secwatch.observer — SEC 8-K summary
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Issuer:     MAIA Biotechnology, Inc. (MAIA)
CIK:        0001878313
Form:       8-K
Filed at:   2025-11-20T23:59:59+00:00
Accession:  0001493152-25-024402
Event type: other_material
Sentiment:  positive
Materiality: 0.55
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

MAIA starts Romania enrollment for Phase 2 THIO-101 Part C; 38% ORR vs standard 6% cited
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- CEO presented at Smart Diaspora 2025; Romania begins screening patients for THIO-101 Part C.
- Observed 38% overall response rate vs current third-line NSCLC treatments with ~6% response rate.
- FDA Fast Track Designation for ateganosine received in July 2025, supports accelerated approval path.
- Third-line NSCLC patients resistant to chemo and immunotherapy are target population.
- Investigator Tudor Ciuleanu, MD, PhD, is key opinion leader in Eastern Europe.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1878313/000149315225024402/0001493152-25-024402-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1878313/000149315225024402/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-25-024402

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