MAIA Biotechnology, Inc. announced dose selection for THIO-101, a Phase 2 clinical trial evaluating its lead asset, THIO, in sequential combination with Regeneron's anti-PD-1 cemiplimab (Libtayo®?) in patients with advanced non-small cell lung cancer (NSCLC). During the dose-finding stage of THIO-101, patients were administered either 60mg, 180mg, or 360mg of THIO per cycle, followed by 350mg of cemiplimab (Libtayo®?). The selected dose, 180mg/cycle, presented better safety profile and outperformed the other doses in the key measures of efficacy for NSCLC trials.

Subsequently, all future trial participants will be treated with THIO 180mg/cycle. The company observed disease control in the first 8 to 9 patients with a post baseline scan in each arm, accelerating goal of disease control in 8 out of 19 patients per arm. Among the three studied doses, the 180mg dose showed stronger DCR and preliminary response rates compared to other doses.

These results are particularly impressive in this pool of patients who were heavily pre-treated and resistant to prior treatments with immune checkpoint inhibitors, a group that does not yet have standard of care treatment. THIO is the only direct telomere targeting agent currently undergoing clinical development in the field of cancer drug discovery and treatment. 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 cemiplimab (LIBtayo®?) will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The use of words such as " may, " might," "will," "should," "will," "could," "plan," "anticipate," "believe," "estimate," "project," "project," "intend," " future," "pot potential," or "continue," and other similar expressions are intended to identify forward looking statements.

However, the absence of these words does not mean that statements are not forward-looking. For example, all statements make regarding (i) the initiation, timing, cost, progress and results of preclinical and clinical studies and research and development programs, (ii) ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) ability to develop, manufacture and commercialize product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of product candidates, (vi) the rate and degree ofmarket acceptance of product candidates, (v) the goal of disease control in8 out of 19 patients per arm, achieving the goal of disease control in 8 up of 19 patients per arm.