MAIA Biotechnology has reported positive initial efficacy results from its Phase II THIO-101 trial, Part C, involving its lead candidate, ateganosine, as a third-line treatment for patients with advanced non-small cell lung cancer (NSCLC).
Early data from the Part C studies report a disease control rate (DCR) of 90.5% among the efficacy evaluable population, with 19 out of 21 patients showing disease control. These patients had at least one tumour scan after beginning treatment.
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Patients in this cohort were administered ateganosine followed by cemiplimab on a 21-day cycle.
International enrolment for the expansion trial has concluded. MAIA confirmed that the combination of ateganosine followed by cemiplimab continues to show an acceptable safety profile among a heavily pre-treated patient population.
Also known as THIO or 6-thio-2’-deoxyguanosine, ateganosine is an investigational telomere-targeting agent. It induces telomerase-dependent deoxyribonucleic acid (DNA) modification and selective cancer cell death while activating immune responses.
It is under development as a second-line or later-line NSCLC treatment, specifically in patients who have progressed after standard checkpoint inhibitor treatments.
THIO-101 is a multi-centre, open-label, dose-finding Phase II trial assessing ateganosine’s anti-tumour activity followed by programmed death-(ligand) 1 {PD-(L)1} inhibition.
The primary goals assess both safety and clinical efficacy, using overall response rate (ORR), in a population resistant to prior therapies. Acceptable safety has been reported so far in this advanced NSCLC group.
MAIA Biotechnology founder and CEO Vlad Vitoc said: “The initial efficacy data from the Part C studies are consistent with the encouraging efficacy signals we previously reported for parts A and B of THIO-101, including an 88% disease control rate in third-line NSCLC patients. This measure of efficacy is close to triple the reported outcome for standard-of-care chemotherapy treatment.
“Importantly, patients enrolled in Part C of our trial represent a more heavily pre-treated population, with all patients having previously received docetaxel in addition to demonstrating resistance to both immunotherapy and other chemotherapies.”
Last month, MAIA Biotechnology activated a new US site, the Winship Cancer Institute of Emory University, and opened patient enrolment for the Phase II THIO-101 expansion trial.
