IO Biotech has published the five‑year follow‑up of its MM1636 Phase 1/2 trial in Nature Communications. The study evaluated the dual‑antigen vaccine IO102‑IO103 (Cylembio) in combination with the PD‑1 inhibitor nivolumab in first‑line metastatic melanoma patients.
The publication reports a median progression‑free survival of 25.5 months and a durable overall survival of 60 months. Biomarker analysis identified vaccine‑specific immune signatures that were associated with long‑term benefit and were not observed in a matched anti‑PD‑1 monotherapy cohort. The paper does not provide explicit objective response or complete response percentages for the five‑year data.
These long‑term results reinforce the scientific rationale for IO Biotech’s T‑win platform and support the company’s decision to launch the pivotal Phase 3 IOB‑013/KN‑D18 trial. The data also provide a compelling argument for future funding and regulatory discussions, as the company seeks to demonstrate the vaccine’s benefit in a larger, randomized setting.
Despite the clinical success, IO Biotech continues to face significant financial headwinds. The company’s rapid cash burn and recent workforce reductions have left a runway that is expected to extend into the first quarter of 2026. In the Phase 3 trial, the primary endpoint for progression‑free survival was narrowly missed for statistical significance, although the study showed a clinically meaningful improvement. These factors have tempered investor enthusiasm and contributed to a mixed market reaction.
CEO Mai‑Britt Zocca said the data “strengthen our belief in Cylembio and in our approach to develop off‑the‑shelf, immune‑modulatory therapeutics with pan‑cancer potential.” Principal Investigator Inge Marie Svane added that the durable overall survival of 60 months “supports the potential of IO102‑IO103 as a first‑line therapy for melanoma as part of a combination regimen.” Investors responded with mixed sentiment, reflecting both excitement about the clinical data and concern about the company’s financial position.
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