PLYMOUTH MEETING, Pa., Sept. 22, 2014 /PRNewswire/ -- Inovio Pharmaceuticals, Inc. (NASDAQ: INO) announced today it has initiated a phase I clinical trial in patients with aerodigestive cancers. The trial will evaluate the safety, tolerability, and immunogenicity of INO-3106. This immunotherapy targets human papillomavirus type 6 (HPV-6), which causes most aerodigestive cancers.
Aerodigestive cancers affect the lips, mouth, tongue, nose, throat, vocal cords, and parts of the esophagus and windpipe. The unmet need for patients suffering from this form of cancer is significant.
This study is part of Inovio's strategy to broadly expand clinical development of its DNA-based immune therapy products to treat different HPV types and the many diseases they cause. It is a phase I, open label compassionate study enrolling patients with invasive cancer who have exhausted all other treatment options (chemotherapy, radiation and surgery). The study will test Inovio's immunotherapy, INO-3106, alone or in combination with DNA-based IL-12, Inovio's proprietary immune activator, in subjects with HPV-6 associated aerodigestive malignancies. Successful results could open a path to pursuing an FDA orphan designation (special status granted for therapies for rare diseases) for aerodigestive cancers.
Earlier this year, Inovio reported positive top-line phase II efficacy data for VGX-3100, its SynCon® immunotherapy targeting pre-cancers and cancers caused by HPV-16 and HPV-18. VGX-3100 showed the ability to eliminate HPV infection and cause full regression of high grade cervical dysplasia (CIN 2/3). Inovio is advancing VGX-3100 into a phase III registration study with target patient characteristics and a treatment regimen similar to the phase II study. In addition, Inovio has initiated two separate studies testing INO-3112 to treat head and neck cancer as well as inoperable cervical cancer.
Dr. J. Joseph Kim, President and CEO, said, "Following our phase II success, we are pleased to expand our HPV franchise with this product and clinical trial targeting a different HPV type. Our SynCon immunotherapies have been shown to activate the immune system to bring about desired efficacy with a very favorable safety profile. This makes them well-suited to potentially treat the broad spectrum of HPV-associated cancers and pre-cancers as well as HPV itself, which is one of the most prevalent cancer-causing viruses."
About Inovio's HPV Immunotherapies
Inovio's SynCon® DNA-based immunotherapies help the immune system activate disease-specific killer T cells to fight a targeted disease. HPV, the most pervasive sexually transmitted virus, causes numerous pre-cancers and cancers. Inovio's HPV immunotherapy called VGX-3100 targets disease associated with the high-risk HPV types 16 and 18, which are responsible for over 70% of cervical pre-cancers and cancers. Inovio is currently advancing this product for cervical pre-cancers. INO-3112 combines VGX-3100 with Inovio's DNA based immune activator encoded for IL-12. This product is being directed to cervical, head & neck, and anogenital cancers caused by HPV types 16 and 18. INO-3106 now extends Inovio's HPV immunotherapy franchise to HPV type 6. Inovio aims to advance therapies against multiple types of HPV and HPV-associated diseases.
About Inovio Pharmaceuticals, Inc.
Inovio is revolutionizing the fight against cancer and infectious diseases. Our immunotherapies uniquely activate best-in-class immune responses to prevent and treat disease, and have shown clinically significant efficacy with a favorable safety profile. With an expanding portfolio of cancer immunotherapies and clinical studies, the company is advancing a growing product pipeline. Partners and collaborators include Roche, the University of Pennsylvania, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S. Military HIV Research Program, US Dept. of Homeland Security, and University of Manitoba. 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 and our capital resources. 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 (including, but not limited to, the fact that pre-clinical and clinical results referenced in this release may not be indicative of results achievable in other trials or for other indications, that the studies or trials may not be successful or achieve the results desired, including safety and efficacy for VGX-3100, that pre-clinical studies and clinical trials may not commence or be completed in the time periods anticipated, that results from one study may not necessarily be reflected or supported by the results of other similar studies and that results from an animal study may not be indicative of results achievable in human studies), 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 broad pipeline of SynCon® active immune therapy and vaccine products, the adequacy of our capital resources, the availability or potential availability of alternative therapies or treatments for the conditions targeted by the company or its collaborators, including alternatives that may be more efficacious or cost-effective than any therapy or treatment that the company and its collaborators hope to develop, evaluation of potential opportunities, issues involving product liability, issues involving patents and whether they or licenses to them will provide the company 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 the company can finance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level of corporate expenditures, assessments of the company's 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, 2013, our Form 10-Q for the quarter ended June 30, 2014, and other regulatory filings from time to time. There can be no assurance that any product in Inovio's pipeline will be successfully developed or manufactured, that final results of clinical studies 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.