CERo Orphan Drug Designation Granted to CER-1236 for Acute Myeloid Leukemia

CERo Therapeutics (NASDAQ: CERO) has received FDA Orphan Drug Designation (ODD) for CER-1236, its lead drug candidate targeting acute myeloid leukemia (AML). CER-1236 is an innovative T cell therapy that engineers patients' own immune cells to deploy phagocytic mechanisms alongside traditional T cell destroying mechanisms. The drug is currently in a Phase 1/1b clinical trial evaluating safety and preliminary efficacy in various AML patient groups. The study includes dose escalation and expansion phases, measuring outcomes such as adverse events, toxicities, and response rates. The ODD status grants CERo significant benefits, including FDA trial design assistance, grant eligibility, fee exemptions, and 7 years of marketing exclusivity upon approval.

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