ateganosine (THIO) / MAIA Biotech - LARVOL DELTA

MAIA Biotechnology Announces $1.08 Million Private Placement (Businesswire) - "MAIA Biotechnology...announced that it has entered into definitive agreements for the purchase and sale of an aggregate of 719,999 shares of common stock at a purchase price of $1.50 per share, in a private placement to accredited investors and certain Company directors. Each share of common stock is being offered together with a warrant to purchase one share of common stock at an exercise price of $2.05 per share....The gross proceeds from the offering are expected to be approximately $1.08 million, prior to offering expenses payable by the Company. The Company intends to use the net proceeds from the offering for to fund the starting cost for Part C of the Phase II trial THIO -101 and for working capital."

Financing • 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 | "Clinical Trial Registration Number: NCT05208944 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Checkpoint inhibition • Clinical • Metastases • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

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

IO biomarker • New P3 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

THIO-101: THIO Sequenced with Cemiplimab in Advanced NSCLC (clinicaltrials.gov) - P2 | N=227 | Active, not recruiting | Sponsor: Maia Biotechnology | Trial primary completion date: Aug 2025 ➔ Dec 2025

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

MAIA Biotechnology CEO Details Anticipated Clinical Milestones for Novel Cancer Immunotherapy in 2025 Letter to Shareholders (Businesswire) - "Phase 2 trial THIO-101 expansion underway; potential filing in 2026 for accelerated approval; Phase 3 THIO-104 set to begin in mid-2025; potential filing in 2026 for early full approval; Multiple THIO trials planned in additional cancer indications."

FDA filing • New trial • Trial status • Non Small Cell Lung Cancer

MAIA Biotechnology Announces Poster Presentation at ESMO's European Lung Cancer Congress 2025 (Businesswire) - "MAIA Biotechnology...announced that an abstract detailing a potential predictive biomarker for THIO treatment was selected for poster presentation at the European Lung Cancer Congress 2025 (ELCC 2025)....'Our poster features our latest findings on cytokine Interleukin-6 (IL-6) as a potential predictive immune response biomarker for THIO sequenced with a checkpoint inhibitor. Predictive biomarkers can further illuminate THIO’s unique mechanisms of action which have shown exceptional efficacy in our Phase 2 clinical trial'."

Biomarker • P2 data • Non Small Cell Lung Cancer

MAIA Biotechnology Announces Publication of Peer-Reviewed Study Featuring Potency and Potential of Novel THIO Prodrug (Businesswire) - "MAIA Biotechnology, Inc...announces the publication of preclinical data for its lead proprietary telomere-targeting THIO dimer in the peer-reviewed scientific journal Naunyn-Schmiedeberg's Archives of Pharmacology....In a preclinical study, THIO and its new described dimer form were found to be potent inhibitors of Glutathione S-transferase Pi (GSTP1), a key enzyme implicated in cancer progression and chemoresistance and a highly important factor for the detoxification of cancer cells. The findings suggest that the dimerized form of THIO could enhance chemotherapeutic efficacy by effectively targeting GSTP1 and reducing drug resistance."

Preclinical • Oncology

MAIA Biotechnology Receives USAN Council Approval for 'Ateganosine' as Nonproprietary Name for Anticancer Agent THIO (Businesswire) - "MAIA Biotechnology, Inc...today announced that the United States Adopted Names (USAN) Council has approved 'ateganosine' as the nonproprietary (generic) name for its lead molecule THIO, a telomere-targeting anticancer agent in clinical development as a first-in-class treatment for advanced non-small cell lung cancer (NSCLC)....MAIA will retain the name THIO in its clinical trial designations (THIO-101, THIO-102, THIO-103, THIO-104)."

Commercial • Non Small Cell Lung Cancer

MAIA Biotechnology to Initiate Phase 3 Pivotal Trial of THIO Sequenced with Checkpoint Inhibitor Compared with Chemotherapy Treatment in Advanced Non-Small Cell Lung Cancer Patients (Businesswire) - "MAIA Biotechnology...announced plans to initiate a Phase 3 pivotal trial in 2025, named THIO-104, to evaluate the efficacy of THIO administered in sequence with a checkpoint inhibitor (CPI) in third-line non-small cell lung cancer (NSCLC) patients who are resistant to checkpoint inhibitors and chemotherapy. The multicenter, open-label, pivotal Phase 3 trial is designed to provide a direct comparison to chemotherapy in a 1:1 randomization of up to 300 patients...MAIA expects to begin enrolling patients in THIO-104 in the second half of 2025 in select countries in Asia, Europe and in the U.S....The primary endpoint of the clinical trial is overall survival for THIO sequenced with a CPI compared to investigator’s choice of chemotherapy in a third line setting. The secondary endpoints include disease control rate, overall response rate, duration of response, progression-free survival and safety."

New P3 trial • Non Small Cell Lung Cancer

MAIA Biotechnology Announces Design for Expansion of THIO-101 Phase 2 Trial in Advanced Non-Small Cell Lung Cancer (Businesswire) - "MAIA Biotechnology...today announced the trial design for the expansion of its THIO-101 pivotal Phase 2 trial in non-small cell lung cancer (NSCLC). Following successful outcomes to date in THIO-101, the expansion of the study will assess overall response rates (ORR) in advanced NSCLC patients receiving third line (3L) therapy who were resistant to previous checkpoint inhibitor treatments (CPI) and chemotherapy....The Company plans to enroll an additional 100 patients for the registration phase of the trial. MAIA expects to conduct the trials in the U.S. and select countries in Europe and Asia....'We have multiple milestones that we believe are attainable for 2025 and we look forward to keeping our shareholders and investors well informed of our progress on value creation'..."

Clinical protocol • Commercial • Non Small Cell Lung Cancer

MAIA Biotechnology Announces Non-Brokered Private Placement of Approximately $1.43 Million (Businesswire) - "MAIA Biotechnology...announced that it has entered into definitive agreements for the purchase and sale of an aggregate of 952,300 shares of common stock at a purchase price of $1.50 per share, in a non-brokered private placement to accredited investors and certain Company directors....The gross proceeds from the offering are expected to be approximately $1.43 million, prior to offering expenses payable by the Company....The Company intends to use the combined net proceeds received from the two private placements to fund the starting cost for Part C of the Phase 2 THIO -101 clinical trial and for working capital."

Commercial • Non Small Cell Lung Cancer

MAIA Biotechnology Announces Private Placement of $2,715,000 (Businesswire) - "MAIA Biotechnology...announced that it has entered into definitive agreements for the purchase and sale of an aggregate of 1,810,000 shares of common stock at a purchase price of $1.50 per share, in a private placement to accredited investors and certain Company directors....The gross proceeds from the offering are expected to be $2,715,000, prior to offering expenses payable by the Company. The Company intends to use the net proceeds received from the private placement to fund the starting cost for Part C of the Phase II trial THIO -101 and for working capital."

Commercial • Non Small Cell Lung Cancer

Investigation of the inhibitory effects of the telomere-targeted compounds on glutathione S-transferase P1. (PubMed, Naunyn Schmiedebergs Arch Pharmacol) - "The dimer form of 6-thio-dG shows strong potential to enhance chemotherapeutic efficacy by effectively inhibiting GSTP1 and overcoming drug resistance. Its superior inhibitory properties make it a valuable candidate for targeted cancer therapies."

Journal • Oncology • GSTP1

MAIA Biotechnology Announces Positive Efficacy Updates for Phase 2 THIO-101 Trial in Advanced Non-Small Cell Lung Cancer (Businesswire) - P2 | N=182 | NCT05208944 | Sponsor: Maia Biotechnology | "As of January 15, 2025, third line (3L) data showed median overall survival (OS) of 16.9 months for the 22 NSCLC patients who received at least one dose of THIO (the intent-to-treat population) in parts A and B of the trial. The analysis demonstrated a 95% confidence interval (CI) lower bound of 12.5 months and a 99% CI lower bound of 10.8 months. The treatment has been generally well-tolerated to date in this heavily pre-treated population. Studies of standard-of-care (SOC) chemotherapy treatments for NSCLC in a similar setting have shown OS of 5 to 6 months....MAIA believes there could be an opportunity for accelerated FDA approval of THIO depending on final results from the ongoing expansion of the THIO-101 trial."

P2 data • Non Small Cell Lung Cancer

MAIA Biotechnology to Present at Biotech Showcase 2025 (Businesswire) - "At the conference, Dr. Vitoc will discuss MAIA’s recent clinical developments and targeted value-driving milestones for 2025 and beyond, including: Expansion of MAIA’s THIO-101 pivotal Phase 2 clinical trial to further assess the efficacy of telomere-targeting agent THIO in advanced non-small cell lung cancer (NSCLC) patients receiving third line (3L) therapy. Multiple THIO trials planned for additional cancer indications. Significant market opportunity for THIO in the top tumor types globally."

New trial • Trial status • Non Small Cell Lung Cancer

MAIA Biotechnology Announces Clinical Supply Agreement with BeiGene for Upcoming Phase 2 Trials in Three Cancer Indications (Businesswire) - "MAIA Biotechnology, Inc...today announced that it has entered into a clinical supply agreement with global oncology company BeiGene to assess the efficacy of THIO, its small molecule telomere-targeting anticancer agent, in combination with BeiGene’s immune checkpoint inhibitor (CPI) tislelizumab in three cancer indications. The single arm pivotal Phase 2 trials will study the drug combination in hepatocellular carcinoma (HCC), small cell lung cancer (SCLC) and colorectal cancer (CRC)....Under the terms of the collaboration, MAIA will sponsor and fund the planned clinical trials and BeiGene will provide tislelizumab. MAIA maintains global development and commercial rights to THIO and is free to develop the programs in combination with other agents and in other indications."

Commercial • New P2 trial • Colorectal Cancer • Hepatocellular Cancer • Lung Cancer • Small Cell Lung Cancer

MAIA Biotechnology Granted FDA Rare Pediatric Disease Designation for THIO as a Treatment for Pediatric High-Grade Gliomas (Businesswire) - "MAIA Biotechnology, Inc...today announced that the FDA has designated THIO for the treatment of pediatric-type diffuse high-grade gliomas (PDHGG) as a drug for a 'rare pediatric disease.'"

FDA event • Glioma

MAIA Biotechnology Announces Expansion of Clinical Supply Agreement with Regeneron for Phase 2 Trial in Non-Small Cell Lung Cancer (Businesswire) - "MAIA Biotechnology, Inc...announced that it has amended the 2021 clinical supply agreement with Regeneron for the expansion portion of THIO-101, its Phase 2 clinical trial evaluating THIO in sequential administration with cemiplimab (Libtayo). The new expansion will further assess the efficacy of MAIA’s lead asset, THIO, sequenced with immune checkpoint inhibitor (CPI) Libtayo (cemiplimab) for advanced non-small cell lung cancer (NSCLC) patients receiving third-line therapy who were resistant to previous checkpoint inhibitor treatments and chemotherapy...Under terms of the amended clinical supply agreement, MAIA continues to sponsor THIO-101 and Regeneron will provide Libtayo for the treatment of all patients in the trial including the additional patients in the THIO 101 expansion. MAIA holds an exclusive worldwide patent license to develop and commercialize THIO....MAIA expects to start enrolling new patients in the expansion of THIO-101 in the near future."

Commercial • Enrollment status • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

THIO-101: THIO Sequenced with Cemiplimab in Advanced NSCLC (clinicaltrials.gov) - P2 | N=182 | Active, not recruiting | Sponsor: Maia Biotechnology | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2024 ➔ Oct 2026 | Trial primary completion date: Jun 2024 ➔ Aug 2025

Enrollment closed • IO biomarker • Metastases • Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CRP • IL6

Telomere-targeting agent THIO in sequence with cemiplimab demonstrates long-term therapeutic benefits beyond treatment cessation – A phase 2 THIO-101 trial in advanced ICI resistant NSCLC patients (SITC 2024) - P2 | "All participants provided informed consent prior to their inclusion in the study. The trial adhered to the Declaration of Helsinki and local regulations for ethical research involving human subjects."

Clinical • IO biomarker • Late-breaking abstract • Metastases • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • TERF1

MAIA Biotechnology Announces Late-Breaking Abstract of THIO-101 Updates Selected for Oral and Poster Presentation at the Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting (Businesswire) - "MAIA Biotechnology, Inc...today announced that a late-breaking abstract (LBA) detailing new updates from its Phase 2 THIO-101 clinical trial was selected for oral and poster presentation at the 2024 Annual Meeting of the Society for Immunotherapy of Cancer (SITC), being held November 6-10, 2024, in Houston, Texas. The updates will include new data on efficacy and safety from its clinical trial evaluating THIO sequenced with Regeneron’s immune checkpoint inhibitor (CPI) cemiplimab (Libtayo) in patients with advanced non-small cell lung cancer (NSCLC) who have failed two or more standard-of-care therapy regimens."

Late-breaking abstract • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

New dual-pharmacophore dinucleotide prodrugs as potent telomere targeting anticancer molecules (EORTC-NCI-AACR 2024) - "The nucleoside analogue THIO (6-thio-2'-deoxyguanosine, a.k.a 6-thio-dG; 6SdG) is a first-in-class telomerase-mediated telomere-targeting anticancer agent currently undergoing Phase II clinical trials for the treatment of immune checkpoint inhibitors resistant non-small cell lung cancer (NSCLC) patients. The obtained data for the new prodrug divalent dinucleotides MAIA-2022-12 and MAIA-2021-20 provide rationale for their further detailed preclinical studies in different cancer type models."

IO biomarker • Colorectal Cancer • Gastrointestinal Cancer • Hepatocellular Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor

MAIA Biotechnology Announces Positive Survival Updates in Phase 2 Study of THIO in Non-Small Cell Lung Cancer (Businesswire) - P2 | N=182 | THIO-101 (NCT05208944) | Sponsor: Maia Biotechnology | "MAIA Biotechnology, Inc...announces favorable interim survival benefit from its lead clinical candidate THIO, a telomere-targeting treatment for patients with advanced non-small cell lung cancer (NSCLC)....Published available results suggest that overall survival (OS) in third-line patients is 5.8 months. As of August 01, 2024, 16 patients had survival follow-up surpassing 12 months, including 9 in third line treatment (3L). Interim median survival follow-up in 3L was 10.6 months....MAIA expects to release full efficacy results of THIO-101 this year."

P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

MAIA Biotechnology to Present New Phase 2 Clinical Trial Data at the H.C. Wainwright 26th Annual Global Investment Conference (Businesswire) - "MAIA Biotechnology, Inc...announced that Chairman and Chief Executive Officer Vlad Vitoc, M.D. will present at the H.C. Wainwright & Co. 26th Annual Global Investment Conference taking place September 9–11, 2024, in New York City. Dr. Vitoc’s presentation will reveal the latest clinical data from MAIA’s Phase 2 THIO-101 clinical trial of lead candidate THIO sequenced with the immune checkpoint inhibitor cemiplimab (Libtayo) in patients with advanced non-small cell lung cancer (NSCLC) who failed 2 or more standard-of-care therapy regimens."

P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

MAIA Biotechnology Announces New Updates from Phase 2 Trial of Novel Cancer Treatment Agent (Businesswire) - P2 | N=182 | NCT05208944 | Sponsor: Maia Biotechnology | "MAIA Biotechnology...announces positive treatment updates from its Phase 2 clinical trial, THIO-101, evaluating THIO sequenced with the immune checkpoint inhibitor (CPI) cemiplimab (Libtayo) in patients with advanced non-small cell lung cancer (NSCLC) who failed two or more standard-of-care therapy regimens....As of the latest clinical cutoff date, June 12, 2024: (i) 6 patients remain on treatment following at least 12 months of therapy; (ii) Treatment with THIO followed by cemiplimab has been well tolerated throughout the trial, with much lower toxicity compared to standard-of care treatments; (iii) Continuing treatment past 12 months demonstrates safety, efficacy and ongoing benefit from MAIA’s novel telomere targeting NSCLC therapy."

P2 data • Non Small Cell Lung Cancer