On July 10, 2023 MAIA Biotechnology, Inc. (NYSE American: MAIA) reported updates on preliminary survival data in the Part A safety lead-in of its ongoing THIO-101 phase 2 trial, evaluating THIO in sequential combination with cemiplimab in patients with advanced Non-Small Cell Lung Cancer (NSCLC) (Press release, MAIA Biotechnology, JUL 10, 2023, View Source [SID1234633148]).
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The first 2 patients enrolled in the study continue to be alive, approximately 12.2 and 11.5 months respectively, from treatment initiation. Both patients have advanced Stage IV metastatic disease and failed 2 prior lines of therapy, including one line with an immune checkpoint inhibitor (CPI), and platinum-based chemotherapy. Following the conclusion of study treatment, they have remained free of disease progression for 10.2 and 8.5 months, respectively, without requiring any additional therapy. No new safety analysis was conducted.
"We are excited by the observed continued progression free survival of the first 2 patients following treatment discontinuation, and these results align with our hypothesis that THIO, followed by an immune CPI, can re-sensitize tumors to the CPI and stimulate a potent and long-lasting anti-cancer immune response. This is particularly encouraging given that patients with advanced NSCLC who failed two or more therapy regimens in real-world scenarios have an expected survival of only 3 to 4 months. With therapy, third-line patients generally survive about 6 months; without therapy, survival is only weeks," said Vlad Vitoc, MAIA’s Chief Executive Officer.
About THIO
THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is an investigational 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 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.
About THIO-101, a Phase 2 Clinical Trial
THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate THIO’s potential immune system activation effects in NSCLC patients by administering THIO in sequential combination with Regeneron’s anti-PD1 therapy, Libtayo (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 a checkpoint inhibitor will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of THIO administered as an anticancer agent and a priming immune system agent (2) to assess the clinical efficacy of THIO using Overall Response Rate (ORR) as the primary clinical endpoint. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.