Institute of Good Manufacturing Practices India®

(An Autonomous Body Recognized by Ministry of Commerce & Industry, Government of India)

MAIA Biotechnology declares positive data from NSCLC therapy trial

MAIA Biotechnology has released positive efficacy results from its Phase II THIO-101 trial, examining THIO combined with cemiplimab (Libtayo) for advanced non-small cell lung cancer (NSCLC). THIO, or 6-thio-2’-deoxyguanosine, is a telomere-targeting agent under investigation.

The multicenter, open-label trial aims to evaluate THIO's anti-tumor activity followed by PD-(L)1 inhibition. Specifically, it investigates whether low doses of THIO preceding cemiplimab can enhance and prolong the immune response in advanced NSCLC patients, particularly those unresponsive to or resistant to first-line treatments with another checkpoint inhibitor.

Primary objectives include assessing THIO's tolerability and safety as an anticancer therapy and immune activator and evaluating clinical efficacy via overall response rate (ORR). Initial findings indicate well-tolerated THIO treatment post-cemiplimab, with a 38% ORR observed in third-line NSCLC patients, irrespective of chemotherapy history. Safety remained consistent with prior data despite incomplete scan records for some subjects. Enrolment in the THIO-101 trial recently concluded.