MAIA's Ateganosine Phase 3 THIO-104 Reaches 65 Randomized Patients in Third-Line NSCLC
核心洞察
MAIA Biotechnology reported that its pivotal Phase 3 THIO-104 trial of ateganosine in third-line advanced NSCLC has reached 65 randomized patients across 38 activated sites in six countries.
The company said it remains on track to exceed 100 randomized patients by year-end, with additional clinical sites expected to begin enrolling.
Ateganosine sequenced with a checkpoint inhibitor showed a 90.5% interim disease control rate in heavily pretreated third-line NSCLC in the Phase 2 THIO-101 trial, versus 25% to 35% for standard third-line chemotherapy.
MAIA Biotechnology said enrollment has reached 65 patients in its ongoing pivotal Phase 3 trial, THIO-104, which is evaluating its telomere-targeting agent ateganosine as a third-line treatment for advanced non-small cell lung cancer (搜索). The trial has 38 sites activated across six countries: Taiwan, Romania, Turkey, Georgia, Poland and Hungary.
"Reaching 65 randomized patients marks an important milestone in our Phase 3 trial. With additional clinical sites expected to begin enrolling patients, we remain on track to achieve our goal of more than 100 randomized patients by year-end," said Vlad Vitoc, M.D., founder and chief executive officer of MAIA.
Trial Design and Endpoints
THIO-104 is a multicenter, open-label, randomized Phase 3 study designed to evaluate ateganosine's telomere-targeting anti-tumor activity when followed by PD-(L)1 (搜索) inhibition in patients with advanced third-line NSCLC who previously did not respond to, or developed resistance to, regimens containing a checkpoint inhibitor and/or chemotherapy and have progressed.
The trial has two primary objectives. The first is to assess clinical efficacy of ateganosine compared with investigator's choice of chemotherapy, using median overall survival as the primary clinical endpoint. The second is to evaluate the safety and tolerability of ateganosine in sequential combination with a checkpoint inhibitor. The trial is registered on ClinicalTrials.gov under identifier NCT06908304.
Phase 2 Disease Control Signal
In its most recent assessment, ateganosine sequenced with a checkpoint inhibitor showed a 90.5% interim disease control rate in heavily pretreated third-line NSCLC in the ongoing Phase 2 THIO-101 trial. MAIA contrasted that figure with reported disease control rates of 25% to 35% for standard third-line chemotherapy regimens.
Vitoc framed third-line NSCLC as the company's chosen entry segment. "We believe third-line NSCLC is an excellent market entry segment due to the substantial unmet medical need in this large immunotherapy-resistant and chemotherapy-resistant population. No current standard of care exists in this NSCLC treatment setting and competition for clinical trial patients is limited," he said.
Mechanism and Regulatory Status
Ateganosine (THIO, 6-thio-dG or 6-thio-2'-deoxyguanosine) is a first-in-class investigational telomere-targeting agent in clinical development for NSCLC. Telomeres, together with the enzyme telomerase (搜索), play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide induces telomerase-dependent telomeric DNA modification, DNA damage responses and selective cancer cell death.
Ateganosine-damaged telomeric fragments accumulate in cytosolic micronuclei and activate both innate (cGAS/STING (搜索)) and adaptive (T-cell) immune responses. In advanced in vivo cancer models, sequential treatment with ateganosine followed by PD-(L)1 (搜索) inhibitors produced profound and persistent tumor regression through induction of cancer type-specific immune memory. The agent is being developed as a second or later line of treatment for NSCLC in patients who have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.
The FDA granted Fast Track designation for ateganosine in NSCLC in July 2025. The designation allows for more frequent FDA communication, potential rolling review, and eligibility for Accelerated Approval and Priority Review. If approved, ateganosine would hold FDA New Chemical Entity five-year marketing exclusivity, a category reserved for small molecule drugs with a novel active ingredient that has not previously been approved or marketed.
MAIA stated that statistical assessments of the Phase 3 trial point to a very high probability of technical success for regulatory approval of ateganosine, citing its latest investor presentation and 2026 shareholder letter.