MAIA Biotechnology has announced the completion of subject enrolment in its Phase II THIO-101 clinical trial of THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) plus cemiplimab (Libtayo) to treat advanced non-small cell lung cancer (NSCLC).

The open-label, multicentre, dose-finding trial is designed to evaluate the anti-tumour activity of THIO following treatment with a programmed cell death ligand 1 (PD-L1) inhibitor.

It will assess if low dosages of THIO given before cemiplimab can boost and lengthen immune response in advanced NSCLC patients who have not responded or are resistant and advanced following initial checkpoint inhibitor therapy.

Assessing the tolerability and safety of THIO as an anticancer compound and priming immune activator is one of the primary goals of the trial.

The study will also analyse THIO’s clinical efficacy as another primary objective.

Overall Response Rate (ORR) is the trial’s primary clinical endpoint.

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The trial enrolment target was met with the recruitment of 41 subjects for assessing the 180mg dose. To date, 79 patients have received doses of 60mg, 180mg, or 360mg.

In December last year, the company selected the dose in Phase II THIO-101 trial of THIO to treat advanced NSCLC patients.

The selected dose of 180mg THIO per cycle is claimed to have shown a better safety profile and efficacy in trials in NSCLC patients.

The trial initially aimed to enrol up to 182 subjects across three dosage levels, but after selecting 180mg per cycle as the optimal dose, all subsequent patients were enrolled at this dose.

MAIA chairman and CEO Vlad Vitoc said: “Enrolment in our Phase II THIO-101 trial has been strong from the start.

“With excellent results across all doses and our selection of the optimal dose in December 2023, we enrolled the necessary number of patients in the Simon 2-stage design to achieve our trial endpoints earlier than expected.

“THIO-101 preliminary data has demonstrated unprecedented rates of disease control and response to date, and we look forward to the long-term efficacy results as we continue to monitor the enrolled patients in the upcoming months.”