MAIA Biotechnology Receives FDA’s Fast Track Designation for Ateganosine

MAIA Biotechnology, Inc., a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, announced that the U.S. Food and Drug Administration has granted Fast Track designation for ateganosine (THIO, 6-thio-dG or 6-thio-2’-deoxyguanosine) to treat non-small cell lung cancer (NSCLC). 

Ateganosine is a first-in-class small molecule that compromises telomere structure and function in cancer cells, leading to rapid tumor cell elimination and specific immune memory. Through telomerase-mediated action, ateganosine reverses intrinsic or acquired resistance to immune checkpoint inhibitors (ICIs).

Ateganosine is currently being evaluated in a pivotal Phase 2 THIO-101 clinical trial assessing its anti-tumor activity when followed with a checkpoint inhibitor.

MAIA’s most recent data from the pivotal Phase 2 THIO-101 clinical trial of ateganosine as of May 15, 2025, showed a median overall survival (OS) of 17.8 months in a heavily pre-treated population. As of the data cut-off date, the patient with the longest survival in the trial had completed 32 cycles of therapy and had 24.3 months of survival. 

The FDA Fast Track is a process designed to facilitate the development and expedite the review of drugs for treating serious conditions and filling an unmet medical need. If relevant criteria are met during the Fast Track process, a drug will be eligible for FDA Accelerated Approval and Priority Review (FDA decision within six months). NSCLC represents one of the largest global oncology indications.

“Ateganosine has demonstrated robust preclinical efficacy and superior clinical median overall survival compared to other FDA-approved treatments for NSCLC patients with prior disease progression on platinum-based chemotherapy and anti-PD-(L)1 antibody. Additionally, advanced NSCLC is a devastating disease that clearly meets the criteria for a serious condition with unmet medical need,” said K. Robinson Lewis, Vice President, Head of Regulatory and Quality at MAIA. “We intend to utilize the incentives of the Fast Track Program to expedite the development and review of ateganosine and bring patient access sooner.”