On May 19, 2022 MAIA Biotechnology, Inc., a targeted therapy, immuno-oncology company focused on developing potential first-in-class oncology drugs ("MAIA"), reported that the company has established two wholly-owned subsidiaries in Romania and Australia to broaden and accelerate its global development plan for THIO, a telomere-targeting agent currently in development to evaluate its activity in multiple cancer indications (Press release, MAIA Biotechnology, MAY 19, 2022, View Source [SID1234614884]).
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"We are pleased to expand our clinical development operations across three continents, which reinforces MAIA’s commitment to delivering our novel therapeutic THIO to cancer patients across the globe," said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer. "Currently, our efforts are focused on site initiation and patient enrollment across Eastern Europe and Australia."
The Romanian subsidiary, MAIA Biotechnology Romania S.R.L., and the Australian subsidiary, MAIA Biotechnology Australia, will be used to conduct various activities including site initiation and patient enrollment, related to THIO-101, a Phase 2 clinical study evaluating the administration of THIO followed by cemiplimab in patients with advanced Non-Small Cell Lung Cancer (NSCLC). 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.
"In Europe, we have identified 22 clinical trial sites across 5 countries. In Australia, we have 3 clinical trial sites, with more coming online soon. We are very pleased with this progress," said Mihail Obrocea, MD, Chief Medical Officer of MAIA.
Joseph F. McGuire, MAIA’s Chief Financial Officer, added, "The establishment of our subsidiaries in Europe and Australia is a critical step in the global expansion of our business."
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 reverse resistance 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. The company has received Ethics Committee approval to proceed with the THIO-101 trial in Australia.
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 non-small cell lung cancer (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 for patients with NSCLC that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.