secwatch.observer — SEC 8-K summary
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Issuer:     IO Biotech, Inc. (IOBTQ)
CIK:        0001865494
Form:       8-K
Filed at:   2024-08-30T23:59:59+00:00
Accession:  0001193125-24-211080
Event type: other_material
Sentiment:  neutral
Materiality: 0.65
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

IO Biotech Phase 3 trial IDMC recommends continuation; PFS endpoint expected H1 2025
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- IDMC recommends Phase 3 trial of IO102-IO103 + pembrolizumab continue without modifications after interim analysis.
- Interim ORR analysis did not meet pre-specified high statistical bar (p≤0.005); most alpha preserved for PFS.
- Primary endpoint PFS event-driven at 226 events; trial 89% powered to detect 35% risk reduction; projected H1 2025.
- No new safety signals observed; 407 patients enrolled across 100+ centers in US, EU, Australia, and elsewhere.
- Phase 2 basket trial data for NSCLC and SCCHN accepted for presentations at ESMO and other fall meetings.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1865494/000119312524211080/0001193125-24-211080-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1865494/000119312524211080/d889003d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-24-211080

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer