secwatch.observer — SEC 8-K summary
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Issuer:     MAIA Biotechnology, Inc. (MAIA)
CIK:        0001878313
Form:       8-K
Filed at:   2025-02-27T23:59:59+00:00
Accession:  0001493152-25-008540
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

MAIA plans Phase 3 pivotal trial of THIO+CPI vs chemo in NSCLC patients
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- Phase 3 trial THIO-104 to enroll up to 300 patients with third-line NSCLC.
- Primary endpoint is overall survival; THIO sequenced with checkpoint inhibitor vs investigator's choice chemo.
- Patient enrollment expected to begin H2 2025 in Asia, Europe, and U.S.
- Based on THIO-101 Phase 2 data that consistently outperformed standard options.
- Trial designed to support FDA commercial approval of THIO.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1878313/000149315225008540/0001493152-25-008540-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1878313/000149315225008540/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-25-008540

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