INOVIO receives Orphan Drug Designation for INO-3107 to treat Recurrent Respiratory Papillomatosis

The open-label, multicenter -3107 Phase 1/2 trial is currently open to enrollment to recruit 63 subjects in the U.S. and will evaluate the efficacy, safety, tolerability, and immunogenicity of -3107 in subjects with HPV 6 and/or 11-associated RRP who have required at least two surgical interventions per year for the past three years for the removal of associated papilloma(s). For this study, adult subjects will first undergo surgical removal of their papilloma(s) and then receive four doses of -3107, one every three weeks. The primary efficacy endpoint will be a doubling or more in the time between surgical interventions following the first dose of -3107 relative to the frequency prior to study therapy. 

Last year, VIO published data from its pilot clinical study of -3106 (DNA medicine candidate targeting HPV 6-caused RRP) in the scientific journal Vaccines (MDPI). Study results demonstrated that -3106 generated immunogenicity and engagement and expansion of an HPV 6-specific cellular response, including cytotoxic T cells. The paper also showed that VIO’s immunotherapy allowed two out of two patients who previously required approximately two surgeries per year for several years to manage this disease to delay the need for surgery to a robust degree; one patient was able to delay surgery for over a year and a half (584 days surgery-free) and a second remained surgery-free for over two and a half years (over 915 days surgery-free).