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.
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