US2013045201A1PendingUtilityA1

Methods of using anti-pd-l1 antibodies and their use to enhance t-cell function to treat tumor immunity

Assignee: GENENTECH INCPriority: Dec 9, 2008Filed: May 23, 2012Published: Feb 21, 2013
Est. expiryDec 9, 2028(~2.4 yrs left)· nominal 20-yr term from priority
A61P 43/00A61P 37/02A61P 37/04A61P 31/04A61P 37/00A61P 31/00A61P 31/10A61P 33/02A61P 31/12A61P 35/00A61P 33/00C07K 16/1145A61K 31/7068C07K 2317/76C07K 16/22A61K 2039/507A61K 2039/505C07K 2317/56A61K 39/39558C07K 2317/14C07K 2317/52C07K 16/2827C07K 2317/74C07K 2317/24C07K 2317/73C07K 2317/565C07K 16/28A61K 39/3955C07K 2317/92C07K 2317/567A61K 45/06C07K 16/30C07K 16/3046C07K 2317/71A61K 39/00Y02A50/30A61K 2300/00
62
PatentIndex Score
0
Cited by
0
References
0
Claims

Abstract

The present application relates to methods of using anti-PD-L1 antibodies to enhance T-cell function to upregulate cell-mediated immune responses and for the treatment of T cell dysfunctional disorders, including infection (e.g., acute and chronic) and tumor immunity.

Claims

exact text as granted — not AI-modified
1 . A method of treating a T-cell dysfunctional disorder resulting from tumor immunity comprising administering an effective amount of an anti-PD-L1 antibody or antigen binding fragment thereof, wherein the antibody or antibody fragment comprises a heavy chain and a light chain variable region sequence, wherein:
 (a) the heavy chain comprises an HVR-H1, HVR-H2 and HVR-H3, wherein further:   
       
         
           
                 
                 
               
                     
                   (i) 
                 
                     
                   the HVR-H1 sequence is 
                 
                     
                   (SEQ ID NO: 1) 
                 
                     
                   GFTFSX 1 SWIH; 
                 
                     
                     
                 
                     
                   (ii) 
                 
                     
                   the HVR-H2 sequence is 
                 
                     
                   (SEQ ID NO: 2) 
                 
                     
                   AWIX 2 PYGGSX 3 YYADSVKG; 
                 
                     
                     
                 
                     
                   (iii) 
                 
                     
                   the HVR-H3 sequence is 
                 
                     
                   (SEQ ID NO: 3) 
                 
                     
                   RHWPGGFDY,; 
                 
                     
                   and 
                 
             
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
               
            
           
         
         (b) the light chain comprises an HVR-L1, HVR-L2 and HVR-L3, wherein further: 
       
       
         
           
                 
                 
               
                     
                   (iv) 
                 
                     
                   the HVR-L1 sequence is 
                 
                     
                   (SEQ ID NOs: 8) 
                 
                     
                   RASQX 4 X 5 X 6 TX 7 X 8 A; 
                 
                     
                     
                 
                     
                   (v) 
                 
                     
                   the HVR-L2 sequence is 
                 
                     
                   (SEQ ID NOs: 9) 
                 
                     
                   SASX 9 LX 10 S; 
                 
                     
                     
                 
                     
                   (vi) 
                 
                     
                   the HVR-L3 sequence is 
                 
                     
                   (SEQ ID NOs: 10) 
                 
                     
                   QQX 11 X 12 X 13 X 14 PX 15 T; 
                 
             
                
                
                
                
                
                
                
                
                
                
                
                
                
                
               
            
           
         
         wherein: X 1  is D or G; X 2  is S or L; X 3  is T or S; X 4  may be D or V; X 5  may be V or I; X 6  may be S or N; X 7  may be A or F; X 8  may be V or L; X 9  may be F or T; X 10  may be Y or A; X 11  may be Y, G, F, or S; X 12  may be L, Y, F or W; X 13  may be Y, N, A, T, G, F or I; X 14  may be H, V, P, T or I; X 15  may be A, W, R, P or T. 
       
     
     
         2 . The method of  claim 1  wherein X 1  is D; X 2  is S and X 3  is T. 
     
     
         3 . The method of  claim 1 , wherein X 4 =D, X 5 =V, X 6 =5, X 7 =A and X 8 =V, X 9 =F, and X 10 =Y, X 11 =Y, X 12 =L, X 13 =Y, X 14 =H and X 15 =A. 
     
     
         4 . The method of  claim 1 , wherein X 1 =D, X 2 =S and X 3 =T, X 4 =D, X 5 =V, X 6 =S, X 7 =A and X 8 =V, X 9 =F, and X 10 =Y, X 11 =Y, X 12 =L, X 13 =Y, X 14 =H and X 15 =A. 
     
     
         5 . The method of  claim 4 , wherein the encoded variable region heavy chain framework sequences are juxtaposed between the HVRs according to the formula: (HC-FR1)-(HVR-H1)-(HC-FR2)-(HVR-H2)-(HC-FR3)-(HVR-H3)-(HC-FR4) and/or the encoded variable region light chain framework sequences juxtaposed between the HVRs according to the formula: (LC-FR1)-(HVR-L1)-(LC-FR2)-(HVR-L2)-(LC-FR3)-(HVR-L3)-(LC-FR4). 
     
     
         6 . The method of  claim 5 , wherein the framework sequences are human. 
     
     
         7 . The method of  claim 6  wherein the variable heavy chain framework sequences are VH subgroup III consensus framework. 
     
     
         8 . The method of  claim 6  wherein the variable region light chain framework sequences are VL kappa I consensus framework. 
     
     
         9 . The method of  claim 7  wherein one or more of the heavy chain framework sequences is the following: 
       
         
           
                 
                 
               
                     
                   HC-FR1 is 
                 
                     
                   (SEQ ID NO: 4) 
                 
                     
                   EVQLVESGGGLVQPGGSLRLSCAAS; 
                 
                     
                     
                 
                     
                   HC-FR2 is 
                 
                     
                   (SEQ ID NO: 5) 
                 
                     
                   WVRQAPGKGLEWV; 
                 
                     
                     
                 
                     
                   HC-FR3 is 
                 
                     
                   (SEQ ID NO: 6) 
                 
                     
                   RFTISADTSKNTAYLQMNSLRAEDTAVYYCAR; 
                 
                     
                     
                 
                     
                   HC-FR4 is 
                 
                     
                   (SEQ ID NO: 7) 
                 
                     
                   WGQGTLVTVSA. 
                 
             
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
               
            
           
         
       
     
     
         10 . The method of  claim 8  wherein one or more of the light chain framework sequences is the following: 
       
         
           
                 
                 
               
                     
                   LC-FR1 is 
                 
                     
                   (SEQ ID NO: 11) 
                 
                     
                   DIQMTQSPSSLSASVGDRVTITC; 
                 
                     
                     
                 
                     
                   LC-FR2 is 
                 
                     
                   (SEQ ID NO: 12) 
                 
                     
                   WYQQKPGKAPKLLIY; 
                 
                     
                     
                 
                     
                   LC-FR3 is 
                 
                     
                   (SEQ ID NO: 13) 
                 
                     
                   GVPSRFSGSGSGTDFTLTISSLQPEDFATYYC,; 
                 
                     
                   and 
                 
                     
                     
                 
                     
                   LC-FR4 is 
                 
                     
                   (SEQ ID NO: 14) 
                 
                     
                   FGQGTKVEIKR. 
                 
             
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
               
            
           
         
       
     
     
         11 . The method of  claim 6  wherein:
 (a) one or more of the heavy chain framework sequences is the following: 
 
       
         
           
                 
                 
               
                     
                   HC-FR1 is 
                 
                     
                   (SEQ ID NO: 4) 
                 
                     
                   EVQLVESGGGLVQPGGSLRLSCAAS; 
                 
                     
                     
                 
                     
                   HC-FR2 is 
                 
                     
                   (SEQ ID NO: 5) 
                 
                     
                   WVRQAPGKGLEWV; 
                 
                     
                     
                 
                     
                   HC-FR3 is 
                 
                     
                   (SEQ ID NO: 6) 
                 
                     
                   RFTISADTSKNTAYLQMNSLRAEDTAVYYCAR; 
                 
                     
                     
                 
                     
                   HC-FR4 is 
                 
                     
                   (SEQ ID NO: 7) 
                 
                     
                   WGQGTLVTVSA; 
                 
                     
                   and 
                 
             
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
               
            
           
         
         (b) one or more of the light chain framework sequences is the following: 
       
       
         
           
                 
                 
               
                     
                   LC-FR1 is 
                 
                     
                   (SEQ ID NO: 11) 
                 
                     
                   DIQMTQSPSSLSASVGDRVTITC; 
                 
                     
                     
                 
                     
                   LC-FR2 is 
                 
                     
                   (SEQ ID NO: 12) 
                 
                     
                   WYQQKPGKAPKLLIY; 
                 
                     
                     
                 
                     
                   LC-FR3 is 
                 
                     
                   (SEQ ID NO: 13) 
                 
                     
                   GVPSRFSGSGSGTDFTLTISSLQPEDFATYYC;, 
                 
                     
                   and 
                 
                     
                     
                 
                     
                   LC-FR4 is 
                 
                     
                   (SEQ ID NO: 14) 
                 
                     
                   FGQGTKVEIKR. 
                 
             
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
               
            
           
         
       
     
     
         12 . The method of  claim 11  further comprising a human constant region. 
     
     
         13 . The method of  claim 12 , wherein the constant region is selected from the group consisting of IgG1, IgG2, IgG3 and IgG4. 
     
     
         14 . The method of  claim 13 , wherein the constant region is IgG1. 
     
     
         15 . The method of  claim 14  having reduced or minimal effector function. 
     
     
         16 . The method of  claim 15 , wherein the minimal effector function results from an effector-less Fc mutation. 
     
     
         17 . The method of  claim 16 , wherein the effector-less Fc mutation is N297A. 
     
     
         18 . The method of  claim 16 , wherein the effector-less Fc mutation is D265A/N297A. 
     
     
         19 . The method of  claim 15 , wherein the minimal effector function results from aglycosylation. 
     
     
         20 . A method of treating tumor immunity comprising administering to a patient a composition comprising a pharmaceutically-acceptable carrier and therapeutically effective amount of an anti-PD-L1 antibody or antigen binding fragment thereof, wherein the antibody or antibody fragment comprises a heavy chain and light chain variable region sequence, wherein:
 (a) the heavy chain comprises the sequence: EVQLVESGGGLVQPGGSLRLS CAASGFTFSDSWIHWVRQAPGKGLEWVAWISPYGGSTYYADSVKGRFTI SADTSKNTAYLQMNSLRAEDTAVYYCARRHWPGGFDYWGQGTLVTVS A (SEQ ID NO:20), and   (b) the light chain comprises the sequence: DIQMTQSPSSLSASVGDRVTITC RASQDVSTAVAWYQQKPGKAPKLLIYSASFLYSGVPSRFSGSGSGTDFTL TISSLQPEDFATYYCQQYLYHPATFGQGTKVEIKR (SEQ ID NO:21).   
     
     
         21 . The method of  claim 20  wherein the antibody further comprises a human constant region. 
     
     
         22 . The method of  claim 21 , wherein the constant region is selected from the group consisting of IgG1, IgG2, IgG3 and IgG4. 
     
     
         23 . The method of  claim 22 , wherein the constant region is IgG1. 
     
     
         24 . The method of  claim 23  having reduced or minimal effector function. 
     
     
         25 . The nucleic acid of  claim 24 , wherein the minimal effector function results from an effector-less Fc mutation. 
     
     
         26 . The method of  claim 25 , wherein the effector-less Fc mutation is N297A. 
     
     
         27 . The method of  claim 25 , wherein the effector-less Fc mutation is D265A/N297A. 
     
     
         28 . The method of  claim 24 , wherein the minimal effector function results from aglycosylation. 
     
     
         29 . The method of  claims 20 - 28 , further comprising the administration of a vaccine. 
     
     
         30 . The method of  claims 20 - 28 , further comprising the administration of a chemotherapeutic agent. 
     
     
         31 . The method of  claims 20 - 28 , wherein the tumor immunity results from a cancer selected from the group consisting of breast, lung, colon, ovarian, melanoma, bladder, kidney, liver, saliary, stomach, gliomas, thyroid, thymic, epithelial, head and neck, gastric and pancreatic. 
     
     
         32 . The method of  claim 30 , wherein the tumor immunity results from a cancer selected from the group consisting of breast, lung, colon, ovarian, melanoma, bladder, kidney, liver, saliary, stomach, gliomas, thyroid, thymic, epithelial, head and neck, gastric and pancreatic. 
     
     
         33 . The method of  claim 30 , wherein the chemotherapeutic agent is an anti-VEGF antibody. 
     
     
         34 . The method of  claim 30 , wherein the chemotherapeutic agent is FOLFOX. 
     
     
         35 . The method of  claim 34 , wherein FOLFOX is a combination of oxaliplatin, 5-fluorouracil and leucovovin. 
     
     
         36 . The method of  claim 30 , wherein the chemotherapeutic agent is oxaliplatin. 
     
     
         37 . The method of  claim 30 , wherein the chemotherapeutic agent is a RAF inhibitor.

Join the waitlist — get patent alerts

Track US2013045201A1 — get alerts on status changes and closely related new filings.

We store only your email — no account needed. See our privacy policy.