# US 12,760,316 B2 · IgG variants for induction of immune response without adjuvant

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- Number: US 12,760,316 B2
- Document ID: US12760316B2
- Status: Granted
- Kind: B2
- Application number: 17/801,110
- Filed: 2021-02-22
- Published: 2023-04-06
- Granted: 2026-10-13
- Earliest claimed: 2020-02-21
- Assignees: Arizona Board of Regents on behalf of Arizona State University
- Applicants: Arizona Board of Regents On Behalf of Arizona State University
- Inventors: Hugh Mason; Andrew Diamos; Mary Pardhe
- Web page: https://patentgrep.com/patent/US12760316B2

## CPC

- C12N 15/8258: {for the production of oral vaccines (antigens) or immunoglobulins}
- A61K 39/12: Viral antigens
- A61K 39/385: Haptens or antigens, bound to carriers
- A61K 39/395: Antibodies (agglutinins A61K38/36 {; as drug carriers A61K47/50}); Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- C12N 15/62: DNA sequences coding for fusion proteins
- A61K 2039/6056: {Antibodies}
- C07K 2317/34: Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
- C07K 2317/60: characterized by non-natural combinations of immunoglobulin fragments
- C07K 2319/30: Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto
- C12N 2770/16034: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)
- 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)
- 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)

## Abstract

The disclosure relates to immunoglobulin variants that are useful for the design of vaccinations against a variety of pathogens and their method of production and use. In some aspects, the immunoglobulin variants are variants of IgG, for example, the 6D8 antibody.

## Claims

### Claim 1

A recombinant protein comprising:
a unit of a Fc fusion comprising a CH2 domain and a CH3 domain of an IgG;
a unit of an antigen, wherein the unit of the antigen is not an epitope of the IgG;
a unit of a variable heavy chain (VH) domain of the IgG; and
a unit of a CH1 domain of the IgG;
an epitope tag consisting of the sequence YKLDIS (SEQ ID NO. 1);
a unit of a light chain variable (VL) domain of the IgG; and
a unit of a light chain constant (CL) domain of the IgG,
wherein:
the unit of the antigen is linked to the unit of the VH domain of the IgG at the N-terminus or to the CH3 domain of IgG at the C-terminus;
the unit of the CH1 domain of the IgG is linked to the CH2 domain of the IgG and to the unit of the VH domain of the IgG;
the unit of the VL domain of the IgG is linked to the unit of the CL domain of the IgG;
the unit of CL domain of the IgG is linked to the CH1 domain of the IgG; and
the unit of the antigen is linked:
(1) to the CH3 domain of IgG at the C-terminus and the epitope tag is linked to the C-terminus of the antigen; or
(2) to the unit of the VH domain of the IgG at the N-terminus and the epitope tag is linked to the C-terminus of the CH3 domain of the IgG.

### Claim 2 (depends on 1)

The recombinant protein of claim 1, wherein the unit of the antigen comprises SEQ ID NO. 34.

### Claim 3 (depends on 1)

A method of inducing an immune response in a subject, the method comprising administering to the subject the recombinant protein of claim 1, thereby inducing the immune response against the antigen in the recombinant protein.

### Claim 4 (depends on 1)

The recombinant protein of claim 1, comprising:
two units of the antigen;
two units of the Fc fusion;
two units of the VH domain of the IgG; and
two units of the CH1 domain of the IgG;
two epitope tags;
two units of the VL domain of the IgG; and
two units of the CL domain of the IgG,
wherein the two units of the Fc fusion are linked together by a disulfide bond formed at the linkage of the CH1 domain of the IgG and the CH2 domain of the IgG.

### Claim 5 (depends on 4)

The recombinant protein of claim 4, wherein the unit of the antigen comprises SEQ ID NO. 34.