PLYMOUTH MEETING, Pa.,
April 3, 2019 /PRNewswire/
-- Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today announced
its novel therapy INO-3106 against the human papilloma virus type 6
(HPV 6) demonstrated clinical efficacy in a study of two patients
with recurrent respiratory papillomatosis (RRP). RRP is an
HPV-associated disease that can cause noncancerous tumor growths
leading to life-threatening airway obstructions, and occasionally
progresses to cancer. RRP is primarily caused by two strains of
HPV, HPV 6 and 11, which also predominantly cause genital warts.
RRP may occur in adults (adult-onset RRP) as well as in children
(juvenile-onset RRP) who are thought to have contracted the virus
during childbirth. 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.
Inovio's pilot clinical study enrolled two adult patients with
RRP and one adult patient with tracheal cancer, all positive for
HPV 6. One patient with tracheal cancer discontinued the study
prior to the completion of follow-up. In the two patients with RRP,
their condition had required surgery approximately every six months
to clear the tumor growths. Following their last dose of Inovio's
HPV therapy, both patients have been surgery-free, due to lack of
tumor recurrence. One patient has not needed surgery for over two
years; the other has been surgery-free for over one year. A
complete study report is being prepared as a medical publication.
Inovio plans to further develop INO-3106 as a novel non-invasive
immunotherapy for the treatment of RRP, a rare, orphan disease, for
both adult and pediatric populations.
This data was presented at this week's Annual Meeting of
American Association for Cancer Research by David B. Weiner, Ph.D., Executive Vice President
and Director of the Vaccine & Immunotherapy Center at the
Wistar Institute and Inovio's co-founder.
Dr. J. Joseph Kim, Inovio's
President and CEO, said, "This exciting new data adds to the
growing body of evidence that Inovio's immunotherapies drive
clinical efficacy in multiple HPV-related diseases. We've already
demonstrated clinical efficacy of our therapies in three separate
clinical indications: in cervical precancers with VGX-3100, in head
and neck cancer with MEDI0457 with our partner AstraZeneca, and now
in a challenging respiratory tumor with INO-3106. Our goal is to
become the "go-to" immunotherapy provider to effectively treat all
major HPV-related precancers and cancers, and I believe we are on
our way there. With this RRP clinical data, Inovio plans to rapidly
advance this product as a non-surgical treatment for this rare
orphan disease."
Inovio's most advanced HPV therapy VGX-3100 in Phase 3 targets
HPV types 16 and 18, which accounts for most HPV-associated
cancers. However, most RRP are caused by HPV types 6 and 11. Inovio
is developing INO-3106 as a separate product through its own
regulatory pathway as part of the company's overall HPV franchise.
For this pilot study, Inovio designed INO-3106 encoding HPV 6
antigens alone or in combination with INO-9012, an IL-12 molecular
adjuvant. Each patient received four doses administered by Inovio's
CELLECTRA® delivery technology.
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 Genital Warts
HPV 6 and HPV 11 collectively cause about 90% of genital warts.
Genital warts are somewhat common in the U.S., with a prevalence of
about 1 to 3 cases per 1,000 females age 15 to 39 years and about 1
to 5 cases per 1,000 males. An estimated 465,000 patients with
initial visits due to this condition occurred in the U.S. in the
year 2014. Anogenital warts are usually asymptomatic, but even
their visibility alone can cause significant psychological and
social distress. In those who have symptoms, pain and/or itching
occur and some cases result in bleeding or ulceration. Latex
condoms do not protect against genital warts, because HPV-6 &
HPV-11 can be transmitted via skin-to-skin contact alone. Current
recommended treatments of genital warts include certain topical
medicated creams, cryotherapy, surgical removal, and application of
acid solutions, and these result resolution of the warts in most
patients. However, these therapies also do not prevent the
skin-to-skin transmission of HPV.
About Inovio Pharmaceuticals, Inc.
Inovio is a late-stage biotechnology company focused on the
discovery, development, and commercialization of DNA-based
immunotherapies and vaccines that transform the treatment and
prevention of cancer and infectious disease. Inovio's
proprietary technology platform applies antigen sequencing and DNA
delivery to activate potent immune responses to targeted
diseases. The technology functions exclusively in vivo,
and 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 for the treatment of HPV-related cervical
pre-cancer. Also in development are Phase 2 immuno-oncology
programs targeting HPV-related cancers, bladder cancer, and
glioblastoma, as well as platform development programs in hepatitis
B, Zika, Ebola, MERS, and HIV. Partners and collaborators
include AstraZeneca, Regeneron, Roche/Genentech, ApolloBio
Corporation, The Wistar Institute, The Bill & Melinda Gates
Foundation, the University of
Pennsylvania, Parker Institute for Cancer Immunotherapy,
CEPI, DARPA, GeneOne Life Science, Plumbline Life Sciences, NIH,
HIV Vaccines Trial Network, National Cancer Institute, Walter Reed
Army Institute of Research, Drexel
University, and Laval University. For more information,
visit www.inovio.com.
This press release contains certain forward-looking
statements relating to our business, including our plans to develop
electroporation-based drug and gene delivery technologies and DNA
vaccines, our expectations regarding our research and development
programs, including the planned initiation and conduct of clinical
trials and the availability and timing of data from those trials.
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 and product
development programs, 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 and other
regulatory filings we make from time to time. 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 licensed 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.