US2003095967A1PendingUtilityA1

BAFF, inhibitors thereof and their use in the modulation of B-cell response and treatment of autoimmune disorders

47
Priority: Jan 25, 1999Filed: Nov 7, 2001Published: May 22, 2003
Est. expiryJan 25, 2019(expired)· nominal 20-yr term from priority
Inventors:Fabienne MackaySusan L. Kalled
A01K 2227/105A01K 2217/00A01K 2267/03C07K 16/2875A01K 67/0275A01K 2267/0325A01K 2267/0331A01K 2217/05A01K 2267/0368C07K 16/2878C07K 14/70575A61K 2039/505C12N 15/8509A01K 2267/0381A01K 67/0278A01K 2207/15A61K 38/00A01K 2267/0375A61P 35/00
47
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Claims

Abstract

The invention provides methods for treating or preventing disorders associated with expression of BAFF comprising BAFF and fragments thereof, antibodies, agonists and antagonists.

Claims

exact text as granted — not AI-modified
What is claimed is:  
     
         1 . A method of stimulating B-cell growth in an animal comprising the step of administering a therapeutically effective amount of a composition selected from the group consisting of: 
 (a) a BAFF ligand or an active fragment thereof;    (b) a BAFF ligand or an active fragment thereof and an anti-T antibody;    (c) a BAFF ligand or an active fragment thereof and a CD40 ligand; and    (d) a BAFF ligand or an active fragment thereof and an anti-CD40 ligand molecule.    
     
     
         2 . A method of stimulating immunoglobulin production in an animal comprising the step of administering a therapeutically effective amount of a composition selected from the group consisting of: 
 (a) a BAFF ligand or an active fragment thereof;    (b) a BAFF ligand or an active fragment thereof and an anti-T antibody;    (c) a BAFF ligand or an active fragment thereof and a CD40 ligand;    (d) a BAFF ligand or an active fragment thereof and an anti-CD40 ligand molecule.    
     
     
         3 . A method of co-stimulating B-cell growth and immunoglobulin production in an animal comprising the step of administering a therapeutically effective amount of a composition selected from the group consisting of: 
 (a) a BAFF ligand or an active fragment thereof;    (b) a BAFF ligand or an active fragment thereof and an anti-T antibody;    (c) a BAFF ligand or an active fragment thereof and a CD40 ligand; and    (d) a BAFF ligand or an active fragment thereof and an anti-CD40 ligand molecule.    
     
     
         4 . A method of stimulating dendritic cell-induced B-cell growth and maturation comprising the step of administering a therapeutically effective amount of a composition selected from the group consisting of: 
 (a) a BAFF ligand or an active fragment thereof;    (b) a BAFF ligand or an active fragment thereof and an anti-T antibody;    (c) a BAFF ligand or an active fragment thereof and a CD40 ligand; and    (d) a BAFF ligand or an active fragment thereof and an anti-CD40 ligand molecule.    
     
     
         5 . The method according to claims  1 - 4  wherein the BAFF ligand is a soluble BAFF ligand.  
     
     
         6 . The method according to  claim 5  wherein the soluble BAFF ligand is a recombinant BAFF ligand.  
     
     
         7 . The method according to claims  1 - 4  wherein the anti-CD40 molecule is a monoclonal antibody.  
     
     
         8 . The method according to claims  1 - 4  wherein the animal is of mammalian origin.  
     
     
         9 . The method according to  claim 8  wherein the mammal is human.  
     
     
         10 . A method of inhibiting B-cell growth in an animal comprising the step of administering a therapeutically effective amount of a composition selected from the group consisting of: 
 (a) a anti-BAFF ligand molecule or an active fragment thereof;    (b) a recombinant, inoperative BAFF ligand molecule or an active fragment thereof;    (c) an antibody specific for BAFF ligand or an active fragment thereof; and    (d) an antibody specific for BAFF ligand receptor or an epitope thereof.    
     
     
         11 . A method of inhibiting immunoglobulin production in an animal comprising the step of administering a therapeutically effective amount of a composition selected from the group consisting of: 
 (a) a anti-BAFF ligand molecule or an active fragment thereof;    (b) a recombinant, inoperative BAFF ligand molecule or an active fragment thereof;    (c) an antibody specific for BAFF ligand or an active fragment thereof; and    (d) an antibody specific for BAFF ligand receptor or an epitope thereof.    
     
     
         12 . A method of co-inhibiting B-cell growth and immunoglobulin production in an animal comprising the step of administering a therapeutically effective amount of a composition selected from the group consisting of: 
 (a) a anti-BAFF ligand molecule or an active fragment thereof;    (b) a recombinant, inoperative BAFF ligand molecule or an active fragment thereof;    (c) an antibody specific for BAFF ligand or an active fragment thereof; and    (d) an antibody specific for BAFF ligand receptor or an epitope thereof.    
     
     
         13 . A method of inhibiting dendritic cell-induced B-cell growth and maturation in an animal comprising the step of administering a therapeutically effective amount of a composition selected from the group consisting of: 
 (a) a anti-BAFF ligand molecule or an active fragment thereof;    (b) a recombinant, inoperative BAFF ligand molecule or an active fragment thereof;    (c) an antibody specific for BAFF ligand or an active fragment thereof; and    (d) an antibody specific for BAFF ligand receptor or an epitope thereof.    
     
     
         14 . The method according to claims  10 - 13 , wherein the anti-BAFF ligand is soluble.  
     
     
         15 . The method according to  claim 14 , wherein the soluble anti-BAFF ligand is a recombinant anti-BAFF ligand.  
     
     
         16 . The method according to claims  10 - 13 , wherein the anti-BAFF antibody is a monoclonal antibody. The method according to claims  10 - 13 , wherein the anti-BAFF receptor antibody is a monoclonal antibody.  
     
     
         17 . A method of treatment of an autoimmune disease comprising the step of administering a therapeutically effective amount of a composition selected from the group consisting of: 
 (a) a BAFF ligand or an active fragment thereof;    (b) a BAFF ligand or an active fragment thereof and an anti-T antibody;    (c) a BAFF ligand or an active fragment thereof and a CD40 ligand;    (d) a BAFF ligand or an active fragment thereof and an anti-CD40 ligand molecule;    (e) a anti-BAFF ligand molecule or an active fragment thereof;    (f) a recombinant, inoperative BAFF ligand molecule or an active fragment thereof;    (g) an antibody specific for BAFF ligand or an active fragment thereof; and    (h) an antibody specific for BAFF ligand receptor or an epitope thereof.    
     
     
         18 . A method of treating a disorder related to BAFF-ligand comprising the steps of: 
 (a) introducing into a desired cell a therapeutically effective amount of a vector containing a gene encoding for a BAFF-related molecule; and    (b) expressing said gene in said cell.    
     
     
         19 . The method according to  claim 18 , wherein the BAFF-related molecule is selected from the group consisting of: 
 (a) a BAFF ligand or an active fragment thereof;    (b) a BAFF ligand or an active fragment thereof and an anti-T antibody;    (c) a BAFF ligand or an active fragment thereof and a CD40 ligand;    (d) a BAFF ligand or an active fragment thereof and an anti-CD40 ligand molecule;    (e) a anti-BAFF ligand molecule or an active fragment thereof,    (f) a recombinant, inoperative BAFF ligand molecule or an active fragment thereof;    (g) an antibody specific for BAFF ligand or an active fragment thereof; and    (h) an antibody specific for BAFF ligand receptor or an epitope thereof.    
     
     
         20 . The method according to claims  17 - 19 , wherein the BAFF ligand is a soluble BAFF ligand.  
     
     
         21 . The method according to  claim 20 , wherein the soluble BAFF ligand is a recombinant BAFF ligand.  
     
     
         22 . The method according to claims  17 - 19 , wherein the anti-CD40 molecule is a monoclonal antibody.  
     
     
         23 . The method according to claims  17 - 19 , wherein the anti-BAFF ligand is soluble.  
     
     
         24 . The method according to  claim 23 , wherein the soluble anti-BAFF ligand is a recombinant anti-BAFF ligand.  
     
     
         25 . The method according to claims  17 - 19 , wherein the anti-BAFF antibody is a monoclonal antibody.  
     
     
         26 . The method according to claims  17 - 19 , wherein the anti-BAFF receptor antibody is a monoclonal antibody.  
     
     
         27 . A method of inducing cell death comprising the administration of an agent capable of interfering with the binding of a BAFF-ligand to a receptor.  
     
     
         28 . A method of treating, suppressing or altering an immune response involving a signaling pathway between a BAFF-ligand and its receptor comprising the step of administering an effective amount of an agent capable of interfering with the association between the BAFF-ligand and its receptor.  
     
     
         29 . A method of inhibiting inflammation comprising the step of administering a therapeutically effective amount of an antibody specific for a BAFF-ligand or an active fragment thereof.  
     
     
         30 . A method of inhibiting inflammation comprising the step of administering a therapeutically effective amount of an antibody specific for a BAFF-ligand receptor or an epitope thereof.  
     
     
         31 . A method of regulating hematopoietic cell development comprising the step of administering a therapeutically effective amount of a BAFF-ligand or an active fragment thereof.  
     
     
         32 . A method of treating, suppressing or altering an immune response involving a signaling pathway between a BAFF-ligand and its receptor comprising the step of administering an effective amount of an agent capable of interfering with the association between the BAFF-ligand and its receptor.  
     
     
         33 . A method of treating hypertension in an animal comprising the step of administering a therapeutically effective amount of a B-cell growth inhibitor.  
     
     
         34 . The method according to  claim 33 , wherein the B-cell growth inhibitor is selected from the group consisting of: 
 (e) (a) a anti-BAFF ligand molecule or an active fragment thereof;    (f) a recombinant, inoperative BAFF ligand molecule or an active fragment thereof;    (g) an antibody specific for BAFF ligand or an active fragment thereof; and    (h) an antibody specific for BAFF ligand receptor or an epitope thereof.    
     
     
         35 . The method according to  claim 34 , wherein the anti-BAFF ligand is soluble.  
     
     
         36 . The method according to  claim 35 , wherein the soluble anti-BAFF ligand is a recombinant anti-BAFF ligand.  
     
     
         37 . The method according to  claim 34 , wherein the anti-BAFF antibody is a monoclonal antibody.  
     
     
         38 . The method according to  claim 34 , wherein the anti-BAFF receptor antibody is a monoclonal antibody.  
     
     
         39 . The method according to  claim 34 , wherein the animal is of mammalian origin.  
     
     
         40 . The method according to  claim 39 , wherein the mammal is human.  
     
     
         41 . A method of treating hypertension in an animal comprising the step of administering a therapeutically effective amount of a co-inhibitor of B-cell growth and immunoglobulin secretion.  
     
     
         42 . A method of treating cardiovascular disorders in an animal comprising the step of administering a therapeutically effective amount of a B-cell growth inhibitor.  
     
     
         43 . A method of treating cardiovascular disorders in an animal comprising the step of administering a therapeutically effective amount of a co-inhibitor of B-cell growth and immunoglobulin production.  
     
     
         44 . A method of treating renal disorders in an animal comprising the step of administering a therapeutically effective amount of a B-cell growth inhibitor.  
     
     
         45 . A method of treating renal disorders in an animal comprising the step of administering a therapeutically effective amount of a co-inhibitor of B-cell growth and immunoglobulin production  
     
     
         46 . A method of treating B-cell lympho-proliferate disorders comprising the step of administering a therapeutically effective amount of a B-cell growth inhibitor.  
     
     
         47 . A method of stimulating B-cell production in the treatment of immunosuppressive diseases comprising the step of administering a therapeutically effective amount of a composition selected from the group consisting of: 
 (e) a BAFF ligand or an active fragment thereof;    (f) a BAFF ligand or an active fragment thereof and an anti-T antibody;    (g) a BAFF ligand or an active fragment thereof and a CD40 ligand;    (h) a BAFF ligand or an active fragment thereof and an anti-CD40 ligand molecule;    (i) a anti-BAFF ligand molecule or an active fragment thereof;    (j) a recombinant, inoperative BAFF ligand molecule or an active fragment thereof;    (k) an antibody specific for BAFF ligand or an active fragment thereof; and    (l) an antibody specific for BAFF ligand receptor or an epitope thereof.    
     
     
         48 . A method of stimulating B-cell production in the treatment of an immunosuppressive disease comprising the step of administering a therapeutically effective amount of a composition selected from the group consisting of: 
 (i) a BAFF ligand or an active fragment thereof;    (j) a BAFF ligand or an active fragment thereof and an anti-T antibody;    (k) a BAFF ligand or an active fragment thereof and a CD40 ligand;    (l) a BAFF ligand or an active fragment thereof and an anti-CD40 ligand molecule;    (m) a anti-BAFF ligand molecule or an active fragment thereof;    (n) a recombinant, inoperative BAFF ligand molecule or an active fragment thereof;    (o) an antibody specific for BAFF ligand or an active fragment thereof; and    
     
     
         49 . A method according to  claim 48  wherein the immunosuppressive disease is HIV.  
     
     
         50 . A method according to  claim 49  wherein the immunosuppressive disease is associated with an organ transplantation.  
     
     
         51 . A method for treating or reducing the advancement, severity or effects of Sjogren's syndrome in a patient comprising the step of administering a pharmaceutical composition comprising a therapeutically effective amount of a BAFF blocking agent and a pharmaceutically acceptable carrier.  
     
     
         52 . The method of  claim 51  wherein the BAFF blocking agent is selected from the group consisting of a soluble BAFF receptor molecule, an antibody directed against BAFF-ligand and an antibody directed against a BAFF receptor.  
     
     
         53 . The method of  claim 52  wherein the soluble BAFF receptor further comprises a human immunoglobulin Fc domain.  
     
     
         54 . The method of  claim 53  wherein the BAFF receptor is TACI.  
     
     
         55 . The method of  claim 53  wherein the BAFF receptor is BCMA.  
     
     
         56 . The method of  claim 53  wherein the BAFF receptor is BAFF R.  
     
     
         57 . The method of  claim 52  wherein the antibody directed against BAFF-ligand is a monoclonal antibody.  
     
     
         58 . The method of  claim 52  wherein the antibody directed against a BAFF receptor is a monoclonal antibody.  
     
     
         59 . The method of  claim 58  wherein the monoclonal antibody is directed against TACI.  
     
     
         60 . The method of  claim 58  wherein the monoclonal antibody is directed against BCMA.  
     
     
         61 . The method of  claim 58  wherein the monoclonal antibody is directed against BAFF R.

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