PLYMOUTH MEETING, Pa.,
Feb. 3, 2020 /PRNewswire/ -- Inovio
Pharmaceuticals, Inc. (NASDAQ: INO) today announced publication of
data from its pilot clinical study of INO-3106, a novel DNA therapy
targeting human papilloma virus type 6 (HPV 6) for the treatment of
recurrent respiratory papillomatosis (RRP), a rare and orphan
disease, in the open access scientific journal Vaccines
(MDPI). The article, entitled "Immune Therapy Targeting E6/E7
Oncogenes of Human Papillomavirus Type 6 (HPV-6) Reduces or
Eliminates the Need for Surgical Intervention in the Treatment of
HPV-6 Associated Recurrent Respiratory Papillomatosis" details the
clinical efficacy seen in a pilot clinical study of two patients
with RRP and is authored by Inovio and its collaborators at
University of Pennsylvania Medical
School as well as The Wistar Institute.
RRP is a rare, orphan, HPV-associated disease that can cause
noncancerous tumor growths leading to life-threatening airway
obstructions, and occasionally progresses to cancer. Currently, the
disease is incurable and can only be treated by surgery to remove
the tumors, which temporarily restores the airway. The tumor always
recurs and the surgery must be repeated, usually multiple times a
year.
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 patients who
previously required approximately two surgeries per year to manage
this disease to delay the need for surgery to a robust degree; with
one patient requiring no surgeries 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).
For this study, Inovio employed INO-3106, targeting specifically
HPV 6 caused RRP. In order to evaluate and treat patients with RRP
caused by both HPV 6 and 11, Inovio is developing a new product
candidate which targets both HPV 6 and 11 named INO-3107. Inovio
plans to advance INO-3107 into Phase 2 clinical trials in the first
half of 2020 as a novel first-in-class immunotherapy for the
treatment of RRP in both adult and pediatric populations.
Dr. J. Joseph Kim, Inovio's
President and CEO, said, "We are pleased that the highly regarded
journal Vaccines has acknowledged Inovio's impressive RRP
pilot study results. We are advancing rapidly to bring relief
to RRP patients whose treatment options today are limited to
repetitive and invasive surgeries. We look forward to initiating a
Phase 2 human trial this year to evaluate INO-3107, a potential
life-changing DNA medicine for this rare disease."
About RRP
Recurrent respiratory papillomatosis (RRP) is a rare disease
(estimated at 20,000 active cases in the U.S.) that is
characterized by the growth of tumors in the respiratory tract
caused by the human papilloma virus. 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 (i.e. less
than 1% of 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 more severe
in children than in adults. In children, the disorder is most often
diagnosed between the ages of 2-4. 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/or
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 has
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 platform development programs in Zika, MERS,
Lassa, and HIV. 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, 484-362-0076,
ben.matone@inovio.com
Media:
Jeff Richardson, 267-440-4211,
jrichardson@inovio.com
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SOURCE Inovio Pharmaceuticals, Inc.