MAIA Biotechnology expands Phase 2 THIO-101 trial to Europe


Regulatory authorities in three European countries, Hungary, Poland, and Bulgaria, have approved implementation of MAIA Biotechnology’s (NASDAQ:MAIA) THIO-101, the company’s Phase 2 clinical trial evaluating its lead therapeutic candidate, THIO, in patients with non-small cell lung cancer (NSCLC). The first patients in THIO-101 were dosed in Australia earlier this year.

THIO-101 is designed to evaluate THIO’s potential immune system activation effects in NSCLC patients by administering THIO in advance of administration of Regeneron’s anti-PD1 therapy, cemiplimab, allowing for immune system activation and sensitivity to the PD-1 inhibitor to take effect.

The primary objectives of the trial are to evaluate the safety and tolerability of THIO administered as a direct anticancer and priming immune system agent prior to cemiplimab administration, as well as to evaluate the clinical efficacy of THIO in patients with advanced NSCLC who either progressed or relapsed through treatment with an immune-check point inhibitor alone or in combination with chemotherapy.