Announcement • Jul 08
Maia Biotechnology Reports Initial Efficacy Data from Phase 2 Thio-101 Part C Expansion Trial in Third-Line Non-Small Cell Lung Cancer MAIA Biotechnology, Inc. announced positive initial efficacy data from its Phase 2 THIO-101 clinical trial expansion, Part C, evaluating its lead candidate, ateganosine, a dual mechanism of action drug incorporating telomere targeting and immunogenicity, as a third-line therapy for patients with advanced non-small cell lung cancer (NSCLC). Initial data from the THIO-101 Part C 3L studies show a disease control rate (DCR) of 90.5% (19 out of 21 patients) in the efficacy evaluable population who had at least one tumor scan after starting treatment. Patients are treated with ateganosine followed by cemiplimab (Libtayo®) in cycles of 21 days. Current chemotherapy treatments deliver an approximate 25-35% disease control rate. Initial Part C efficacy observations align with previously reported THIO-101 clinical activity despite a more heavily pre-treated patient population. Patients enrolled in Part C of the trial represent a more heavily pre-treated population, with all patients having previously received docetaxel in addition to demonstrating resistance to both immunotherapy and other chemotherapies. MAIA recently announced that it has completed international enrollment in Part C of the Phase 2 THIO-101 expansion trial. Treatment with ateganosine followed by cemiplimab has shown an acceptable safety profile to date in a heavily pre-treated population. Ateganosine (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 induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. Ateganosine-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment of ateganosine 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. Ateganosine 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. THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate ateganosine’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of ateganosine administered prior to cemiplimab (Libtayo®) 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 ateganosine administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of ateganosine using Overall Response Rate (ORR) as the primary clinical endpoint. The expansion of the study will assess overall response rates (ORR) in advanced NSCLC patients receiving third line therapy who were resistant to previous checkpoint inhibitor treatments (CPI) and chemotherapy. Treatment with ateganosine followed by cemiplimab (Libtayo®) has shown an acceptable safety profile to date in a heavily pre-treated population. Announcement • Jun 26
MAIA Biotechnology, Inc. Completes International Enrollment In Part C Of Phase 2 THIO-101 Expansion Trial In Third-Line Non-Small Cell Lung Cancer MAIA Biotechnology, Inc. has completed international enrollment in Part C of its Phase 2 THIO-101 expansion trial evaluating its lead candidate, ateganosine, in advanced non-small cell lung cancer (NSCLC) patients receiving third line (3L) therapy. Ateganosine is an investigational dual-mechanism therapy targeting telomeres and immune activation in difficult-to-treat cancers. THIO-101 Part C patients, who are resistant to prior checkpoint inhibitor (CPI) therapy and chemotherapy, are randomized between MAIA’s proposed combination regimen of ateganosine followed by cemiplimab (Libtayo®) and treatment with ateganosine alone for two cycles. International screening was conducted in Taiwan, Turkey, Poland, Hungary, Romania and Georgia, with 41 patients enrolled and receiving treatment. The Part C study is currently screening patients at multiple clinical sites in the United States. In Parts A and B of THIO-101, MAIA reported data showing median survival of 17.8 months. Overall survival (OS) beyond two years was observed for eight patients in Parts A and B of THIO-101; the patients did not receive subsequent lines of therapy. One patient in this cohort receiving 3L therapy has survived for over 33 months. Expected survival in this heavily pre-treated population is 5.8 months. The FDA has granted Fast Track designation for ateganosine in NSCLC treatment, potentially expediting the regulatory process to a potential Accelerated Approval and Priority Review. Ateganosine (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 induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. Ateganosine-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment of ateganosine 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. Ateganosine 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. THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate ateganosine’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of ateganosine administered prior to cemiplimab (Libtayo®) 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 ateganosine administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of ateganosine using Overall Response Rate (ORR) as the primary clinical endpoint. The expansion of the study will assess overall response rates (ORR) in advanced NSCLC patients receiving third line (3L) therapy who were resistant to previous checkpoint inhibitor treatments (CPI) and chemotherapy. Treatment with ateganosine followed by cemiplimab (Libtayo®) has shown an acceptable safety profile to date in a heavily pre-treated population. Announcement • Jun 19
MAIA Biotechnology, Inc. Opens Enrollment For Phase 2 Expansion Trial Of Novel Telomere-Targeting Agent At Winship Cancer Institute Of Emory University MAIA Biotechnology, Inc. announced that the third U.S. clinical site in its Phase 2 THIO-101 expansion trial, Winship Cancer Institute of Emory University, is activated and now enrolling patients. The trial studies MAIA’s lead investigational telomere-targeting agent, ateganosine, as a third-line treatment for non-small cell lung cancer (NSCLC). The principal investigator for the THIO-101 expansion trial at Winship is Ticiana Leal, M.D., a professor in the Department of Hematology and Medical Oncology at the Emory University School of Medicine. Dr. Leal’s clinical research focuses on trials involving chemotherapy and immunotherapy agents for lung cancer. THIO-101 is an ongoing Phase 2, open-label trial evaluating ateganosine followed by cemiplimab for NSCLC patients resistant to checkpoint inhibitors and chemotherapy. Parts A and B of the trial have shown strong early efficacy, with some patients showing survival exceeding two years, and now MAIA continues to expand the trial in the U.S. Ateganosine (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 induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. Ateganosine-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment of ateganosine 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. Ateganosine 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. THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate ateganosine’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of ateganosine administered prior to cemiplimab (Libtayo®) 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 ateganosine administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of ateganosine using Overall Response Rate (ORR) as the primary clinical endpoint. The expansion of the study will assess overall response rates (ORR) in advanced NSCLC patients receiving third line therapy who were resistant to previous checkpoint inhibitor treatments and chemotherapy. Treatment with ateganosine followed by cemiplimab (Libtayo®) has shown an acceptable safety profile to date in a heavily pre-treated population. 
