PLYMOUTH MEETING, Pa.,
June 23, 2020 /PRNewswire/
-- INOVIO (NASDAQ:INO) today announced it has received
$71 million funding from the U.S.
Department of Defense (DoD) to support the large-scale manufacture
of the company's proprietary CELLECTRA® 3PSP smart
device and the procurement of CELLECTRA® 2000 devices,
which are used to deliver INO-4800 directly into the skin.
CELLECTRA® 3PSP is designed to deliver INO-4800
directly into the skin, where the vaccine prompts the body's immune
system to drive a robust immune response. Interim results of U.S.
Phase 1 clinical studies of INO-4800 will be available later this
month. A Phase 2/3 efficacy trial is planned to begin this summer
(July/August).
The DoD contract, from the JPEO-CRBND-EB through funding
provided by the Defense Health Program, builds upon two separate
prior $5 million grants from the Bill
& Melinda Gates Foundation and the Coalition for Epidemic
Preparedness Innovations (CEPI), to accelerate the testing of
CELLECTRA® 3PSP. Initial development of this next
generation CELLECTRA® 3PSP smart device began in
2019 with $8.1 million in funding from the medical arm of
the U.S. Defense Threat Reduction Agency's Medical CBRN Defense
Consortium.
Dr. J. Joseph Kim, INOVIO's
President and CEO, said, "INOVIO is very pleased to receive this
significant funding from the U.S. Department of Defense to continue
our rapid scale-up capacity for our breakthrough DNA medicines
delivery device CELLECTRA®. We look forward to working
closely with DoD, JPEO-CBRND and JPL-CBRND-EB to provide much
needed protection to DoD personnel and their families through
development of a safe and effective vaccine against COVID-19. This
next generation smart device leverages the efficacy delivery and
safety track record of an earlier version that has received CE mark
certification and has been used in clinical trials to safely dose
more than 2,000 patients in over 7,000 administrations of INOVIO's
DNA medicines. The current DoD contract further supports INOVIO's
large-scale production of devices and arrays to deliver potentially
hundreds of millions of doses of INO-4800 next year to combat the
global COVID-19 pandemic."
CELLECTRA® 3PSP is a small, portable, hand-held,
user-friendly device that runs on "AA" batteries. The device is
designed to function reliably in challenging environments and can
be stockpiled in large quantities without maintenance,
characteristics that are critical in a pandemic situation. INOVIO's
San Diego device manufacturing
facility has produced initial quantities of the device, while also
showing that the design and scale-up of the manufacturing processes
can be transferred to contract manufacturers in order to further
increase supply.
About the JPEO-CBRND
The Joint Program Executive Office for Chemical, Biological,
Radiological and Nuclear Defense is the Joint Service's lead for
development, acquisition, fielding and life-cycle support of
chemical, biological, radiological and nuclear defense equipment
and medical countermeasures. As an effective acquisition program,
we put capable and supportable systems in the hands of the service
members and first responders, when and where it is needed, at an
affordable price. Our vision is a resilient Joint Force enabled to
fight and win unencumbered by a chemical, biological, radiological,
or nuclear environment; championed by innovative and
state-of-the-art solutions. JPL-CBRND Enabling Biotechnologies (EB)
is an organization established for the purpose of providing medical
solutions, during a crisis, against future threats.
About INO-4800
INO-4800 is INOVIO's DNA vaccine candidate being developed 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
extensive experience working with coronaviruses and is the only
company with a vaccine in Phase 2 development 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 require to be
frozen in transport or 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 DoD.
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 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 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)/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 availability and timing of data
from the company's ongoing Phase 1 clinical trial of INO-4800 and
the company's plans and ability to outsource manufacturing of its
delivery devices to contract manufacturers. 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, our ability to secure
adequate third-party manufacturing resources for the production of
our product candidates, including the transfer of necessary
processes, 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.