IO Biotech(IOBT)2025-03-04 21:47Clinical Trials and Development - The primary endpoint readout of the pivotal Phase 3 trial for Cylembio is now expected in the third quarter of 2025, with a total enrollment of 407 patients completed ahead of schedule[4] - Initial data from the Phase 2 basket trial of Cylembio as neoadjuvant/adjuvant treatment for resectable melanoma or head and neck cancer is anticipated in the second half of 2025[4] - The Phase 2 basket trial IOB-022/KN-D38 showed promising activity in first-line treatment for metastatic non-small cell lung cancer, with approximately 50% of patients having no disease progression at 12 months[7] - The primary endpoint of overall response rate (ORR) was met in the Phase 2 basket trial investigating Cylembio in combination with pembrolizumab for squamous cell carcinoma of the head and neck[7] - The pivotal Phase 3 trial IOB-013/KN-D18 is evaluating Cylembio in combination with Merck's KEYTRUDA in patients with advanced melanoma, with top-line data readout expected in Q3 2025[11] Financial Position - Cash and cash equivalents at the end of Q4 2024 were approximately $60.0 million, with secured debt financing of up to €57.5 million from the European Investment Bank, extending the cash runway into Q2 2026[4] Regulatory Submissions - The company plans to submit a Biologics License Application (BLA) for Cylembio to the FDA by the end of 2025, with a potential launch in the US in 2026[3] - The company plans to submit an Investigational New Drug Application (IND) for its second candidate, IO112, targeting Arginase-1, to the FDA in 2025[7] Product Development - Cylembio has been adopted as the US brand name for the lead investigational therapeutic cancer vaccine, previously known as IO102-IO103[7] - The company is advancing its lead cancer vaccine candidate, Cylembio, in clinical trials while also developing additional pipeline candidates through preclinical development[15]