MAIA Biotechnology has reported new positive efficacy data from its Phase II THIO-101 clinical trial of THIO (6-thio-2′-deoxyguanosine) sequenced with checkpoint inhibitor cemiplimab (Libtayo) to treat advanced non-small cell lung cancer (NSCLC).
The results were presented during the ongoing American Society of Clinical Oncology (ASCO) Annual Meeting taking place in Chicago until 4 June.
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Updated data from the THIO-101 study (NCT05208944) show a disease control rate (DCR) of 85% from THIO and Libtayo in NSCLC patients who failed two or more standard-of-care therapy regimens. The primary objectives of the trial are to examine the safety and tolerability of THIO as an anticancer drug and as an immune system primer, as well as the clinical efficacy of THIO in the form of overall response rate (ORR).
The company previously announced results in March 2024, demonstrating that the overall response rate (ORR) was 38% for the combination of THIO 180mg plus Libtayo in third-line NSCLC patients who did not respond to immune checkpoint inhibitors in previous lines of therapy, irrespective of chemotherapy status.
The trial is designed to analyse if low doses of THIO administered before Libtayo can boost and prolong the immune response in advanced NSCLC patients who have not responded or have developed resistance to first-line treatments containing another checkpoint inhibitor.
THIO is a first-in-class small molecule cancer telomere-targeting agent. The candidate has received three orphan drug designations, including one each for glioblastoma multiforme (GBM) in 2023, hepatocellular carcinoma (HCC), and small cell lung cancer (SCLC) in 2022.
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By GlobalDataIn the announcement accompanying the data, MAIA CEO Vlad Vitoc said: “The data presented at ASCO advances THIO’s excellent clinical profile as a strong, safe, and highly effective alternative for patients who progressed following chemotherapy and other available treatments. We eagerly anticipate full efficacy data from THIO-101 in the second half of this year.”
According to a report on GlobalData’s Pharma Intelligence Center, the diagnosed incident cases of NSCLC are expected to increase from 1,097,467 cases in 2022 to 1,463,151 cases in 2032 in the eight major markets (UK, US, France, Spain, Italy, Germany, Japan, and urban China).
MAIA is also researching other drug treatments, using telomere-targeting agents as a foundation. The company’s programme aims to discover new compounds with potentially improved specificity toward cancer cells relative to normal cells and increased anticancer activity.
