Company: IOBT
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0000950170-25-047744
Chunk: 18

Company: IO Biotech, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 18
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 300 patients randomized into either the experimental arm of Cylembio in combination with pembrolizumab or the pembrolizumab control arm. As of June 2023, we had randomized 225 patients. In addition, on June 14, 2023, we announced that we increased enrollment in the IOB-013/KN-D18 study to 380 randomized patients and the trial reached full enrollment ahead of schedule in November 2023. 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. All patients will receive pembrolizumab 200 mg intravenously every three weeks for a maximum of 35 cycles, corresponding to approximately two years of treatment. Patients randomized to the experimental arm will also be given Cylembio every three weeks with an additional dose given during the induction period on Day 8 of cycles 1 and 2. Cylembio will thereafter be administered subcutaneously every three weeks during the maintenance period. Each patient can be treated for a maximum of 37 administrations in total, corresponding to approximately two years of treatment. 

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. We completed enrollment in the IOB-013/KN-D18 trial in December 2023 with 407 patients. 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, concurrent safety reviews continue to be conducted by the 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