Country for PR: United States
Contributor: PR Newswire New York
Thursday, April 04 2019 - 00:00
AsiaNet
Inovio's Novel HPV Therapy INO-3106 Demonstrates Clinical Efficacy Against Rare Respiratory Tract Tumors in Pilot Clinical Study
PLYMOUTH MEETING, Pennsylvania, April 3, 2019 /PRNewswire-AsiaNet/ --

-- Clinical Data Presented at Annual Meeting of American Association for Cancer 
Research 

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(R) 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(R) 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, +1 484-362-0076, ben.matone@inovio.com 
Media: Jeff Richardson, +1 267-440-4211, jrichardson@inovio.com

SOURCE: Inovio Pharmaceuticals, Inc.
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