MAIA Biotechnology, Inc. announced that late-breaking data from its Phase 2 THIO-101 clinical trial will be presented at the Society for Immunotherapy of Cancer (SITC) 2024 Annual Meeting. The presentation will highlight new efficacy and safety data from the trial, which evaluates THIO sequenced with Regeneron's cemiplimab (Libtayo®) in patients with advanced non-small cell lung cancer (NSCLC) who have failed two or more standard-of-care therapy regimens. The findings suggest that THIO, in combination with a CPI, shows promise as a durable and effective NSCLC treatment, especially for patients resistant to CPI and chemotherapy.
THIO-101 Trial Design and Objectives
The THIO-101 trial 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 aims to assess the safety, tolerability, and clinical efficacy of THIO in enhancing and prolonging immune response in patients with advanced NSCLC who previously did not respond or developed resistance after first-line treatment containing a checkpoint inhibitor. The primary clinical endpoint is the Overall Response Rate (ORR).
Presentation Details at SITC 2024
The late-breaking abstract, 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 on Friday, November 8, 2024, from 11:45 a.m. to 12:15 p.m. CST. The abstract number is 1492, and the presenter will be Victor Zaporojan, M.D., Sr. Medical Director. The poster will be accessible on MAIA’s website.
Survival Benefits and Clinical Significance
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 surpasses the current standard-of-care overall survival of 5.8 months for third-line NSCLC, indicating a substantial survival benefit with THIO.
About THIO
THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent in clinical development for NSCLC. It induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments activate both innate (cGAS/STING) and adaptive (T-cell) immune responses. Sequential treatment with THIO followed by PD-(L)1 inhibitors has shown profound and persistent tumor regression in advanced, in vivo cancer models by inducing cancer type–specific immune memory. THIO is being developed as a second or later line of treatment for NSCLC patients who have progressed beyond existing checkpoint inhibitors.
