CERo Therapeutics Holdings, Inc. (CERO) has received Orphan Drug Designation from the U.S. Food and Drug Administration for its lead drug candidate CER-1236, targeting acute myeloid leukemia.
CER-1236 is a novel therapy that modifies a cancer patient’s own T cells to utilize phagocytic mechanisms along with built-in target cell destruction capabilities.
The therapy is currently undergoing Phase 1 clinical trials for acute myeloid leukemia (AML).
The FDA’s Orphan Drug program aims to encourage the development of treatments for diseases affecting 200,000 or fewer patients annually in the United States.
This designation supports efforts to bring rare disease therapies to market.
