ateganosine (THIO) / MAIA Biotech - LARVOL DELTA

MAIA Biotechnology, Inc…announced that it has received regulatory approval by the Spanish Agency for Medicines and Medical Devices (AEMPS) and Portugal’s National Authority of Medicines and Health Products (INFARMED) to begin screening patients for its ongoing pivotal Phase 3 THIO-104 clinical trial in non-small cell lung cancer (NSCLC). (GlobeNewswire) - "MAIA targets 100 patients dosed in THIO-104 by year-end 2026 and expects to have sufficient survival data to conduct an interim data analysis in 2027."

P3 data • Trial status • Non Small Cell Lung Cancer

THIO and Cadonilimab in Resectable Hepatocellular Carcinoma (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: University of Texas Southwestern Medical Center | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatocellular Cancer • Oncology • Solid Tumor

MAIA Biotechnology…announced that enrollment has reached 65 patients in its ongoing pivotal Phase 3 trial, THIO-104, evaluating its novel telomere-targeting therapy as a third-line (3L) treatment for advanced non-small cell lung cancer (NSCLC) (GlobeNewswire) - "The THIO-104 trial currently has 38 trial sites activated in 6 foreign countries (Taiwan, Romania, Turkey, Georgia, Poland and Hungary)."

Trial status • Non Small Cell Lung Cancer

MAIA Biotechnology…announced that the first U.S. patient has been dosed in its Phase 2 THIO-101 trial expansion evaluating its telomere-targeting lead candidate, ateganosine, in third-line non-small cell lung cancer (NSCLC) (GlobeNewswire) - "The U.S. Phase 2 expansion is funded by a $2.3 million grant from the National Institutes of Health (NIH) to support third-line treatment evaluation and MAIA has activated 3 sites in the U.S."

Financing • Trial status • Non Small Cell Lung Cancer

Quantitative Vascular Tortuosity (QVT) Radiomics Identifies Therapeutic Response Beyond RECIST 1.1 in Heavily Pretreated NSCLC Patients Receiving Ateganosine/THIO-Based Immunotherapy (EORTC-NCI-AACR 2026) - "Abstract will be available as of 4 November (with consent of the author)"

Clinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

MAIA Biotechnology Reports Strong Initial Efficacy Data in Third-Line Non-Small Cell Lung Cancer from Phase 2 THIO-101 Part C Expansion Trial (The Manila Times) - "Initial data from the THIO-101 Part C 3L studies1 show a disease control rate (DCR) of 90.5% (19 out of 21 patients) in the efficacy evaluable population who had at least one tumor scan after starting treatment. Patients are treated with ateganosine followed by cemiplimab (Libtayo) in cycles of 21 days. Current chemotherapy treatments deliver an approximate 25-35% disease control rate."

P2 data • Non Small Cell Lung Cancer

THIO and Cadonilimab in Resectable Hepatocellular Carcinoma (clinicaltrials.gov) - P1 | N=60 | Not yet recruiting | Sponsor: University of Texas Southwestern Medical Center | Trial completion date: Aug 2031 ➔ Sep 2030 | Trial primary completion date: Sep 2030 ➔ Sep 2029

Trial completion date • Trial primary completion date • Hepatocellular Cancer • Oncology • Solid Tumor

THIO and Cadonilimab in Resectable Hepatocellular Carcinoma (clinicaltrials.gov) - P1 | N=60 | Not yet recruiting | Sponsor: University of Texas Southwestern Medical Center | Trial completion date: May 2031 ➔ Aug 2031 | Initiation date: May 2026 ➔ Sep 2026 | Trial primary completion date: May 2030 ➔ Sep 2030

Trial completion date • Trial initiation date • Trial primary completion date • Hepatocellular Cancer • Oncology • Solid Tumor

MAIA Biotechnology, Inc…announced that it 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. (GlobeNewswire) - "THIO-101 Part C patients, who are resistant to prior checkpoint inhibitor (CPI) therapy and chemotherapy, are randomized between MAIA’s proposed combination regimen of ateganosine followed by cemiplimab (Libtayo) and treatment with ateganosine alone for two cycles. International screening was conducted in Taiwan, Turkey, Poland, Hungary, Romania and Georgia, with 41 patients enrolled and receiving treatment. The Part C study is currently screening patients at multiple clinical sites in the United States."

Enrollment status • Non Small Cell Lung Cancer

MAIA Biotechnology…announced that the third U.S. clinical site in its Phase 2 THIO-101 expansion trial, Winship Cancer Institute of Emory University ('Winship'), is activated and now enrolling patients (GlobeNewswire) - "THIO-101 is an ongoing Phase 2, open-label trial evaluating ateganosine followed by cemiplimab for NSCLC patients resistant to checkpoint inhibitors and chemotherapy. Parts A and B of the trial have shown strong early efficacy, with some patients showing survival exceeding two years, and now MAIA continues to expand the trial in the U.S."

Trial status • Non Small Cell Lung Cancer

Phase 2 study of PFS in third-line immune checkpoint inhibitor–resistant advanced NSCLC treated with the telomere-targeting agent ateganosine (THIO; 6-thio-2'-deoxyguanosine) sequenced with ICI. (ASCO 2026) - P2 | "THIO followed by cemiplimab was generally well tolerated in this difficult-to-treat population. Ateganosine 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. Baseline LDH levels provide prognostic information across populations and may help identify patients most likely to benefit from therapy."

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

A phase 3 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. (ASCO 2026) - "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 Ateganosine's mechanism of action and its potential to predict patient response to therapy."

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

MAIA Biotechnology Activates and Opens Enrollment at Second U.S. Clinical Site for International Phase 2 THIO-101 Expansion Trial (The Manila Times) - "The THIO-101 expansion trial is ongoing in Europe and Asia with 44 active sites in 6 countries along with 2 in the U.S. The additional data from the trial’s expansion may further support an accelerated approval filing with the FDA...In parallel with the Phase 2 clinical trial, MAIA is actively screening and enrolling patients in a pivotal Phase 3 clinical trial 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."

Trial status • Non Small Cell Lung Cancer

MAIA Biotechnology…provided a patient enrollment update for its ongoing pivotal Phase 3 trial, THIO-104, evaluating its novel telomere-targeting therapy as a third-line (3L) treatment for advanced non-small cell lung cancer (NSCLC) (GlobeNewswire) - "To date, 29 patients have been dosed among 34 activated trial sites in 6 foreign countries....'Based on this early momentum, we are targeting up to 100 patients by year-end and expect to have sufficient survival data to conduct an interim analysis in 2027'."

Enrollment status • P3 data • Non Small Cell Lung Cancer

MAIA Biotechnology…announced that the…FDA has cleared an amendment to update its investigational new drug (IND) application which enables MAIA to open U.S. enrollment for the expansion of the Phase 2 THIO-101 trial of its lead candidate, ateganosine, as a treatment for advanced non-small cell lung cancer (NSCLC) (GlobeNewswire) - "MAIA obtained FDA clearance of its updated IND highlighting MAIA’s improved efficiencies to its manufacturing capabilities, including new manufacturers, formulation and storage conditions for ateganosine, and MAIA is now cleared to enroll patients in the U.S. for the expansion of the Phase 2 THIO-101 study of patients receiving advanced third-line (3L) NSCLC treatment. In addition to the U.S., the THIO-101 study is ongoing at 44 clinical sites in six countries....Additional data from THIO-101 trial expansion studies may further support a potential Accelerated Approval filing with FDA."

IND • Trial status • Non Small Cell Lung Cancer

THIO-101: THIO Sequenced With Cemiplimab in Advanced NSCLC (clinicaltrials.gov) - P2 | N=227 | Active, not recruiting | Sponsor: Maia Biotechnology | Recruiting ➔ Active, not recruiting

Enrollment closed • IO biomarker • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • TIGIT

MAIA Biotechnology…announced that it has activated the first U.S. clinical site in its Phase 2 THIO-101 expansion trial of its lead investigational therapy as a third-line (3L) treatment for non-small cell lung cancer (NSCLC) (GlobeNewswire) - "The trial’s expansion into the U.S. marks a key milestone for MAIA, which is expected to open a significantly larger patient pool for evaluation of ateganosine, a novel dual mechanism of action drug candidate incorporating telomere targeting and immunogenicity. In addition to the first location, Summit Medical Group in New Jersey, MAIA intends to open four additional sites in U.S. in 2026. The trial is ongoing in Europe and Asia with 44 active sites in 6 countries."

Trial status • Non Small Cell Lung Cancer

Immunomodulatory and anti-tumor effect of radiation and induced telomere damage to treat pediatric high-grade gliomas (AACR 2024) - "We will present results on the potential of THIO and IR treatments to stimulate anti-tumor immunity through the activation of STING pathway in a syngeneic mouse model of DIPG. These preclinical studies will support the potential use of THIO and IR to treat children with high-risk pediatric brain tumors."

Clinical • Immunomodulating • IO biomarker • Tumor mutational burden • Brain Cancer • CNS Tumor • Diffuse Intrinsic Pontine Glioma • Gastrointestinal Cancer • Glioma • Hepatocellular Cancer • High Grade Glioma • Medulloblastoma • Oncology • Solid Tumor • STAT1 • TMB

Sustained response and long-term therapeutic benefits beyond treatment cessation in NSCLC relapsed-patients treated with ateganosine and ICI in the THIO-101 trial (ELCC 2026) - P2 | "The regimen demonstrates sustained duration of response and long-term benefits beyond treatment cessation, including extended survival post treatment cessation. These findings support Ateganosine sequenced by ICI as a potential strategy to expand treatment options and improve outcomes for ICI-resistant NSCLC."

Clinical • IO biomarker • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • CTCs • PD-L1

MAIA Biotechnology Reports Overall Survival Exceeding Two Years for Eight Patients in Ongoing Phase 2 Clinical Trial in Non-Small Cell Lung Cancer (The Manila Times) - "1 patient in third-line (3L) therapy with survival of 33 months. Expected survival in this heavily pre-treated population is 5.8 months; 4 patients in 2L therapy with survival over 30 months. Documented OS for standard of care treatment (chemotherapy or checkpoint inhibitors alone) in second-line (2L) therapy is 10.5 months.; All patients have failed previous treatment (prior to THIO-101) with a checkpoint inhibitor (CPI) alone; All patients completed 29-34 cycles of therapy, except for 1 patient who completed 2 cycles of therapy with survival follow-up of 725 off therapy; 5 of the 8 patients have survival follow-up ongoing...THIO-101 treated 79 patients in Parts A and B of the trial. The Part C expansion is currently enrolling up to 48 participants in Asia and Europe."

Enrollment status • P2 data • Non Small Cell Lung Cancer

THIO and Cadonilimab in Resectable Hepatocellular Carcinoma (clinicaltrials.gov) - P1 | N=60 | Not yet recruiting | Sponsor: University of Texas Southwestern Medical Center

New P1 trial • Hepatocellular Cancer • Oncology • Solid Tumor

MAIA Biotechnology Advances Ateganosine Cancer Treatment Program, Outlines Targeted 2026 Clinical Milestones and Growth Momentum (GlobeNewswire) - "Targeted 2026 Milestones: Initial measures of efficacy from Phase 3 study. Interim disease control rates (DCR), overall response rates (ORR) and progression free survival (PFS) analysis of ateganosine compared to the control arm will support regulatory discussions. Strong interim data could lead to early full commercial approval."

Approval • P3 data • Non Small Cell Lung Cancer

Advanced the THIO-101 Phase 2 clinical trial to the Part C expansion phase, substantially increasing the patient pool to include countries in Asia and Europe. (GlobeNewswire) - "Targeted 2026 Milestones: Conclusion of Part C of Phase 2 study. Expansion of the trial provides additional clinical efficacy data to support regulatory review for commercial approval."

P2 data • Trial status • Non Small Cell Lung Cancer

THIO-101: THIO Sequenced With Cemiplimab in Advanced NSCLC (clinicaltrials.gov) - P2 | N=227 | Recruiting | Sponsor: Maia Biotechnology | Trial completion date: Dec 2026 ➔ Dec 2027 | Trial primary completion date: Jun 2026 ➔ Sep 2027

IO biomarker • Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • TIGIT

Targeted 2026 Milestones (GlobeNewswire) - "Engage in regulatory interactions with the FDA. Expand ongoing FDA dialogue under the Fast Track designation, including discussions around trial enhancements and prospects for Accelerated Approval and Priority Review. Clinical development of second-generation molecules to start in Phase 1 trials. Additional small molecules fully developed in-house with better expected efficacy compared to ateganosine."

FDA event • New P1 trial • Non Small Cell Lung Cancer