MAIA Biotechnology Doses First Patient In THIO-104 Phase 3 Trial Testing Ateganosine As A Third-Line Treatment For Advanced NSCLC

MAIA Biotechnology, Inc., a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, announced that the first patient has now been dosed in its THIO-104 Phase 3 pivotal clinical trial. This study is designed to evaluate the effectiveness of ateganosine, given in sequence with a checkpoint inhibitor (CPI), as a third-line treatment option for patients with advanced non-small cell lung cancer (NSCLC).

The THIO-104 trial is a multicenter, open-label study enrolling patients whose disease has progressed despite prior treatment with both a CPI and chemotherapy. The purpose of the trial is to compare overall survival between two groups: one receiving ateganosine followed by a CPI, and the other receiving the investigator’s choice of standard chemotherapy. Up to 300 patients will be enrolled and randomized equally between the two treatment arms. MAIA has received regulatory approval to begin screening patients in Taiwan, Turkey, several countries within the European Medicines Agency (EMA) region, and Georgia. Screening and enrollment activities are currently underway.

According to Vlad Vitoc, M.D., Chief Executive Officer of MAIA, advancing ateganosine into a Phase 3 pivotal study represents significant progress in the company’s plan to bring its telomere-targeting therapy to market. He noted that multiple international sites are actively screening patients and that dosing the first participant is an important milestone in the path toward potential U.S. FDA commercial approval. Dr. Vitoc also expressed confidence in the anticipated outcomes of the Phase 3 trial, based on earlier clinical data showing a median overall survival of 17.8 months with ateganosine, compared to approximately six months typically seen with chemotherapy. He stated that the company believes ateganosine has the potential to become a new standard of care for patients with advanced NSCLC.

Previous clinical results support this optimism. In the THIO-101 study, ateganosine given before a CPI demonstrated strong efficacy in third-line NSCLC patients. As of September 17, 2025, the observed progression-free survival was 5.6 months, more than double the standard of care of 2.5 months. One patient who started treatment in March 2023 has achieved a survival duration of 30 months, or 912 days. Ateganosine has also received Fast Track designation from the U.S. Food and Drug Administration (FDA) for the treatment of NSCLC, recognizing its potential to address an unmet medical need.