MAIA Biotechnology, Inc. has announced promising new efficacy data from its Phase 2 THIO-101 clinical trial, evaluating THIO sequenced with the immune checkpoint inhibitor cemiplimab (Libtayo®) in patients with advanced non-small cell lung cancer (NSCLC) who have failed two or more standard-of-care therapy regimens. The data, presented as a late-breaking abstract at the Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting on November 8, 2024, highlights the potential of THIO-101 in addressing a critical unmet need in heavily pre-treated NSCLC patients.
THIO-101 Efficacy Data
As of September 16, 2024, 19 patients had survival follow-up surpassing 12 months, including 10 patients in the third-line treatment (3L) setting. Interim median survival follow-up in 3L across all dose levels of THIO was 11.5 months. Specifically, the interim median survival follow-up in 3L in the THIO 180mg dose was 11.4 months.
Clinical Significance
The advanced NSCLC patient population that has failed multiple lines of therapy represents a significant challenge in oncology. These patients often have limited treatment options and poor prognoses. The encouraging survival data from the THIO-101 trial suggests that this therapeutic approach could offer a meaningful benefit for these individuals. The combination of THIO, a telomere-targeting agent, with cemiplimab, an anti-PD-1 antibody, aims to enhance the anti-tumor immune response and improve patient outcomes.
Mechanism of Action
THIO-101 is designed to activate telomerase reverse transcriptase (TERT) which can make tumors more sensitive to immune checkpoint inhibitors. By targeting telomeres, THIO may induce a form of immunogenic cell death, further stimulating the immune system to recognize and attack cancer cells.
About the THIO-101 Trial
The Phase 2 THIO-101 trial is evaluating the safety and efficacy of THIO sequenced with cemiplimab in patients with advanced NSCLC who have progressed on prior therapies. The trial includes patients who have failed at least two prior lines of systemic therapy. The primary endpoint of the trial is overall survival, with secondary endpoints including objective response rate, progression-free survival, and safety.
MAIA Biotechnology plans to continue to analyze the data from the THIO-101 trial and present further updates at future medical conferences. The company is also exploring potential regulatory pathways for THIO-101 in advanced NSCLC.
