US2020247885A1PendingUtilityA1

P2x4 antibodies & uses thereof

50
Assignee: MEDIMMUNE LTDPriority: May 2, 2014Filed: Apr 6, 2020Published: Aug 6, 2020
Est. expiryMay 2, 2034(~7.8 yrs left)· nominal 20-yr term from priority
C07K 2317/92C07K 2317/622C07K 2317/56C07K 2317/21C07K 16/28C07K 2317/24C07K 2317/34C07K 2317/76A61P 25/04A61K 2039/505C07K 2317/565C07K 2317/75
50
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Claims

Abstract

The invention provides antibodies that specifically bind a P2X4 polypeptide and modulate P2X4 channel activity, recombinant P2X4 polypeptides and methods for generating such polypeptides, as well as compositions and methods for generating anti-P2X4 antibodies, and methods of using P2X4 antibodies for the treatment of neuropathic pain and other indications.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . An antibody or antigen binding fragment thereof that specifically binds a human P2X4 polypeptide and modulates channel activity. 
     
     
         2 . The antibody of  claim 1 , wherein the antibody is a P2X4 potentiator. 
     
     
         3 . The antibody of  claim 1 , wherein the antibody is a P2X4 antagonist. 
     
     
         4 . The antibody of  claim 1 , wherein the antibody binds an epitope comprising human P2X4 amino acids 110-166. 
     
     
         5 . The antibody of  claim 4 , wherein the antibody binds an epitope comprising one or more human P2X4 amino acids selected from the group consisting of amino acids 118, 122-139, 145, 159, 180, 183, 184, 231, and 244. 
     
     
         6 . The antibody of  claim 1 , wherein the antibody or fragment thereof comprises:
 a. a heavy chain variable region CDR1 comprising a sequence:   
       
         
           
                 
               
                   (SEQ ID NO: 1009) 
                 
                   X 1 X 2 X 3 X 4 X 5 , 
                 
             
                
                
               
            
           
         
       
       wherein
 X 1  is G, N, S, D, or R; 
 X 2  is Y, A, H, F, or S; 
 X 3  is A, W, Y, S, G, F, W, E, D, or P; 
 X 4  is M, I, W, L, I, F, or V; 
 X 5  is S, G, T, H, or N; and/or 
 b. a heavy chain variable region CDR2 comprising a sequence: 
 
       
         
           
                 
               
                   (SEQ ID NO: 1010) 
                 
                   X 1 X 2 X 3 X 4 X 5 X 6 X 7 X 8 X 9 X 10 X 11 X 12 X 13 X 14 X 15 X 16 , 
                 
             
                
                
               
            
           
         
       
       wherein
 X 1  is A, R, I, T, E, S, A, V, W, N, G, E, R, or Y; 
 X 2  is I or M; 
 X 3  is S, K, Y, D, N, W, or I; 
 X 4  is S, D, G, H, N, R, Y, or V; 
 X 5  is G, D, S, F, N, R, F, D, or T; 
 X 6  is G, S, N, or T; 
 X 7  is S, T, D, Y, N, A, E, M, F, or D; 
 X 8  is T, I, K, or A; 
 X 9  is Y, D, R, N, G, Q, E, H, or K; 
 X 10  is Y, Q, S, or V; 
 X 11  is A, S, N, or V; 
 X 12  is D, A, P, R, or Q; 
 X 13  is S, P, K, or N; 
 X 14  is V, F, L, or A; 
 X 15  is K, Q, or E; 
 X 16  is G, S, A, or D; 
 wherein the heavy chain variable region CDR2 optionally comprises an insertion of 1-3 amino acids, X a X b X c  between amino acids X 3  and X 4 , wherein 
 X a  is G, S, P, W, Y, E, A, R, or N; and 
 X b X c  are KT, respectively 
 and/or 
 c. a heavy chain variable region CDR3 comprising a sequence: 
 
       
         
           
                 
               
                   (SEQ ID NO: 1011) 
                 
                   X 1 X 2 X3X 4 X 5 X 6 X 7 X 8 , 
                 
             
                
                
               
            
           
         
         X 1  is E, N, D, R, K, G, S, A, Y, V, P, or H; 
         X 2  is E, L, R, Q, T, G, F, P, Y, K, A, S, V, or F; 
         X 3  is R, A, T, G, V, S, M, W, Y, D, H, N, E, L, or I; 
         X 4  is G, L, R, D, T, G, Y, S, E, F, Q, C, I, M, V, N, K, or P; 
         X 5  is S, G, Y, D, W, T, S, N, I, D, V, E, or C; 
         X 6  is Y, A, S, W, T, L, G, E, F, K, V, I, or D; 
         X 7  is D, E, or G; and 
         X 8  is Y, S, V, L, M, Q, I, S, I, H, F, or D; 
         wherein the heavy chain variable region CDR3 optionally comprises an insertion of 1-14 amino acids X a -X n  (SEQ ID NO: 1012), wherein 
         X a  is F, R, S, Y, L, D, G, V, I, T, or A; 
         X b  is G, R, Y, F, T, D, S, G, V, M, D, or R; 
         X c  is F, W, A, G, T, I, S, F, Y, C, L, V, R, or N; 
         X d  is S, F, M, G, Y, L, S, A, D, L, R, V, C, or S; 
         X e  is G, Y, S, T, P, F, Y, R, A, E, G, Q, N, or L; 
         X f  is Y, N, G, T, R, F, A, M, W, P, or V; 
         X g  is Y, M, S, V, F, A, P, S, D, R, H, P, E, or R 
         X h  is Y, G, M, F, G, P, V, F, H, T, or G, 
         X i  is T, I G, R, or F; 
         X j  is Y, G, H, or E; 
         X k  is Y, G, F, or N; 
         X 1  is F, or N; 
         X m  is Y; and 
         X n  is F. 
       
     
     
         7 . The antibody of  claim 1 , wherein the antibody or fragment thereof comprises,
 a. a light chain variable region CDR1 comprising a sequence:   
       
         
           
                 
               
                   (SEQ ID NO: 1013) 
                 
                   X 1 X 2 X 3 X 4 X 5 X 6 X 7 X 8 X 9 X 10 X 11 , 
                 
             
                
                
               
            
           
         
       
       wherein
 X 1  is T, G, R, S, or Q; 
 X 2  is G, A, or L; 
 X 3  is S, T, D, or H; 
 X 4  is S, N, K, A, Q, T, or V; 
 X 5  is G, I, L, S, or D; 
 X 6  is A, G, R, P, I, D, S, E, or T; 
 X 7  is G, N, M, D, K, S, R, Y, or T; 
 X 8  is Y, K, F, Q, S, N, Y, D, H, or R; 
 X 9  is D, N, Y, W, F, M, G, or S; 
 X 10  is V, A, L, I, G, or P; 
 X 11  is H, T, S, Y, A, Q, Y, N, or F; 
 wherein the light chain variable region CDR1 optionally comprises an insertion of between 1 and 3 amino acids X a -X c  between X 4  and X 5 , wherein 
 X a  is S or G; 
 X b  is N, D or S; and 
 X c  is I or V; 
 b. a light chain variable region CDR2 comprising a sequence: 
 
       
         
           
                 
               
                   (SEQ ID NO: 1014) 
                 
                   X 1 X 2 X 3 X 4 X 5 X 6 X 7 , 
                 
             
                
                
               
            
           
         
       
       wherein
 X 1  is G, Y, Q, K, N, D, R, A, or E; 
 X 2  is N, D, K, A, V, G, or T; 
 X 3  is N, S, T, I, K, Y, or D; 
 X 4  is N, D, Y, K, E, T, N, S, or Q; 
 X 5  is R, or L; 
 X 6  is P, E, A, S, or Q; 
 X 7  is S, P, or T; and/or 
 c. a light chain variable region CDR3 comprising a sequence: 
 
       
         
           
                 
               
                   (SEQ ID NO: 1015) 
                 
                   X 1 X 2 X 3 X 4 X 5 X 6 X 7 X 8 X 9 , 
                 
             
                
                
               
            
           
         
       
       wherein
 X 1  is Q, N, A, G, D, S, or L; 
 X 2  is S, V, A, Q, T, L, or H; 
 X 3  is Y, W, R, A, S, Q, T, or G; 
 X 4  is D, Y, I, N, M, or H; 
 X 5  is T, M, S, N, D, R, G, or K; 
 X 6  is N, T, S, G, F, L, or D; 
 X 7  is L, T, G, P, A, I, or N; 
 X 8  is K, W, V, I, P, G, L, R, or Y; and 
 X 9  is V, L, or T; 
 wherein the light chain variable region CDR3 optionally comprises an insertion of between 1 and 3 amino acids X a -X c  between X 7  and Xs, wherein 
 X a  is D, N, A, T, S, I or H; 
 X b  is H, Y, G, A, R, L, S, or P; and 
 X c  is S. 
 
     
     
         8 . The antibody of  claim 1 , wherein the antibody or fragment thereof comprises a V H  comprising:
 a. a heavy chain variable region CDR1 comprising the sequence: SX 1 AMS (SEQ ID NO: 1016) where X 1  is Y or F;   b. a heavy chain variable region CDR2 comprising the sequence: AISGSG XISTYYADSVKG (SEQ ID NO: 1017) where X 1  is S or G;   c. a heavy chain variable region CDR3 comprising the sequence:   X 1 X 2 DX 3 WSX 4 X 5 X 6 X 7 X 8 TAFDL (SEQ ID NO: 1018), where X 1  is H, D or Q; X 2  is W, M, F, H, or R; X 3  is W, Y or F; X 4  is T, N, G, or P; X 5  is R, A, S, G, or Y; X 6  is S, P, N or T; X 7  is G, S, R, or K: X 8  is P, M, A or L.   optionally in combination with a V L  comprising   a. a light chain variable region CDR1 comprising the sequence SGDALPRQYAY (SEQ ID NO: 1019)   b. a light chain variable region CDR2 comprising the sequence KDSX 1 RPS (SEQ ID NO: 1020) where X 1  is E or F.   c. a light chain variable region CDR3 comprising the sequence QSADSSGTYXIV (SEQ ID NO: 1021), where X 11 s V or A.   
     
     
         9 . The antibody of  claim 8 , wherein the antibody or fragment thereof comprises a V H  comprising:
 a. a heavy chain variable region CDR1 comprising the sequence: SFAMS (SEQ ID NO: 813);   b. a heavy chain variable region CDR2 comprising the sequence: AISGSG GSTYYADSVKG (SEQ ID NO: 814);   c. a heavy chain variable region CDR3 comprising the sequence:   
       
         
           
                 
               
                   (SEQ ID NO: 815) 
                 
                   QFDYWSTYSGPTAFDL; 
                 
             
                
                
               
            
           
         
         in combination with a V L  comprising 
         a. a light chain variable region CDR1 comprising the sequence SGDALPRQYAY (SEQ ID NO: 822) 
         b. a light chain variable region CDR2 comprising the sequence KDSERPS (SEQ ID NO: 823) 
         c. a light chain variable region CDR3 comprising the sequence QSADSSGTYVV (SEQ ID NO: 824). 
       
     
     
         10 . The antibody of  claim 1 , wherein the antibody or fragment thereof comprises:
 a. a heavy chain variable region CDR1 comprising a sequence:   
       
         
           
                 
               
                   (SEQ ID NO: 1022) 
                 
                   X 1 X 2 X 3 X 4 X 5 , 
                 
             
                
                
               
            
           
         
       
       wherein
 X 1  is S, N, D, T, or R; 
 X 2  is G, Y, or F; 
 X 3  is Y, H, S, G, D, or F; 
 X 4  is D, V, or I; 
 X 5  is N, H, C, R, S or is absent; 
 wherein the heavy chain variable region CDR1 optionally comprises amino acids X 6  and X 7 , which are V and S, respectively; 
 b. a heavy chain variable region CDR2 comprising a sequence: 
 
       
         
           
                 
               
                   (SEQ ID NO: 1023) 
                 
                   X 1 X 2 X 3 X 4 X 5 X 6 X 7 X 8 X 9 X 10 X 11 X 12 X 13 X 14 X 15 X 16 , 
                 
             
                
                
               
            
           
         
       
       wherein
 X 1  is M, V, L, I, A, G, or T; 
 X 2  is G or I; 
 X 3  is Y, W, N, or C; 
 X 4  is Y, G, D, or W; 
 X 5  is S, D, or E; 
 X 6  is G or D; 
 X 7  is S, Y, N, or I; 
 X 8  is T, P, or K; 
 X 9  is N, A, G, D, or V; 
 X 10  is Y or F; 
 X 11  is N; 
 X 12  is P, S, or E; 
 X 13  is S, A, or N; 
 X 14  is L or F; 
 X 15  is K; 
 X 16  is S, G, or N; 
 wherein the heavy chain variable region CDR2 optionally comprises an insertion of amino acids X a  and X b  between X 3  and X 4 , wherein X a  is I or P and X b  is S; 
 c. a heavy chain variable region CDR3 comprising a sequence: 
 
       
         
           
                 
               
                   (SEQ ID NO: 1024) 
                 
                   X 1 X 2 X 3 X 4 X 5 X 6 X 7 X 8 , 
                 
             
                
                
               
            
           
         
       
       wherein
 X 1  is G, S, A, or R; 
 X 2  is M, G, Y, S, L, R, or V; 
 X 3  is M, D, I, V, H, M, or S; 
 X 4  is V, Y, M, W, or S; 
 X 5  is L, Y, S or absent; 
 X 6  is I, D, V, T, G, S, Y, or absent; 
 X 7  is P, G, D, S, or A; and 
 X 8  is N, Y, or T; 
 wherein the heavy chain variable region CDR3 optionally comprises an insertion of between 1 and 6 amino acids of X a -X f  (SEQ ID NO: 1025) between X 6  and X 7 , wherein 
 X a  is G, T, D, or Y; 
 X b  is S, A, G, or F; 
 X c  is Y, V, P, or F; 
 X d  is Y or F; 
 X e  is Y; and 
 X f  is E, F, or G. 
 
     
     
         11 . The antibody of  claim 1 , wherein the antibody or fragment thereof comprises:
 a. a light chain variable region CDR1 comprising a sequence:   
       
         
           
                 
               
                   (SEQ ID NO: 1026) 
                 
                   X 1 X 2 X 3 X 4 X 5 X 6 X 7 X 8 X 9 X 10 X 11 , 
                 
             
                
                
               
            
           
         
       
       wherein
 X 1  is K, Q, or R; 
 X 2  is A or T; 
 X 3  is S, R, or N; 
 X 4  is K or Q; 
 X 5  is S, D, R, N, L, or I; 
 X 6  is I or S; 
 X 7  is T, G, V, or N; 
 X 8  is N, S, H, or K; 
 X 9  is Y or W; 
 X 10  is L, M, or I; 
 X 11  is A, S, or Y; 
 b. a light chain variable region CDR2 comprising a sequence: 
 
       
         
           
                 
               
                   (SEQ ID NO: 1027) 
                 
                   X 1 X 2 X 3 X 4 X 5 X 6 X 7 , 
                 
             
                
                
               
            
           
         
       
       wherein
 X 1  is S, D, E, or Y; 
 X 2  is G, A, or T; 
 X 3  is S or T; 
 X 4  is T, S, K, or A; 
 X 5  is L; 
 X 6  is Q, A, or V; 
 X 7  is S or D; 
 c. a light chain variable region CDR3 comprising a sequence: 
 
       
         
           
                 
               
                   (SEQ ID NO: 1028) 
                 
                   X 1 X 2 X 3 X 4 X 5 X 6 X 7 X 8 X 9 , 
                 
             
                
                
               
            
           
         
       
       wherein
 X 1  is Q, L, or H 
 X 2  is Q or K; 
 X 3  is Y, A, W, or T; 
 X 4  is Y, H, S, or D; 
 X 5  is E, S, R, T, or N; 
 X 6  is K, N, T, L, or H; 
 X 7  is P; 
 X 8  is Y, W, L, N, P, or R; 
 X 9  is T. 
 
     
     
         12 . A polynucleotide encoding the antibody or antigen binding fragment thereof of  claim 1 . 
     
     
         13 . A host cell comprising a vector comprising the polynucleotide of  claim 12 . 
     
     
         14 . A method for treating neuropathic pain, the method comprising administering to a patient in need thereof an effective amount of an antibody of  claim 1  or antigen binding fragment thereof. 
     
     
         15 . A method for the large scale production of a recombinant P2X4 polypeptide, the method comprising expressing a human P2X4 protein in an SF9 cell at 27° C. for 72 hours;
 extracting the P2X4 protein by solubilizing in a buffer comprising n-Dodecyl-beta-D-Maltoside, n-Dodecyl thio-Maltoside, CHAPS, and the Cholesteryl Hemisuccinate; 
 then isolating the solubilized protein. 
 
     
     
         16 . A pharmaceutical composition comprising one or more antibodies or antigen binding fragment thereof according to  claim 1  and a pharmaceutically acceptable excipient. 
     
     
         17 . A pharmaceutical composition comprising one or more antibodies or antigen binding fragment thereof according to  claim 8  and a pharmaceutically acceptable excipient. 
     
     
         18 . A polynucleotide encoding the antibody or antigen binding fragment thereof of  claim 8 . 
     
     
         19 . A host cell comprising a vector comprising the polynucleotide of  claim 18 . 
     
     
         20 . A method for treating neuropathic pain, the method comprising administering to a patient in need thereof an effective amount of an antibody of  claim 8  or antigen binding fragment thereof.

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