MAIA Biotechnology has received approval from regulatory authorities in three European countries for its Phase II THIO-101 clinical trial of THIO to treat non-small cell lung cancer (NSCLC) patients.

The company received approval from regulatory authorities from Hungary, Poland, and Bulgaria for implementing the trial.

The open-label, dose finding, multicentre Phase II clinical trial has been designed to assess the potential immune system activation effects of the company’s lead therapeutic candidate THIO in NSCLC patients.

In the trial, THIO will be given before administering Regeneron’s Libtayo (cemiplimab) to enable immune system activation and PD-1 sensitivity to take effect.

It will assess the hypothesis that low THIO doses given before treatment with the checkpoint inhibitor will improve and prolong immune responses in advanced NSCLC patients who did not respond, or progressed, after the first-line treatment regimen.

The safety and tolerability of THIO given as a direct anticancer and priming immune system agent before cemiplimab will be one of the trial’s primary objectives.

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The trial will also assess THIO’s clinical efficacy in advanced NSCLC patients who either progressed or relapsed through treatment with an immune-check point inhibitor, alone or along with chemotherapy.

MAIA chairman and CEO Vlad Vitoc said: “THIO-101 is a critical component of THIO’s clinical development process and it is of the utmost importance that we collaborate with leading cancer institutes in Australia, and now in Europe, for a target total of 30 clinical trial sites in six countries.

“European sites will be excellent additions to this clinical trial. We look forward to the role they will play in the evolution and expansion of this trial, which will continue validating our telomere-targeting approach.”

A telomere-targeting agent, THIO is currently being developed as a second or higher line of treatment for NSCLC patients whose disease progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.