MAIA Biotechnology is set to present late-breaking data from its Phase 2 THIO-101 clinical trial at the Society for Immunotherapy of Cancer (SITC) 2024 Annual Meeting, highlighting the potential of THIO-101 in treating advanced non-small cell lung cancer (NSCLC). The trial evaluates THIO sequenced with Regeneron's cemiplimab (Libtayo®) in patients who have failed two or more standard-of-care regimens.
The updates include new efficacy and safety data, with a poster presentation focusing on the long-term therapeutic benefits of THIO sequenced with cemiplimab beyond treatment cessation. 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 Cancer Therapy
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 Implications
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). The interim median survival follow-up in 3L was 10.6 months, exceeding the current standard-of-care overall survival of 5.8 months for third-line NSCLC. 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 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 developed resistance after first-line treatment containing another checkpoint inhibitor.
The trial's primary objectives are to evaluate the safety and tolerability of THIO and to assess its clinical efficacy using Overall Response Rate (ORR) as the primary clinical endpoint. Treatment with THIO followed by cemiplimab has been generally well-tolerated in a heavily pre-treated population.
