MAIA Biotech Reports Positive Efficacy in Phase 2 THIO-101 Trial for Advanced NSCLC

CHICAGO—MAIA Biotechnology, Inc., a clinical-stage biopharmaceutical company on the NYSE American under the ticker MAIA, announced promising new data from its THIO-101 pivotal Phase 2 clinical trial. This study focuses on the lead candidate, THIO, in combination with Regeneron's immune checkpoint inhibitor, cemiplimab (Libtayo®), for patients suffering from advanced non-small cell lung cancer (NSCLC) who have not responded to two or more standard treatments.

As of January 15, 2025, the results from the third-line treatment part of the trial showed a median overall survival of 16.9 months among the 22 NSCLC patients who received at least one dose of THIO. These patients represented the intent-to-treat population in both parts A and B of the study. Impressively, the analysis revealed a 95% confidence interval with a lower bound of 12.5 months and a 99% confidence interval with a lower bound of 10.8 months. The treatment has shown a good safety profile in this group, who had already undergone multiple treatments. In comparison, studies of standard chemotherapy for NSCLC in similar circumstances have indicated an overall survival of only 5 to 6 months.

Dr. Vlad Vitoc, CEO of MAIA, emphasized the significance of these results, stating, "Treatment with THIO now shows a 99% probability that overall survival will extend past chemotherapy’s measure by a wide margin." He noted that THIO's performance in advanced stages of NSCLC surpasses expectations, particularly in third-line treatments where resistance to therapy is common. This suggests significant benefits for patients with limited options.

The company is optimistic about the potential for accelerated FDA approval of THIO, depending on the final results of the ongoing THIO-101 trial expansion.

THIO, known chemically as 6-thio-dG or 6-thio-2’-deoxyguanosine, is a pioneering investigational agent targeting telomeres, essential components in the survival of cancer cells, particularly in NSCLC. It works by modifying telomeric DNA in a way that induces selective cancer cell death while avoiding healthy cells. The damaged DNA accumulates in micronuclei within cells, triggering both innate and adaptive immune responses, including T-cell activation. The sequence of treating with THIO followed by PD-(L)1 inhibitors like cemiplimab has shown profound tumor regression and the creation of cancer-type-specific immune memory in advanced models.

The THIO-101 trial is a multicenter, open-label, Phase 2 clinical study, the first of its kind to assess the anti-tumor activity of THIO followed by PD-(L)1 inhibition. This trial investigates whether small doses of THIO before cemiplimab can enhance the immune response in patients with advanced NSCLC who did not respond to initial treatments. The trial's primary goals are to evaluate the safety and tolerability of THIO and to measure its clinical effectiveness through the Overall Response Rate (ORR). Treatment with THIO and cemiplimab has been well-received among a heavily pre-treated group of patients.

 

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!