MAIA Biotechnology unveiled significant progress for its lead oncology candidate, with Ateganosine—an innovative deoxyguanosine-based therapeutic—marking important clinical milestones heading into 2026. The clinical-stage immuno-oncology company outlined ambitious goals for its telomere-targeting agent, which is being developed to address treatment-resistant non-small cell lung cancer (NSCLC).
Ateganosine, chemically known as 6-thio-2’-deoxyguanosine, represents a novel approach to NSCLC treatment. This deoxyguanosine derivative functions as a second or later-line therapy for patients who have exhausted standard checkpoint inhibitor regimens. The drug’s unique mechanism—targeting telomeres while sequenced with checkpoint inhibitor therapy—distinguishes it from conventional immunotherapy approaches.
The Phase 2 THIO-101 trial data unveiled in May 2025 showed Ateganosine achieved a median overall survival of 17.8 months in heavily pre-treated NSCLC patients—substantially outperforming the approximately 6-month survival typically observed with chemotherapy alone. This survival advantage became the catalyst for FDA Fast Track designation in July 2025, recognizing the drug’s potential to address an unmet medical need.
The trial’s four-part design evaluated different dosing strategies, with Part A and B enrolling 79 patients across varying deoxyguanosine-based Ateganosine dose levels (60 mg, 180 mg, or 360 mg per cycle) combined with cemiplimab, a PD-1 checkpoint inhibitor. The open-label design facilitated dose optimization leading into the pivotal Phase 3 THIO-104 trial, which launched in December 2025 and is expected to confirm the Phase 2 survival findings.
Phase 3 Expansion and 2026 Development Roadmap
MAIA’s 2026 agenda centers on advancing the THIO-104 Phase 3 trial, where the company will track disease control rates, overall response rates, and progression-free survival data. These efficacy metrics will support regulatory discussions as the company pursues commercial approval for Ateganosine.
Additionally, MAIA plans to complete Part C of the Phase 2 study in 2026, refining dosing and study design protocols based on accumulated data. The company also intends to initiate Phase 1 trials for next-generation small molecules from its pipeline—candidates anticipated to demonstrate superior efficacy profiles compared to the current Ateganosine deoxyguanosine platform.
Strategic Partnerships and Financial Progress Supporting Pipeline Growth
The company strengthened its competitive position through high-profile collaborations. In June 2025, MAIA signed a master agreement with Roche to explore atezolizumab combinations across multiple cancer indications. Earlier that year, a clinical supply agreement with BeOne Medicines enabled evaluation of tislelizumab combinations in hepatocellular carcinoma, small cell lung cancer, and colorectal cancer.
Funding momentum accelerated development timelines. MAIA secured a $2.3 million NIH grant in September 2025 to expand THIO-101 trial capacity, while raising $17.6 million total capital throughout 2025. As of December 31, 2025, company directors and officers maintain over 5 million shares—approximately 13% ownership.
Market performance reflected broader biotech dynamics. MAIA shares traded between $0.87 and $2.74 during 2025, closing the year at $2.12, up 26.44% annually. However, overnight trading showed a 3.64% decline at $2.12 per share, underscoring the volatility typical of clinical-stage pharmaceutical development.
The deoxyguanosine-based Ateganosine program now enters a critical validation phase, with 2026 results expected to determine whether the telomere-targeting mechanism can sustain meaningful survival advantages in the broader NSCLC patient population.
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MAIA's Ateganosine Shows Promise: Deoxyguanosine-Based Drug Advances Through 2026 Phase 3 Expansion
MAIA Biotechnology unveiled significant progress for its lead oncology candidate, with Ateganosine—an innovative deoxyguanosine-based therapeutic—marking important clinical milestones heading into 2026. The clinical-stage immuno-oncology company outlined ambitious goals for its telomere-targeting agent, which is being developed to address treatment-resistant non-small cell lung cancer (NSCLC).
Ateganosine, chemically known as 6-thio-2’-deoxyguanosine, represents a novel approach to NSCLC treatment. This deoxyguanosine derivative functions as a second or later-line therapy for patients who have exhausted standard checkpoint inhibitor regimens. The drug’s unique mechanism—targeting telomeres while sequenced with checkpoint inhibitor therapy—distinguishes it from conventional immunotherapy approaches.
Novel Deoxyguanosine Derivative Demonstrates Compelling Clinical Results
The Phase 2 THIO-101 trial data unveiled in May 2025 showed Ateganosine achieved a median overall survival of 17.8 months in heavily pre-treated NSCLC patients—substantially outperforming the approximately 6-month survival typically observed with chemotherapy alone. This survival advantage became the catalyst for FDA Fast Track designation in July 2025, recognizing the drug’s potential to address an unmet medical need.
The trial’s four-part design evaluated different dosing strategies, with Part A and B enrolling 79 patients across varying deoxyguanosine-based Ateganosine dose levels (60 mg, 180 mg, or 360 mg per cycle) combined with cemiplimab, a PD-1 checkpoint inhibitor. The open-label design facilitated dose optimization leading into the pivotal Phase 3 THIO-104 trial, which launched in December 2025 and is expected to confirm the Phase 2 survival findings.
Phase 3 Expansion and 2026 Development Roadmap
MAIA’s 2026 agenda centers on advancing the THIO-104 Phase 3 trial, where the company will track disease control rates, overall response rates, and progression-free survival data. These efficacy metrics will support regulatory discussions as the company pursues commercial approval for Ateganosine.
Additionally, MAIA plans to complete Part C of the Phase 2 study in 2026, refining dosing and study design protocols based on accumulated data. The company also intends to initiate Phase 1 trials for next-generation small molecules from its pipeline—candidates anticipated to demonstrate superior efficacy profiles compared to the current Ateganosine deoxyguanosine platform.
Strategic Partnerships and Financial Progress Supporting Pipeline Growth
The company strengthened its competitive position through high-profile collaborations. In June 2025, MAIA signed a master agreement with Roche to explore atezolizumab combinations across multiple cancer indications. Earlier that year, a clinical supply agreement with BeOne Medicines enabled evaluation of tislelizumab combinations in hepatocellular carcinoma, small cell lung cancer, and colorectal cancer.
Funding momentum accelerated development timelines. MAIA secured a $2.3 million NIH grant in September 2025 to expand THIO-101 trial capacity, while raising $17.6 million total capital throughout 2025. As of December 31, 2025, company directors and officers maintain over 5 million shares—approximately 13% ownership.
Market performance reflected broader biotech dynamics. MAIA shares traded between $0.87 and $2.74 during 2025, closing the year at $2.12, up 26.44% annually. However, overnight trading showed a 3.64% decline at $2.12 per share, underscoring the volatility typical of clinical-stage pharmaceutical development.
The deoxyguanosine-based Ateganosine program now enters a critical validation phase, with 2026 results expected to determine whether the telomere-targeting mechanism can sustain meaningful survival advantages in the broader NSCLC patient population.