US2004146504A1PendingUtilityA1

Anti-IgE vaccines

56
Assignee: PFIZERPriority: Aug 30, 2000Filed: Jan 5, 2004Published: Jul 29, 2004
Est. expiryAug 30, 2020(expired)· nominal 20-yr term from priority
Inventors:Mohamad MorseyMichael G. SheppardDavid W. Wheeler
A61P 37/08A61P 37/02A61P 37/00A61P 27/14A61P 27/02A61P 11/02A61P 1/04Y10S435/81C07K 2317/52A61K 2039/505A61P 13/12C07K 2319/00A61P 1/00Y10S530/868Y10S424/805A61K 39/0008A61P 11/06C07K 16/00A61K 39/00
56
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Claims

Abstract

The present invention provides compositions and methods for the use of antigenic peptides derived from the Fc portion of the epsilon heavy chain of an IgE molecule as vaccines for the treatment and prevention of IgE-mediated allergic disorders. In particular, the invention provides compositions, methods for the treatment and prevention of IgE-mediated allergic disorders comprising an immunogenic amount of one or more antigenic peptides derived from the CH3 domain or junction of Ch-3/CH4 domain of an IgE molecule and methods for the evaluation of IgE mediated allergies in dogs.

Claims

exact text as granted — not AI-modified
1 . An isolated antigenic peptide comprising an amino acid sequence of SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: 5, SEQ ID NO: 6, SEQ ID NO: 7, SEQ ID NO: 8, SEQ ID NO: 9, SEQ ID NO: 10, SEQ ID NO: 11, SEQ ID NO: 12, SEQ ID NO: 13, or SEQ ID NO: 14 that induces an anti-IgE immune response that does not cause anaphylaxis when administered to an animal.  
     
     
         2 . An isolated antigenic fusion protein comprising an amino acid sequence of SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: 5, SEQ ID NO: 6, SEQ ID NO: 7, SEQ ID NO: 8, SEQ ID NO: 9, SEQ ID NO: 10, SEQ ID NO: 11, SEQ ID NO: 12, SEQ ID NO: 13, or SEQ ID NO: 14 that induces an anti-IgE immune response that does not cause anaphylaxis when administered to an animal.  
     
     
         3 . An isolated polynucleotide sequence encoding an antigenic peptide comprising an amino acid sequence of SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: 5, SEQ ID NO: 6, SEQ ID NO: 7, SEQ ID NO: 8, SEQ ID NO: 9, SEQ ID NO: 10, SEQ ID NO: 11, SEQ ID NO: 12, SEQ ID NO: 13, or SEQ ID NO: 14, wherein said antigenic peptide inducing an anti-IgE immune response that does not cause anaphylaxis when administered to an animal.  
     
     
         4 . An isolated polynucleotide sequence encoding an antigenic fusion protein comprising an amino acid sequence of SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: 5, SEQ ID NO: 6, SEQ ID NO: 7, SEQ ID NO: 8, SEQ ID NO: 9, SEQ ID NO: 10, SEQ ID NO: 11, SEQ ID NO: 12, SEQ ID NO: 13, or SEQ ID NO: 14, wherein said antigenic fusion protein inducing an anti-IgE immune response that does not cause anaphylaxis when administered to an animal.  
     
     
         5 . A genetically engineered host cell that contains the polynucleotide sequence of  claim 3  or  4 .  
     
     
         6 . A genetically engineered host cell that contains the polynucleotide sequence of  claim 3  or  4  in operative association with a nucleotide regulatory sequence that controls expression of the polynucleotide sequence in the host cell.  
     
     
         7 . A pharmaceutical composition for inducing an anti-IgE immune response that does not cause anaphylaxis comprising one or more antigenic peptides having an amino acid sequence comprising amino acid residues of a CH3 domain of an IgE molecule or a fragment thereof.  
     
     
         8 . The pharmaceutical composition of  claim 7 , wherein at least one antigenic peptide has the amino acid sequence of SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: 5, SEQ ID NO: 6, SEQ ID NO: 7, SEQ ID NO: 8, SEQ ID NO: 9, SEQ ID NO: 10, SEQ ID NO: 11, SEQ ID NO: 12, SEQ ID NO: 13, or SEQ ID NO: 14.  
     
     
         9 . A pharmaceutical composition for inducing an anti-IgE immune response that does not cause anaphylaxis comprising one or more antigenic fusion proteins having an amino acid sequence comprising amino acid residues of a CH3 domain of an IgE molecule or a fragment thereof and a heterologous carrier protein.  
     
     
         10 . The pharmaceutical composition of  claim 9 , wherein at least one antigenic fusion protein has the amino acid sequence of SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: 5, SEQ ID NO: 6, SEQ ID NO: 7, SEQ ID NO: 8, SEQ ID NO: 9, SEQ ID NO: 10, SEQ ID NO: 11, SEQ ID NO: 12, SEQ ID NO: 13, or SEQ ID NO: 14.  
     
     
         11 . The pharmaceutical composition of  claim 9 , wherein the heterologous carrier protein is selected from the group consisting of KLh, PhoE, rmLT, TraT, and gD from BhV-1 virus.  
     
     
         12 . The pharmaceutical composition of  claim 7  or  9 , wherein the anti-IgE immune response is the production of anti-IgE antibodies which bind to soluble IgE in serum and other bodily fluids, prevent IgE from binding to its high affinity receptors on mast cells and basophils, and do not cross-link receptor-bound IgE.  
     
     
         13 . The pharmaceutical composition of  claim 7  or  9  further comprising an adjuvant.  
     
     
         14 . A pharmaceutical composition for inducing an anti-IgE immune response that does not cause anaphylaxis comprising one or more polynucleotide sequences encoding an antigenic peptide having an amino acid sequence comprising amino acid residues of a CH3 domain of an IgE molecule or a fragment thereof.  
     
     
         15 . The pharmaceutical composition of  claim 14 , wherein at least one polynucleotide sequence encodes an antigenic peptide having the amino acid sequence of SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: 5, SEQ ID NO: 6, SEQ ID NO: 7, SEQ ID NO: 8, SEQ ID NO: 9, SEQ ID NO: 10, SEQ ID NO: 11, SEQ ID NO:  12 , SEQ ID NO: 13, or SEQ ID NO: 14.  
     
     
         16 . A pharmaceutical composition for inducing an anti-IgE immune response that does not cause anaphylaxis comprising one or more polynucleotide sequences encoding an antigenic fusion protein having an amino acid sequence comprising amino acid residues of a CH3 domain of an IgE molecule or a fragment thereof and a heterologous carrier protein.  
     
     
         17 . The pharmaceutical composition of  claim 16 , wherein at least one polynucleotide sequence encodes an antigenic fusion protein having the amino acid sequence of SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: 5, SEQ ID NO: 6, SEQ ID NO: 7, SEQ ID NO: 8, SEQ ID NO: 9, SEQ ID NO: 10, SEQ ID NO:  11 , SEQ ID NO: 12, SEQ ID NO: 13, or SEQ ID NO: 14  
     
     
         18 . The pharmaceutical composition of  claim 16 , wherein the heterologous carrier protein is selected from the group consisting of KLh, PhoE, rmLT, TraT, and gD from BhV-1 virus.  
     
     
         19 . A method for the treating or preventing an IgE-mediated allergic disorder comprising administering to an animal in which such treatment or prevention is desired a immunogenically effective amount of one or more antigenic peptides having an amino acid sequence comprising amino acid residues of a CH3 domain of an IgE molecule or a fragment thereof.  
     
     
         20 . The method of  claim 19 , wherein at least one antigenic peptide has the amino acid sequence of SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: 5, SEQ ID NO: 6, SEQ ID NO: 7, SEQ ID NO: 8, SEQ ID NO: 9, SEQ ID NO: 10, SEQ ID NO: 11, SEQ ID NO: 12, SEQ ID NO: 13, or SEQ ID NO: 14.  
     
     
         21 . A method for the treating or preventing an IgE-mediated allergic disorder comprising administering to an animal in which such treatment or prevention is desired a immunogenically effective amount of one or more antigenic fusion protein having an amino acid sequence comprising amino acid residues of a CH3 domain of an IgE molecule or a fragment thereof and a heterologous carrier protein.  
     
     
         22 . The method of  claim 21 , wherein at least one antigenic peptide has the amino acid sequence of SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: 5, SEQ ID NO: 6, SEQ ID NO: 7, SEQ ID NO: 8, SEQ ID NO: 9, SEQ ID NO: 10, SEQ ID NO: 11, SEQ ID NO: 12, SEQ ID NO: 13, or SEQ ID NO: 14.  
     
     
         23 . A method for the treating or preventing an IgE-mediated allergic disorder comprising administering to an animal in which such treatment or prevention is desired a immunogenically effective amount of one or more polynucleotide sequences encoding one or more antigenic peptides having an amino acid sequence comprising amino acid residues of a CH3 domain of an IgE molecule or a fragment thereof.  
     
     
         24 . The method of  claim 23 , wherein at least one antigenic peptide has the amino acid sequence of SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: 5, SEQ ID NO: 6, SEQ ID NO: 7, SEQ ID NO: 8, SEQ ID NO: 9, SEQ ID NO: 10, SEQ ID NO: 11, SEQ ID NO: 12, SEQ ID NO: 13, or SEQ ID NO: 14.  
     
     
         25 . A method for the treating or preventing an IgE-mediated allergic disorder comprising administering to an animal in which such treatment or prevention is desired a immunogenically effective amount of one or more polynucleotide sequences encoding one or more antigenic fusion proteins having an amino acid sequence comprising amino acid residues of a CH3 domain of an IgE molecule or a fragment thereof and a heterologous carrier protein.  
     
     
         26 . The method of  claim 25 , wherein at least one antigenic peptide has the amino acid sequence of SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: 5, SEQ ID NO: 6, SEQ ID NO: 7, SEQ ID NO: 8, SEQ ID NO: 9, SEQ ID NO: 10, SEQ ID NO: 11, SEQ ID NO: 12, SEQ ID NO: 13, or SEQ ID NO: 14.  
     
     
         27 . The method of  claim 19 ,  21 ,  23  or  25  in which the animal is human.  
     
     
         28 . The method of  claim 19 ,  20 ,  21 ,  22 ,  23 ,  24 ,  25  or  26  in which the animal is a dog.  
     
     
         29 . The method of  claim 19 ,  20 ,  21 ,  22 ,  23 ,  24 ,  25  or  26 , wherein the IgE-mediated allergic disorder is asthma, allergic rhinitis, gastrointestinal allergies such as food allergies, eosinophilia, conjunctivitis, or glomerular nephritis.  
     
     
         30 . An isolated polynucleotide sequence comprising the polynucleotide sequence of SEQ ID NO: 15, SEQ ID NO: 16, SEQ ID NO: 17, SEQ ID NO: 18, SEQ ID NO: 19, SEQ ID NO: 20, or SEQ ID NO: 21.  
     
     
         31 . An isolated polynucleotide sequence comprising the polynucleotide sequence of SEQ ID NO: 22, SEQ ID NO: 23, SEQ ID NO: 24, SEQ ID NO: 25, SEQ ID NO: 26 SEQ ID NO: 27, or SEQ ID NO: 28.  
     
     
         32 . A method for evaluating the effect of anti-IgE vaccines in dogs which comprises sensitization of the dogs to an allergen by concurrent administration of the allergen and ricin in amountsl sufficient to induce hypersensitivity in the dogs, followed by challenge with the allergen and observation of the resulting sensitivity of the dogs to the challenge allergen.  
     
     
         33 . A method for inducing high levels of IgE and clinical signs of hypersensitivity in dogs for evaluating the effect of anti-IgE vaccines in the dogs which comprises: sensitization of the dogs to an allergen sufficient to induce hypersensitivity in the dogs by concurrent administration of amounts of the allergen and ricin sufficient to to the dogs, followed by challenge with the allergen and observation of the resulting sensitivity of the dogs to the challenge allergen.  
     
     
         34 . The method of  claim 32  or  33  wherein the allergen is a flea allergen.  
     
     
         35 . The method of  claim 32  or  33  wherein the allergen is a food allergen.  
     
     
         36 . The method of  claim 32  or  33  wherein the food allergen is an ascaris allergen.  
     
     
         37 . The method of  claim 32  or  33  wherein the hypersentivity is type I hpersensitivity.  
     
     
         38 . The method of  claim 32  or  33  wherein sensitization results in higher levels of IgE in the hypersensitized dogs than found in non-hypersensitized dogs.  
     
     
         39 . An isolated antigenic peptide comprising an amino acid sequence of SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: 5, SEQ ID NO: 6, SEQ ID NO: 7, SEQ ID NO: 8, SEQ ID NO: 9, SEQ ID NO: 10, SEQ ID NO: 11, SEQ ID NO: 12, SEQ ID NO: 13, or SEQ ID NO: 14 or a fragment thereof, that induces an anti-IgE immune response that does not cause anaphylaxis when administered to an animal.  
     
     
         40 . An isolated antigenic fusion protein comprising an amino acid sequence of SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: 5, SEQ ID NO: 6, SEQ ID NO: 7, SEQ ID NO: 8, SEQ ID NO: 9, SEQ ID NO: 10, SEQ ID NO: 11, SEQ ID NO:  12 , SEQ ID NO: 13, or SEQ ID NO: 14 or a fragment thereof that induces an anti-IgE immune response that does not cause anaphylaxis when administered to an animal.  
     
     
         41 . A pharmaceutical kit comprising one or more containers filled with one or more of the ingredients of the pharmaceutical compositions of  claim 7 ,  9 ,  14  or  16 .

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