THIO will now be evaluated in the U.S. as a part of the current THIO-101 global phase 2 clinical trial. 

As of July 2023, the company announced that 35 patients had been dosed in MAIA's Phase 2 clinical trial, THIO-101. 

"The FDA IND clearance represents an essential milestone in the clinical development of THIO, as a first-in-class telomere targeting agent in clinical development for patients with advanced NSCLC," said Mihail Obrocea, M.D., MAIA's Chief Medical Officer.

THIO is being tested sequentially with Regeneron Pharmaceuticals, Inc's (NASDAQ:REGN) anti PD-1 monoclonal antibody cemiplimab (Libtayo) to evaluate the anti-tumor activity and immune response in NSCLC patients, the company said. 

"We worked diligently with the FDA throughout the pre-IND/IND process to successfully align with their regulatory guidance and recommendations and we remain committed to developing novel, safe and effective treatments for patients with cancer," added K. Robinson Lewis, MAIA's Head of Regulatory and Quality.

Price Action: MAIA shares are trading lower by 11.22% to $2.25 on the last check Tuesday.