MAIA Biotechnology announced that new data from its Phase 2 THIO-101 clinical trial will be presented at the Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting. The trial evaluates THIO-101 sequenced with Regeneron's cemiplimab (Libtayo®) in advanced non-small cell lung cancer (NSCLC) patients who have failed two or more standard-of-care regimens. These findings suggest a potential new treatment option for patients with limited alternatives.
Vlad Vitoc, M.D., Chairman and CEO of MAIA, stated, "Our findings to date are particularly significant for advanced-stage patients resistant to CPI and chemotherapy treatments who are in desperate need of new treatment options. In our opinion, the combination of THIO with a CPI is showing promise as a durable and effective NSCLC treatment."
THIO-101 Trial Design and Objectives
THIO-101 is a multicenter, open-label, dose-finding Phase 2 clinical trial evaluating THIO's anti-tumor activity when followed by PD-(L)1 inhibition. The trial aims to assess the safety, tolerability, and clinical efficacy of THIO, using Overall Response Rate (ORR) as the primary clinical endpoint. The study hypothesizes that low doses of THIO administered prior to cemiplimab will enhance and prolong immune response in patients with advanced NSCLC who progressed after prior checkpoint inhibitor treatment.
Survival Benefits in Advanced NSCLC
As of August 1, 2024, 16 patients in the THIO-101 trial had survival follow-up surpassing 12 months, including 9 in third-line treatment (3L). Interim median survival follow-up in 3L was 10.6 months, compared to the current standard-of-care overall survival of 5.8 months in third-line NSCLC.
Mechanism of Action
THIO (6-thio-dG) is a first-in-class investigational telomere-targeting agent. It induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei and activate both innate (cGAS/STING) and adaptive (T-cell) immune responses. This mechanism suggests that THIO can enhance the effectiveness of subsequent PD-(L)1 inhibitor treatment.
Presentation Details at SITC 2024
The late-breaking abstract (LBA) presentation at SITC will provide further details on the efficacy and safety of THIO-101. The presentation, titled "Telomere-Targeting Agent THIO in Sequential Combination with Cemiplimab Demonstrates Long Term Therapeutic Benefits Beyond Treatment Cessation — A Phase 2 Trial in Advanced Immune Checkpoint Inhibitor Resistant Non-Small Cell Lung Cancer Patients," will be presented by Victor Zaporojan, M.D., Sr. Medical Director, on Friday, November 8, 2024, from 11:45 a.m.-12:15 p.m. CST.
