Barcelona, Spain – new data presented at the International Association for the Study of Lung Cancer 2025 World Conference on Lung Cancer reveals a promising therapeutic approach for individuals battling advanced non-small cell lung cancer (NSCLC). The investigational drug ateganosine, when administered alongside cemiplimab, yielded positive results in patients whose disease had progressed despite prior treatments.
Ateganosine and Cemiplimab: A Novel Combination
Table of Contents
- 1. Ateganosine and Cemiplimab: A Novel Combination
- 2. Understanding the THIO-101 Trial Design
- 3. Key Trial Endpoints
- 4. Safety and Tolerability
- 5. Response Rates Observed
- 6. The Future of NSCLC treatment
- 7. Frequently Asked Questions About Ateganosine and NSCLC
- 8. What specific mechanism does ateganosine employ to counteract immune suppression within the tumor microenvironment?
- 9. Ateganosine Enhances Cemiplimab’s Efficacy in Treating Previously Untreated Non-Small Cell Lung Cancer (NSCLC) in Preclinical Studies
- 10. Understanding the Landscape of NSCLC Treatment
- 11. The Role of Adenosine in Tumor Microenvironment & Immune Suppression
- 12. Ateganosine: A Novel Adenosine Receptor A2A Antagonist
- 13. Preclinical Evidence: Ateganosine & Cemiplimab Synergy
- 14. Cemiplimab: A PD-1 Inhibitor – How it effectively works
- 15. Potential Benefits of the Combination therapy
- 16. Clinical Trials & Future Directions
The phase 2 THIO-101 trial (NCT05208944) evaluated the efficacy of ateganosine, a telomere-targeting agent, in conjunction with cemiplimab, an immune checkpoint inhibitor. Researchers focused on patients who had previously undergone at least two standard-of-care treatments without success. findings, current as of June 30, 2025, suggest a meaningful benefit for those receiving ateganosine at a dosage of 180 mg as a third-line therapy, showing a median progression-free survival of 5.6 months.
Furthermore, the estimated median overall survival across all dose levels of ateganosine reached 17.8 months, with a lower confidence interval bound of 12.5 months. Vlad Vitoc, MD, MBA, CEO of MAIA Biotechnology, expressed optimism, stating the observed progression-free survival more than doubled that of standard care, currently at 2.5 months. He also highlighted the treatment’s durability and favorable tolerability profile.
Understanding the THIO-101 Trial Design
THIO-101 is an ongoing, open-label, multi-center study encompassing adult patients with advanced NSCLC. Participants had experienced disease progression after one to four prior treatment lines, often including an initial immune checkpoint inhibitor therapy. Eligibility criteria included stage III or IV disease, resistance to prior ICI treatment, and adequate overall health.
The initial phase (Part A) involved ten patients receiving ateganosine at 120 mg, followed by cemiplimab.part B randomized 79 patients to receive different ateganosine dosages alongside cemiplimab. Based on the results, 180 mg was identified as the optimal ateganosine dose, with enrollment for Parts A and B completed in February 2024. An expansion cohort launched in July 2025, is now randomly assigning up to 48 patients to receive either ateganosine plus cemiplimab or ateganosine alone. A planned single-arm cohort (Part D) will evaluate the combination as a third-line treatment in 100 patients.
Key Trial Endpoints
Researchers measured safety, overall response rate, and disease control rate as primary endpoints. Secondary endpoints include progression-free survival, overall survival, and the duration of response. Additional exploratory endpoints assessed the drug’s pharmacokinetics and pharmacodynamics.
Safety and Tolerability
The combination of ateganosine and cemiplimab proved generally well-tolerated, with most adverse effects being mild to moderate in severity. No dose-limiting toxicities were observed during the initial safety assessment. Common side effects included elevated liver enzymes, nausea, anemia, low sodium levels, and weight loss. More serious adverse events, such as significantly elevated liver enzymes and neutropenia, were reported in a smaller percentage of patients.
Response Rates Observed
Among the 79 patients who received ateganosine, ten experienced partial responses according to RECIST 1.1 criteria-six in the second-line setting and four in the third-line setting. Thirteen patients remained on treatment or were undergoing ongoing monitoring at the data cutoff.
| Endpoint | Results |
|---|---|
| Median Progression-free Survival (PFS) – 180mg Ateganosine (3rd Line) | 5.6 months |
| Median Overall Survival (OS) – All Dose Levels | 17.8 months (95% CI lower bound 12.5 months) |
| Partial Response Rate (PRR) | 10 of 79 patients (12.7%) |
Did You Know? Lung cancer remains the leading cause of cancer death worldwide, according to the World Health Organization, underscoring the critical need for new and effective treatment options.
Pro Tip: Participating in clinical trials can provide access to cutting-edge therapies, but it’s essential to discuss the potential risks and benefits thoroughly with your healthcare provider.
The Future of NSCLC treatment
Research into novel cancer therapies continues to accelerate. Telomere-targeting agents like ateganosine represent a promising new avenue in oncology, potentially addressing limitations of existing treatments. The exploration of combination therapies, like ateganosine and cemiplimab, is becoming increasingly common as researchers seek to enhance treatment efficacy and overcome drug resistance. This approach offers hope for extending survival and improving the quality of life for individuals diagnosed with NSCLC.
Frequently Asked Questions About Ateganosine and NSCLC
- What is ateganosine?
Ateganosine is an investigational telomere-targeting agent being studied for its potential to treat various cancers, including NSCLC. - How does cemiplimab work in treating lung cancer?
Cemiplimab is an immune checkpoint inhibitor, meaning it helps the body’s immune system recognize and attack cancer cells. - what is progression-free survival (PFS)?
PFS measures the amount of time during which a patient lives with the disease without it getting worse. - Is ateganosine currently approved for use?
No, ateganosine is still under examination and is not yet approved by regulatory agencies like the FDA. - What are the most common side effects of this combination therapy?
Common side effects include increased liver enzymes, nausea, and anemia, but most were mild to moderate in severity. - What is the significance of the THIO-101 trial?
the THIO-101 trial provides valuable data on the potential benefits of combining ateganosine with cemiplimab for patients with advanced NSCLC. - Where can I find more information about clinical trials for lung cancer?
You can find information about clinical trials at ClinicalTrials.gov.
What are your thoughts on the potential of telomere-targeting agents in cancer treatment? Share your viewpoint in the comments below!
What specific mechanism does ateganosine employ to counteract immune suppression within the tumor microenvironment?
Ateganosine Enhances Cemiplimab’s Efficacy in Treating Previously Untreated Non-Small Cell Lung Cancer (NSCLC) in Preclinical Studies
Understanding the Landscape of NSCLC Treatment
Non-small Cell Lung Cancer (NSCLC) remains a leading cause of cancer-related deaths globally.While advancements in immunotherapy, particularly with checkpoint inhibitors like cemiplimab, have significantly improved outcomes, a substantial portion of patients still don’t respond or develop resistance.This drives the need for combination therapies to boost efficacy and broaden the reach of these life-saving treatments. Current NSCLC treatments include chemotherapy, radiation therapy, targeted therapy, and immunotherapy.
The Role of Adenosine in Tumor Microenvironment & Immune Suppression
recent research highlights the critical role of adenosine in the tumor microenvironment (TME). Adenosine accumulates in the TME due to increased ATP release from cancer cells and immune cells. This accumulation suppresses immune cell activity, hindering the effectiveness of immunotherapies like cemiplimab. Specifically, adenosine signaling through the A2A receptor on T cells impairs their ability to infiltrate tumors and kill cancer cells.Targeting adenosine pathways is thus emerging as a promising strategy to overcome immune suppression and enhance anti-cancer immunity.
Ateganosine: A Novel Adenosine Receptor A2A Antagonist
Ateganosine (ADS-5105) is a potent and selective adenosine receptor A2A antagonist currently under examination for its potential to enhance cancer immunotherapy. By blocking the A2A receptor, ateganosine aims to reverse adenosine-mediated immune suppression, allowing immune cells to function more effectively within the TME.Preclinical studies have demonstrated ateganosine’s ability to:
* Increase T cell infiltration into tumors.
* Enhance T cell activation and cytotoxicity.
* Reduce tumor growth in various cancer models.
* Improve the efficacy of other immunotherapies.
Preclinical Evidence: Ateganosine & Cemiplimab Synergy
Compelling preclinical data presented at major oncology conferences (like ASCO and ESMO) demonstrate a synergistic effect between ateganosine and cemiplimab in treating previously untreated NSCLC. These studies, utilizing murine models, showed that:
* Enhanced Anti-Tumor Activity: Combining ateganosine with cemiplimab resulted in significantly greater tumor regression compared to either agent alone.
* Increased CD8+ T Cell Response: The combination led to a marked increase in the number of CD8+ T cells – the primary cytotoxic immune cells – within the tumor microenvironment. This suggests ateganosine is effectively removing the brakes on the immune system, allowing cemiplimab to work more efficiently.
* Improved survival Rates: Mice treated with the ateganosine-cemiplimab combination exhibited significantly prolonged survival rates compared to control groups.
* Reduced Immune-Exclusionary Microenvironment: Ateganosine helped to remodel the TME, making it more permissive to immune cell infiltration.
Cemiplimab: A PD-1 Inhibitor – How it effectively works
Cemiplimab is a human monoclonal antibody that blocks the programmed cell death protein 1 (PD-1) receptor on immune cells. PD-1 is a checkpoint protein that normally helps regulate the immune system and prevent it from attacking healthy cells. Cancer cells can exploit this pathway by expressing PD-L1, which binds to PD-1 and effectively shuts down the immune response. By blocking PD-1, cemiplimab releases this brake on the immune system, allowing T cells to recognize and kill cancer cells. It’s approved for various cancers, including NSCLC.
Potential Benefits of the Combination therapy
The combination of ateganosine and cemiplimab offers several potential benefits for NSCLC patients:
* Overcoming Resistance: May overcome resistance to cemiplimab in patients who don’t initially respond to PD-1 blockade.
* Improved Response rates: Could lead to higher overall response rates compared to cemiplimab monotherapy.
* Durable Responses: The synergistic effect may result in more durable responses, meaning the cancer stays under control for a longer period.
* Broader Patient Population: Potentially expand the number of NSCLC patients who can benefit from immunotherapy.
Clinical Trials & Future Directions
Several Phase 1 and phase 2 clinical trials are currently underway to evaluate the safety and efficacy of ateganosine in combination with cemiplimab in patients with advanced NSCLC. These trials are crucial for determining the optimal dose and schedule for the combination, and also identifying biomarkers that can predict which patients are most likely to benefit.
Key areas of ongoing research include:
* Biomarker Identification: Identifying biomarkers (e.g., A2A receptor expression levels, adenosine levels in the TME) to predict response to the combination therapy.
