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.

These findings are highly encouraging and provide compelling new evidence as we work to solve for the critical factors contributing to the needs of this patient population

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