MAIA Gets FDA Clearance for Enrollment in Expanded Phase 2 Cancer Study

MT Newswires Live06-03

MAIA Biotechnology (MAIA) said Wednesday it has received clearance from the US Food and Drug Administration to open enrollment for the expansion of the phase 2 THIO-101 trial of ateganosine for advanced non-small cell lung cancer.

The firm said it obtained clearance of its updated investigational new drug application highlighting improved manufacturing capabilities, including new manufacturers and formulation.

In addition to the US, the THIO-101 study is ongoing at 44 clinical sites in six countries, it added.

The additional data from the expansion studies may further support a filing for an accelerated approval, MAIA said.

Shares were up over 4% in morning trading.

Price: 1.41, Change: +0.06, Percent Change: +4.44

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