US-based MAIA Biotechnology has dosed the first subject in Taiwan in the expansion phase of its multicentre THIO-101 Phase II trial, aimed at treating advanced non-small cell lung cancer (NSCLC).
This development signifies the trial’s progression into another continent, broadening the patient base for assessing ateganosine (THIO). Screening for the study is underway in Asia and Europe.
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The expansion study will assess the therapy in individuals who have been heavily pre-treated in third-line (3L) NSCLC, who have not responded to prior treatments with chemotherapy and checkpoint inhibitors (CPIs).
The open-label, dose-finding trial is exploring two treatment arms with ateganosine sequenced with cemiplimab (Libtayo) and ateganosine as a single agent, with Regeneron providing Libtayo for the combo cohort.
It is claimed to be the first study to assess the anti-tumour activity of the therapy when followed by PD-(L)1 inhibition.
The trial hypothesis is that low doses of the therapy administered before Libtayo could prolong the immune response in advanced NSCLC patients, who have shown resistance or progression after first-line treatment with other CPIs previously.
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By GlobalDataThe two primary objectives of the trial are to assess the safety and tolerability of the therapy as an anticancer compound and a priming immune activator; and to test ateganosine’s clinical efficacy by using the overall response rate (ORR) as the primary clinical endpoint.
The study’s expansion will further evaluate the ORR in advanced NSCLC subjects undergoing 3L therapy who were resistant to previous CPI and chemotherapy treatments.
MAIA Biotechnology CEO Vlad Vitoc said: “We are excited to have the expansion of the trial officially started. Ateganosine’s observed OS in third-line NSCLC exceeds all known benchmarks.
“This potentially positions us for first-mover advantage in a multibillion-dollar space with no currently approved standard of care.”
MAIA Biotechnology noted that as of May 2025, the median overall survival (OS) for the 22 subjects in the 3L treatment arm stood at 17.8 months, compared to the five to six months of OS typically seen in similar chemotherapy trials for NSCLC.
