On October 10, 2023 MAIA Biotechnology, Inc. (NYSE American: MAIA), a clinical stage company developing telomere-targeting immunotherapies for cancer, reported that 49 patients have been dosed in MAIA’s Phase 2 clinical trial, THIO-101, evaluating THIO in sequential combination with an immune checkpoint inhibitor (CPI) in patients with advanced Non-Small Cell Lung Cancer (NSCLC) (Press release, MAIA Biotechnology, OCT 10, 2023, View Source [SID1234635834]).
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"In feedback received from the clinical trial investigators, the encouraging efficacy observed in dosed patients is prompting physicians to speed up trial enrollment even further. Following U.S. Food and Drug Administration (FDA) clearance of the Investigational New Drug (IND) application, we expect to more than double the number of sites in the near future," said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer. "We are pleased with the pace of enrollment for THIO-101, our go-to-market trial, which is currently exceeding the average enrollment pace in similar NSCLC trials. We look forward to sharing preliminary safety and efficacy data in the coming weeks."
"Out of the 49 patients dosed, 37 already completed at least 1 post baseline assessment, providing key data for our preliminary readings on the safety and efficacy of the treatment with THIO in NSCLC," said Mihail Obrocea, MD, MAIA’s Chief Medical Officer.
THIO is a first-in-class cancer telomere targeting agent administered in sequence with a CPI. The main objectives of the THIO-101 trial are to evaluate the safety, tolerability, and preliminary clinical efficacy of THIO in patients with advanced NSCLC who have experienced disease progression or relapse after initial treatments with an immune CPI alone or in combination with chemotherapy. The trial dosed its first patient in Australia in July 2022 and expanded to include European patients in March 2023.
About THIO
THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class 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. The modified nucleotide 6-thio-2’-deoxyguanosine (THIO) induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. THIO is presently 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, 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 anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of THIO administered prior to an anti-PD-1 agent 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 compound and a priming immune activator (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.