INO-3107 Awarded the Innovation Passport Designation Under U.K. Government's Innovative Licensing and Access Pathway

Core Insights - INOVIO's lead DNA medicine candidate, INO-3107, has received the U.K. Innovation Passport designation, which recognizes its potential to transform treatment for Recurrent Respiratory Papillomatosis (RRP) patients [1][7] - The Innovation Passport is part of the Innovative Licensing and Access Pathway (ILAP) aimed at accelerating market access and regulatory approval for promising medicines in the U.K. [2][7] - INO-3107 is designed to elicit a T cell response against HPV-6 and HPV-11, potentially reducing the need for surgical interventions in RRP patients [2][8] Company Overview - INOVIO is a biotechnology company focused on developing DNA medicines for HPV-related diseases, cancer, and infectious diseases [12] - The company utilizes proprietary technology to design DNA plasmids and deliver them using its investigational device, CELLECTRA® [11][12] Product Details - INO-3107 has shown promising results in a Phase 1/2 clinical trial, with 81.3% of patients experiencing a decrease in surgical interventions after treatment [2][9] - The treatment generated a strong immune response, with activated CD4 and CD8 T cells observed, indicating a persistent cellular memory response [2][8] - INO-3107 was well tolerated, with mostly low-grade adverse effects reported [2][8] Regulatory Context - The ILAP, launched by the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) in 2021, aims to facilitate the development and access to innovative medicines [2][7] - Benefits of the ILAP include a potential 150-day accelerated assessment for Marketing Authorization Applications (MAA) and continuous benefit-risk assessments [2][7] Market Potential - RRP is a rare disease caused by HPV-6 and HPV-11, characterized by the growth of papillomas in the respiratory tract, which can lead to severe complications [10] - Market research indicates that even a reduction of one surgery is significant for patients, as each surgery carries risks of permanent damage [10]