PLYMOUTH MEETING, Pa.,
Dec. 15, 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, today announced
the company and a team of scientists from The Wistar Institute,
AstraZeneca, the University of
Pennsylvania, and Indiana
University received a $37.6
million grant from the U.S. Defense Advanced Research
Projects Agency (DARPA), a research and development agency of the
U.S. Department of Defense (DoD) and the Joint Program Executive
Office for Chemical, Biological, Radiological and Nuclear Defense
(JPEO-CBRND), to use INOVIO's innovative DNA-encoded monoclonal
antibody (dMAb®) technology to develop
anti-SARS-CoV-2-specific dMAbs which could offer versatile
capabilities to function as both a therapeutic and preventive
treatment for COVID-19.
Dr. J. Joseph Kim, President and CEO of INOVIO, said, "INOVIO's
anti-SARS-CoV-2 dMAbs present a unique complement to our DNA
vaccine candidate for COVID-19 prevention, INO-4800, which
currently is in the Phase 2 segment of our INNOVATE Phase 2/3
clinical trial with funding from the DoD/JPEO-CBRND, as well as our
other candidates in our DNA medicines platform. This public-private
partnership allows us to not only broaden the scope and application
of our DNA medicines platform across the spectrum of needed
COVID-19 treatment modalities, but also to open the door for better
patient administration and more cost-effective, scalable production
of monoclonal antibody products for other infectious diseases and
cancers. We are excited about the potential this funding offers for
both situations requiring immediate clinical response and
benefit."
Dario C. Altieri, M.D.,
President and Chief Executive
Officer of The Wistar Institute, said, ""DARPA has recognized the
revolutionary potential of dMAb technology to positively impact
lives around the world with the most cutting-edge scientific
solutions. Having assembled an academic-industry collaboration with
laser-focused vision, we are honored to work together and bring our
expertise and innovation to the urgency of this worldwide global
health crisis."
As part of DARPA's two-year grant, INOVIO and Wistar teams will
construct COVID-19 dMAb candidates mirroring AstraZeneca's
traditional recombinant monoclonal antibody candidates currently
being tested in clinical trials to treat COVID-19. dMAb candidates
can be quickly developed and produced in vivo, offering a
cost-effective and scalable therapeutic and preventive option for
treatment of SARS-CoV-2 virus infection. The dMAb candidates will
then be advanced into preclinical studies and then into rigorous,
first-in-human clinical trials within one year of funding.
Mark Esser, Vice President and
Head of Microbial Sciences, AstraZeneca, said, "We are excited to
combine capabilities with this world-class team to evaluate the
potential of these DNA-delivered antibodies to impact the way we
can respond to prevent and treat infection."
Recombinant monoclonal antibodies, which represent the largest
segment of pharmaceutical markets today with more than $100 billion in sales, are designed to enhance
the immune system's ability to regulate cell functions. However,
the technology has some limitations, including long and costly
laboratory development and large-scale production, limited duration
of in vivo potency, and a pharmacokinetic profile that can
result in toxicity. INOVIO's dMAb technology offers a disruptive
and differentiated solution to the challenges and limitations
associated with conventional recombinant monoclonal antibody-based
treatments. The company can encode the DNA sequence for a specific
monoclonal antibody in a DNA plasmid and deliver the plasmid
directly into cells of the body using the company's proprietary
smart device called CELLECTRA®. This specific DNA
medicine serves as a genetic blueprint that instruct the patient's
body to build its own highly specific antibodies in
vivo.
INOVIO and its collaborators pioneered the development of
dMAb® technology as a unique asset to not only combat
the COVID-19 pandemic, but also for any pathogen or disease that
can be treated by an antibody therapy, including cancer. Empowered
by more than $80 million in previous
development funding from DARPA, as well as from the Bill and
Melinda Gates Foundation and the National Institutes of Health,
INOVIO's dMAb® technology offers a breadth of several
unique advantages across disease and pathogen targets, including
high specificity for the target, rapid injection in subjects
requiring minimal clinical settings, rapid manufacturing, low cost
of production, and temperature-stable storage and distribution. In
animal studies, dMAbs have also been applied to both prevent
infection as well as to treat infection, indicating the potential
for bimodal application.
About INOVIO's DNA-encoded Monoclonal Antibody
Platform
dMAb technology has the potential to overcome the
limitations typically associated with traditional monoclonal
antibodies, primarily cost, large-scale manufacturing and
post-production storage and formulation requirements. The
simplified design of a DNA plasmid encoding for monoclonal
antibodies facilitates rapid development, improved product
stability, and cost-effective manufacturing and deployment.
The dMAb® platform provides potential new avenues for
treating a range of diseases. The DNA plasmids are delivered
directly into cells of the body and the encoded monoclonal antibody
is then produced by the locally transfected cells. Previously
published studies show that a single administration of a highly
optimized DNA-encoded monoclonal antibody targeting Zika virus
(INO-A002) produced a high level of expression of the antibody in
the bloodstream of mice that was protective against lethal animal
challenge. INOVIO initiated the first human study of INO-A002,
marking a major step towards the development of a broad range of
INOVIO's dMAb and DNA-encoded Bi-specific T Cell engagers (dBTE)
programs. Additional studies similarly reported data showing that
dMAbs® against Ebola, flu, chikungunya, Lyme, and dengue
protected animals against lethal or pathogenic challenge.
Anti-tumor dMAb candidates, including those for PD-1 and CTLA-4
checkpoint inhibitors, have demonstrated therapeutic effects
against prostate, breast, and ovarian cancers in animal models.
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 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)/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. 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, 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 September 30,
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.