Clinical TrialJun 3, 2026, 09:46 AM
MAIA Biotechnology gets FDA clearance for THIO-101 trial expansion
AI Summary
MAIA Biotechnology announced that the FDA has cleared an amendment to its investigational new drug (IND) application, allowing the company to expand U.S. enrollment for the Phase 2 THIO-101 trial of ateganosine for advanced non-small cell lung cancer (NSCLC). This clearance, along with the Fast Track designation granted in July 2025, may support a potential Accelerated Approval filing. The company also highlighted positive overall survival data from earlier parts of the THIO-101 trial and confirmed ongoing enrollment for its pivotal Phase 3 THIO-104 study.
Key Highlights
- FDA cleared an amendment to update its IND application for ateganosine.
- Enables MAIA to open U.S. enrollment for the expansion of the Phase 2 THIO-101 trial.
- The trial targets advanced third-line (3L) non-small cell lung cancer (NSCLC).
- Additional data from expansion studies may support a filing for FDA Accelerated Approval.
- FDA granted Fast Track designation for ateganosine for NSCLC in July 2025.
- Overall survival beyond two years observed for eight patients in Parts A and B of THIO-101.
- MAIA is also screening and enrolling patients in a pivotal Phase 3 THIO-104 clinical trial.
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