Core Insights - IO Biotech is focused on developing novel immune-modulatory, off-the-shelf cancer therapies targeting various tumors, including melanoma, lung, and head and neck cancers [2][15] - The IOB-013 study showed improvements in progression-free survival (PFS) but narrowly missed statistical significance on the primary endpoint, which the company believes has de-risked the program [2][5] - The company plans to discuss the next Phase 3 study design for Cylembio with the FDA in December 2025 [2][5] Recent Business Highlights - The company presented topline data from the Phase 3 clinical trial (IOB-013) at the ESMO congress, indicating clinically relevant improvements in PFS across various subgroups [5][6] - A meeting with the FDA is scheduled for December to align on the design of a potential new Phase 3 registrational trial for IO102-IO103 in advanced melanoma [5][6] - Pre-clinical data for additional candidates targeting arginase 1 and TGF-β were presented at the SITC Annual Meeting [5][6] Financial Results - For Q3 2025, total operating expenses were $19.4 million, down from $26.5 million in Q3 2024 [12][20] - Research and development expenses decreased to $13.7 million from $20.2 million year-over-year [12][20] - Cash and cash equivalents as of September 30, 2025, were approximately $31 million, expected to support operations through Q1 2026 [5][12] Clinical Trials Overview - The IOB-013/KN-D18 trial evaluated Cylembio in combination with Merck's KEYTRUDA in 407 patients with advanced melanoma, with enrollment completed by December 2023 [11][12] - The primary endpoint of the trial was progression-free survival, with secondary endpoints including overall response rate and safety [11][13] - The company is also conducting a Phase 2 basket trial (IOB-022/KN-D38) for advanced non-small cell lung cancer and head and neck cancer [14]

Core Insights - IO Biotech presented detailed results from its global Phase 3 trial of Cylembio in combination with Merck's KEYTRUDA for treating advanced melanoma, showing promising progression-free survival outcomes [1][3][12] Phase 3 Trial Results - The Phase 3 trial involved 407 patients with untreated advanced melanoma, comparing Cylembio plus pembrolizumab to pembrolizumab alone, achieving a median progression-free survival (mPFS) of 19.4 months versus 11.0 months for pembrolizumab alone [3][12] - The combination narrowly missed the primary endpoint for statistical significance with a p-value of 0.0558 [3][8] - Subgroup analyses indicated improved outcomes for the combination therapy across various patient categories, including those with PD-L1-negative tumors and BRAFV600 mutations [4][8] Safety and Tolerability - The combination therapy was well tolerated, showing no significant increase in immune-mediated adverse events or grade ≥3 treatment-related events compared to pembrolizumab alone [5][9] - Local vaccine-related injection-site reactions were mild and transient, primarily grade 1/2 [5] Phase 2 Basket Trial Results - Final results from the Phase 2 basket trial evaluating Cylembio with pembrolizumab in advanced non-small cell lung cancer (NSCLC) and squamous cell carcinoma of the head and neck (SCCHN) were also presented, showing a median progression-free survival of 8.1 months for NSCLC and 7.0 months for SCCHN [2][9][13] - The safety profile in the Phase 2 trial remained consistent with anti-PD-1 monotherapy, with no new safety signals reported [9] Company Overview - IO Biotech is focused on developing immune-modulatory, off-the-shelf therapeutic cancer vaccines, with Cylembio being its lead candidate currently in pivotal clinical trials [10][14] - The company maintains global commercial rights to Cylembio and is collaborating with Merck for the supply of pembrolizumab in its clinical trials [11][14]

Core Insights - IO Biotech is set to present significant findings from its clinical trials at the 2025 ESMO Congress in Berlin, focusing on its cancer vaccine candidates [1][2][5] Group 1: Clinical Trials and Presentations - The company will present results from a randomized Phase 3 trial of the IO102-IO103 cancer vaccine in combination with pembrolizumab for first-line advanced melanoma [2][5] - A poster session will feature final data from a Phase 2 basket trial assessing the same vaccine in combination with pembrolizumab for various advanced solid tumors [3][5] - The pivotal Phase 3 trial (IOB-013/KN-D18) enrolled 407 patients across over 100 centers globally, with the primary endpoint being progression-free survival [8] Group 2: Vaccine Development and Mechanism - Cylembio, the lead candidate, is designed to target both tumor cells and immune-suppressive cells in the tumor microenvironment by activating T cells against IDO1 and PD-L1 positive cells [4][10] - The company is conducting multiple trials, including a Phase 2 basket trial for non-small cell lung cancer (NSCLC) and squamous cell carcinoma of the head and neck (SCCHN) [9][10] Group 3: Company Overview - IO Biotech is a clinical-stage biopharmaceutical company headquartered in Copenhagen, Denmark, with a focus on developing immune-modulatory cancer vaccines [10]

Core Insights - IO Biotech is a clinical-stage biopharmaceutical company focused on developing immune-modulatory, off-the-shelf therapeutic cancer vaccines [5] - The company will participate in the TD Cowen 6th Annual Oncology Summit and the Jefferies Global Healthcare Conference, showcasing its leadership and ongoing clinical trials [1][2] Company Overview - IO Biotech is headquartered in Copenhagen, Denmark, with a US office in New York, New York [5] - The company is advancing its lead cancer vaccine candidate, Cylembio, through various clinical trials, including a pivotal Phase 3 trial in combination with Merck's KEYTRUDA [3][5] - Cylembio is designed to target both tumor cells and immune-suppressive cells in the tumor microenvironment [3] Clinical Trials - IO Biotech is conducting three ongoing clinical trials for Cylembio, with enrollment now complete [3] - The pivotal Phase 3 trial (IOB-013/KN-D18) is investigating Cylembio in combination with KEYTRUDA for patients with advanced melanoma [3] - Additional Phase 2 trials are exploring Cylembio's efficacy in various treatment settings for advanced solid tumors [3] Collaborations - The clinical trials are sponsored by IO Biotech in collaboration with Merck, which supplies KEYTRUDA [4] - IO Biotech retains global commercial rights to Cylembio, indicating a strong position in the market [4]