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Cordex Biologics, a subsidiary of ExCellThera, has developed UM171 Cell Therapy (INN: dorocubicel), an orphan-designated, allogeneic cord blood-derived CD34+ cell therapy evaluated in 120+ patients with hematological malignancies. Phase 2 trials demonstrated strong safety and efficacy signals in high-risk acute leukemia and myelodysplasia; an EMA-accelerated Phase 3 trial is planned for late 2024. The therapy has received Orphan Drug, RMAT, PRIME, and ATMP designations from major regulators[5][6][9][11].
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