MAIA Biotech holds meeting with FDA to expand THIO-101 study for NSCLC

MAIA Biotechnology announced that it completed a pre-Investigational New Drug or pre-IND meeting with the U.S. Food and Drug Administration for the planned U.S. expansion of the THIO-101 Phase 2 trial evaluating THIO, an investigational telomere-targeting agent, in patients with advanced non-small cell lung cancer NSCLC. MAIA received positive feedback from the FDA regarding its manufacturing, preclinical and clinical development plan. MAIA also obtained guidance from the FDA on the assessment of its safety and efficacy in the THIO-101 Phase 2 trial that will be incorporated in the U.S. IND application. 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. "We appreciate the FDA’s guidance as we prepare to file the IND application for our Phase 2 trial and open enrollment of patients in the U.S.," said Mihail Obrocea, MD, MAIA’s Chief Medical Officer. "The successful completion of this engagement with the FDA is an important milestone that has helped provide regulatory direction with our planned THIO clinical development program." .