MAIA Biotechnology Initiates Phase 3 Trial for THIO in Advanced NSCLC Patients

MAIA Biotechnology, Inc. (NYSE American: MAIA) announced on February 27, 2025, that it will initiate a pivotal Phase 3 clinical trial, named THIO-104, evaluating its investigational agent THIO in combination with a checkpoint inhibitor (CPI) versus standard chemotherapy in advanced non‐small cell lung cancer (NSCLC) patients. The study is designed as a multicenter, open‐label, randomized trial that will enroll up to 300 patients in a 1:1 randomization.

The Phase 3 trial is set to assess the overall survival benefits of THIO sequenced with a checkpoint inhibitor compared with an investigator’s choice of chemotherapy in a third-line treatment setting for patients who have shown resistance to checkpoint inhibitors and chemotherapy. Secondary endpoints include disease control rate, overall response rate, duration of response, progression-free survival, and treatment safety.

“THIO has consistently and substantially outperformed standard treatment options in our THIO-101 Phase 2 trial to date. THIO-104 will give us direct comparative data from a randomized study in patients in third line of treatment,” said Vlad Vitoc, M.D., CEO of MAIA Biotechnology. He added that the trial represents an important milestone in advancing THIO toward FDA commercial approval.

The company expects to begin patient enrollment in the second half of 2025, with study sites located in select countries across Asia, Europe, and the United States.

MAIA Biotechnology is focused on developing targeted immunotherapies for cancer and is advancing THIO—a first-in-class telomere-targeting agent—through clinical development for NSCLC patients with telomerase-positive cancer cells. The trial seeks to further clarify THIO’s potential benefit in improving survival outcomes for patients with advanced stage NSCLC, a population with significant unmet medical need.

Forward-looking statements included in the filing reflect management’s current expectations and are subject to risks and uncertainties that could cause actual results to differ materially from those anticipated.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read MAIA Biotechnology’s 8K filing here.

MAIA Biotechnology Company Profile

MAIA Biotechnology, Inc, a clinical stage biotechnology company, engages in the discovery, development, and commercialization of therapies targeting cancer. The company's lead product candidate is THIO, a telomere-targeting agent that is in Phase II clinical study to evaluate its activity in patients with non-small cell lung cancer.