On December 13, 2022 MAIA Biotechnology, Inc. (NYSE American: MAIA) ("MAIA," "the Company"), reported 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) (Press release, MAIA Biotechnology, DEC 13, 2022, View Source [SID1234625166]). The first patients in THIO-101 were dosed in Australia earlier this year.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"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."
Tweet this
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 (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."
"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," said MAIA Chairman and Chief Executive Officer Vlad Vitoc, M.D. "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."