Clinical assessment of m-protein response in multiple myeloma

Abstract

Applicant discloses an anti-idiotypic antibody to MOR202, which when fused to human albumin, shifted the antibody in IFE thus mitigating any potential interference of MOR202 with the M-protein clinical assessment.

1 . A monoclonal anti-idiotypic antibody that is specific for an anti-CD38 antibody, wherein the anti-CD38 antibody comprises a variable heavy chain comprising the amino acid sequence of SEQ ID NO: 7, and a variable light chain comprising the amino acid sequence of SEQ ID NO: 8. 
     
     
         2 . The monoclonal anti-idiotypic antibody according to  claim 1 , wherein said anti-idiotypic antibody comprises a variable heavy chain comprising an HCDR1 of the amino acid sequence of SEQ ID NO: 18, an HCDR2 of the amino acid sequence of SEQ ID NO: 19, an HCDR3 of the amino acid sequence of SEQ ID NO: 20, and a variable light chain comprising an LCDR1 of the amino acid sequence of SEQ ID NO: 21, an LCDR2 of the amino acid sequence of SEQ ID NO: 22, an LCDR3 of the amino acid sequence of SEQ ID NO: 23. 
     
     
         3 . The monoclonal anti-idiotypic antibody according to  claim 2 , wherein said anti-idiotypic antibody comprises a variable heavy chain of amino acid sequence of SEQ ID NO: 16, and a variable light chain of amino acid sequence SEQ ID NO: 17. 
     
     
         4 . The monoclonal anti-idiotypic antibody according to  claim 1 , wherein the anti-idiotypic antibody is a human antibody. 
     
     
         5 . The monoclonal anti-idiotypic antibody according to  claim 1 , wherein the anti-idiotypic antibody is an IgG. 
     
     
         6 . The monoclonal anti-idiotypic antibody according to  claim 1 , wherein the anti-idiotypic antibody is an IgM. 
     
     
         7 . A method of evaluating a blood sample obtained from a patient undergoing treatment for multiple myeloma or other gammopathy comprising
 a) obtaining a blood sample from said patient,   b) incubating the blood sample with an anti-idiotypic antibody,   c) performing immunofixation electrophoresis (IFE), and   d) reporting the results of the IFE,   wherein the patient is undergoing treatment with a monoclonal anti-idiotypic antibody that is specific for an anti-CD38 antibody, wherein the anti-CD38 antibody comprises a variable heavy chain comprising the amino acid sequence of SEQ ID NO: 7, and a variable light chain comprising the amino acid sequence of SEQ ID NO: 8.   
     
     
         8 . The method according to  claim 7 , wherein said anti-idiotypic antibody comprises a variable heavy chain comprising an HCDR1 of the amino acid sequence of SEQ ID NO: 18, an HCDR2 of the amino acid sequence of SEQ ID NO: 19, an HCDR3 of the amino acid sequence of SEQ ID NO: 20, and a variable light chain comprising an LCDR1 of the amino acid sequence of SEQ ID NO: 21, an LCDR2 of the amino acid sequence of SEQ ID NO: 22, an LCDR3 of the amino acid sequence of SEQ ID NO: 23. 
     
     
         9 . The method according to  claim 8 , wherein said anti-idiotypic antibody comprises a variable heavy chain of amino acid sequence of SEQ ID NO: 16, and a variable light chain of amino acid sequence SEQ ID NO: 17. 
     
     
         10 . The method according to  claim 7 , wherein said anti-idiotypic antibody is a human antibody. 
     
     
         11 . The method according to  claim 7 , wherein said anti-idiotypic antibody is an IgG. 
     
     
         12 . The method according to  claim 7 , wherein the anti-idiotypic antibody is an IgM.