Inovio Pharmaceuticals Granted U.S. Patent Protection for Synthetic Vaccine for Cervical Dysplasia and Cancer Cancer Vaccine in Phase II Clinical Study
BLUE BELL, Pa., May 1, 2012 /PRNewswire/ -- Inovio Pharmaceuticals, Inc. (NYSE AMEX: INO) announced today that the United States Patent and Trademark Office granted U.S. Patent No. 8,168,769, covering Inovio's SynCon® vaccine for cervical dysplasias and cancers caused by human papillomavirus (HPV). The patent granted to the Trustees of The University of Pennsylvania has been exclusively licensed to Inovio under its existing license agreement with the university. The patent includes claims that cover Inovio's synthetic consensus HPV antigens and DNA constructs and vaccines that include these antigens, including Inovio's cervical dysplasia/cancer vaccine, VGX-3100. This patent also covers methods of treating a patient using the SynCon® cervical dysplasia/cancer vaccine.
Dr. J. Joseph Kim, Inovio's president and CEO, said: "This additional patent grant bolsters the strong intellectual property portfolio around our SynCon synthetic vaccines. Because there is neither a therapeutic live virus vaccine nor non-replicating vaccine available for cervical dysplasias and cancers, Inovio's synthetic vaccine for these diseases answers an unmet need by providing a non-invasive and potentially more effective approach for treating women with this condition."
Inovio reported data demonstrating long-term durability of T cell immune responses of over two years in 87% (7 of 8) of evaluated patients following a fourth vaccination of VGX-3100. The data further highlighted the viability of using multiple booster vaccinations with a synthetic vaccine delivered using electroporation, in contrast to other non-replicating vaccine vectors that may induce unwanted immune responses against the vector after multiple vaccinations. Inovio's vaccine generated best-in-class T cell immune responses, which are widely believed to be important in clearing cancerous cells. VGX-3100 recently won the Edward Jenner Poster Award First Prize, a prestigious award that recognized the most promising research at the 5th Vaccine and ISV Global Congress.
Inovio is currently recruiting participants for its Phase II study of VGX-3100, which is designed to enroll 148 patients with cervical dysplasia at approximately 25 study centers. This randomized, placebo-controlled study will assess regression of cervical lesions from CIN 2/3 or CIN 3 to CIN 1 or less and clearance of HPV 16 or 18. The secondary endpoint is to assess immune responses to VGX-3100. Subjects will also be monitored for tolerability and safety.
Inovio's VGX-3100 is designed to raise immune responses against the E6 and E7 oncogenes associated with HPV types 16 and 18, i.e. it targets four antigens. These oncogenes are responsible for transforming HPV-infected cells into pre-cancerous and cancerous cells. The goal is to stimulate a T-cell immune response strong enough to cause the rejection of these infected or transformed cells from the body. The potential of such a therapeutic vaccine would be to treat precancerous dysplasias (CINs), cervical cancers, as well as other anogenital and head and neck cancers caused by these HPV types.
About Inovio Pharmaceuticals, Inc.
Inovio is revolutionizing vaccines to prevent and treat today's cancers and challenging infectious diseases. Its SynCon® vaccines are designed to provide universal cross-strain protection against known as well as newly emergent unmatched strains of pathogens such as influenza. These synthetic vaccines, in combination with Inovio's proprietary electroporation delivery, have been shown in humans to generate best-in-class immune responses with a favorable safety profile. Inovio's clinical programs include Phase II studies for cervical dysplasia, leukemia and hepatitis C virus and Phase I studies for influenza and HIV. Partners and collaborators include the University of Pennsylvania, Merck, ChronTech, National Cancer Institute, U.S. Military HIV Research Program, NIH, HIV Vaccines Trial Network, University of Southampton, US Dept. of Homeland Security and PATH Malaria Vaccine Initiative. More information is available at 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 synthetic 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, 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 synthetic vaccines, 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, 2011, 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.
Investors: Bernie Hertel, Inovio Pharmaceuticals, 858-410-3101
Media: Jeff Richardson, Richardson & Associates, 805-491-8313
SOURCE Inovio Pharmaceuticals, Inc.