Orca Bio, a late-stage biotechnology company, on March 17 announced results from the pivotal phase III Precision-T study of Orca-T, its lead investigational allogeneic T-cell immunotherapy, in patients with acute myeloid leukemia, acute lymphoblastic leukemia, high-risk myelodysplastic syndrome and mixed-phenotype acute leukemia. 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.
In the phase II CAR-PRISM (PRecision Intervention Smoldering Myeloma) clinical trial, the first to investigate CAR T-cell therapy in patients with high-risk smoldering multiple myeloma, all 20 patients were negative for minimal residual disease within two months of treatment and remained MRD-negative after a median of 15.3 months of follow-up.
