The phase 2 THIO-101 clinical trial evaluating THIO in combination with cemiplimab in patients with advanced non—small cell lung cancer has dosed its first patient.
The first patient has been dosed in the phase 2 THIO-101 clinical trial evaluating the administration of first-in-class small molecule telomere targeting agent, THIO (6-thio-dG), in combination with cemiplimab (Libtayo), in patients with advanced non—small cell lung cancer (NSCLC), according to MAIA Biotechnology, Inc.1
"Dosing our first patient in this phase 2 trial with THIO is an important milestone for MAIA, marking the continued development of our telomere-targeting approach," said Vlad Vitoc, MD, chairman, and chief executive officer of MAIA Biotechnology Inc, in the press release. "Despite the advancements made in the field with checkpoint inhibitors, monoclonal antibodies and newer immunotherapies, very limited treatment options exist for patients that have progressed beyond the standard-of-care regimens. We believe THIO has the potential to hold a significant place in the NSCLC treatment paradigm."
This multicenter, open-label, dosing finding, phase 2 trial is designed to evaluate the potential immune system activation effects of THIO in patients with NSCLC. Within the trial, THIO will be administered prior to cemiplimab, 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 treatment with a checkpoint inhibitor will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or who progressed after first-line treatment regimen containing a checkpoint inhibitor.
To be included in the trial, patients must be aged 18 years and older with stage 3 or 4 NSCLC that has either progressed or relapsed after an immune checkpoint inhibitor. Other eligibility requirements include having at least 1 measurable target lesion as defined by RECIST v1.1, a life expectancy of greater than 12 weeks, an ECOG performance status of 0-1, and adequate organ function.
Primary end points of the trial are to determine the incidence of dose limiting toxicities, incidence of treatment-emergent adverse events, the incidence of serious adverse events, and to assess the efficacy of THIO administered in sequence with cemiplimab in subjects with advanced NSCLC by observing the overall response rate and disease control rate. Secondary end points of the trial include duration of response, progression-free survival, and overall survival.
The study is actively recruiting in Australia and the company plans to submit another application in 2022, with the hopes of conducting the same phase 2 study in Europe.
"Lung cancer is the second most diagnosed cancer worldwide and NSCLC is the most common form of lung cancer, accounting for more than eighty percent of all lung cancer diagnoses. This represents a significant unmet medical need across the globe, and we remain enthusiastic about THIO’s observed mechanism of action," added Sergei Gryaznov, PhD, chief scientific officer of MAIA Biotechnology Inc, in the press release.