# US 11,305,001 B2 · Multiple antigen presenting system (MAPS)-based Staphylococcus aureus vaccine, immunogenic composition, and uses thereof

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- Number: US 11,305,001 B2
- Document ID: US11305001B2
- Status: Granted
- Kind: B2
- Application number: 16/498,856
- Filed: 2018-03-28
- Published: 2021-01-14
- Granted: 2022-04-19
- Earliest claimed: 2017-03-28
- Assignees: Children's Medical Center Corporation
- Applicants: The Children's Medical Center Corporation
- Inventors: Richard Malley; Fan Zhang; Yingjie Lu
- Web page: https://patentgrep.com/patent/US11305001B2

## CPC

- A61K 39/085: Staphylococcus
- A61P 31/04: Antibacterial agents
- A61K 39/39: characterised by the immunostimulating additives, e.g. chemical adjuvants
- A61K 2039/522: {avirulent or attenuated}
- A61K 2039/545: {characterised by the dose, timing or administration schedule}
- A61K 2039/55505: {Inorganic adjuvants}
- A61K 2039/57: {characterised by the type of response, e.g. Th1, Th2}
- A61K 2039/572: {cytotoxic response}
- A61K 2039/6068: {Other bacterial proteins, e.g. OMP}
- A61K 2039/645: {Dendrimers; Multiple antigen peptides}
- 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

## Abstract

The present embodiments provide for an S. aureus (SA) Multiple Antigen Presenting System (MAPS) immunogenic composition comprising an immunogenic polysaccharide which induces an immune response, where at least one S. aureus (SA) peptide or polypeptide antigen is associated to the immunogenic polysaccharide by complementary affinity molecules. In some embodiments, the immunogenic polysaccharide can be an antigenic capsular polysaccharide of a Type 5 or Type 8 from S. aureus, or alternatively, a different immunogenic capsular or noncapsular polysaccharide, and where the protein or peptide SA antigens are indirectly linked via an affinity binding pair. The present SA-MAPS immunogenic compositions can elicit both humoral and cellular immune responses to the immunogenic polysaccharide and one or multiple SA antigens at the same time.

## Claims

### Claim 1

An immunogenic composition comprising:
at least one immunogenic polysaccharide,
at least two S. aureus or polypeptide antigens, and
at least one pair of affinity molecules,
wherein the at least one pair of affinity molecules comprises:
(i) a first affinity molecule comprising biotin, and
(ii) a second affinity molecule comprising a biotin-binding protein,
wherein in each pair of affinity molecules:
the first affinity molecule is associated with the at least one immunogenic polysaccharide, and
the second affinity molecule is associated with at least one of the S. aureus polypeptide antigens,
wherein the first affinity molecule non-covalently associates with the second affinity molecule to link the S. aureus polypeptide antigens and the immunogenic polysaccharide;
wherein the at least one immunogenic polysaccharide comprises a type 1 capsular polysaccharide of Streptococcus pneumoniae, a type 5 capsular polysaccharide of S. aureus, and/or a type 8 capsular polysaccharide of S. aureus; and
wherein the at least two S. aureus polypeptide antigens comprise (i) a hemolysin having the amino acid sequence of SEQ ID NO: 16; and (ii) a serine-aspartate repeat protein D (SdrD) protein having the amino acid sequence of SEQ ID NO: 7.

### Claim 2 (depends on 1)

The immunogenic composition of claim 1, wherein the immunogenic composition comprises two S. aureus polypeptide antigens, which are (i) a hemolysin having the amino acid sequence of SEQ ID NO: 16; and (ii) a serine-aspartate repeat protein D (SdrD) protein having the amino acid sequence of SEQ ID NO: 7.

### Claim 3 (depends on 1)

The immunogenic composition of claim 1, wherein the biotin-binding protein comprises rhizavidin set forth as SEQ ID NO: 1 or an amino acid sequence that has at least 85% sequence identity to the amino acid sequence of SEQ ID NO: 1.

### Claim 4 (depends on 1)

The immunogenic composition of claim 1, wherein at least one of the S. aureus polypeptide antigens is fused to the second affinity molecule.

### Claim 5 (depends on 1)

The immunogenic composition of claim 1, further comprising a flexible linker peptide attached to at least one of the S. aureus polypeptide antigens, wherein the flexible linker peptide attaches the antigens to the second affinity molecule.

### Claim 6 (depends on 1)

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

### Claim 7 (depends on 1)

The immunogenic composition of claim 1 for use in any one or more of:
a. as a diagnostic for exposure to a pathogen or immune threat,
b. to prevent or treat an infection by S. aureus,
c. to prevent colonization of a subject by S. aureus,
d. to elicit an immune response to S. aureus in a subject, wherein the immune response is selected from any of:
i. an antibody or B-cell response,
ii. an antibody or B-cell response and T-cell response,
iii. an immune response to at least one immunogenic polysaccharide and at least one of the S. aureus polypeptide antigens,
iv. an immune response that is a CD4+ T cell response, including Th1, Th2, or Th17 or Th22 response, or a CD8+ T cell response, or CD4+ and CD8+ T cell response,
v. an antibody or B cell response to at least one immunogenic polysaccharide and a CD4+ T cell response, including Th1, Th2, or Th17 or Th22 response, or a CD8+ T cell response, or CD4+/CD8+ T cell response to at least one of the S. aureus polypeptide antigens,
vi. an antibody or B cell response to at least one immunogenic polysaccharide, and an antibody or B cell response and a CD4+ T cell response, including Th1, Th2, Th17 or Th22 responses, or a CD8+ T cell response, or CD4+/CD8+ T cell response to at least one of the S. aureus polypeptide antigens,
vii. an immune response results in activation of INF-γ, IL-17A or IL-22 producing cells, or INF-γ, IL-17A and IL-22 producing cells, or
viii. an antibody or B-cell response against at least one of the S. aureus polypeptide antigens which associates with the at least one immunogenic polysaccharide.