Orca Bio prepares BLA after stellar cell therapy results

18 March 2025

Californian cell therapy company Orca Bio has announced positive results from the pivotal Phase III Precision-T study of Orca-T, its lead investigational allogeneic T-cell immunotherapy, acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), high-risk myelodysplastic syndrome (MDS) and mixed-phenotype acute leukemia (MPAL).

Orca-T is manufactured using highly purified regulatory T-cells, hematopoietic stem cells and conventional T-cells derived from peripheral blood from either related or unrelated matched donors.

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