Additional data from THIO-101 trial expansion studies may further support a potential Accelerated Approval filing with FDA

FDA-cleared IND updates detail latest efficacy data and enriched manufacturing protocols

CHICAGO, June 03, 2026 (GLOBE NEWSWIRE) -- MAIA Biotechnology, Inc. (NYSE:MAIA) ("MAIA", the "Company"), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced that the U.S. Food and Drug Administration (FDA) has cleared an amendment to update its investigational new drug (IND) application which enables MAIA to open U.S. enrollment for the expansion of the Phase 2 THIO-101 trial of its lead candidate, ateganosine, as a treatment for advanced non-small cell lung cancer (NSCLC). Ateganosine is a novel dual mechanism of action drug candidate incorporating telomere targeting and immunogenicity. Ateganosine sequenced with a monoclonal antibody checkpoint inhibitor is being evaluated as a therapy for patients in ongoing Phase 2 and Phase 3 clinical trials.

MAIA obtained FDA clearance of its updated IND highlighting MAIA's improved efficiencies to its manufacturing capabilities, including new manufacturers, formulation and storage conditions for ateganosine, and MAIA is now cleared to enroll patients in the U.S. for the expansion of the Phase 2 THIO-101 study of patients receiving advanced third-line (3L) NSCLC treatment. In addition to the U.S., the THIO-101 study is ongoing at 44 clinical sites in six countries. MAIA recently activated its first U.S. clinical site at Summit Medical Group in New Jersey.

In July 2025, the FDA granted Fast Track designation for ateganosine for the treatment of NSCLC. This designation allows for more frequent FDA communication, potential rolling review, and eligibility for Accelerated Approval and Priority Review. The additional data from the expansion studies may further support a filing for FDA Accelerated Approval.