MAIA Biotechnology Opens Alabama Site for THIO-101 Phase 2 Expansion, Targets $70B NSCLC Market
MAIA•MAIA launched enrollment at its second U.S. Phase 2 THIO-101 expansion site in Homewood, Alabama, testing ateganosine as a third-line NSCLC treatment after checkpoint inhibitors and chemotherapy. The 46-site global trial (44 active plus two U.S.) seeks data for an accelerated FDA filing targeting a $70B NSCLC market.
1. Trial Expansion and New U.S. Site
MAIA has activated its second U.S. clinical site at Central Alabama Research in Homewood, Alabama, to enroll third-line NSCLC patients who have failed both checkpoint inhibitors and chemotherapy. This expansion builds on Parts A and B of the Phase 2 trial, which identified optimal dosing parameters for ateganosine in a targeted patient subgroup.
2. Global Footprint and Enrollment Strategy
The THIO-101 expansion trial now spans 46 sites, comprising 44 active locations across six countries in Europe and Asia plus two in the U.S. MAIA aims to accelerate patient recruitment by broadening geographic reach, including underserved and rural populations in the Southeast.
3. FDA Accelerated Approval Prospects
Additional data from the global expansion are intended to support a rolling submission for FDA accelerated approval under Fast Track designation. Positive interim results could validate ateganosine’s dual-action mechanism and strengthen its positioning against existing NSCLC therapies.
4. Parallel Phase 3 Development
In parallel, MAIA is screening and enrolling up to 300 patients in a pivotal Phase 3 trial comparing ateganosine sequenced with checkpoint inhibitors versus investigator’s choice chemotherapy. Regulatory approvals for Phase 3 screening have been secured in Taiwan, Turkey, select EMA countries and Georgia.
