MAIA Biotechnology announces updated data from THIO-101 trial

MAIA Biotechnology (MAIA) announced updated data from its THIO-101 pivotal Phase 2 clinical trial evaluating its lead clinical candidate, ateganosine, sequenced with Regeneron’s (REGN) immune checkpoint inhibitor cemiplimab in patients with advanced non-small cell lung cancer who are resistant to immune therapy and chemotherapy. As of May 15, third line data showed median overall survival of 17.8 months for the 22 NSCLC patients who received at least one dose of ateganosine in parts A and B of the trial. The updated analysis continues to demonstrate a 95% confidence interval lower bound of 12.5 months and a 99% CI lower bound of 10.8 months. The treatment has been generally well-tolerated to date in this heavily pre-treated population.1 Studies of standard-of-care chemotherapy treatments for NSCLC in a similar setting have shown OS of 5 to 6 months. MAIA’s multiple potential regulatory pathways for ateganosine could provide accelerated FDA approval and robust exclusivity in NSCLC, with a potential FDA decision as early as next year.