Company: IOBT
Filing Date: 2025-09-29
Form Type: 8-K
Source: 0001193125-25-221704
Chunk: 2

Company: IO Biotech, Inc.
Filing Date: 2025-09-29
Form: 8-K
Item: Item 8.01
Chunk 2
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Item 8.01.      Other Events  

On September 29, 2025, the Company announced that the FDA has recommended that the Company not submit a BLA based on the data from the IOB-013clinical trial. As previously announced, in theIOB-013trial treatment with Cylembio plus pembrolizumab improved progression free survival, but the results narrowly missed statistical significance. The Company plans to continue the dialogue with FDA to align on an efficient path to market for Cylembio, including the design of a potential additional registrational study for Cylembio. The Company also plans to discuss the data from theIOB-13 clinicaltrial with the European regulators and determine a path to approval in the EU.