CHICAGO, July 8, 2026
MAIA Biotechnology announced encouraging interim efficacy results from Part C of its Phase 2 THIO-101 clinical trial, evaluating ateganosine (THIO) in combination with cemiplimab (Libtayo®) as a third-line treatment for advanced non-small cell lung cancer (NSCLC). The initial analysis demonstrated a 90.5% disease control rate (DCR), with 19 of 21 efficacy-evaluable patients achieving disease control after at least one tumor assessment. According to the company, these findings are particularly notable because participants had advanced disease and had previously failed multiple standard therapies, including checkpoint inhibitors, chemotherapy, and docetaxel. The interim results remain consistent with earlier findings from Parts A and B of the THIO-101 study, reinforcing the clinical potential of ateganosine as a first-in-class telomere-targeting immunotherapy for patients with limited treatment options.
Phase 2 Expansion Trial Demonstrates Consistent Clinical Activity in Heavily Pretreated Patients
The THIO-101 Part C expansion trial enrolled patients with advanced NSCLC who had progressed after multiple prior lines of therapy and required third-line (3L) treatment. All participants had previously demonstrated resistance to immune checkpoint inhibitors and conventional chemotherapy, making them one of the most difficult populations to treat. Despite these challenges, treatment with ateganosine followed by cemiplimab every 21 days achieved a 90.5% interim disease control rate, substantially exceeding the approximately 25% to 35% disease control rate generally reported with currently available chemotherapy options in similar treatment settings. MAIA Biotechnology Founder and Chief Executive Officer Vlad Vitoc stated that the findings closely mirror the previously reported 88% disease control rate observed in earlier THIO-101 study cohorts, while highlighting that Part C included an even more heavily pretreated patient population. The company also confirmed that international enrollment has been completed for the expansion cohort, supporting continued clinical evaluation of the investigational therapy.
Ateganosine Targets Telomeres While Enhancing Anti-Tumor Immune Response
Ateganosine (THIO) is a first-in-class investigational telomere-targeting therapy designed to selectively attack telomerase-positive cancer cells, which are commonly associated with tumor survival and resistance to treatment. The therapy works by incorporating modified nucleotides into telomeric DNA, triggering DNA damage responses that lead to selective cancer cell death. In addition to its direct anti-cancer effects, ateganosine stimulates both the innate and adaptive immune systems by activating the cGAS/STING signaling pathway and enhancing T-cell immune responses through the release of damaged telomeric DNA fragments. Preclinical studies have shown that sequential administration of ateganosine followed by PD-(L)1 inhibitors, including cemiplimab, can produce durable tumor regression and generate long-lasting immune memory against cancer cells. This dual mechanism of action, combining telomere disruption with immune activation, differentiates the therapy from conventional chemotherapy and positions it as a promising candidate for overcoming resistance to existing immunotherapies.
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THIO-101 Trial Continues to Evaluate Safety and Clinical Benefit in Advanced Lung Cancer
The THIO-101 study is an open-label, multicenter Phase 2 clinical trial designed to evaluate both the safety and clinical efficacy of ateganosine administered before cemiplimab in patients with advanced NSCLC who have progressed after prior checkpoint inhibitor therapy. The trial’s primary objectives include assessing safety and tolerability while measuring Overall Response Rate (ORR) as the principal efficacy endpoint. The ongoing expansion phase focuses specifically on patients receiving third-line therapy, where treatment options remain limited and clinical outcomes are generally poor. To date, MAIA Biotechnology reports that the ateganosine and cemiplimab combination has maintained an acceptable safety profile, even among heavily pretreated patients. The encouraging interim efficacy results strengthen the rationale for further development of the company’s telomere-targeting immuno-oncology platform, with additional clinical updates expected as patient follow-up continues and the Phase 2 study advances.
Source: MAIA Biotechnology press release
