MAIA Biotechnology, Inc. 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. The trial investigates THIO-101 in combination with Regeneron's cemiplimab (Libtayo®), an immune checkpoint inhibitor, for patients with advanced non-small cell lung cancer (NSCLC) who have progressed after two or more lines of standard treatment.
THIO-101 Trial Design and Patient Population
The THIO-101 trial is a multicenter, open-label, dose-finding Phase 2 study. It aims to assess the anti-tumor activity of THIO when administered before PD-(L)1 inhibition. 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).
Preclinical Evidence
Preclinical models indicate that sequential treatment with THIO followed by PD-(L)1 inhibitors leads to significant and lasting tumor regression in advanced, in vivo cancer models. This effect is attributed to the induction of cancer type-specific immune memory.
Implications for NSCLC Treatment
THIO is being developed as a second- or later-line treatment for NSCLC patients who have not responded to standard checkpoint inhibitor regimens. The data presented at SITC 2024 will offer insights into THIO-101's efficacy and safety profile in this challenging patient population.
