MAIA Biotechnology announced that regulatory authorities in three European countries, Hungary, Poland, and Bulgaria, have approved the implementation of THIO-101, MAIA‘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, Libtayo or 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. "Adding EU sites to the THIO-101 study increases patient access to THIO on a global scale. Lung cancer is the second most common cancer indication, so addressing it requires worldwide research efforts," said MAIA Chief Medical Officer Mihail Obrocea, M.D. "Adding EU sites to THIO-101 officially makes it a global trial. We believe the data that THIO-101 generates will further validate THIO and be a major step towards bringing effective therapies to lung cancer patients."
Published first on TheFly
