US2003129251A1PendingUtilityA1

Biodegradable immunomodulatory formulations and methods for use thereof

51
Priority: Mar 10, 2000Filed: Mar 9, 2001Published: Jul 10, 2003
Est. expiryMar 10, 2020(expired)· nominal 20-yr term from priority
Inventors:Gary Van NestStephen Tuck
A61P 43/00A61P 37/02A61P 37/08A61P 31/06A61P 31/04A61P 35/00A61P 33/10A61P 29/00A61P 31/12A61P 33/02A61P 27/14A61P 31/00A61P 27/16Y10T428/2982A61K 9/167A61K 47/6925A61P 11/00A61K 9/1647A61K 9/1075A61K 9/1617A61P 1/04A61P 13/12A61P 11/06A61P 17/00Y02A50/30
51
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Claims

Abstract

The invention provides new compositions and methods for immunomodulation of individuals. Immunomodulation is accomplished by administration of immunomodulatory polynucleotide/microcarrier (IMP/MC) complexes. The IMP/MC complexes may be covalently or non-covalently bound, and feature a polynucleotide comprising at least one immunostimulatory sequence bound to a biodegradable microcarrier or nanocarrier.

Claims

exact text as granted — not AI-modified
What is claimed is:  
     
         1 . An immunomodulatory polynucleotide/microcarrier (IMP/MC) complex, comprising: 
 a polynucleotide comprising an immunostimulatory sequence (ISS) linked to a biodegradable microcarrier (MC), wherein the ISS comprises the sequence 5′-C, G-3′ and wherein said MC is less than 10 μm in size.    
     
     
         2 . The IMP/MC complex of  claim 1 , wherein said polynucleotide is covalently linked to said microcarrier.  
     
     
         3 . The IMP/MC complex of  claim 1 , wherein said polynucleotide is non-covalently linked to said microcarrier.  
     
     
         4 . The IMP/MC complex of  claim 1 , wherein said microcarrier is a liquid phase microcarrier.  
     
     
         5 . The IMP/MC complex of  claim 1 , wherein said microcarrier is a solid phase microcarrier.  
     
     
         6 . The IMP/MC complex of  claim 1 , wherein said microcarrier is from 25 nm to 5 μm in size.  
     
     
         7 . The IMP/MC complex of  claim 6 , wherein said microcarrier is from 1.0 μm to 2.0 μm in size.  
     
     
         8 . The IMP/MC complex of  claim 7 , wherein said microcarrier is 1.4 μm in size.  
     
     
         9 . The IMP/MC complex of  claim 7 , wherein said microcarrier is cationic.  
     
     
         10 . The IMP/MC complex of  claim 1 , wherein said complex is antigen-free.  
     
     
         11 . The IMP/MC complex of  claim 1 , wherein the ISS comprises the sequence 5′-T, C, G-3′.  
     
     
         12 . The IMP/MC complex of  claim 1 , wherein the ISS comprises the sequence 5′-C, G, pyrimidine, pyrimidine, C, G-3′.  
     
     
         13 . The IMP/MC complex of  claim 1 , wherein the ISS comprises the sequence 5′-purine, purine, C, G, pyrimidine, pyrimidine, C, G-3′.  
     
     
         14 . The IMP/MC complex of  claim 1 , wherein the ISS comprises the sequence SEQ ID NO:1.  
     
     
         15 . A method of modulating an immune response in an individual comprising administering to an individual an immunomodulatory polynucleotide/microcarrier (IMP/MC) complex, said complex comprising a polynucleotide comprising an immunostimulatory sequence (ISS) linked to a biodegradable microcarrier (MC), wherein the ISS comprises the sequence 5′-C, G-3′ and wherein said MC is less than 10 μm in size, in an amount sufficient to modulate an immune response in said individual.  
     
     
         16 . The method of  claim 15 , wherein said microcarrier is a solid phase microcarrier.  
     
     
         17 . The method of  claim 15 , wherein said microcarrier is a liquid phase microcarrier.  
     
     
         18 . The method of  claim 15 , wherein the IMP/MC complex is covalently linked.  
     
     
         19 . The method of  claim 15 , wherein the IMP/MC complex is non-covalently linked.  
     
     
         20 . The method of  claim 15 , wherein said complex is antigen-free.  
     
     
         21 . The method of  claim 15 , wherein a Th1-type immune response is stimulated.  
     
     
         22 . The method of  claim 15 , wherein a Th2-type immune response is suppressed.  
     
     
         23 . The method of  claim 15 , wherein the ISS comprises the sequence 5′-T, C, G-3′.  
     
     
         24 . The method of  claim 15 , wherein the ISS comprises the sequence 5′-C, G, pyrimidine, pyrimidine, C, G-3′.  
     
     
         25 . The IMP/MC complex of  claim 15 , wherein the ISS comprises the sequence 5′-purine, purine, C, G, pyrimidine, pyrimidine, C, G-3′.  
     
     
         26 . The IMP/MC complex of  claim 15 , wherein the ISS comprises the sequence SEQ ID NO:1.  
     
     
         27 . A method of increasing interferon-gamma (IFN-γ) in an individual, comprising: 
 administering an effective amount of an immunomodulatory polynucleotide/microcarrier (IMP/MC) complex to said individual, said complex comprising a polynucleotide comprising an immunostimulatory sequence (ISS) linked to a biodegradable microcarrier (MC), wherein the ISS comprises the sequence 5′-C, G-3′, wherein said MC is less than 10 μm in size and wherein an effective amount is an amount sufficient to increase IFN-γ in said individual.  
 
     
     
         28 . The method of  claim 27 , wherein said microcarrier is a solid phase microcarrier.  
     
     
         29 . The method of  claim 27 , wherein said microcarrier is a liquid phase microcarrier.  
     
     
         30 . The method of  claim 27 , wherein the IMP/MC complex is covalently linked.  
     
     
         31 . The method of  claim 27 , wherein the IMP/MC complex is non-covalently linked.  
     
     
         32 . The method of  claim 27 , wherein said complex is antigen-free.  
     
     
         33 . The method of  claim 27 , wherein the ISS comprises the sequence 5′-T, C, G-3′.  
     
     
         34 . The method of  claim 27 , wherein the ISS comprises the sequence 5′-C, G, pyrimidine, pyrimidine, C, G-3′.  
     
     
         35 . The IMP/MC complex of  claim 27 , wherein the ISS comprises the sequence 5′-purine, purine, C, G, pyrimidine, pyrimidine, C, G-3′.  
     
     
         36 . The IMP/MC complex of  claim 27 , wherein the ISS comprises the sequence SEQ ID NO:1.  
     
     
         37 . A method of increasing interferon-alpha (IFN-α) in an individual, comprising: 
 administering an effective amount of an immunomodulatory polynucleotide/microcarrier (IMP/MC) complex to said individual, said complex comprising a polynucleotide comprising an immunostimulatory sequence (ISS) linked to a biodegradable microcarrier (MC), wherein the ISS comprises the sequence 5′-C, G-3′, wherein said MC is less than 10 μm in size and wherein an effective amount is an amount sufficient to increase IFN-α in said individual.  
 
     
     
         38 . The method of  claim 37 , wherein said individual has a viral infection.  
     
     
         39 . The method of  claim 37 , wherein said microcarrier is a solid phase microcarrier.  
     
     
         40 . The method of  claim 37 , wherein said microcarrier is a liquid phase microcarrier.  
     
     
         41 . The method of  claim 37 , wherein the IMP/MC complex is covalently linked.  
     
     
         42 . The method of  claim 37 , wherein the IMP/MC complex is non-covalently linked.  
     
     
         43 . The method of  claim 37 , wherein said complex is antigen-free.  
     
     
         44 . The method of  claim 37 , wherein the ISS comprises the sequence 5′-T, C, G-3′.  
     
     
         45 . The method of  claim 37 , wherein the ISS comprises the sequence 5′-C, G, pyrimidine, pyrimidine, C, G-3′.  
     
     
         46 . The IMP/MC complex of  claim 37 , wherein the ISS comprises the sequence 5′-purine, purine, C, G, pyrimidine, pyrimidine, C, G-3′.  
     
     
         47 . The IMP/MC complex of  claim 37 , wherein the ISS comprises the sequence SEQ ID NO:1.  
     
     
         48 . A method of reducing levels of IgE in an individual, comprising: 
 administering an effective amount of an immunomodulatory polynucleotide/microcarrier (IMP/MC) complex to said individual, said complex comprising a polynucleotide comprising an immunostimulatory sequence (ISS) linked to a biodegradable microcarrier (MC), wherein the ISS comprises the sequence 5′-C, G-3′, wherein said MC is less than 10 μm in size and wherein an effective amount is an amount sufficient to reducing levels of IgE in said individual.    
     
     
         49 . The method of  claim 48 , wherein said microcarrier is a solid phase microcarrier.  
     
     
         50 . The method of  claim 48 , wherein said microcarrier is a liquid phase microcarrier.  
     
     
         51 . The method of  claim 48 , wherein the IMP/MC complex is covalently linked.  
     
     
         52 . The method of  claim 48 , wherein the IMP/MC complex is non-covalently linked.  
     
     
         53 . The method of  claim 48 , wherein said complex is antigen-free.  
     
     
         54 . The method of  claim 48 , wherein the ISS comprises the sequence 5′-T, C, G-3′.  
     
     
         55 . The method of  claim 48 , wherein the ISS comprises the sequence 5′-C, G, pyrimidine, pyrimidine, C, G-3′.  
     
     
         56 . The IMP/MC complex of  claim 48 , wherein the ISS comprises the sequence 5′-purine, purine, C, G, pyrimidine, pyrimidine, C, G-3′.  
     
     
         57 . The IMP/MC complex of  claim 48 , wherein the ISS comprises the sequence SEQ ID NO:1.  
     
     
         58 . A kit, comprising: 
 a container comprising an immunomodulatory polynucleotide/microcarrier (IMP/MC) complex, wherein the ISS comprises the sequence 5′-C, G-3′, wherein said MC is a biodegradable MC and wherein said MC is less than 10 μm in size; and instructions for use of IMP/MC complex in immunodulation of an individual.    
     
     
         59 . The kit of  claim 58 , wherein said polynucleotide is covalently linked to said microcarrier.  
     
     
         60 . The kit of  claim 58 , wherein said polynucleotide is non-covalently linked to said microcarrier.  
     
     
         61 . The kit of  claim 58 , wherein said microcarrier is a liquid phase microcarrier.  
     
     
         62 . The kit of  claim 58 , wherein said microcarrier is a solid phase microcarrier.  
     
     
         63 . The kit of  claim 58 , wherein said microcarrier is from 25 nm to 5 μm in size.  
     
     
         64 . The kit of  claim 63 , wherein said microcarrier is from 1.0 μm to 2.0 μm in size.  
     
     
         65 . The kit of  claim 64 , wherein said microcarrier is 1.4 μm in size.  
     
     
         66 . The kit of  claim 58 , wherein said microcarrier is cationic.  
     
     
         67 . The kit of  claim 58 , wherein said complex is antigen-free.  
     
     
         68 . The kit of  claim 58 , wherein the ISS comprises the sequence 5′-T, C, G-3′.  
     
     
         69 . The kit of  claim 58 , wherein the ISS comprises the sequence 5′-C, G, pyrimidine, pyrimidine, C, G-3′.  
     
     
         70 . The kit of  claim 58 , wherein the ISS comprises the sequence 5′-purine, purine, C, G, pyrimidine, pyrimidine, C, G-3′.  
     
     
         71 . The kit of  claim 58 , wherein the ISS comprises the sequence SEQ ID NO:1.

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