# US 11,299,535 B2 · Human IgE antibodies binding to aspergillus allergens

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- Number: US 11,299,535 B2
- Document ID: US11299535B2
- Status: Granted
- Kind: B2
- Application number: 16/653,147
- Filed: 2019-10-15
- Published: 2020-04-16
- Granted: 2022-04-12
- Earliest claimed: 2018-10-16
- Assignees: Vanderbilt University
- Applicants: Vanderbilt University
- Inventors: Scott A. Smith
- Web page: https://patentgrep.com/patent/US11299535B2

## CPC

- C07K 16/14: against material from fungi, algea or lichens
- A61K 39/0002: {Fungal antigens, e.g. Trichophyton, Aspergillus, Candida}
- A61P 31/10: Antimycotics
- C07K 14/47: from mammals
- C07K 16/00: Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
- G01N 33/56961: {Plant cells or fungi}
- G01N 33/6878: {in epitope analysis}
- C07K 2317/10: characterized by their source of isolation or production
- C07K 2317/21: from primates, e.g. man
- C07K 2317/24: containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
- C07K 2317/31: multispecific
- C07K 2317/54: F(ab')2
- C07K 2317/55: Fab or Fab'
- C07K 2317/565: Complementarity determining region [CDR]
- C07K 2317/622: Single chain antibody (scFv)
- C07K 2317/94: Stability, e.g. half-life, pH, temperature or enzyme-resistance
- C07K 2319/30: Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto
- 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)
- 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
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)

## Abstract

The present disclosure is directed to antibodies binding to Aspergillus allergens and methods for use thereof.

## Claims

### Claim 1

A monoclonal antibody, wherein the antibody or antibody fragment is characterized by heavy and light chain CDR1, CDR2 and CDR3 sequences of SEQ ID NOS: 17, 18 and 19 and SEQ ID NOS: 29, 30 and 31, respectively.

### Claim 2 (depends on 1)

The monoclonal antibody of claim 1, wherein said antibody or antibody fragment is encoded by light and heavy chain variable sequences SEQ ID NO: 2 and SEQ ID NO: 1, respectively.

### Claim 3 (depends on 1)

The monoclonal antibody of claim 1, wherein said antibody or antibody fragment is encoded by light and heavy chain variable sequences having at least 70%, 80%, or 90% identity to SEQ ID NO: 2 and SEQ ID NO: 1, respectively.

### Claim 4 (depends on 1)

The monoclonal antibody of claim 1, wherein said antibody or antibody fragment is encoded by light and heavy chain variable sequences having at least 95% identity to SEQ ID NO: 2 and SEQ ID NO: 1, respectively.

### Claim 5 (depends on 1)

The monoclonal antibody of claim 1, wherein said antibody or antibody fragment comprises light and heavy chain variable sequences SEQ ID NO: 10 and SEQ ID NO: 9, respectively.

### Claim 6 (depends on 1)

The monoclonal antibody of claim 1, wherein said antibody or antibody fragment comprises light and heavy chain variable sequences having 95% identity to SEQ ID NO: 10 and SEQ ID NO: 9, respectively.

### Claim 7 (depends on 1)

The monoclonal antibody of claim 1, wherein the antibody fragment is a recombinant scFv (single chain fragment variable) antibody, Fab fragment, F(ab′)2 fragment, or Fv fragment.

### Claim 8 (depends on 1)

The monoclonal antibody of claim 1, wherein said antibody is a chimeric antibody, or is bispecific antibody.

### Claim 9 (depends on 1)

The monoclonal antibody of claim 1, wherein said antibody is a recombinant IgG antibody or antibody fragment.

### Claim 10 (depends on 9)

The monoclonal antibody of claim 9, wherein the recombinant IgG or IgG fragment comprises an Fc portion carrying a LALA, N297, GASD/ALIE, YTE or LS mutation.

### Claim 11 (depends on 9)

The monoclonal antibody of claim 9, wherein the recombinant IgG or IgG fragment comprises a glycan modification selected from enzymatic or chemical addition or removal of glycans or that result from expression in a cell line engineered with a defined glycosylating pattern.

### Claim 12 (depends on 1)

The monoclonal antibody of claim 1, wherein said antibody or antibody fragment further comprises a cell penetrating peptide and/or is an intrabody.

### Claim 13

A method of producing an IgG immune response to an Aspergillus allergen comprising:
(a) identifying an IgE epitope in an allergen by mapping the binding of an IgE antibody binding site, wherein said antibody has clone-paired heavy and light chain CDR1, CDR2 and CDR3 sequences of SEQ ID NOS: 17, 18 and 19 and SEQ ID NOS: 29, 30 and 31, respectively;
(b) modifying one or more residues in said IgE antibody binding site to reduce or eliminate IgE antibody binding to said binding site, thereby producing a hypoallergenic Aspergillus allergen;
(c) immunizing a subject with said hypoallergenic Aspergillus allergen to produce and IgG response to said hypoallergenic Aspergillus allergen, while producing a reduced or no IgE response as compared to the allergen of step (a).
