On March 15, 2022 MAIA Biotechnology, Inc., a targeted therapy, immuno-oncology company focused on developing potential first-in-class oncology drugs ("MAIA"), reported that the company’s lead compound, THIO, has received approval by the Bellberry Human Research Ethics Committee (HREC) in Australia to initiate the THIO-101 Phase 2 clinical study evaluating the administration of THIO followed by cemiplimab in patients with advanced Non-Small Cell Lung Cancer (NSCLC) (Press release, MAIA Biotechnology, MAR 15, 2022, View Source [SID1234610136]). The primary objectives of the trial are to evaluate the safety of THIO administered as a direct anticancer and priming immune system agent prior to cemiplimab administration and to assess the clinical efficacy of THIO in patients.
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"We are thrilled to receive the Ethics Committee approval to proceed with our Phase 2 clinical study, THIO-101, in Australia," said Mihail Obrocea, M.D., MAIA’s Chief Medical Officer and Head of Clinical Development. "Our approach to treating NSCLC patients with THIO is unique – we look forward to exploring the utility of THIO as a lead-in agent for checkpoint inhibitors, which we believe will enhance and extend the immune system’s response, allowing for a more effective and targeted therapeutic approach. In the near term, we look forward to dosing our first patient with THIO in this Phase 2 study."
About THIO-101, a Phase 2 Clinical Trial
This trial (THIO-101) will be the first to test THIO’s potential immune system activation effects in NSCLC patients by administering THIO in advance of administration of the checkpoint inhibitor cemiplimab (co-developed by Regeneron and Sanofi), potentially allowing for immune activation and PD-1 sensitivity to take effect. The trial will test the hypothesis that low doses of THIO administered prior to checkpoint inhibitor treatment will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or progressed after first-line treatment regimen containing a checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety of THIO administered as an anticancer agent and a priming immune system agent prior to cemiplimab administration and (2) to assess the clinical efficacy of THIO followed by cemiplimab using Overall Response Rate (ORR) as the primary clinical endpoint. We expect the study to start initially in Australia and Europe followed by the United States.
About THIO
THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a telomere-targeting agent currently in clinical development to evaluate its activity in NSCLC. Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. THIO is being developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.