MAIA Biotechnology reported a 90.5% disease control rate (DCR) in its Phase 2 THIO-101 Part C expansion trial evaluating ateganosine as a third-line therapy for advanced non-small cell lung cancer (NSCLC). The interim data, observed in 19 out of 21 efficacy evaluable patients, compares favorably to the approximate 25-35% DCR typically delivered by current chemotherapy treatments.

The trial involves treating patients with ateganosine followed by cemiplimab in 21-day cycles. MAIA Biotechnology noted that the initial efficacy observations align with previously reported clinical activity from Parts A and B of the THIO-101 trial, which demonstrated an 88% DCR in third-line NSCLC patients. The company highlighted that patients in Part C represent a more heavily pre-treated population, having all previously received docetaxel and demonstrated resistance to both immunotherapy and other chemotherapies.

Key Trial Data

MAIA Biotechnology confirmed that international enrollment in Part C of the Phase 2 expansion trial is complete. The company stated that the combination therapy has shown an acceptable safety profile to date within the heavily pre-treated patient group.

About Ateganosine and THIO-101

Ateganosine (THIO) is a first-in-class investigational telomere-targeting agent incorporating dual mechanisms of action: telomere targeting and immunogenicity. It is designed to induce telomerase-dependent telomeric DNA modification and selective cancer cell death, subsequently activating innate and adaptive immune responses.

The THIO-101 trial is a multicenter, open-label, dose finding Phase 2 study. It is the first trial designed to evaluate ateganosine’s anti-tumor activity when followed by PD-(L)1 inhibition. The primary objectives are to evaluate safety and tolerability, and to assess clinical efficacy using Overall Response Rate (ORR) as the primary endpoint. The trial identifier is NCT05208944.

MAIA Biotechnology, Inc. (NYSE: MAIA) 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. The trial enrolled 41 patients across Taiwan, Turkey, Poland, Hungary, Romania, and Georgia.

Trial Design and Objectives

THIO-101 Part C patients, who are resistant to prior checkpoint inhibitor therapy and chemotherapy, are randomized between MAIA’s proposed combination regimen of ateganosine followed by cemiplimab and treatment with ateganosine alone for two cycles. The trial is a multicenter, open-label, dose finding Phase 2 clinical trial designed to evaluate ateganosine’s anti-tumor activity when followed by PD-(L)1 inhibition.

Key Clinical Data

In Parts A and B of THIO-101, MAIA reported data showing median survival of 17.8 months. Overall survival beyond two years was observed for eight patients in Parts A and B; these patients did not receive subsequent lines of therapy. One patient in this cohort receiving third-line therapy has survived for over 33 months. Expected survival in this heavily pre-treated population is 5.8 months.

Regulatory Status and Future Steps

The FDA has granted Fast Track designation for ateganosine in non-small cell lung cancer treatment, potentially expediting the regulatory process to a potential Accelerated Approval and Priority Review. Patient screening is ongoing at three activated clinical sites in the United States. The trial’s primary objectives are to evaluate the safety and tolerability of ateganosine and to assess clinical efficacy using Overall Response Rate as the primary endpoint.