MAIA Biotechnology's THIO-101, when sequenced with Regeneron's cemiplimab (Libtayo®), is showing promising results in patients with advanced non-small cell lung cancer (NSCLC) who have failed two or more standard-of-care therapy regimens. The company announced that late-breaking abstract (LBA) detailing new updates from its Phase 2 THIO-101 clinical trial was selected for oral and poster presentation at the Society for Immunotherapy of Cancer (SITC) 2024 Annual Meeting.
The updates include new data on efficacy and safety from the clinical trial evaluating THIO sequenced with cemiplimab in patients with advanced NSCLC. These findings are particularly significant for advanced-stage patients resistant to CPI and chemotherapy treatments who are in desperate need of new treatment options.
THIO-101: Targeting Telomeres for Immunotherapy
THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent. Telomeres and telomerase play a crucial role in cancer cell survival and resistance to therapies. THIO induces telomerase-dependent telomeric DNA modification, leading to DNA damage responses and selective cancer cell death. This process activates both innate (cGAS/STING) and adaptive (T-cell) immune responses.
Clinical Trial Results and Survival Benefits
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. This is a substantial improvement compared to the current standard-of-care overall survival of 5.8 months in third-line NSCLC.
Vlad Vitoc, M.D., Chairman and CEO of MAIA, stated, "We believe that our latest data is compelling and further supports the ability of THIO to produce cancer cell specific immune memory and to remain active against cancer cells after extended periods of time."
THIO-101 Phase 2 Trial Design
THIO-101 is a multicenter, open-label, dose-finding Phase 2 clinical trial designed to evaluate THIO’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of THIO administered prior to cemiplimab will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or progressed after first-line treatment containing another checkpoint inhibitor. The primary objectives are to evaluate the safety, tolerability, and clinical efficacy of THIO, using Overall Response Rate (ORR) as the primary clinical endpoint.
Presentation Details at SITC 2024
The late-breaking abstract will be presented at the SITC 2024 Annual Meeting in Houston, Texas:
- Title: 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
- Abstract number: 1492
- Session: Late Breaking Abstract Session 1
- Date: Friday, November 8, 2024
- Time: 11:45 a.m.-12:15 p.m. CST
