PLYMOUTH MEETING, Pa.,
April 28, 2020 /PRNewswire/ -- INOVIO
(NASDAQ:INO) today announced that its Phase 1 U.S. clinical trial
for COVID-19 DNA vaccine INO-4800 is fully enrolled with all 40
healthy volunteers receiving their first dose, with interim immune
responses and safety results expected in late June. The 40
healthy volunteers now enrolled at sites at the University of Pennsylvania in Philadelphia, PA, and a clinic in Kansas City, MO, will receive two doses of
INO-4800 four weeks apart. The Phase 1 study is designed to assess
the safety profile and immunogenicity of INO-4800 in support of
advancing rapidly to a Phase 2/3 efficacy trial, which is planned
to potentially initiate this summer.
Dr. J. Joseph Kim, INOVIO's
President and CEO, said, "We are extremely grateful to the
volunteers in Philadelphia and
Kansas City who have stepped
forward in the midst of this deadly pandemic to help advance our
promising DNA vaccine against COVID-19. Without these volunteers,
we would not be able to advance the clinical study of INO-4800 at
record speed and potentially provide INO-4800 as a viable vaccine
against the global COVID-19 pandemic."
Working in parallel with the clinical trial program in humans,
INOVIO is conducting several challenge studies in multiple animal
models in collaborations with some of the leading research groups
in the world – as well as working to scale up manufacturing of
INO-4800. Preclinical data have shown that INO-4800 resulted in
promising immune responses across multiple preclinical models, and
the company is on track with its plan to deliver one million doses
by year-end for additional studies and potential emergency use,
pending appropriate regulatory guidance and external funding.
Lead Principal Investigator of the U.S. Phase 1 INO-4800 study
Pablo Tebas, M.D., infectious
disease specialist and Professor of Medicine at the Hospital of the
University of Pennsylvania, said, "We
anticipated rapid enrollment of this study and the response at both
our Philadelphia and Kansas City study sites exceeded all
expectations. We are profoundly inspired by this level of
volunteerism for the greater good as well as grateful to our
dedicated team of health care professionals for their tireless
dedication to this worldwide effort."
INOVIO has assembled a global coalition of collaborators,
partners, manufactures, and funders to rapidly advance INO-4800.
R&D collaborators to date include the Wistar Institute, the
University of Pennsylvania, Université
Laval, and the University of Texas.
INOVIO has partnered with Beijing 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, and Ology Biosciences to produce an anticipated one
million doses of INO-4800 by year end and seeking additional
external funding and partnerships to scale up manufacturing
capacities to satisfy the urgent global demand for a safe and
effective vaccine. To date, CEPI, the Bill & Melinda Gates
Foundation, and the U.S. Department of Defense have contributed
significant funding to the advancement and manufacturing of
INO-4800.
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 rapidly designed using INOVIO's proprietary DNA
medicine platform 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 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 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 6,000 applications across a range of
clinical trials, INOVIO has a strong track record of rapidly
generating DNA medicine candidates to meet urgent global health
needs.
About INOVIO
INOVIO is a biotechnology company focused on rapidly bringing to
market precisely designed DNA medicines to potentially treat and
protect people from diseases associated with HPV, cancer, and
infectious diseases. 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, Plumbline
Life Sciences, Regeneron, Richter-Helm, 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, as well as commercialization activities,
including the planned initiation and conduct of clinical trials,
the availability and timing of data from those trials and our
commercialization strategy and tactics. Actual events or results
may differ from the expectations set forth herein as a result of a
number of factors, including uncertainties inherent in preclinical
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 vaccines, our ability to
support our pipeline of SynCon® active immunotherapy and vaccine
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, 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.