Company: IOBT
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0000950170-25-047744
Chunk: 7

Company: IO Biotech, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 7
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oma. We were granted BTD by the FDA for our IO102-IO103 cancer vaccine in combination with pembrolizumab in December 2020 and enrolled the first patient in the IOB-013/KN-D18 trial of Cylembio in combination with pembrolizumab as a first-line treatment in advanced melanoma in May of 2022. We completed total enrollment (407 patients) of the trial in December 2023 and expect the outcome of the PFS analysis in the third quarter of 2025. If the data are supportive based on the primary endpoint of PFS, we plan to submit marketing applications in a number of countries, including the U.S and European Union;

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•Broaden clinical development of Cylembio® into other solid tumor settings through basket trials in the first line metastatic and neoadjuvant / adjuvant treatment settings. We are executing a Phase 2 basket trial, the IOB-022/KN-D38 trial, of Cylembio in combination with pembrolizumab in the first line solid tumor setting. We enrolled the first patient in our Phase 2 basket trial in solid tumors in 2022 and completed enrollment of the trial in June 2024. Encouraging data providing signal of activity in other hard to treat patient populations from the study was presented at ESMO and SITC for SCCHN (cohort B) and NSCLC (cohort A), respectively, and final follow up data is expected in 2025 for each cohort. Additionally, in April 2023, the FDA cleared the Company’s IND for the evaluation of Cylembio in the neoadjuvant/adjuvant treatment of solid tumors in the IOB-032/PN-E40 trial. As of January 2025, the study has completed enrollment for all cohorts ahead of schedule and we expect to begin reporting data from this trial in the second half of 2025. These two basket trials build on the data that we have generated from prior trials of our product candidates, IO102 and IO103, including the anti-tumor activity that we have observed with the use of our first-generation IDO compound in NSCLC; 

•Leverage our T-win® platform to design and advance a portfolio of novel immune-modulatory, off-the-shelf therapeutic cancer vaccine product candidates, including IO112 and additional future product candidates. Since inception, our T-win platform has allowed us to rapidly identify and develop