Data Published in The Laryngoscope shows INO-3107 Resulted in Long-Term Surgery Reduction in Recurrent Respiratory Papillomatosis (RRP)

Core Insights - INOVIO announced positive long-term clinical data for INO-3107, showing a significant reduction in surgeries for patients with recurrent respiratory papillomatosis (RRP) [1][2] - The retrospective study published in The Laryngoscope indicates that the majority of patients maintained or improved their surgical response two years post-treatment [2][5] Summary by Sections Clinical Data and Efficacy - A retrospective study involving 28 of the original 32 patients from a Phase 1/2 trial showed an Overall Response Rate (ORR) improvement to 86% at the end of Year 2, up from 72% at Year 1 [5][6] - The Complete Response (CR) rate increased from 28% in Year 1 to 50% in Year 2, indicating that half of the patients required no surgeries at all [5][6] - The mean number of surgeries needed dropped from 4.1 per year prior to treatment to 1.7 in Year 1 and further to 0.9 in Year 2 [5][6] Safety and Tolerability - INO-3107 was well tolerated, with no serious adverse events or long-term safety concerns reported [6][8] - Most treatment-emergent adverse effects were low-grade, such as injection site pain and fatigue [8] Market Potential and Regulatory Designations - INOVIO believes that the sustained reduction in surgeries could position INO-3107 as a preferred treatment option for RRP if approved [2][9] - The FDA has granted INO-3107 Orphan Drug and Breakthrough Therapy designations, allowing for accelerated approval processes [9] - INOVIO has also received CE-marking for its CELLECTRA delivery device in the EU, facilitating commercialization [9] Background on RRP and INO-3107 - RRP is a rare disease primarily caused by HPV-6 and HPV-11, leading to benign growths in the respiratory tract that can cause severe complications [4][8] - INO-3107 is designed to elicit a T cell response against HPV-6 and HPV-11, potentially preventing or slowing the growth of new papillomas [8][11]