PLYMOUTH MEETING, Pa.,
March 12, 2020 /PRNewswire/ -- INOVIO
Pharmaceuticals, Inc. (NASDAQ:INO) announced today that it has
received a new $5 million grant from
the Bill & Melinda Gates Foundation to accelerate the testing
and scale up of CELLECTRA® 3PSP proprietary smart device for the
intradermal delivery of INO-4800, a DNA vaccine for COVID-19.
INO-4800 is in preclinical studies and is planned to advance into
Phase 1 clinical trials in the U.S. in April with up to
$9 million funding from CEPI. INOVIO
plans to accelerate the testing and scale up of the CELLECTRA 3PSP
devices to support large scale manufacturing of INO-4800 doses by
the end of 2020.
The next generation CELLECTRA 3PSP device is designed
specifically for a COVID-19 type pandemic scenario. It is a small,
portable, hand-held, user-friendly device that runs on readily
available "AA" batteries. This allows for stockpiling of the device
in quantity without maintenance. It is easy to use and is based on
our current device with extensive history (over 6,000
administrations) which has received the CE mark and has an
acceptable safety profile. The streamlined design also allows it to
be readily produced at reduced costs and large scale.
The device has been designed with reliability, challenging
environments, user needs and ease of large scale manufacturing in
mind. INOVIO's San Diego Device Manufacturing facility will build
initial quantities and demonstrate the design and scale up of
manufacturing processes which can then be transferred to additional
contract manufacturers for increased capacity. Initial development
of CELLECTRA 3PSP was started in 2019 with $8.1 million funding from the medical arm of the
U.S. Defense Threat Reduction Agency (DTRA)'s Medical CBRN Defense
Consortium. The new funding will help to accelerate the testing and
completion of the device development and scale up to combat the
COVID-19 disease.
Dr. J. Joseph Kim, INOVIO's
President & CEO, said, "INOVIO is grateful to the Bill &
Melinda Gates Foundation for their continued investment in INOVIO's
DNA medicines platform and for their support for DNA vaccines to
potentially protect those at risk globally given the current
COVID-19 outbreak. Our team of vaccine experts are working around
the clock to advance INO-4800 and we look forward to attracting
additional partnerships to expedite its development to meet this
urgent global health need."
INOVIO aims to deliver one million doses of INO-4800 and devices
to support them by year end with existing resources and capacity
with the appropriate support from its funding partners. INOVIO also
is working to scale up both INO-4800 and CELLECTRA 3PSP devices to
potentially make available millions of doses to combat this
outbreak.
INOVIO's DNA medicine platform is ideally suited to rapidly
respond 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. INO-4700 is the
only MERS-CoV vaccine in Phase 1/2a setting, 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 previous CEPI funding of up to $56 million and from other collaborators and
partners.
About INOVIO's DNA Medicines
INOVIO has 15 DNA medicine clinical programs currently in
development focused on HPV-associated diseases, cancer, and
infectious diseases, including coronaviruses MERS and COVID-19
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®. CELLECTRA® uses a brief
electrical pulse to open small pores in the cell reversibly to
allow the plasmids to enter, overcoming a key limitation of other
DNA and mRNA approaches. Once inside the cell, the plasmids are
used by the cell's own machinery to generate coded antigens, which
then stimulate an immune response, thereby strengthening the body's
own natural defense mechanisms. Administration with the CELLECTRA
device ensures that the DNA medicine is delivered directly into the
body's cells, where it can go to work immediately mounting 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 constructed 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 Pharmaceuticals, Inc.
INOVIO is a biotechnology company focused on rapidly bringing to
market precisely designed DNA medicines to treat, cure, 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, demonstrated it 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, 90%
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 MERS and COVID-19. Partners and collaborators include
Advaccine, ApolloBio Corporation, AstraZeneca, The Bill &
Melinda Gates Foundation, Coalition for Epidemic Preparedness
Innovations (CEPI), Defense Advanced Research Projects Agency,
GeneOne Life Science, HIV Vaccines Trial Network, Medical CBRN
Defense Consortium (MCDC), National Cancer Institute, National
Institutes of Health, National Institute of Allergy and Infectious
Diseases, Plumbline Life Sciences, Regeneron, 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.
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 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, 2018, our
Quarterly Report on Form 10-Q for the quarter ended September 30, 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.
CONTACTS:
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Investors:
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Ben Matone,
484-362-0076, ben.matone@inovio.com
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Media:
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Jeff Richardson,
267-440-4211, jrichardson@inovio.com
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SOURCE Inovio Pharmaceuticals, Inc.