Company: IOBT
Filing Date: 2025-11-14
Form Type: 10-Q
Source: 0001193125-25-281820
Chunk: 5

Company: IO Biotech, Inc.
Filing Date: 2025-11-14
Form: 10-Q
Item: Item 2
Chunk 5
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 and etimupepimut, adjuvanted), is designed to target cancer cells and immune-suppressive cells in the TME that express indoleamine 2,3-dioxygenase (“IDO”) and programmed death ligand 1 (“PD-L1”). In an investigator-initiated, single-arm Phase 1/2 trial of 30 anti PD-1/PD-L1 naïve patients with metastatic melanoma, IO102-IO103 in combination with nivolumab, an anti-programmed cell death 1 (“PD-1”) checkpoint inhibitor, demonstrated proof of concept by increasing the overall response rate (“ORR”) and median progression free survival (“PFS”) compared to what has been reported with an anti-PD-1 antibody alone. The primary endpoint of the trial was feasibility and safety, secondary endpoints included efficacy and immunogenicity. The clinical efficacy endpoints in this trial included objective response (“OR”), PFS and overall survival (“OS”). The combination induced meaningful tumor regression and achieved rapid, deep and durable responses with a favorable tolerability profile without adding systemic toxicity to what is typically seen with an anti-PD-1 monotherapy in this patient population. As of the January 5, 2023 data cut as published in the May 2023 Journal for ImmunoTherapy of Cancer, we observed a confirmed ORR of 73% as per RECIST 1.1, a complete response rate (“CRR”) of 50% and 25.5 months of PFS. Based on the results from this study, IO102-IO103, in combination with pembrolizumab, was granted BTD by the FDA for treatment of unresectable/metastatic melanoma and we initiated a global Phase 3 trial. 

Recent Developments

On August 11, 2025, the Company issued a press release announcing topline results from our Phase 3 trial of Cylembio plus KEYTRUDA® (pembrolizumab) for the treatment of first-line advanced melanoma. In the trial, Cylembio plus pembrolizumab demonstrated clinical improvement in PFS compared to pembrolizumab alone, but statistical significance was narrowly missed on the primary endpoint. The randomized, open-label study enrolled 407 patients across more than 100 sites worldwide. Patients received either Cylembio in combination with pembrolizumab (n=203) or pembrolizumab alone (n=204).