LARGE-SCALE MANUFACTURING OF B43(ANTI-CD19)-GENISTEIN FOR CLINICAL-TRIALS IN LEUKEMIA AND LYMPHOMA

We have conjugated the murine monoclonal anti-CD19 antibody B43 to the tyrosine kinase inhibitor genistein to construct an effective immunoc onjugate against CD19 antigen positive hematologic malignancies. The s caled-up production and purification of B43 antibody, genistein, and B 43-Genistein immunoconjugate permitted the manufacturing of a highly p urified clinical-grade B43-Genistein preparation. In clonogenic assays , B43-Genistein elicited selective and potent cytotoxicity against CD1 9 antigen positive human leukemia cells. To our knowledge, this work r epresents the first effort of producing a clinical-grade genistein imm unoconjugate for treatment of B-lineage leukemia and lymphoma.