Inovio (INO) Up as Lead Drug Gets Innovative Medicine Tag in UK

Core Viewpoint - Inovio's lead DNA medicine candidate, INO-3107, has received the Innovation Passport designation under the UK's Innovative Licensing and Access Pathway (ILAP), which is expected to enhance its potential to transform treatment for recurrent respiratory papillomatosis (RRP) patients [2][13]. Company Developments - Inovio plans to initiate a confirmatory study of INO-3107 for RRP before submitting the Biologics License Application (BLA) to the FDA, with submission expected in the second half of 2024 [3][21]. - The company has completed a phase I/II study for INO-3107, which met its efficacy endpoint, indicating promising results for the treatment of HPV-related RRP [9][20]. - If approved, INO-3107 could be the first DNA medicine available for RRP patients in the United States and Inovio's first approved product [10]. Clinical Pipeline - Inovio's clinical pipeline includes several other DNA medicine candidates targeting various cancers and infectious diseases, indicating a diverse development strategy [4]. Market Performance - Year to date, Inovio's shares have surged by 80.3%, significantly outperforming the industry average rise of 5.1% [8]. - The Zacks Consensus Estimate for Inovio's 2024 earnings per share has not changed, remaining at 5 cents, while the 2025 loss per share estimate is pegged at 11 cents [5]. Regulatory Pathway - The Innovation Passport designation provides a streamlined process for regulatory approval, including a potential 150-day accelerated marketing authorization application assessment and continuous benefit-risk assessment [7]. - Inovio plans to engage with ILAP partners to determine the regulatory pathway for INO-3107's approval in the UK [15].