MAIA Biotechnology Reports Pivotal Phase 3 Clinical Trial Progress in Advanced Non-Small Cell Lung Cancer
MAIA advances enrollment in its pivotal Phase 3 lung cancer trial while highlighting strong interim disease control and prior FDA Fast Track status.
Rhea-AI Summary
MAIA Biotechnology (MAIA) reported progress in its pivotal Phase 3 THIO-104 trial of ateganosine as a third-line treatment for advanced non-small cell lung cancer, with enrollment reaching 65 randomized patients and 38 active sites across six countries.
The company expects additional clinical sites to begin enrolling and says it remains on track to exceed 100 randomized patients by year-end. MAIA cites prior statistical assessments indicating a "very high probability of technical success" for regulatory approval. In the ongoing Phase 2 THIO-101 trial, ateganosine sequenced with a checkpoint inhibitor achieved a 90.5% interim disease control rate in heavily pretreated third-line NSCLC, compared with reported 25%–35% DCRs for standard third-line chemotherapy regimens.
The FDA granted ateganosine Fast Track designation for NSCLC in July 2025, enabling more frequent FDA interaction, potential rolling review, and eligibility for Accelerated Approval and Priority Review, as well as five-year New Chemical Entity marketing exclusivity if approved.
Positive
- 65 patients enrolled so far in pivotal Phase 3 THIO-104 trial
- THIO-104 has 38 active sites across 6 countries
- Company targets 100+ randomized patients in Phase 3 by year-end
- Phase 2 ateganosine combo shows 90.5% interim DCR in 3L NSCLC
- Reported standard 3L chemotherapy DCR is only 25%–35%
- Ateganosine has FDA Fast Track and potential 5-year NCE exclusivity if approved
Negative
- None.
Key Figures
- Randomized patients
- 65 patients
- Ongoing pivotal Phase 3 THIO-104 trial
- Activated trial sites
- 38 sites
- THIO-104 trial across 6 foreign countries
- Foreign countries
- 6 countries
- THIO-104 trial site footprint
- Disease control rate
- 90.5%
- Interim THIO-101 Phase 2 assessment in heavily pretreated third-line NSCLC
- Standard third-line DCR
- 25%–35%
- Reported disease control rates for standard third-line chemotherapy regimens
- Fast Track designation
- July 2025
- FDA designation for ateganosine in NSCLC
- NCE marketing exclusivity
- 5 years
- Conditional on FDA approval of ateganosine
Previous Clinical trial Reports
-
First U.S. patient dosed in the ongoing THIO-101 NSCLC expansion study
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THIO-101 Part C reported a 90.5% disease control rate
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Part C completed international enrollment in third-line NSCLC
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A third U.S. site opened enrollment in the THIO-101 expansion trial
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
disease control rate medical
checkpoint inhibitor medical
fast track regulatory
new chemical entity regulatory
AI-generated analysis. How Rhea-AI works. Not financial advice.
Strong pace of patient enrollment supports continued advancement toward regulatory milestones
Most recent assessment of novel telomere targeting agent sequenced with a checkpoint inhibitor showed
CHICAGO, Sept. 22, 2026 (GLOBE NEWSWIRE) -- MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today 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). The THIO-104 trial currently has 38 trial sites activated in 6 foreign countries (Taiwan, Romania, Turkey, Georgia, Poland and Hungary).
“Reaching 65 randomized patients marks an important milestone in our Phase 3 trial. With additional clinical sites expected to begin enrolling patients, we remain on track to achieve our goal of more than 100 randomized patients by year-end,” said Vlad Vitoc, M.D., Founder and Chief Executive Officer of MAIA. “As we’ve stated previously, statistical assessments of the Phase 3 trial point to a very high probability of technical success for regulatory approval of ateganosine.1 We believe third-line NSCLC is an excellent market entry segment due to the substantial unmet medical need in this large immunotherapy-resistant and chemotherapy-resistant population. No current standard of care exists in this NSCLC treatment setting and competition for clinical trial patients is limited.”
In its most recent assessment, ateganosine sequenced with a checkpoint inhibitor showed
In July 2025, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for ateganosine for the treatment of NSCLC. This designation allows for more frequent FDA communication, potential rolling review, and eligibility for Accelerated Approval and Priority Review. If approved, ateganosine will hold FDA New Chemical Entity (NCE) five-year marketing exclusivity. An NCE is a small molecule drug with a novel active ingredient that hasn’t been previously approved or marketed.
About Ateganosine
Ateganosine (THIO, 6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in non-small cell lung cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. Ateganosine-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment of ateganosine followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. Ateganosine is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.
About MAIA Biotechnology, Inc.
MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is ateganosine (THIO), a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.
About THIO-104 Phase 3 Clinical Trial
THIO-104 is a multicenter, open-label, randomized Phase 3 clinical trial, designed to evaluate ateganosine’s telomere-targeting anti-tumor activity when followed by PD-(L)1 inhibition in patients with advanced third-line NSCLC who previously did not respond or developed resistance to treatment regimens containing checkpoint inhibitor and/or chemotherapy and have progressed. The trial has two primary objectives: (1) to assess the clinical efficacy of ateganosine compared to investigator’s choice of chemotherapy, using median Overall Survival (OS) as the primary clinical endpoint (2) to evaluate the safety and tolerability of ateganosine in sequential combination with a checkpoint inhibitor. For more information on this Phase 3 trial, please visit ClinicalTrials.gov using the identifier NCT06908304.
Forward Looking Statements
MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.
Investor Relations Contact
+1 (872) 270-3518
ir@maiabiotech.com
1 See latest MAIA investor presentation and 2026 shareholder letter at ir.maiabiotech.com/company-information/presentations.
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What is the THIO-104 trial evaluating for MAIA Biotechnology?
THIO-104 is a pivotal Phase 3 clinical trial evaluating MAIA’s novel telomere-targeting therapy, ateganosine, as a third-line treatment for advanced non-small cell lung cancer (NSCLC).
Where is the THIO-104 trial currently being conducted?
The THIO-104 trial has 38 sites activated in six countries: Taiwan, Romania, Turkey, Georgia, Poland and Hungary.
Why does MAIA view third-line NSCLC as an attractive initial market segment?
The company describes third-line NSCLC as an excellent market entry segment due to substantial unmet medical need in a large immunotherapy-resistant and chemotherapy-resistant population, the absence of a current standard of care in this setting, and limited competition for clinical trial patients.
What benefits does FDA Fast Track designation provide for ateganosine?
Fast Track designation allows for more frequent FDA communication, potential rolling review, and eligibility for Accelerated Approval and Priority Review. If ateganosine is approved, it will receive five-year New Chemical Entity marketing exclusivity.