ateganosine (THIO) / MAIA Biotech - LARVOL DELTA

MAIA Biotechnology Announces First Patient Dosed in THIO-104 Phase 3 Pivotal Trial Evaluating Ateganosine as Third-Line Treatment for Advanced Non-Small Cell Lung Cancer (GlobeNewswire) - "The multicenter, open-label trial of patients who are resistant to CPI and chemotherapy treatments, is designed to assess overall survival for ateganosine sequenced with a CPI compared to investigator’s choice of chemotherapy in a 1:1 randomization of up to 300 patients. MAIA has received regulatory approval to screen patients in Taiwan, Turkey, select European Medicines Agency (EMA) countries, and Georgia. Screening and enrollment are now underway."

Trial status • Non Small Cell Lung Cancer

MAIA Biotechnology Highlights Ongoing Momentum of Ateganosine Clinical Program at SITC 2025 (GlobeNewswire) - "The Trials in Progress posters focus on MAIA’s ongoing Phase 2 THIO-101 expansion (Part C) and Phase 3 THIO-104 clinical trials of its first-in-class small molecule telomere targeting agent, ateganosine, as a treatment for non-small cell lung cancer (NSCLC)...As of September 17, 2025, a patient that began therapy in March 2023 in the THIO-101 Phase 2 trial has shown survival of 30 months, or 912 days."

Trial status • Non Small Cell Lung Cancer

MAIA Biotechnology CEO Presents Telomere Targeting Efficacy at Romania’s 2025 Smart Diaspora Conference on Oncology Research and Innovation (GlobeNewswire) - "Dr. Vitoc noted Romania as the most recent country to begin screening patients for the expansion phase of its THIO-101 Phase 2 clinical trial which evaluates ateganosine sequenced with an immune checkpoint inhibitor as a third-line treatment for non-small cell lung cancer (NSCLC)."

Trial status • Non Small Cell Lung Cancer

Maia Biotechnology, Inc…announced...that it presented two clinical trial posters at the Society for Immunotherapy of Cancer (SITC) 2025 conference. (Investing.com) - "The first poster, titled 'A Phase 3 Study of Ateganosine (THIO) Sequenced with Immune Checkpoint Inhibitor (ICI) versus Standard of Care Chemotherapy in ICI-Resistant Advanced NSCLC: THIO-104 Trial in Progress'...The second poster, titled 'A Phase 2 Study of Ateganosine (THIO; 6-thio-2’-deoxyguanosine) in Combination with Immune Checkpoint Inhibitor (ICI) in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) Resistant to Prior ICI and Chemotherapy: THIO-101 Trial in Progress,' will be presented at the same conference"

Trial status • Non Small Cell Lung Cancer

A Phase 2 Study of Ateganosine (THIO) in Combination with Immune Checkpoint Inhibitor (ICI) in Patients with Advanced NSCLC Resistant to Prior ICI and Chemotherapy: THIO-101 Trial in Progress. (SITC 2025) - P2 | "Once incorporated, Ateganosine compromises the telomere structure and function, leading to 'uncapping' of the chromosome ends and thus resulting in rapid tumor cell death and activation of antitumor immunogenicity.Methods The study (NCT05208944) includes adults with advanced NSCLC, who had relapsed after 2 prior treatments which had prior ICI, Chemotherapy and Docetaxel...Participants receive THIO followed by cemiplimab administered every 3 weeks...Safety data and preliminary efficacy outcomes will be reported as they become available.Conclusions THIO-101 aims to provide evidence on the potential of THIO to restore sensitivity to ICIs in patients with advanced NSCLC resistant to prior ICI therapies. This trial will asses the feasibility of this novel sequential treatment approach and explore key biomarkers for predicting response.Trial Registration 01-Mar-2022 (Australia) CT-2021-CTN-04933-1 20-Jul-2022 (Hungary) EudraCT Number 2021-005136-34 22-Nov-2022..."

Checkpoint inhibition • Clinical • Combination therapy • IO biomarker • Metastases • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Phase 3 Study of Ateganosine (THIO) Sequenced with Immune Checkpoint Inhibitor (ICI) versus Standard of Care Chemotherapy in ICI-Resistant Advanced NSCLC: THIO-104 Trial in Progress (SITC 2025) - P2 | "Participants will be randomized 1:1 to receive either THIO 180 mg per cycle (60 mg IV on Days 1-3 of a 3-week cycle) followed by cemiplimab 350 mg IV on Day 5, or single-agent chemotherapy (vinorelbine, gemcitabine, or docetaxel). Secondary endpoints include objective response rate (ORR), progression-free survival (PFS) and duration of response (DoR).Current Status: Enrollment is ongoing, preliminary safety data and efficacy outcomes will be assessed through scheduled interim analyses.Results and Conclusions THIO-104 will provide critical insights into the potential role of telomere-targeting agents in restoring tumor sensitivity to ICIs in NSCLC. The study will also explore key biomarkers to further characterize THIO's mechanism of action and it's potential to predict patient response to therapy.Trial Registration Country approvals: 01-Mar-2022 (Australia) CT-2021-CTN-04933-1 20-Jul-2022 (Hungary) EudraCT Number 2021-005136-34 22-Nov-2022 (Poland) EudraCT..."

Checkpoint inhibition • IO biomarker • Metastases • P3 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Phase 2 Study of Ateganosine (THIO) in Combination with Immune Checkpoint Inhibitor (ICI) in Patients with Advanced NSCLC Resistant to Prior ICI and Chemotherapy: THIO-101 Trial in Progress. (AACR-NCI-EORTC 2025) - P2 | " The study (NCT05208944) includes adults with advanced NSCLC, who had relapsed after 2 prior treatments which had prior ICI, Chemotherapy and Docetaxel...Participants receive THIO followed by cemiplimab administered every 3 weeks... THIO-101 aims to provide evidence on the potential of THIO to restore sensitivity to ICIs in patients with advanced NSCLC resistant to prior ICI therapies. This trial will asses the feasibility of this novel sequential treatment approach and explore key biomarkers for predicting response."

Checkpoint inhibition • Clinical • Combination therapy • IO biomarker • Metastases • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A phase II study of ateganosine (THIO; 6-thio-2'-deoxyguanosine) in combination with immune checkpoint inhibitor (ICI) in patients with advanced non-small cell lung cancer (NSCLC) resistant to prior ICI and chemotherapy: THIO-101 trial in progress (ESMO 2025) - P2 | "Trial design The study (NCT05208944) includes adults with advanced NSCLC, who had relapsed after 2 prior treatments which had prior ICI, Chemotherapy and Docetaxel...Participants receive THIO followed by cemiplimab administered every 3 weeks... THIO-101 aims to provide evidence on the potential of THIO to restore sensitivity to ICIs in patients with advanced NSCLC resistant to prior ICI therapies. This trial will asses the feasibility of this novel sequential treatment approach and explore key biomarkers for predicting response. Clinical trial identification NCT05208944."

Checkpoint inhibition • Clinical • Combination therapy • IO biomarker • Metastases • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A phase III study of ateganosine (THIO; 6-thio-2'-deoxyguanosine) sequenced with immune checkpoint inhibitor (ICI) versus standard of care chemotherapy in ICI-resistant advanced NSCLC: THIO-104 trial in progress (ESMO 2025) - "Participants will be randomized 1:1 to receive either THIO 180 mg per cycle (60 mg IV on Days 1-3 of a 3-week cycle) followed by cemiplimab 350 mg IV on Day 5, or single-agent chemotherapy (vinorelbine, gemcitabine, or docetaxel). THIO-104 will provide critical insights into the potential role of telomere-targeting agents in restoring tumor sensitivity to ICIs in NSCLC. The study will also explore key biomarkers to further characterize THIO's mechanism of action and it's potential to predict patient response to therapy. Legal entity responsible for the study MAIA Biotechnology."

Checkpoint inhibition • IO biomarker • Metastases • P3 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

MAIA Biotechnology Presents Trial in Progress Poster at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics (GlobeNewswire) - "MAIA also announced that it has enrolled five patients from Taiwan and Turkey in the expansion phase of its THIO-101 Phase 2 trial. Screening for the trial is ongoing in Europe and Asia."

Trial status • Non Small Cell Lung Cancer

MAIA Biotechnology Details 30-Month Patient Survival in Ongoing Phase 2 Clinical Trial in Non-Small Cell Lung Cancer (GlobeNewswire) - "...MAIA showcased two e-posters at ESMO detailing its ongoing Phase 2 and Phase 3 clinical trials....'The posters showcased at ESMO 2025 featured exceptional extended survival in third-line NSCLC patients. In addition, as of September 17, 2025, a patient that began therapy in March 2023 has shown survival of 30 months, or 912 days, an outstanding measure relative to many of the high-risk cancers'....The THIO-101 patient with 30-month survival received therapy every three weeks, and concluded treatment upon reaching the maximum treatment duration of 2 years based on protocol requirements."

Trial status • Non Small Cell Lung Cancer

A Phase III Study With THIO + Cemiplimab vs Chemotherapy as 3rd Line Treatment in Advanced/Metastatic NSCLC (clinicaltrials.gov) - P3 | N=300 | Not yet recruiting | Sponsor: Maia Biotechnology | Initiation date: Jul 2025 ➔ Nov 2025

IO biomarker • Trial initiation date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

MAIA Biotechnology Awarded $2.3 Million Grant by National Institutes of Health for THIO-101 Phase 2 Trial of Cancer-Fighting Agent (GlobeNewswire) - "The grant is intended to support expenses related to the enrollment of U.S. patients who are resistant to chemo and immunotherapy. The NIH grant allocations will be distributed over three years from 2025-2027."

Financing • Non Small Cell Lung Cancer

Study of THIO Sequenced With Cemiplimab in 3rd Line Immune Checkpoint Inhibitor-Resistant aNSCLC: Improvement in PFS (IASLC-WCLC 2025) - P2 | "Conclusions : THIO demonstrates clinically meaningful PFS improvement in third line patients with advanced NSCLC, independent of PD-L1 status. The improved (PFS) observed in patients treated with THIO in sequential combination with an immune checkpoint inhibitor (ICI), compared to standard chemotherapy, supports its potential to expand treatment options for ICI-resistant advanced NSCLC."

Checkpoint inhibition • IO biomarker • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

MAIA Biotechnology Highlights Positive Efficacy Data from THIO-101 Phase 2 Clinical Trial in Non-Small Cell Lung Cancer (GlobeNewswire) - "As of June 30, 2025: Estimated median progression free survival (PFS) in third-line treatment (180 mg dose) was 5.6 months. The comparable PFS threshold in standard of care treatments is 2.5 months1; Estimated median overall survival (OS) was 17.8 months, with a 95% confidence interval (CI) lower bound of 12.5 months and a 99% CI lower bound of 10.8 months, consistent with the prior data readout (May 15, 2025); Across patients of all treatment lines, 2 patients have completed 33 cycles of therapy, highlighting ateganosine’ potential for extended dosing, which usually translates into longer patient survival."

P2 data • Non Small Cell Lung Cancer

MAIA Biotechnology Abstract Selected for Poster Presentation at 2025 IASLC World Conference on Lung Cancer (GlobeNewswire)

P2 data • Non Small Cell Lung Cancer

MAIA Biotechnology Granted European Patent for Next Generation Telomere-Targeting Agents for Cancer Therapy (GlobeNewswire) - "MAIA Biotechnology...announced that the European Patent Office has decided to grant a patent broadly covering a portfolio of ateganosine-based analogues for telomere-targeting anticancer therapy and methods of using ateganosine (THIO) alone or before administration of checkpoint inhibitors (CPIs)....Cancer-fighting immunosuppressive agents shown to disrupt telomeres and suspend growth of cancer cells."

Patent • Oncology

MAIA Biotechnology, Inc…announced that a manuscript detailing developments in its Phase 2 THIO-101 clinical trial was accepted and published in the international peer-reviewed open access scientific journal, Cells, in a special issue, "Cellular Mechanisms of Anti-Cancer Therapies” (The Manila Times)

P2 data • Non Small Cell Lung Cancer

MAIA Biotechnology Receives FDA’s Fast Track Designation for Ateganosine as a Treatment for Non-Small Cell Lung Cancer (Businesswire) - "MAIA Biotechnology, Inc...announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for ateganosine (THIO, 6-thio-dG or 6-thio-2’-deoxyguanosine) for the treatment of non-small cell lung cancer (NSCLC)....'If we are successful in the Fast Track regulatory pathway, ateganosine could qualify for accelerated FDA approval and robust exclusivity in NSCLC, with a potential FDA decision as early as next year.'"

Fast track • FDA approval • Non Small Cell Lung Cancer

MAIA Biotechnology Announces First Patient Dosed in Expansion of Phase 2 Trial for Ateganosine in Advanced Non-Small Cell Lung Cancer (Businesswire) - "MAIA Biotechnology...announced dosing of the first patient in Taiwan in the expansion phase of its THIO-101 Phase 2 trial for advanced non-small cell lung cancer (NSCLC). The trial’s entry into another continent marks a key milestone for MAIA, opening a significantly larger patient pool for its evaluations of ateganosine (THIO). Screening for the trial is ongoing in Europe and Asia....The expansion study evaluates ateganosine in heavily pre-treated patients in third-line (3L) NSCLC who have previously failed treatment with checkpoint inhibitors (CPIs) and chemotherapy."

Trial status • Non Small Cell Lung Cancer

Novel telomere-targeting dual-pharmacophore dinucleotide prodrugs for anticancer therapy. (PubMed, Nucleic Acids Res) - "We designed and synthesized divalent dinucleotide prodrugs comprised of 6-thio-2'-deoxyguanosine (6-thio-dG; THIO) and 5-fluoro-2'-deoxyuridine (5-FdU) nucleosides. The sequential combination of MAIA-2022-12 or MAIA-2021-20 with the immune anti-PD-1 or anti-PD-L1 checkpoint inhibitors demonstrated superior anticancer efficacy compared with the corresponding monotherapies. We conclude that MAIA-2022-12 and MAIA-2021-20 are promising candidates for future preclinical and potential clinical studies."

IO biomarker • Journal • Oncology

MAIA Biotechnology Announces Master Clinical Supply Agreement with Roche for Hard-to-Treat Cancer Therapies (Businesswire) - "MAIA Biotechnology, Inc...announced its entry into a clinical master supply agreement with Roche for future studies investigating the combination of MAIA’s telomere-targeting agent ateganosine (THIO), sequenced with Roche’s checkpoint inhibitor (CPI), atezolizumab (Tecentriq), for the treatment of multiple hard-to-treat cancers."

Commercial • Solid Tumor

MAIA Biotechnology to Present at BIO International Convention 2025 (Yahoo Finance) - "MAIA Chairman and CEO Vlad Vitoc, MD, MBA will deliver a presentation featuring the latest findings from the Company’s THIO-101 Phase 2 clinical trial evaluating ateganosine (THIO) sequenced with the immune checkpoint inhibitor (CPI) cemiplimab (Libtayo) in advanced non-small cell lung cancer (NSCLC)."

P2 data • Non Small Cell Lung Cancer

Phase 2 study of telomere-targeting agent THIO sequenced with cemiplimab in third-line immune checkpoint inhibitor–resistant advanced NSCLC: Evaluation of overall survival (OS). (ASCO 2025) - P2 | "THIO demonstrates clinically meaningful OS improvement in third line patients with advanced NSCLC, independent of PD-L1 status. The improved OS observed in patients treated with THIO in sequential combination with an ICI, compared to standard chemotherapy, supports its potential to expand treatment options for ICI-resistant advanced NSCLC."

Checkpoint inhibition • Clinical • IO biomarker • Metastases • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

THIO Plus Cemiplimab Shows Activity and Is Safe in ICI-Resistant Advanced NSCLC (OncLive) - P2 | N=227 | NCT05208944 | Sponsor: Maia Biotechnology | "THIO (ateganosine, 6-thio-2’-deoxyguanosine, 6-thio-dG) combined with cemiplimab (Libtayo) was generally well tolerated and showed clinical activity in patients with advanced non–small cell lung cancer (NSCLC) resistant to immune checkpoint inhibitors (ICIs) in the second- and third-line settings, according to findings from the phase 2 dose-optimization THIO-101 study (NCT05208944) presented at the 2025 ASCO Annual Meeting...Results showed that, across all THIO dose levels, partial responses (PRs) occurred in 10 patients, which included 6 in the second-line setting and 4 in the third-line setting. Through a second scan via investigator assessment, there were 4 PRs in each of the 2 settings. The disease control rate (DCR) overall was 77%....The estimated median overall survival (OS) in the third-line setting (n = 22) across all dose levels was 17.8 months..."

P2 data • Non Small Cell Lung Cancer