MAIA Biotechnology, Inc. reported positive preliminary efficacy data from its ongoing Phase 2 clinical trial, THIO-101, evaluating THIO in patients with advanced Non-Small Cell Lung Cancer (NSCLC) in sequential combination with Regeneron's anti-PD-1 cemiplimab (Libtayo). Key findings: 100% Preliminary DCR observed in second-line and 88% in third-line, in highly difficult-to-treat patients who already progressed through previous lines of treatment. DCRs across all dose levels met the pre-determined statistical requirements earlier than expected to proceed to next stage of the trial.

The Company presented the data at the European Society for Medical Oncology (ESMO) Congress 2023 in Madrid, Spain, on October 23, 2023. Full preliminary data is detailed in the poster available here. THIO (6-thio-dG or 6-thio-2'-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer ("NSCLC").

The sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type-specific immune memory. THIO is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors. THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial.

It is the first trial designed to evaluate THIO's anti-tumor activity when followed by PD-(L)2 inhibition. The trial is testing the hypothesis that low doses of THIO administered prior to Regeneron's anti-PD -1 cemiplimab ("Libtayo®?") will enhance and long immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing a checkpoint inhibitor. The use of words such as " may, might, will, should, "could, "expect," "plan," "believe," "estimate," "project," "intend, future," or "continue," and other similar expressions are intended to identify forward looking statements.

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