MAIA Biotechnology highlights momentum of ateganosine clinical program

MAIA Biotechnology (MAIA) announced highlights from two poster presentations delivered at SITC 2025, an annual conference hosted by the Society for Immunotherapy of Cancer, held November 5-9, 2025, in National Harbor, MD. The Trials in Progress posters focus on MAIA’s ongoing Phase 2 THIO-101 expansion and Phase 3 THIO-104 clinical trials of its first-in-class small molecule telomere targeting agent, ateganosine, as a treatment for non-small cell lung cancer. The U.S. Food and Drug Administration has granted Fast Track designation for ateganosine for the treatment of NSCLC. MAIA’s Sr. Medical Director, Victor Zaporojan, presenter at SITC 2025 commented, “It was a privilege to return to SITC for its 40th anniversary. This event was an ideal forum to highlight the continued success of our Phase 2 clinical trial. We are making steady progress in the expansion phase of this trial, with patient enrollment now underway in European Medicines Agency countries. Sites in Hungary and Poland, which were instrumental in Parts A and B of the trial, are actively screening patients along Turkey and Taiwan, and we have 12 patients enrolled in the expansion to date. We expect further momentum in identifying and enrolling patients for THIO-101 Part C in the near term”. “We also began screening patients in our Phase 3 trial, THIO-104, and noticed great excitement from physicians in the sites we’re bringing our trial to,” added MAIA CEO Vlad Vitoc. “In this population, third-line NSCLC patients resistant to chemo and immunotherapy, current treatments show overall survival of around 6 months, and based on the 17.8 months OS observed in THIO-101 to date, we believe that our Phase 3 trial could lead to an early commercial approval of ateganosine by the FDA. It’s only a matter of successful execution to bring our novel NSCLC treatment to this large patient population with significant unmet medical need.” The posters presented at SITC 2025 feature trial designs for the Phase 2 and Phase 3 studies in advanced NSCLC patients receiving ateganosine followed by a checkpoint inhibitor, cemiplimab. As of September 17, 2025, a patient that began therapy in March 2023 in the THIO-101 Phase 2 trial has shown survival of 30 months, or 912 days.