MAIA Biotechnology Doses 29 Patients in Phase 3 NSCLC Trial, Aims 100 by Year-End
MAIA•MAIA has dosed 29 patients in its Phase 3 THIO-104 trial across 34 sites in six countries and targets 100 enrollees by year-end. It expects enough survival data for an interim analysis in 2027 after Phase 2 results showed 17.8-month median overall survival.
1. Phase 3 Trial Enrollment
MAIA’s THIO-104 pivotal Phase 3 trial has activated 34 sites across six countries and has dosed 29 advanced NSCLC patients to date. The company aims to enroll up to 100 third-line treatment participants by the end of 2026, maintaining strong momentum in patient recruitment.
2. Interim Analysis Timeline
Based on current enrollment and dosing pace, MAIA expects to collect sufficient survival data to conduct an interim analysis in 2027. This milestone will assess early efficacy signals and guide potential regulatory discussions.
3. Phase 2 Efficacy Benchmarks
In Phase 2 THIO-101 parts A and B, ateganosine achieved a median overall survival of 17.8 months versus an expected 5.8 months with standard chemotherapy in a heavily pre-treated NSCLC population. These results underpin the statistical probability of technical success in the Phase 3 trial.
4. Commercial Opportunity and Fast Track Status
Ateganosine is designed as a dual-mechanism telomere-targeting immunotherapy with Fast Track designation for third-line NSCLC. The therapy addresses a projected $70 billion global NSCLC market by 2030, highlighting significant commercial potential.
