MAIA Biotechnology reports topline data from Part A of THIO-101 trial

MAIA Biotechnology announced topline data from the completed Part A safety lead-in of the company’s THIO-101 Phase 2 go-to-market trial in advanced Non-Small Cell Lung Cancer, or NSCLC, and has commenced recruitment in Part B randomized efficacy/dose selection. Topline data from Part A demonstrated that MAIA‘s telomere-targeting agent, THIO, administered in sequential combination with Regeneron’s anti-PD-1 therapy, Libtayo, were generally well-tolerated. No dose-limiting toxicities, or DLTs, or significant treatment-related adverse events were observed. Part A was designed to assess the safety and tolerability of the highest dose of 360 mg/cycle in six patients. Mild toxicities, such as grade 1 fatigue, and muscle pain, were reported, as well as only one occurrence of grade 3 nausea, but no grade 4 adverse events, reported. Part B of the study will allow randomization of patients to three THIO dose levels, including 60 mg, 180 mg and 360 mg, followed by cemiplimab treatment every 3 weeks. Safety and tolerability will continue to be monitored across all THIO doses. The objective of Part B is to determine the most efficacious and safe dose, which will guide Part C of the trial.