# US 2014/0193450 A1 · Peptide carrier fusion proteins as allergy vaccines

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- Number: US 2014/0193450 A1
- Document ID: US20140193450A1
- Status: Published application
- Kind: A1
- Application number: 14/124,925
- Filed: 2012-06-11
- Published: 2014-07-10
- Earliest claimed: 2011-06-09
- Assignees: Biomay AG
- Inventors: Katarzyna Niespodziana; Margarete Focke-Tejkl; Susanne Vrtala; Srinita Banerjee; Kuan-Wei Chen; Milena Weber; Rudolf Valenta; Katharina Marth
- Web page: https://patentgrep.com/patent/US20140193450A1

## CPC

- A61K 39/292: {Serum hepatitis virus, hepatitis B virus, e.g. Australia antigen}
- A61K 39/12: Viral antigens
- A61K 39/36: from pollen
- A61K 39/385: Haptens or antigens, bound to carriers
- A61P 37/08: Antiallergic agents (antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14)
- C07K 14/005: from viruses
- C07K 14/415: from plants
- A61K 2039/53: {DNA (RNA) vaccination}
- A61K 2039/57: {characterised by the type of response, e.g. Th1, Th2}
- A61K 2039/6075: {Viral proteins}
- A61K 2039/64: {characterised by the architecture of the carrier-antigen complex, e.g. repetition of carrier-antigen units}
- A61K 2039/645: {Dendrimers; Multiple antigen peptides}
- C07K 2319/00: Fusion polypeptide
- C12N 2730/10122: New viral proteins or individual genes, new structural or functional aspects of known viral proteins or genes
- C12N 2730/10134: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00)
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)

## Abstract

The present invention relates to a polypeptide comprising at least three peptide fragments consisting of 10 to 50 consecutive amino acid residues of at least one wild-type allergen fused to the N- and C-terminus of a surface polypeptide of a virus of the hepadnaviridae family or at least one fragment of said surface polypeptide.

## Claims

### Claim 1

A polypeptide comprising at least four peptide fragments consisting of 20 to 50 consecutive amino acid residues of a wild-type allergen fused to the N- and C-terminus of a surface polypeptide of a virus of a hepadnaviridae family or a fragment of the surface polypeptide.

### Claim 2 (depends on 1)

The polypeptide according to claim 1, wherein the virus of the hepadnaviridae family is Hepatitis B virus.

### Claim 3 (depends on 1)

The polypeptide according to claim 1, wherein the surface polypeptide of the virus of the hepadnaviridae family is PreS.

### Claim 4 (depends on 3)

The polypeptide according to claim 3, wherein the fragment of the surface polypeptide is Hepatitis B PreS1 or Hepatitis B PreS2.

### Claim 5 (depends on 1)

The polypeptide according to claim 1, wherein a peptide fragment derived from the wild-type allergen is a B cell binding peptide.

### Claim 6 (depends on 1)

The polypeptide according to claim 1, wherein the peptide fragments exhibit no or reduced IgE-binding capacity compared to the wild-type allergen.

### Claim 7 (depends on 1)

The polypeptide according to claim 1, wherein a peptide fragment exhibits no or substantially no T-cell reactivity.

### Claim 8 (depends on 1)

The polypeptide according to claim 1, wherein the wild-type allergen is selected from the group consisting of major birch pollen allergen, major timothy grass pollen allergen, major house dust mite allergen, major cat allergen Fel d 1 and Fel d 2, major bee allergen, major wasp allergen, profilin, olive allergen, Parietaria judaica allergen, Ragweed allergen, mugwort pollen allergen, and Japanese ceder pollen.

### Claim 9 (depends on 1)

The polypeptide according to claim 1, wherein the peptide fragment is selected from the group consisting of amino acids 151 to 177, 87 to 117, 1 to 30, 43 to 70 or 212 to 241 of Phl p 1, amino acids 1 to 33, 8 to 39, 34 to 65 or 66 to 96 of Phl p 2, amino acids 93 to 128, 98 to 128, 26 to 53, 26 to 58, 132 to 162, 217 to 246, 252 to 283 or 176 to 212 of Phl p 5, amino acids 23 to 54, 56 to 90, 73 to 114 or 95 to 127 of Phl p 6, amino acids 1 to 34 or 35 to 70 of chain 1 of Fel d 1, amino acids 1 to 34, 35 to 63 or 64 to 92 of chain 2 of Fel d 1, amino acids 30 to 59, 50 to 79, 75 to 104, 30 to 74 or 60 to 104 of Bet v 1, amino acids 1 to 30, 52 to 84 or 188 to 222 of Der p 1, amino acids 1 to 33, 21 to 51, 42 to 73, 62 to 103 or 98 to 129 of Der p 2, amino acids 1 to 30, 20 to 50, 50 to 80, 90 to 125, 125 to 155 or 165 to 198 of Der p 7, amino acids 1-35, 36-70, 71-110, 111-145, 140-170, 175-205, 210-250 or 250-284 of Der p 10, amino acids 1 to 35, 35 to 72, 70 to 100 or 90 to 122 of Der p 21, amino acids 1 to 32, to 48 or 32 to 70, 32 to 60, 52 to 84, 32 to 70 (Cys->Ser) of Der p 23, amino acids 19 to 58, 59 to 95, 91 to 120 or 121 to 157 of Alt a 1, amino acids 31 to 60, 45 to 80, 60 to 96 or 97 to 133 of Par j 2, amino acids 1 to 40, 36 to 66, 63 to 99, 86 to 120 or 107 to 145 of Ole e 1, amino acids 25 to 58, 99 to 133, 154 to 183, 277 to 307, 334 to 363, 373 to 402, 544 to 573, 579 to 608, 58 to 99, 125 to 165, 183 to 224, 224 to 261, 252 to 289, 303 to 340, 416 to 457, 460 to 500 or 501 to 542 of Fel d 2, amino acids 19 to 58, 52 to 91, 82 to 119, 106 to 144 or 139 to 180 of Can f 2, amino acids 19 to 56, 51 to 90, 78 to 118, 106 to 145 or 135-174 of Can f 1, amino acids 27 to 70, 70 to 100 or 92 to 132 of Art v 1, amino acids 31 to 70, 80 to 120, 125 to 155, 160 to 200, 225 to 263, 264 to 300 305 to 350 or 356 to 396 of Amb a 1, amino acids 1 to 34, 35 to 74, 74 to 115, 125 to 165, 174 to 213, 241 to 280, 294 to 333, 361 to 400 or 401 to 438 of Alt a 6, and amino acids 1 to 40, 41 to 80, 81 to 120, 121 to 160 of Alt a 2 or fragments or sequence variations thereof.

### Claim 10 (depends on 1)

The polypeptide according to claim 1, wherein the surface polypeptide of the virus of the hepadnaviridae family or a fragment thereof comprises at least two peptide fragments derived from a wild-type allergen fused to its N-terminus and at least two peptide fragments derived from a wild-type allergen fused to its C-terminus.

### Claim 11 (depends on 1)

The polypeptide according to claim 1, wherein at least two of the at least four peptides are identical.

### Claim 12 (depends on 1)

The polypeptide according to claim 1, wherein the polypeptide comprises an amino acid sequence selected from the group consisting of SEQ ID No. 14, SEQ ID No. 15, SEQ ID No. 16, SEQ ID No. 17, SEQ ID No. 18, SEQ ID No. 19, SEQ ID No. 20, SEQ ID No. 149, SEQ ID No. 150, SEQ ID No. 151 and SEQ ID No. 152.

### Claim at position 13

13-16. (canceled)

### Claim 17 (depends on 1)

A nucleic acid molecule encoding a polypeptide according to claim 1.

### Claim 18 (depends on 17)

A vector comprising a nucleic acid molecule according to claim 17.

### Claim at position 16

19-20. (canceled)

### Claim 21 (depends on 17)

A host comprising a nucleic acid molecule according to claim 17.

### Claim 22 (depends on 1)

A vaccine formulation comprising a polypeptide according to claim 1.

### Claim 23

A vaccine formulation comprising a mixture of hypoallergenic polypeptides derived from grass pollen allergens, wherein the polypeptide comprises an amino acid sequence selected from the group consisting of SEQ ID No. 14, SEQ ID No. 15, Seq ID No. 16, and SEQ ID No. 17.

### Claim 24

A vaccine formulation comprising a mixture of hypoallergenic polypeptides derived from birch pollen allergens, wherein the polypeptide comprises an amino acid sequence selected from the group consisting of SEQ ID NO. 18 AND SEQ ID NO. 19.

### Claim at position 21

25-27. (canceled)

### Claim 28 (depends on 1)

The polypeptide according to claim 1, wherein the wild-type allergen is selected from the group consisting of Bet v 1, Phl p 1, Phl p 2, Phl p 5, Phl p 6, Phl p 7, Der p 1, Der p 2, Der p 23, Fel d 1, Fel d 2, Phl p 12, Ole e 1, Par j 2, Amb a 1, Art v 1, Cry j 1, and Cry j 2.

### Claim 29 (depends on 1)

A vaccine formulation, comprising a mixture of more than one polypeptide according to claim 1, wherein the wild-type allergen is selected from the group consisting of Phl p 1, Phl p 2, Phl p 5, Phl p 6 and the surface polypeptide is hepatitis B virus preS protein.

### Claim 30

A method of treating or preventing an allergy in a human or an animal, comprising administering a polypeptide comprising at least four peptide fragments consisting of 20 to 50 consecutive amino acid residues of a wild-type allergen fused to a N- and C-terminus of a surface polypeptide of a virus of a hepadnaviridae family or a fragment of the surface polypeptide.

### Claim 31

A method of treating or preventing an allergy in a human or an animal, comprising administering a mixture of more than one hypoallergenic polypeptide, wherein the polypeptide comprises at least four peptide fragments consisting of 20 to 50 consecutive amino acid residues of a wild-type allergen fused to a N- and C-terminus of a surface polypeptide of a virus of a hepadnaviridae family or a fragment of the surface polypeptide.

### Claim 32 (depends on 31)

The method according to claim 31, comprising administering a mixture of hypoallergenic polypeptides derived from grass pollen allergens, wherein the polypeptide comprises an amino acid sequence selected from the group consisting of SEQ ID NO. 14, SEQ ID NO. 15, SEQ ID NO. 16, AND SEQ ID NO. 17, and wherein the allergy is a grass pollen allergy.

### Claim 33 (depends on 31)

The method according to claim 31, comprising administering a mixture of hypoallergenic polypeptides derived from birch pollen allergens, wherein the polypeptide comprises an amino acid sequence selected from the group consisting of SEQ ID NO. 18 and SEQ ID NO. 19, and wherein the allergy is a birch pollen allergy.