MAIA Biotechnology, Inc. (NYSE:MAIA) ("MAIA", the "Company"), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today provided a patient enrollment update for its ongoing pivotal Phase 3 trial, THIO-104, evaluating its novel telomere-targeting therapy as a third-line (3L) treatment for advanced non-small cell lung cancer (NSCLC). To date, 29 patients have been dosed among 34 activated trial sites in 6 foreign countries.
Vlad Vitoc, M.D., Founder and Chief Executive Officer of MAIA, commented, "Enrollment and dosing in our Phase 3 study is progressing at a strong pace. Based on this early momentum, we are targeting up to 100 patients by year-end and expect to have sufficient survival data to conduct an interim analysis in 2027."
Dr. Vitoc has previously stated that statistical assessments of MAIA's lead therapeutic, ateganosine, suggest a high probability of technical success in the THIO-104 full approval trial if Phase 3 data is consistent with Phase 2 THIO-101 trial results. Median overall survival was 17.8 months in parts A and B of the Phase 2 trial. With chemotherapy, which is the standard utilized treatment for 3L NSCLC patients, expected survival in a heavily pre-treated population is 5.8 months.1
Ateganosine is a first-of-its-kind dual mechanism therapy designed to break down telomere structure and function in cancer cells while inducing immune activation. As a potential breakthrough therapeutic, ateganosine holds substantial commercial opportunity in a projected $70 billion global NSCLC treatment market by 2030.2
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for ateganosine as a 3L NSCLC treatment.