MAIA Activates U.S. Site for Phase 2 Lung Cancer Trial

CHICAGO, April 16, 2026

MAIA Biotechnology, Inc. has announced the activation of its first U.S. clinical site for the ongoing Phase 2 THIO-101 expansion trial, evaluating its novel telomere-targeting therapy ateganosine in patients with advanced non-small cell lung cancer (NSCLC). This milestone marks a significant step in expanding clinical development within the United States and advancing a first-in-class immunotherapy approach designed to address patients with limited treatment options after failure of standard therapies.

Phase 2 Expansion Strengthens Clinical Development Strategy

The activation of the U.S. site enables MAIA to significantly broaden patient enrollment in its international multi-center Phase 2 trial, which is already active across Europe and Asia with 44 clinical sites in six countries. The study focuses on third-line NSCLC patients who have previously failed chemotherapy and checkpoint inhibitors, representing a population with high unmet medical need.

The THIO-101 trial evaluates ateganosine both as a monotherapy and in combination with cemiplimab (Libtayo®), a checkpoint inhibitor, to assess its ability to enhance immune response and improve clinical outcomes. Early results from the study have demonstrated exceptional efficacy signals, including improved disease control rates, response rates, and overall survival exceeding standard-of-care benchmarks, reinforcing the therapy’s potential as a best-in-class treatment candidate.

Novel Telomere-Targeting Mechanism Drives Innovation

Ateganosine represents a first-in-class telomere-targeting agent, designed to disrupt cancer cell survival by inducing telomerase-dependent DNA damage and activating immune responses. The therapy triggers both innate (cGAS/STING pathway) and adaptive (T-cell) immune activation, enabling a dual mechanism that enhances tumor sensitivity to immunotherapy.

This innovative approach allows ateganosine to be used as a priming agent before checkpoint inhibitors, improving their effectiveness in patients who have developed resistance to prior treatments. The therapy has also received FDA Fast Track designation, highlighting its potential to address serious conditions with limited treatment options and enabling accelerated regulatory pathways and priority review opportunities.

Strong Clinical Outcomes and Regulatory Momentum

Clinical data from the THIO-101 study have shown remarkable survival outcomes, including patients achieving overall survival beyond 24 months, significantly exceeding historical benchmarks in advanced NSCLC. Some patients have demonstrated survival durations of over 30 months, indicating the therapy’s potential to deliver durable and meaningful clinical benefit in a heavily pre-treated population.

The expansion of the trial into the U.S. is further supported by a $2.3 million grant from the National Institutes of Health (NIH), underscoring the scientific and clinical significance of the program. MAIA plans to open additional U.S. sites in 2026, further accelerating enrollment and advancing the therapy toward later-stage development.

Implications for Oncology Innovation and Clinical Research

The advancement of ateganosine highlights a broader trend in oncology toward targeted immunotherapies and combination treatment strategies designed to overcome resistance to existing therapies. With approximately 50,000 advanced NSCLC cases annually in the United States, the demand for innovative treatment options remains critical.

MAIA’s development strategy emphasizes GxP-compliant clinical execution, global trial expansion, and data-driven validation, ensuring regulatory readiness and scientific rigor. By integrating novel mechanisms of action with established immunotherapy approaches, the company is contributing to the evolution of precision oncology and personalized cancer treatment.

The activation of the first U.S. site for the THIO-101 trial represents a key milestone in MAIA Biotechnology’s clinical development journey, positioning ateganosine as a promising first-in-class therapy in advanced lung cancer. With strong early efficacy data, innovative mechanism, and regulatory support, the program has the potential to transform treatment outcomes for patients with limited options, reinforcing its importance in the evolving biopharma landscape.

Source: MAIA Biotechnology press release