MAIA Biotechnology, Inc. and Regeneron have expanded their clinical collaboration to further assess a novel treatment approach for advanced non-small cell lung cancer (NSCLC). The amended clinical supply agreement will support the Phase 2 THIO-101 trial, evaluating MAIA's lead asset, THIO, in sequential administration with Regeneron's cemiplimab (Libtayo®). This expansion aims to provide a new therapeutic option for NSCLC patients who have developed resistance to previous checkpoint inhibitor treatments and chemotherapy.
The THIO-101 trial is designed to evaluate the safety and efficacy of THIO, a first-in-class investigational telomere-targeting agent, when followed by PD-(L)1 inhibition with cemiplimab. The trial specifically targets advanced NSCLC patients receiving third-line therapy who have progressed after prior checkpoint inhibitor treatment. The study's primary objectives include assessing the safety and tolerability of THIO and evaluating its clinical efficacy using Overall Response Rate (ORR) as the primary clinical endpoint.
THIO: A Novel Telomere-Targeting Agent
THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is designed to induce telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. By damaging telomeric fragments, THIO activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. Preclinical studies have demonstrated that sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in significant tumor regression in advanced cancer models.
Clinical Trial Design and Objectives
The THIO-101 trial is a multicenter, open-label, dose-finding Phase 2 clinical trial. It is designed to test the hypothesis that low doses of THIO administered prior to cemiplimab will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance after first-line treatment regimen containing another checkpoint inhibitor. According to MAIA, treatment with THIO followed by cemiplimab has been generally well-tolerated to date in a heavily pre-treated population.
Potential for Accelerated Approval
MAIA Biotechnology is currently evaluating its regulatory strategy and believes that the ultimate outcome of the ongoing THIO-101 trial could provide an opportunity for accelerated approval in the United States. "In keeping with our clinical strategy for THIO, we look forward to continuing our collaboration with Regeneron to evaluate THIO’s anti-tumor activity when followed by PD-(L)1 inhibition. So far, THIO-101 has demonstrated favorable disease control, progression free survival, overall response rates, and we remain on track to achieve our overall survival goals," said MAIA Chairman and Chief Executive Officer Vlad Vitoc, M.D.
MAIA expects to start enrolling new patients in the expansion of THIO-101 in the near future. The expansion of the clinical supply agreement underscores the commitment of both MAIA Biotechnology and Regeneron to address the unmet medical needs of patients with advanced NSCLC.
