Company: IOBT
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0000950170-25-047744
Chunk: 2

Company: IO Biotech, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 2
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 3 trial (380 patients) ahead of schedule with nearly half the patients enrolled during the final six months of enrollment. We included all patients who met the study criteria and who were in screening when the target enrollment was achieved, resulting in a total of 407 patients being enrolled in our IOB-013/KN-D18 trial.

 The PFS analysis is event-driven and has been planned to be conducted when 226 events (progression or death) in the trial have occurred in the study. With 226 events, the primary endpoint of PFS is powered at 89% to detect a hazard ratio of 0.65.  The rate of events has slowed in the study, as such, we now expect the readout of the PFS primary endpoint in the third quarter of 2025. We continue to plan to submit a BLA to the FDA in 2025 and potentially make our first therapeutic cancer vaccine available for patients in the U.S. with advanced melanoma in 2026.

To ensure the safety of patients in the IOB-013/KN-D18 trial, safety reviews continue to be conducted by the independent data monitoring committee (“IDMC”). As of December 31, 2024, five IDMC safety reviews have been completed for an assessment of patient safety across both treatment arms in the trial. The recommendation after all five IDMC reviews was that the trial continue without modifications.

The Phase 3 trial protocol also called for a planned interim analysis of ORR to be conducted 12 months after the 225th patient was randomized. When we designed the interim analysis, we assumed that patients treated with Cylembio in combination with pembrolizumab would show an ~18- percentage point improvement in ORR compared to the patients treated with pembrolizumab alone. There was a high statistical bar for the Phase 3 interim analysis (p≤0.005), which was set to preserve most of the alpha for the primary endpoint of PFS. In August 2024, the IDMC for the IOB-013/KN-D18 trial conducted its review of planned interim analysis and determined that the data did not meet the criteria to declare superiority of ORR. Based on their review of safety and efficacy data, the IDMC recommended that the trial continue without modifications to the PFS analysis and noted that no new safety signals were observed. 

7

Phase 2 IOB-022/KN-D38 Basket Trial

We are also investigating Cylembio® in several