Monoclonal antibody and a method of use for the treatment of lupus

Abstract

The present invention relates to compositions and methods useful for the treatment of lupus using a humanized IgG1 anti-CD6 monoclonal antibody (T1h) that binds to the SRCR domain 1 (D1) of CD6 without blocking the interaction of CD6 with the CD6 ligandActivated Leukocyte Cell Adhesion Molecule (ALCAM).

1 - 11 . (canceled) 
     
     
         12 . A method for treating cutaneous lupus erythematosus in a subject comprising administering an anti-CD6 monoclonal antibody (T1h) that binds to domain 1 (D1) of CD6 without interfering with ALCAM binding to CD6, wherein the anti-CD6 monoclonal antibody comprises amino acid sequences of SEQ ID NO: 1 and SEQ ID NO: 2, and wherein the anti-CD6 monoclonal antibody is in a therapeutically effective amount to reduce the symptoms of lupus in the treated subject. 
     
     
         13 - 14 . (canceled) 
     
     
         15 . The method of  claim 12 , wherein the anti-CD6 monoclonal antibody reduces or prevents the activation of T-cells, inhibits T-cell proliferation and/or reduces induction of complement-dependent cytotoxicity (CDC). 
     
     
         16 . The method of  claim 12 , wherein the anti-CD6 monoclonal antibody is encoded by a nucleotide sequence comprising SEQ ID NO: 3 and SEQ ID NO: 4 or nucleotide sequences have at least 90% identity thereto and encodes for SEQ ID NO: 1 and SEQ ID NO: 2. 
     
     
         17 . The method of  claim 12 , wherein the anti-CD6 monoclonal antibody is administered by parenteral delivery. 
     
     
         18 . The method of  claim 12 , further comprising combining the anti-CD6 monoclonal antibody with a pharmaceutically acceptable carrier. 
     
     
         19 . The method of  claim 12 , wherein the anti-CD6 monoclonal antibody is combined with a chemotherapeutic agent, an immunosuppressive agent, an anti-malarial drug, a cytotoxic agent, an integrin antagonist, a cytokine antagonist, or a hormone. 
     
     
         20 . The composition of  claim 12 , wherein the therapeutically effective amount is about 0.01 to about 100 mg/kg per subject body weight. 
     
     
         21 . The method of  claim 12 , wherein the anti-CD6 monoclonal antibody causes a reduction in pro inflammatory cytokines. 
     
     
         22 . The method of  claim 12 , wherein the subject does not have an autoimmune disease other than lupus. 
     
     
         23 - 25 . (canceled)