Full Press Release Details
Biotechnology Announces First Patient Dosed in Expansion of Phase 2 Trial for Ateganosine in Advanced Non-Small Cell Lung Cancer
- July 09, 2025 - MAIA Biotechnology, Inc. (NYSE American: MAIA), a clinical-stage biopharmaceutical
company focused on developing targeted immunotherapies for cancer, today announced dosing of the first patient in Taiwan in the expansion
phase of its THIO-101 Phase 2 trial for advanced non-small cell lung cancer (NSCLC). The trial's entry into another
continent marks a key milestone for MAIA, opening a significantly larger patient pool for its evaluations of ateganosine (THIO). Screening
for the trial is ongoing in Europe and Asia.
Design: The expansion study evaluates ateganosine in heavily pre-treated patients in third-line (3L) NSCLC who have previously
failed treatment with checkpoint inhibitors (CPIs) and chemotherapy. Two treatment arms are being studied: ateganosine sequenced with
cemiplimab (Libtayo ) and ateganosine monotherapy. Regeneron is supplying Libtayo for the combination cohort.
Opportunity: NSCLC represents one of the largest global oncology indications. The market was valued at $34.1B in 2024,
and is projected to reach $68.8B by 2033 with a projected CAGR of 8.1%.1
Data: As of May 15, 2025, the median overall survival (OS) for the 22 patients in the third-line treatment was 17.8 months,
with 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 in the trial's heavily pre-treated population.2
studies of chemotherapy for NSCLC in a similar setting have shown overall survival of 5-6 months.3
are excited to have the expansion of the trial officially started. Ateganosine's observed OS in third-line NSCLC exceeds all known
benchmarks," said MAIA's Chief Executive Officer Vlad Vitoc, M.D. "This potentially positions us for first-mover advantage
in a multibillion-dollar space with no currently approved standard of care."
(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 with 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.
Custom Market Insights, Global NSCLC Drug Market Size Likely to Surpass at a CAGR of 8.1% By 2033, Apr. 2024
Details on safety can be found on the previously announced SITC 2024 presentation available on MAIA's website.
Girard N, et al. J Thorac Onc 2009;12:1544-1549.
THIO-101, a Phase 2 Clinical Trial
is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate ateganosine's anti-tumor
activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of ateganosine administered prior to
cemiplimab (Libtayo ) will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or
developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has
two primary objectives: (1) to evaluate the safety and tolerability of ateganosine administered as an anticancer compound and a priming
immune activator (2) to assess the clinical efficacy of ateganosine using Overall Response Rate (ORR) as the primary clinical endpoint.
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. Treatment with ateganosine followed by cemiplimab
(Libtayo ) has been generally well-tolerated to date in a heavily pre-treated population. For more information on this Phase II trial,
please visit ClinicalTrials.gov using the identifier NCT05208944.
MAIA Biotechnology, Inc.
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
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.
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