MAIA Biotechnology Reports FDA's

MAIA Biotechnology Reports FDA's Fast Track Designation For Ateganosine

MAIA Biotechnology (MAIA) announced that the FDA has granted Fast Track designation for ateganosine for the treatment of non-small cell lung cancer. Ateganosine is currently being evaluated in a Phase 2 THIO-101 clinical trial evaluating its anti-tumor activity when followed by a checkpoint inhibitor.

MAIA CEO Vlad Vitoc, said: "If we are successful in the Fast Track regulatory pathway, ateganosine could qualify for accelerated FDA approval and robust exclusivity in NSCLC, with a potential FDA decision as early as next year. If approved, ateganosine would have a first-to-market competitive position within a $34 billion NSCLC treatment market with significant unmet medical need."

Ateganosine is a telomerase inhibitor and apoptosis inducer currently under investigation for the treatment of various cancers, including non-small cell lung cancer (NSCLC).

MAIA Biotechnology, Inc. is a public, immune-oncology company based in Chicago, IL focused on the development of telomere targeting agents for the treatment of telomerase-positive cancer cells.

Shares of MAIA Biotechnology are up 8% in pre-market trade on Monday.