IO Biotech Reports 2024 Business Highlights

Core Insights - IO Biotech has made significant progress in 2024, particularly in advancing clinical programs for Cylembio, a therapeutic cancer vaccine targeting advanced melanoma, metastatic head and neck cancer, and metastatic lung cancer [2][5] - The company anticipates a pivotal Phase 3 trial readout for Cylembio in combination with pembrolizumab in Q3 2025, with plans to submit a Biologics License Application (BLA) to the FDA by the end of 2025 and a potential product launch in the US in 2026 [2][5][6] Company Developments - Cylembio's pivotal Phase 3 trial has completed enrollment with 407 patients, and the primary endpoint is progression-free survival (PFS), with a readout now expected in Q3 2025 [5][6][10] - The company has also completed enrollment ahead of schedule in a Phase 2 basket trial for Cylembio as neoadjuvant/adjuvant treatment for resectable melanoma and head and neck cancer, with initial data expected in the second half of 2025 [5][6][13] - Cash and cash equivalents at the end of Q4 2024 were approximately $60 million, and the company secured up to €57.5 million in debt financing from the European Investment Bank to extend its cash runway into Q2 2026 [5][12] Clinical Trials and Data - The ongoing Phase 3 trial (IOB-013/KN-D18) is evaluating Cylembio in combination with Merck's KEYTRUDA for advanced melanoma, with a total of 407 patients enrolled across multiple countries [10][14] - The Phase 2 basket trial (IOB-022/KN-D38) is investigating Cylembio in combination with KEYTRUDA for first-line treatment of metastatic non-small cell lung cancer and squamous cell carcinoma of the head and neck, with promising initial results [7][11] - The company has reported that the primary endpoint of overall response rate (ORR) was met in the Phase 2 trial, along with encouraging PFS data [6][7] Future Plans - IO Biotech plans to submit an Investigational New Drug Application (IND) for its second cancer vaccine candidate, IO112, in 2025 [12] - The company is focused on commercializing Cylembio as a first-in-class immune-modulatory, off-the-shelf therapeutic cancer vaccine, aiming to address significant unmet medical needs in oncology [2][14]