# US 2014/0154287 A1 · Multiple antigen presenting immunogenic composition, and methods and uses thereof

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- Number: US 2014/0154287 A1
- Document ID: US20140154287A1
- Status: Published application
- Kind: A1
- Application number: 14/116,402
- Filed: 2012-05-11
- Published: 2014-06-05
- Earliest claimed: 2011-05-11
- Assignees: Children's Medical Center Corporation
- Inventors: Richard Malley; Yingjie Lu; Fan Zhang
- Web page: https://patentgrep.com/patent/US20140154287A1

## CPC

- C07K 14/31: from Staphylococcus (G)
- A61K 39/092: {Streptococcus}
- A61K 39/385: Haptens or antigens, bound to carriers
- A61K 47/543: {Lipids, e.g. triglycerides; Polyamines, e.g. spermine or spermidine}
- A61K 47/557: {the modifying agent being biotin}
- A61K 47/61: the organic macromolecular compound being a polysaccharide or a derivative thereof
- A61P 31/04: Antibacterial agents
- A61K 2039/55505: {Inorganic adjuvants}
- A61K 2039/6031: {Proteins}
- A61K 2039/6093: {Synthetic polymers, e.g. polyethyleneglycol [PEG], Polymers or copolymers of (D) glutamate and (D) lysine}
- A61K 2039/625: {binding through the biotin-streptavidin system or similar}
- A61K 2039/627: {characterised by the linker}
- A61K 2039/645: {Dendrimers; Multiple antigen peptides}
- A61K 2039/70: {Multivalent vaccine}
- C07K 2319/00: Fusion polypeptide
- C07K 2319/20: containing a tag with affinity for a non-protein ligand
- Y02A 50/30: Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
- 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
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## Abstract

The present embodiments provide for an immunogenic multiple antigen presenting system comprising a polymer to which antigens are associated by complementary affinity molecules. For example, the polymer can be a polysaccharide, or antigenic polysaccharide, to which protein or peptide antigens from the same or different pathogens are indirectly linked. The present immunogenic compositions can elicit both humoral and cellular immune responses to one or multiple antigens at the same time.

## Claims

### Claim 1

An immunogenic composition comprising a polymer, at least one antigen, and at least one complementary affinity-molecule pair comprising:
a first affinity molecule associated with the polymer, and
a complementary affinity molecule associated with the antigen,
wherein the first affinity molecule associates with the complementary affinity molecule to link the antigen and the polymer.

### Claim at position 2

2-78. (canceled)

### Claim 79 (depends on 1)

The immunogenic composition of claim 1, wherein the polymer is a polysaccharide or polyethylene glycol.

### Claim 80 (depends on 1)

The immunogenic composition of claim 1, wherein the first affinity molecule is cross-linked or covalently bonded to the polymer.

### Claim 81 (depends on 80)

The immunogenic composition of claim 80, wherein the first affinity molecule is cross-linked to the polymer using a cross-linking reagent selected from any in the group consisting of: CDAP (1-cyano-4-dimethylaminopyridinium tetrafluoroborate); EDC (1-Ethyl-3-[3-dimethylaminopropyl]carbodiimide hydrochloride); sodium cyanoborohydride; cyanogen bromide; and ammonium bicarbonate/iodoacetic acid.

### Claim 82 (depends on 1)

The immunogenic composition of claim 1, wherein the complementary affinity molecule pair can be selected from a group consisting of: biotin/biotin-binding protein, antibody/antigen, enzyme/substrate, receptor/ligand, metal/metal-binding protein, carbohydrate/carbohydrate binding protein, lipid/lipid-binding protein, His tag/His tag-binding substance.

### Claim 83 (depends on 1)

The immunogenic composition of claim 1, wherein the first affinity molecule is biotin or a derivative or mimic molecule thereof.

### Claim 84 (depends on 1)

The immunogenic composition of claim 1, wherein the antigen is a fusion protein comprising the antigen fused to the complementary affinity molecule or a protein affinity binding molecule.

### Claim 85 (depends on 1)

The immunogenic composition of claim 1, wherein the antigen is non-covalently or covalently attached to the complementary affinity molecule.

### Claim 86 (depends on 1)

The immunogenic composition of claim 1, wherein the complementary affinity molecule is a biotin-binding protein, or an avidin-like protein or a derivative or functional portion thereof.

### Claim 87 (depends on 86)

The immunogenic composition of claim 86, wherein the avidin-like protein is selected from the group consisting of: rhizavidin, avidin, streptavidin or a homologue or derivative thereof.

### Claim 88 (depends on 1)

The immunogenic composition of claim 1, wherein the polymer is branched chain polysaccharide or a straight chain polysaccharide.

### Claim 89 (depends on 1)

The immunogenic composition of claim 1, comprising at least two antigens, wherein the at least two antigens are selected from the group consisting of: different antigens, different variants of the same antigen, or different domains or portions of the same antigen.

### Claim 90 (depends on 1)

The immunogenic composition of claim 1, further comprising a flexible linker peptide attached to the antigen, wherein the flexible linker peptide attaches the antigen to the complementary affinity molecule.

### Claim 91 (depends on 1)

The immunogenic composition of claim 1, comprising between 2-10 different antigens or between 10-20 different antigens, or between 20-50 different antigens or between 50-100 different antigens or more than 100 different antigens.

### Claim 92 (depends on 1)

The immunogenic composition of claim 1, wherein the antigen is from a pathogenic organism or a tumor.

### Claim 93 (depends on 1)

The immunogenic composition of claim 1, wherein the antigen from a pathogenic organism is selected from the group consisting of: pneumococcal antigens, tuberculosis antigens, anthrax antigens, HIV antigens, seasonal or epidemic influenza antigens, Pertussis antigens, Staphylococcus aureus antigens, Meningococcal antigens, Haemophilus antigens, HPV antigens, toxoids, toxins or toxin portions, or combinations thereof.

### Claim 94 (depends on 1)

The immunogenic composition of claim 1, wherein the polysaccharide is selected from the group consisting of: dextran, Vi polysaccharide, pneumococcal capsular polysaccharides, pneumococcal cell wall polysaccharide, Haemophilus influenzae Type b polysaccharide, Meningococcal polysaccharide, lipopolysaccharide from Gram-positive bacteria and other bacterial capsular or cell wall polysaccharides.

### Claim 95 (depends on 1)

The immunogenic composition of claim 1, further comprising at least one co-stimulation factor associated to the polymer or polysaccharide.

### Claim 96 (depends on 95)

The immunogenic composition of claim 95, wherein the co-stimulation factor is selected from the group consisting of: Toll like receptor ligand or agonists, NOD ligand or agonists, or activator/agonists of the inflammasome.

### Claim 97 (depends on 1)

The immunogenic composition of claim 1, further comprising at least one adjuvant.

### Claim 98 (depends on 1)

A method for inducing an immune response in a subject to at least one antigen, comprising administering to the subject a composition of claim 1.

### Claim 99 (depends on 98)

The method of claim 98, wherein the immune response is an antibody or B cell response.

### Claim 100 (depends on 98)

The method of claim 98, wherein the immune response is a CD4+ T cell response, including Th1, Th2, or Th17 response, or a CD8+ T cell response, or CD4+/CD8+ T cell response.

### Claim 101

A kit comprising:
a container comprising a polysaccharide cross-linked with a plurality of first affinity molecules; and
a container comprising a complementary affinity molecule which associates with the first affinity molecule, wherein the complementary affinity molecule associates with an antigen, and optionally a means to attach the complementary affinity molecule to the antigen; or
a container comprising an expression vector for expressing an antigen-complementary affinity molecule fusion protein.

### Claim 102 (depends on 101)

The kit of claim 101, further comprising at least one co-stimulation factor and optionally at least one cross-linking reagent selected from the group consisting of: CDAP (1-cyano-4-dimethylaminopyridinium tetrafluoroborate), EDC (1-Ethyl-3-[3-dimethylaminopropyl]carbodiimide hydrochloride), sodium cyanoborohydride, cyanogen bromide, or ammonium bicarbonate/iodoacetic acid for linking the co-factor to the polysaccharide.

### Claim 103 (depends on 101)

The kit of claim 101, wherein the expression vector can optionally comprise a sequence for a linker peptide, wherein the expression vector can expresses an antigen-complementary affinity molecule fusion protein comprising a linker peptide between the antigen and the complementary affinity molecule.