THIO-101 Phase 2 NSCLC Trial Enrollment Completed by MAIA Biotechnology

MAIA Biotechnology, a clinical-stage biopharmaceutical firm, has announced the completion of patient enrollment in its Phase 2 clinical trial for THIO-101, an innovative telomere-targeting agent for cancer treatment. The study, which combines THIO with the immune checkpoint inhibitor cemiplimab, aims to assess its efficacy in treating advanced non-small cell lung cancer (NSCLC). The trial enrolled 41 patients at the 180mg/dose mark, surpassing the target, and the optimal dose was determined in December 2023.

MAIA's CEO, Vlad Vitoc, highlighted the strong enrollment and the preliminary data showing exceptional disease control and response rates. He emphasized THIO-101's potential to become a new standard for NSCLC treatment, given its unique telomere targeting approach, which could offer a time-to-market advantage.

THIO is a novel investigational agent that targets telomeres and telomerase, key components in cancer cell survival and resistance to therapies. It induces DNA damage and triggers immune responses, leading to cancer cell death. The Phase 2 trial is designed to evaluate THIO's safety, tolerability, and preliminary clinical efficacy in NSCLC patients who have not responded to initial treatments.

The trial's primary objectives include assessing the safety and tolerability of THIO as an anticancer compound and immune activator, as well as its clinical efficacy using the Overall Response Rate as the main endpoint. The treatment with cemiplimab followed by THIO has been well-tolerated in a population that has undergone extensive prior treatment.

MAIA Biotechnology is dedicated to developing and commercializing first-in-class drugs with novel mechanisms to improve the lives of cancer patients. Their lead program, THIO, is in clinical development for NSCLC patients with telomerase-positive cancer cells. Further information on the Phase II trial can be found on ClinicalTrials.gov under the identifier NCT05208944.