US2001010820A1PendingUtilityA1

Targeting of peg antibody conjugates to islet cells

23
Priority: Sep 21, 1995Filed: Dec 29, 1998Published: Aug 2, 2001
Est. expirySep 21, 2015(expired)· nominal 20-yr term from priority
Inventors:Harvey JacobsSung Wan KimVirginie Menard
A61P 3/10A61K 39/44A61K 47/6871A61P 3/00A61K 47/60C07K 16/40A61K 38/00C07K 2317/55
23
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Claims

Abstract

A method for delaying onset of insulin dependent diabetes mellitus (IDDM) in an individual predisposed to developing the disease is disclosed. The method comprises administering a composition comprising an immunologically effective monoclonal antibody or fragment thereof against glutamic acid decarboxylase (GAD) coupled to a nonimmunogenic hydrophilic polymer that provides a hydration shell around the monoclonal antibody for inhibiting immune recognition thereof. Poly(ethylene glycol) is a preferred polymer. A method of reducing insulitis in an IDDM patient and a composition therefor are also described.

Claims

exact text as granted — not AI-modified
We claim:  
     
         1 . A method for delaying onset of insulin dependent diabetes mellitus in an individual predisposed to developing the disease comprising administering to said individual an effective amount of a composition comprising (a) an immunologically active monoclonal antibody or fragment thereof against glutamic acid decarboxylase coupled to (b) a nonimmunogenic hydrophilic polymer that provides a hydration shell around said monoclonal antibody for inhibiting immune recognition thereof.  
     
     
         2 . The method of    claim 1    wherein said polymer is a poly(ethylene glycol).  
     
     
         3 . The method of    claim 2    wherein said poly(ethylene glycol) has a molecular weight in the range of about 200 to 8,000.  
     
     
         4 . The method of    claim 2    wherein said monoclonal antibody or fragment thereof is an F(ab′) fragment.  
     
     
         5 . The method of    claim 2    wherein said poly(ethylene glycol) is methoxy-poly(ethylene glycol).  
     
     
         6 . The method of    claim 5    wherein said monoclonal antibody or fragment thereof is an F(ab′) fragment.  
     
     
         7 . The method of    claim 2    wherein said monoclonal antibody or fragment thereof is covalently coupled to said poly(ethylene glycol).  
     
     
         8 . The method of    claim 7    wherein said monoclonal antibody or fragment thereof is covalently coupled to said poly(ethylene glycol) with a crosslinker.  
     
     
         9 . The method of    claim 8    wherein said crosslinker is sulfosuccinimidyl 4-(N-maleimidomethyl)cyclohexane-1-carboxylate).  
     
     
         10 . The method of    claim 9    wherein said monoclonal antibody or fragment thereof is an F(ab′) fragment.  
     
     
         11 . The method of    claim 1    wherein said monoclonal antibody or fragment thereof is against a GAD-65 isomer of glutamic acid decarboxylase.  
     
     
         12 . The method of    claim 11    wherein the monoclonal antibody or fragment thereof is derived from ATCC no. HB184.  
     
     
         13 . A method for reducing insulitis in beta cells of an individual predisposed to developing insulin dependent diabetes mellitus comprising administering to said individual an effective amount of a composition comprising (a) an immunologically active monoclonal antibody or fragment thereof against glutamic acid decarboxylase coupled to (b) a nonimmunogenic hydrophilic polymer that provides a hydration shell around said monoclonal antibody for inhibiting immune recognition thereof.  
     
     
         14 . The method of    claim 13    wherein said polymer is a poly(ethylene glycol).  
     
     
         15 . The method of    claim 14    wherein said poly(ethylene glycol) has a molecular weight in the range of about 200 to 8,000.  
     
     
         16 . The method of    claim 14    wherein said monoclonal antibody or fragment thereof is an F(ab′) fragment.  
     
     
         17 . The method of    claim 14    wherein said poly(ethylene glycol) is methoxy-poly(ethylene glycol).  
     
     
         18 . The method of    claim 17    wherein said monoclonal antibody or fragment thereof is an F(ab′) fragment.  
     
     
         19 . The method of    claim 14    wherein said monoclonal antibody or fragment thereof is covalently coupled to said poly(ethylene glycol).  
     
     
         20 . The method of    claim 19    wherein said monoclonal antibody or fragment thereof is covalently coupled to said poly(ethylene glycol) with a crosslinker.  
     
     
         21 . The method of    claim 20    wherein said crosslinker is sulfosuccinimidyl  4 -(N-maleimidomethyl)cyclohexane-1-carboxylate).  
     
     
         22 . The method of    claim 21    wherein said monoclonal antibody or fragment thereof is an F(ab′) fragment.  
     
     
         23 . The method of    claim 13    wherein said monoclonal antibody or fragment thereof is against a GAD-65 isomer of glutamic acid decarboxylase.  
     
     
         24 . The method of    claim 23    wherein the monoclonal antibody or fragment thereof is derived from ATCC no. HB184.  
     
     
         25 . A composition for delaying onset of insulin dependent diabetes mellitus in an individual predisposed to developing the disease comprising (a) an immunologically active monoclonal antibody or fragment thereof against glutamic acid decarboxylase coupled to (b) a nonimmunogenic hydrophilic polymer that provides a hydration shell around said monoclonal antibody for inhibiting immune recognition thereof.  
     
     
         26 . The composition of    claim 25    wherein said polymer is a poly(ethylene glycol).  
     
     
         27 . The composition of    claim 26    wherein said poly(ethylene glycol) has a molecular weight in the range of about 200 to 8,000.  
     
     
         28 . The composition of    claim 26    wherein said monoclonal antibody or fragment thereof is an F(ab′) fragment.  
     
     
         29 . The composition of    claim 26    wherein said poly(ethylene glycol) is methoxy-poly(ethylene glycol).  
     
     
         30 . The composition of    claim 29    wherein said monoclonal antibody or fragment thereof is an F(ab′) fragment.  
     
     
         31 . The composition of    claim 26    wherein said monoclonal antibody or fragment thereof is covalently coupled to said poly(ethylene glycol).  
     
     
         32 . The composition of    claim 31    wherein said monoclonal antibody or fragment thereof is covalently coupled to said poly(ethylene glycol) with a crosslinker.  
     
     
         33 . The composition of    claim 32    wherein said crosslinker is sulfosuccinimidyl 4-(N-maleimidomethyl)cyclohexane-1-carboxylate).  
     
     
         34 . The composition of    claim 33    wherein said monoclonal antibody or fragment thereof is an F(ab′) fragment.  
     
     
         35 . The composition of    claim 25    wherein said monoclonal antibody or fragment thereof is against a GAD-65 isomer of glutamic acid decarboxylase.  
     
     
         36 . The composition of    claim 35    wherein the monoclonal antibody or fragment thereof is derived from ATCC no. HB184.

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