INOVIO in 2018 to advance
its promising vaccine candidate. This Phase 2 trial is the first of
its kind to assess a vaccine candidate against MERS and represents
an important step towards combatting this deadly coronavirus."
Despite the continuing threat of MERS outbreaks, there are no
licensed vaccines or treatments for MERS. Since the virus was first
identified in Saudi Arabia in
2012, the World Health Organization has reported more than 2,500
people with MERS disease globally and approximately 34% of those
patients died. Twenty-seven countries have reported cases,
including Korea where an outbreak in the summer of 2015 resulted in
186 cases with 20% dying. In contrast, the case-fatality ratio for
COVID-19 before population vaccination was approximately 0.3% to
0.5%; while the case-fatality ratio for the 2003 SARS epidemic was
10%. MERS causes a rapidly progressive respiratory illness that may
require intensive care treatment and mechanical ventilation in many
patients.
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 observed in clinical trials.
With more than 3,000 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 met primary and secondary endpoints for all
evaluable subjects in REVEAL 1, in the first of two Phase 3 trials
for precancerous cervical dysplasia, demonstrating ability to
destroy and clear both high-grade cervical lesions and the
underlying high-risk HPV 16 and 18. INOVIO is also evaluating
INO-4800, a DNA vaccine candidate against COVID-19, in a Phase 2
clinical trial in the U.S., as well as Phase 2 trials in
China and South Korea. 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), HIV Vaccines Trial Network, International Vaccine Institute
(IVI), Kaneka Eurogentec, 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, Thermo Fisher
Scientific, University of Pennsylvania,
Walter Reed Army Institute of Research, and The Wistar Institute.
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
and commercialize 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, and
our ability to successfully manufacture and produce large
quantities of our product candidates if they receive regulatory
approval. 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, our ability to secure sufficient manufacturing capacity
to mass produce our product candidates, 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 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, 2020, our
Quarterly Report on Form 10-Q for the quarter ended March 31, 2021 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.