PLYMOUTH MEETING, Pa.,
Feb. 10, 2020 /PRNewswire/ -- Inovio
Pharmaceuticals, Inc. (NASDAQ: INO) today announced the U.S. Food
and Drug Administration (FDA) has accepted its Investigational New
Drug (IND) application to evaluate its DNA medicine INO-3107 in a
Phase 1/2 trial for treatment of Recurrent Respiratory
Papillomatosis or RRP. RRP is a rare disease caused by the human
papillomavirus (HPV) types 6 and 11 infections, a condition that
causes noncancerous tumor growths leading to life-threatening
airway obstructions, and occasionally can progress to cancer.
Currently, the disease is incurable and is mostly treated by
surgery, which temporarily restores the airway. The tumor almost
always recurs and the surgery must be repeated, often multiple
times a year. RRP can severely impact the quality of life for those
living with the disease.
The open-label, multicenter Phase 1/2 trial will enroll
approximately 63 subjects in the U.S. and will evaluate the
efficacy, safety, tolerability, and immunogenicity of INO-3107 in
subjects with HPV 6 and/or 11-associated RRP 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. Upon obtaining
sufficient safety and potential efficacy data in adults, Inovio
plans to expand the trial to include pediatric patients as well as
a potential booster regimen.
"Inovio's investigational DNA medicine INO-3107 is designed to
destroy and clear tumors caused by HPV 6 and 11 infections from the
body exactly where they are hiding," said Jeffrey Skolnik, M.D., Inovio's Vice President
of Clinical Development. "We believe this DNA medicine has the
potential to provide people living with RRP a long-term, if not
life-long, improvement in their disease, especially as an
alternative to often successive and debilitating surgeries that may
temporarily remove HPV growths from the airways but do not address
the underlying recurring virus."
J. Joseph Kim, Ph.D., Inovio's
President and Chief Executive Officer, said "Our mission at Inovio
is to rapidly provide patients with urgent health needs access to
our novel DNA medicines. We are pleased the FDA has authorized our
INO-3107 clinical trial, and look forward to working closely with
the RRP patient and medical community to drive recruitment as
quickly as possible."
In addition to initiating this efficacy trial, Inovio also plans
to attain Orphan Disease designation with the FDA's Office of
Orphan Products Development (OOPD). The FDA grants orphan status to
drugs and biologic products that are intended for the safe and
effective treatment, diagnosis, or prevention of rare diseases or
disorders that affect fewer than 200,000 people in the United States. OOPD provides a drug
developer with certain benefits and incentives, including a period
of marketing exclusivity if regulatory approval is ultimately
received for the designated indication.
Inovio recently published data from its pilot clinical study of
INO-3106 (DNA medicine candidate targeting HPV6 caused RRP) in the
scientific journal Vaccines (MDPI). Study results
demonstrated that INO-3106 generated immunogenicity and engagement
and expansion of an HPV 6-specific cellular response, including
cytotoxic T cells. The paper also showed that Inovio's
immunotherapy allowed two out of two patients who previously
required approximately two surgeries per year for several years to
manage this disease to delay the need for surgery to a robust
degree; with one patient able to delay surgery for over a year and
a half (584 days surgery-free) and a second that remained
surgery-free for over two and a half years (over 915 days
surgery-free).
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 the novel coronavirus (2019-nCoV)
under a grant from the Coalition for Epidemic Preparedness
Innovations (CEPI). DNA medicines are medicines 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. Once inside the cell,
the plasmids begin replicating, thereby strengthening the body's
own natural response 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 are not interfering with or
changing in any way an individual's own DNA, which is the case with
gene therapy or gene editing.
With more than 2,000 patients receiving Inovio investigational
DNA medicines in more than 6,000 applications across a range of
clinical trials, Inovio's DNA medicines have consistently activated
safe, robust, and fully functional T cell and antibody responses
against targeted pathogens and cancers.
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 extremely rare cases (less than
1%), 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 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 safely produce
a robust immune response to destroy and clear high-risk HPV 16 and
18, which are responsible for 70% of cervical cancer, 90% of anal
cancer and 69% of vulvar cancer. In addition to HPV, Inovio's
optimized plasmid design and delivery technology have been
demonstrated to consistently activate robust and fully functional T
cell and antibody responses against targeted cancers and pathogens.
Inovio's most advanced clinical program, VGX-3100, is in Phase 3
development for the treatment of HPV-related cervical pre-cancer.
Also in development are Phase 2 immuno-oncology programs targeting
HPV-related cancers and GBM, as well as externally funded vaccine
development programs in Zika, MERS, Lassa, HIV, and the novel
coronavirus (2019-nCoV). Partners and collaborators include
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, Regeneron,
Roche/Genentech, University of
Pennsylvania, Walter Reed Army Institute of Research, and
The Wistar Institute. 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 vaccines, our ability to
support our pipeline of SynCon® active immunotherapy
and vaccine 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:
|
|
Investors:
|
Ben Matone, Inovio,
484-362-0076, ben.matone@inovio.com
|
Media:
|
Jeff Richardson,
Inovio, 267-440-4211, jrichardson@inovio.com
|
View original
content:http://www.prnewswire.com/news-releases/inovio-receives-authorization-from-the-us-fda-to-begin-phase-12-clinical-trial-for-ino-3107-a-dna-medicine-to-treat-a-rare-disease----recurrent-respiratory-papillomatosis-rrp-301001634.html
SOURCE Inovio Pharmaceuticals, Inc.