- MAIA Biotechnology Inc MAIA released topline data from the completed Part A safety lead-in of its THIO-101 Phase 2 go-to-market trial in advanced Non-Small Cell Lung Cancer (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 sequentially with Regeneron Pharmaceuticals Inc's REGN Libtayo (cemiplimab), was generally well-tolerated.
- No dose-limiting toxicities (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 were reported.
- Part B of the study will allow the randomization of patients to three THIO dose levels, including 60 mg, 180 mg, and 360 mg, followed by cemiplimab treatment every three weeks.
- The objective of Part B is to determine the most efficacious and safe dose, which will guide Part C of the trial.
- Price Action: MAIA shares are up 0.35% at $3.62 on the last check Tuesday.
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