PLYMOUTH MEETING, Pa.,
Nov. 23, 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
it has dosed its first subject with DNA medicine INO-3107 in a
Phase 1/2 clinical trial for the treatment of Recurrent Respiratory
Papillomatosis (RRP).
RRP is a rare disease caused by the human papillomavirus (HPV)
types 6 and 11 infections, a condition that causes non-cancerous
tumor growths leading to life-threatening airway obstructions. The
disease is currently incurable and is mostly treated by surgery,
which temporarily restores the airway. The majority of tumors are
recurring, necessitating repeated surgery and severely impacting
the quality of life for those living with the disease. Earlier this
year, the US Food and Drug Administration (FDA) granted INO-3107
Orphan Drug Designation.
Dr. J. Joseph Kim, President and
CEO of INOVIO, said, "We are extremely excited to be able to
advance a potentially life-changing, innovative therapy like
INO-3107 to patients with RRP, a devastating disease that
significantly impacts quality of life. Our Phase 1/2 trial builds
on our promising pipeline of HPV programs that also includes our
Phase 3 REVEAL studies in HPV-16/HPV-18-related pre-cancerous
cervical disease, as well as in HPV-16/HPV-18 vulvar and anal
neoplasia. We are encouraged by the plethora of prior data
from these programs, and the potential for INO-3107 to show
clinical benefit to these patients who suffer from the life-long
illness of RRP."
Dr. Ted Mau, Assistant Professor
of Otolaryngology, Head and Neck Surgery, at UT Southwestern
Medical Center, and lead investigator for INOVIO's RRP Phase 1/2
clinical trial, said, "As a surgeon, I have had patients who
have required dozens of surgeries and are looking at many more
during their lifetimes. This new systemic therapy is specific for
RRP and has the potential to meaningfully alter the treatment
paradigm for patients living with this disease."
About the INO-3107 Phase 1/2 Clinical Trial
The trial, called RRP-001, is a clinical trial investigating the
efficacy and safety of INOVIO's novel HPV-6/HPV-11 therapy in
subjects with RRP, designed to eradicate both the cause, and
sequelae, of infection of the airway with HPV. The open-label,
multicenter INO-3107 Phase 1/2 trial is currently open to
enrollment to recruit up to 63 subjects and will evaluate the
efficacy, safety, tolerability, and immunogenicity of INO-3107 in
subjects who have required at least two surgical interventions per
year for the past three years for the removal of associated
papilloma(s). For this study, adult subjects will first undergo
surgical removal of their papilloma(s) and then receive four doses
of INO-3107, one every three weeks. The primary efficacy endpoint
will be a doubling or more in the time between surgical
interventions following the first dose of INO-3107 relative to the
frequency prior to study therapy. The study is currently open in
the United States and is listed on
ClinicalTrials.Gov (NCT04398433).
Dr. Jeffrey Skolnik, Senior Vice
President of Clinical Development at INOVIO, said, "The opportunity
of clinical improvement that INO-3107 may provide to patients with
RRP, coupled with the potential to eradicate the HPV virus in these
patients, would forever alter the treatment landscape, offering
great clinical and lifestyle benefit to patients dealing with this
disease. Few, if any, other therapies have shown consistent
clinical benefit when studied to date, outside of surgery, in this
disease, and no other therapy has provided the potential for a
cure, the ultimate goal of any therapeutic intervention. We are
proud to be able to contribute to helping patients with this rare
disease."
About RRP
Recurrent respiratory papillomatosis (RRP) is a rare disease
(estimated at 15,000 active cases in the U.S.) that is
characterized by the growth of tumors in the respiratory tract
caused by the human papillomavirus. Although benign, papillomas can
cause severe, even life-threatening airway obstruction and
respiratory complications. A distinguishing aspect of this disease
is the tendency for the papilloma to recur after surgical
procedures to remove them. Left untreated, if RRP develops in the
lungs, affected individuals can potentially experience recurrent
pneumonia, chronic lung disease (bronchiectasis) and, ultimately,
progressive pulmonary failure. In rare cases papillomas can become
cancerous (malignant transformation) developing into squamous cell
carcinoma. Additional symptoms of RRP can include hoarse voice,
difficulty in sleeping and swallowing, and chronic coughing. RRP
symptoms are usually more severe in children than in adults. In
children, the disorder is most often diagnosed at or around the age
of four years. In adults, the disorder occurs most often in the
third or fourth decade.
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 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)/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, 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:
Investors: Ben
Matone, 484-362-0076, ben.matone@inovio.com
Media: Jeff Richardson,
267-440-4211, jrichardson@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 planned initiation and conduct
of preclinical studies and clinical trials and the availability and
timing of data from those studies and trials, 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 pre-clinical 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.