Part A of the THIO-101 trial evaluated the safety and tolerability of the maximum dose of 360mg/cycle. Credit: Julia Koblitz from Unsplash.

MAIA Biotechnology has reported positive topline results from the completed Part A safety lead-in of its Phase ll THIO-101 trial of THIO to treat advanced non-small cell lung cancer (NSCLC).

The results showed that THIO, a telomere-targeting agent, when given in sequential combination with Libtayo (cemiplimab), the anti-PD-1 therapy of Regeneron, were found to be generally well-tolerated.

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Researchers of the multicentre, open-label, dose-finding trial did not observe any dose-limiting toxicities (DLTs) or significant treatment-related adverse events.

Part A of the trial evaluated the safety and tolerability of the maximum dose of 360mg/cycle in six subjects.

Mild toxicities, including grade 1 fatigue, muscle pain and only one occurrence of grade 3 nausea, were reported during Part A.

However, no grade 4 adverse events were reported throughout this part of the study.

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MAIA chief medical officer Mihail Obrocea said: “Part A’s safety profile is in sharp contrast with the typical safety profile of chemotherapy treatment where 70-80% of NSCLC patients experience grade 3 and 4 toxicities.

“The next dose levels of THIO in Part B are lower compared to Part A. Based on the initial safety profile seen at the highest dose in Part A, we are optimistic about the safety profile of THIO.”

The company has already started patient recruitment for a Part B randomised efficacy/dose selection portion.

Under Part B of the trial, patients will be randomised to receive three THIO doses, including 60mg, 180mg and 360mg, followed by cemiplimab every three weeks.

Safety and tolerability of THIO will continue to be checked across all the doses.

This part aims to find out the most efficacious and safe dose of the therapy, which will help MAIA during Part C of the trial.