IO Biotech(IOBT)2025-05-27 15:30Summary of IO Biotech (IOBT) FY Conference Call - May 27, 2025 Company Overview - Company: IO Biotech (IOBT) - Lead Asset: Xilenvio (IL-102, IL-103) - Focus: Immuno-oncology, specifically targeting advanced melanoma Key Points Upcoming Data and Trials - Pivotal Phase III Trial: Expected readout in Q3 2025 for advanced melanoma patients, with 407 patients fully enrolled as of December 2023 [4][7] - Primary Analysis: Based on 226 progression-free survival (PFS) events, with a target of achieving this by Q3 2025 [10][11] - Event Rate: Slower than anticipated, leading to a revised guidance for PFS events [8][11] Trial Design and Expectations - Trial Design: Randomized 1:1 comparison of Xilenvio plus pembrolizumab (pembro) versus pembro alone [7][17] - Response Rate: Previous studies indicated an 80% response rate with 50% complete responses (CRs) and a median PFS of approximately 26 months [13] - Statistical Power: The study is powered at 89% with a hazard ratio of 0.65, indicating a 35% improvement in PFS over Keytruda [26][27] Safety and Efficacy - Safety Profile: Favorable safety profile with no significant added systemic toxicity compared to pembrolizumab [31][32] - PD-L1 Status: The trial includes both PD-L1 positive and negative patients, which may provide a broader efficacy profile compared to emerging treatments that target only PD-L1 negative patients [40] Financial Position - Cash Position: Ended Q1 2025 with over €37 million, with a recent drawdown of €10 million from a financing tranche [63][64] - Future Financing: Eligible for additional tranches totaling €20 million, contingent on product approval [65][66] Manufacturing and Logistics - Manufacturing: Secured manufacturing capabilities in Europe with multiple suppliers for drug substance and product [44][46] - Adjuvant Used: Monostinide, which allows for slow release of antigens upon injection [49] Future Developments - Neoadjuvant Melanoma Study: Preliminary data expected by the end of 2025, focusing on major pathological response (MPR) as a primary endpoint [74][76] - Head and Neck Cancer Data: Encouraging response rates observed, with updates on PFS and durability expected in the second half of 2025 [61][62] Regulatory Interactions - FDA Communication: Ongoing interactions with the FDA, including feedback and review meetings, with breakthrough status confirmed [58][59] Additional Insights - Market Context: The competitive landscape in immuno-oncology is evolving, with IO Biotech positioning itself to address both PD-L1 positive and negative patient populations [40][78] - Clinical Relevance: Emphasis on not just statistical significance but also clinical relevance and quality of life for patients [31][32] This summary encapsulates the critical aspects of IO Biotech's current status, upcoming milestones, and strategic positioning within the immuno-oncology sector.