20.12.2022 14:38:08
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MAIA Completes Pre-IND Meeting For U.S. Expansion Of THIO-101 Phase 2 Trial Evaluating THIO
(RTTNews) - MAIA Biotechnology, Inc. (MAIA) has completed a pre-Investigational New Drug meeting with the FDA for the planned U.S. expansion of the THIO-101 Phase 2 trial evaluating THIO in patients with advanced non-small cell lung cancer. The company said it received positive feedback from the FDA regarding its manufacturing, preclinical and clinical development plan. MAIA also received guidance on the assessment of its safety and efficacy in the THIO-101 Phase 2 trial.
MAIA plans to file its U.S. IND in the first half of 2023 and commence enrolling patients in the U.S. in the second half of 2023. The trial is currently enrolling patients in Australia and the European Union.
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