MAIA Biotechnology Enters New Phase with THIO-104 Trial Milestone
Key milestone achieved as Company advances clinical program to full approval trial of ateganosine sequenced with a checkpoint inhibitor in comparison to chemotherapy
MAIA Biotechnology, Inc. (NYSE American: MAIA) is making significant strides in the fight against advanced non-small cell lung cancer (NSCLC). The company recently reached a crucial milestone as the first patient has been dosed in their THIO-104 Phase 3 pivotal trial. This trial evaluates the efficacy of ateganosine administered alongside a checkpoint inhibitor (CPI) as a potential third-line treatment for patients battling this aggressive form of cancer.
The THIO-104 trial is designed as a multicenter, open-label study, focusing on patients who have not responded to previous CPI and chemotherapy treatments. With a goal of assessing overall survival, the trial will involve up to 300 patients and will compare ateganosine sequenced with a CPI to investigator's choice of standard chemotherapy in a 1:1 randomization format. Regulatory approval has been secured to initiate patient screenings in various countries, including locations in Europe, Asia, and Turkey, with screening and enrollment actively underway.
Vlad Vitoc, M.D., CEO of MAIA, shared his enthusiasm, stating, "Advancing our ateganosine program to a Phase 3 trial is a significant step in our plan to bring this innovative treatment to market. With the first patient now dosed, we have reached an essential milestone on our journey towards FDA approval. We anticipate that the Phase 3 results will align with our Phase 2 trial findings, which indicated a median survival of 17.8 months, notably greater than the approximate six months of survival typically associated with chemotherapy treatments. We are optimistic that ateganosine has the potential to become the new standard for patients struggling with this challenging disease."
Impressively, ateganosine combined with a CPI has shown remarkable efficacy in patients dealing with third-line NSCLC. Data indicates that patients in the earlier THIO-101 trial experienced a progression-free survival (PFS) of 5.6 months—a significant improvement over the standard care PFS of 2.5 months. One patient who began therapy in March 2023 has impressively survived for 30 months, marking a milestone of 912 days.
Additionally, MAIA has been granted Fast Track designation from the U.S. Food and Drug Administration (FDA) for ateganosine, aimed at treating advanced NSCLC, signifying a positive step in its development journey.
About Ateganosine
Ateganosine, also known as THIO or 6-thio-2'-deoxyguanosine, represents a pioneering investigational agent that targets telomeres. Currently, it is in clinical development to assess its activity in treating non-small cell lung cancer. Telomeres and the enzyme telomerase play crucial roles in the longevity of cancer cells and their resistance to therapies. The novel nucleotide, 6-thio-2'-deoxyguanosine, incites crucial telomerase-dependent modifications in DNA, instigating DNA damage responses and selectively inducing cancer cell death. The treatment's efficacy has been underscored by its ability to drive cancer type–specific immune responses, with sequential administration alongside PD-(L)1 inhibitors leading to substantial tumor regression.
About the THIO-104 Phase 3 Clinical Trial
THIO-104 is designed as a multicenter, open-label, randomized Phase 3 clinical trial that investigates the anti-tumor activity of ateganosine followed by PD-(L)1 inhibitors in advanced NSCLC patients who have either not responded or have developed resistance to previous treatments. The trial aims to accomplish two main objectives:
- Evaluate the clinical efficacy of ateganosine compared to the investigator's choice of chemotherapy, with median Overall Survival (OS) as the primary endpoint.
- Assess the safety and tolerability of ateganosine in combination with a checkpoint inhibitor.
Details about this Phase 3 trial can be found on ClinicalTrials.gov under the identifier NCT06908304.
About MAIA Biotechnology, Inc.
MAIA Biotechnology is at the forefront of targeted therapy and immuno-oncology development. The company is committed to advancing potential first-in-class therapies with novel actions that aim to significantly enhance and prolong the lives of individuals battling cancer. Their lead agent, ateganosine (THIO), is being explored as a second or later line treatment option for patients with telomerase-positive cancers, particularly in the NSCLC category. For more information, please visit www.maiabiotech.com.
Frequently Asked Questions
What is ateganosine and how does it work?
Ateganosine is a first-in-class telomere-targeting agent designed to induce cancer cell death by modifying telomerase activity. This helps combat cancer cells that evade conventional therapies.
What is the focus of the THIO-104 Phase 3 trial?
The trial seeks to evaluate the efficacy of ateganosine when used sequentially with a checkpoint inhibitor in patients with advanced non-small cell lung cancer resistant to previous treatments.
How many patients will participate in the study?
Up to 300 patients will be enrolled in the THIO-104 trial, all of whom will be monitored for their overall survival and response to the treatment.
What are the expected outcomes of the Phase 3 trial?
The trial aims to show an increase in overall survival for patients treated with ateganosine compared to standard chemotherapy, potentially positioning ateganosine as a new treatment standard.
How can I learn more about this clinical trial?
Detailed information about the THIO-104 Phase 3 trial can be found on ClinicalTrials.gov by searching the identifier NCT06908304.
