MAIA Secures FDA Clearance Of IND Application For THIO For Non-Small Cell Lung Cancer

MAIA Biotechnology, Inc. MAIA announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug application for THIO, a first-in-class telomere targeting agent for the treatment of non-small-cell-lung-cancer, or NSLC.

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.

Also Read: MAIA Biotechnology Touts Positive Safety Data From Its Potential Lung Cancer Candidate

THIO is being tested sequentially with Regeneron Pharmaceuticals, Inc's 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.

With the addition of sites in Hungary, Poland, and Bulgaria in March 2023, THIO-101 has rapidly increased the number of patients enrolled and dosed with THIO, the company said in its Q2 press release dated August 8.

MAIA, which had a tremendous run last week, had approved a share repurchase program with authorization to purchase up to $800,000 of its Class A common stock through September 2024.

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