Marker Therapeutics' MT-401 receives EMA Orphan Drug Designation for AML

Marker Therapeutics, Inc.

EMA granted Orphan Drug Designation for zedenoleucel (MT-401) for acute myeloid leukemia (AML).
MT-401 is a non-genetically modified multiTAA-specific T cell therapy targeting four AML-associated antigens.
Phase 2 trial ongoing for relapsed AML after allogeneic HSCT; FDA also granted orphan designation in 2020.
Benefits include 10-year EU market exclusivity post-approval, reduced regulatory fees, and scientific advice.
Relapsed AML after HSCT has median survival <1 year, underscoring the need for new therapies.

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