US2003103985A1PendingUtilityA1

Cytotoxic CD44 antibody immunoconjugates

Assignee: BOEHRINGER INGELHEIM INTPriority: May 18, 2001Filed: May 17, 2002Published: Jun 5, 2003
Est. expiryMay 18, 2021(expired)· nominal 20-yr term from priority
A61K 47/68033A61K 47/6849
51
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Claims

Abstract

The invention relates to novel conjugates of CD44 antibodies with cytotoxic compounds, pharmaceutical compositions comprising such compounds, and their use in tumor therapy.

Claims

exact text as granted — not AI-modified
What is claimed is:  
     
         1 . A compound of formula (I): 
       A(LB) n   
       wherein 
 A is an antibody molecule which is specific for CD44;  
 L is a linker moiety;  
 B is a compound which is toxic to cells; and  
 n is an decimal number with n=1 to 10.  
 
     
     
         2 . The compound of  claim 1  wherein said linker moiety comprises a chemical bond, wherein said chemical bond is cleavable inside a cell.  
     
     
         3 . The compound of  claim 2  wherein said chemical bond is a disulfide bond.  
     
     
         4 . The compound of  claims 1  to  3 , wherein the antibody molecule is specific for the exon v6 of human CD44.  
     
     
         5 . The compound of  claims 1  to  4 , wherein the antibody molecule is specific for an epitope within the amino acid sequence SEQ ID NO:3.  
     
     
         6 . The compound of  claims 1  to  5 , wherein the antibody molecule is the monoclonal antibody VFF-18 (DSM ACC2174) or a recombinant antibody having the complementary determining regions (CDRs) of VFF-18.  
     
     
         7 . The compound of  claims 1  to  6 , wherein the antibody molecule comprises light chains having the amino acid sequence SEQ ID NO:4, or SEQ ID NO:8, and heavy chains having the amino acid sequence SEQ ID NO:6.  
     
     
         8 . The compound of  claims 1  to  7 , wherein the toxic compound B is a maytansinoid.  
     
     
         9 . The compound of  claim 8  wherein the maytansinoid has the formula  
       
         
           
           
               
               
           
         
       
       wherein 
 R 1  represents H or SR 4 , wherein R 4  represents methyl, ethyl, linear alkyl, branched alkyl, cyclic alkyl, simple or substituted aryl, or heterocyclic;  
 R 2  represents Cl or H;  
 R 3  represents H or CH 3 ; and  
 m represents 1, 2, or 3.  
 
     
     
         10 . The compound of  claim 9 , wherein R 1  is H or CH 3 , R 2  is Cl, R 3  is CH 3 , and m=2  
     
     
         11 . The compound of  claims 1  to  10  of formula:  
       
         
           
           
               
               
           
         
       
       wherein 
 (A) is an antibody molecule which is specific for CD 44    
 (L′) is an optional linker moiety  
 p is a decimal number with p=1 to 10.  
 
     
     
         12 . The compound of  claims 1  to  11  wherein p is 3 to 4.  
     
     
         13 . A conjugate of a CD44v6 specific antibody molecule and a maytansinoid.  
     
     
         14 . The conjugate of  claim 13 , wherein the antibody molecule is specific for an epitope within the amino acid sequence SEQ ID NO:3.  
     
     
         15 . The conjugate of  claim 13 , wherein the antibody molecule is the monoclonal antibody VFF-18 (DSM ACC2174).  
     
     
         16 . The conjugate of  claim 13 , wherein the antibody molecule is a recombinant antibody having the complementary determining regions (CDRs) of VFF-18.  
     
     
         17 . The conjugate of  claim 13 , wherein the antibody molecule comprises light chains having the amino acid sequence SEQ ID NO:4 or SEQ ID NO:8, and heavy chains having the amino acid sequence SEQ ID NO:6.  
     
     
         18 . The conjugate of any one of  claims 13  to  17 , wherein the maytansinoid is linked to the antibody molecule by a disulfide moiety.  
     
     
         19 . A conjugate of a CD44v6 specific antibody molecule and a maytansinoid, wherein the maytansinoid has the formula:  
       
         
           
           
               
               
           
         
       
     
     
         20 . The conjugate of  claim 19 , wherein the antibody molecule is specific for an epitope within the amino acid sequence SEQ ID NO:3.  
     
     
         21 . The conjugate of  claim 19 , wherein the antibody molecule is the monoclonal antibody VFF-18 (DSM ACC2174).  
     
     
         22 . The conjugate of  claim 19 , wherein the antibody molecule is a recombinant antibody having the complementary determining regions (CDRs) of VFF-18.  
     
     
         23 . The conjugate of  claim 19 , wherein the antibody molecule comprises light chains having the amino acid sequence SEQ ID NO:4 or SEQ ID NO:8, and heavy chains having the amino acid sequence SEQ ID NO:6.  
     
     
         24 . A conjugate of a CD44v6 specific antibody molecule and a maytansinoid, wherein the antibody comprises light chains having the amino acid sequence SEQ ID NO:4, and heavy chains having the amino acid sequence SEQ ID NO:6, and wherein the maytansinoid has the formula:  
       
         
           
           
               
               
           
         
       
       and is linked to the antibody through a disulfide bond.  
     
     
         25 . The conjugate of any one of  claims 19  to  24 , wherein one or more maytansinoid residues are linked to an antibody molecule.  
     
     
         26 . The conjugate of  claim 25 , wherein 3 to 4 maytansinoid residues are linked to an antibody molecule.  
     
     
         27 . The conjugate of any one of  claims 19  to  24 , wherein the maytansinoid is linked to the antibody molecule through a —S—CH 2 CH 2 —CO—, a —S—CH 2 CH 2 CH 2 CH 2 —CO—, or a —S—CH(CH 3 )CH 2 CH 2 —CO— group.  
     
     
         28 . A pharmaceutical composition comprising a compound according to any one of  claims 1  to  12 , and a pharmaceutically acceptable carrier, diluent, or excipient.  
     
     
         29 . A pharmaceutical composition comprising a conjugate according to any one of  claims 13  to  17 , and a pharmaceutically acceptable carrier, diluent, or excipient.  
     
     
         30 . A pharmaceutical composition comprising a conjugate according to any one of  claims 19  to  24 , and a pharmaceutically acceptable carrier, diluent, or excipient.  
     
     
         31 . A method of treatment of cancer in a patient in need thereof comprising administering to the patient a therapeutically effective amount of a compound according to any one of  claims 1  to  12 .  
     
     
         32 . A method of treatment of cancer in a patient in need thereof comprising administering to the patient a therapeutically effective amount of a conjugate according to  claims 13  to  17 .  
     
     
         33 . A method of treatment of cancer in a patient in need thereof comprising administering to the patient a therapeutically effective amount of a conjugate according to  claims 19  to  24 .  
     
     
         34 . The method of  claim 31 , wherein the cancer is selected from the group consisting of: 
 head and neck squameous cell carcinoma, esophagus squameous cell carcinoma, lung squameous cell carcinoma, skin squameous cell carcinoma, cervix squameous cell carcinoma, breast adenocarcinoma, lung adenocarcinoma, pancreas adenocarcinoma, colon adenocarcinoma, and stomach adenocarcinoma.    
     
     
         35 . The method of  claim 32 , wherein the cancer is selected from the group consisting of: 
 head and neck squameous cell carcinoma, esophagus squameous cell carcinoma, lung squameous cell carcinoma, skin squameous cell carcinoma, cervix squameous cell carcinoma, breast adenocarcinoma, lung adenocarcinoma, pancreas adenocarcinoma, colon adenocarcinoma, and stomach adenocarcinoma    
     
     
         36 . The method of  claim 33 , wherein the cancer is selected from the group consisting of: 
 head and neck squameous cell carcinoma, esophagus squameous cell carcinoma, lung squameous cell carcinoma, skin squameous cell carcinoma, cervix squameous cell carcinoma, breast adenocarcinoma, lung adenocarcinoma, pancreas adenocarcinoma, colon adenocarcinoma, and stomach adenocarcinoma

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