PLYMOUTH MEETING, Pa.,
Sept. 28, 2020 /PRNewswire/ -- INOVIO
(NASDAQ:INO), a biotechnology company focused on bringing to market
precisely designed DNA medicines to treat and protect people from
infectious diseases and cancer, announced that the U.S. Food and
Drug Administration (FDA) has notified the company it has
additional questions about the company's planned Phase 2/3 trial of
its COVID-19 vaccine candidate INO-4800, including its CELLECTRA®
2000 delivery device to be used in the trial. Until the FDA's
questions have been satisfactorily addressed, INOVIO's
Investigational New Drug Application (IND) for the Phase 2/3 trial
is on partial clinical hold. The company is actively working to
address the FDA's questions and plans to respond in October, after
which the FDA will have up to 30 days to notify INOVIO of its
decision as to whether the trial may proceed.
This partial clinical hold is not due to the occurrence of any
adverse events related to INOVIO's ongoing expanded Phase 1 study
of INO-4800, the conduct of which may continue and is not impacted
by the FDA's notification. In addition, this partial clinical hold
does not impact the advancement of INOVIO's other product
candidates in development. INOVIO and its partners are continuing
to prepare for a planned Phase 2/3 trial of INO-4800, following
resolution of the FDA's partial clinical hold and subject to the
receipt of external funding to conduct the trial.
About INOVIO's Global Coalition Advancing INO-4800
INOVIO has assembled a global coalition of collaborators,
partners, and funders to rapidly advance the development of
INO-4800. R&D collaborators to date include the Wistar
Institute, the University of
Pennsylvania, the University of
Texas, Fudan University and Laval
University. INOVIO has partnered with Advaccine and the
International Vaccine Institute to conduct clinical trials of
INO-4800 in China and South Korea, respectively. INOVIO is also
assessing nonclinical 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 working with
a team of contract manufacturers including Thermo Fisher
Scientific, Richter-Helm BioLogics, and Ology Bioservices to
manufacture INO-4800 on a commercial scale and is seeking
additional external funding and partnerships to further scale up
manufacturing capacities to satisfy the urgent global demand for
safe and effective vaccines. To date, the Coalition for Epidemic
Preparedness Innovations (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 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 simple-to-use
CELLECTRA device provides a brief electrical pulse to reversibly
open small pores in the local skin area cells resulting in more
than a hundred-fold increase in product delivery providing dose
sparing and consistency. Once inside the cell, the DNA plasmids
instruct the cell to produce the targeted antigen. The antigen is
processed naturally in the cell and triggers specific T cell and
antibody-mediated immune responses. Administration with the
CELLECTRA device, which takes only a few seconds, is designed to
ensure that the DNA medicine is efficiently delivered directly into
the body's cells, where it can go to work to drive the immune
responses. INOVIO's DNA medicines are transient, and 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 consistent immune response, safety profile, and
tolerability that have been observed in clinical trials with
multiple products.
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 an
efficacious, 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), 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, Thermo Fisher Scientific, University of Pennsylvania, VGXI, 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
and manufacture DNA medicines, our expectations regarding our
research and development programs, including the planned conduct of
a Phase 2/3 clinical trial of INO-4800, 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 preclinical 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 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 INO-4800 or any other 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.