# US 11,305,000 B2 · Chimeric OspA genes, proteins and methods of use thereof

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- Number: US 11,305,000 B2
- Document ID: US11305000B2
- Status: Granted
- Kind: B2
- Application number: 15/875,479
- Filed: 2018-01-19
- Published: 2018-10-18
- Granted: 2022-04-19
- Earliest claimed: 2010-05-14
- Assignees: Brookhaven Science Associates, LLC; The Research Foundation of State University of New York; Baxalta Incorporated
- Applicants: The Research Foundation of the State University of New York; Baxalta Incorporated; Baxalta GmbH; Brookhaven Science Associates, LLC
- Inventors: Brian A. Crowe; Ian Livey; Maria O'Rourke; Michael Schwendinger; John J. Dunn; Benjamin J. Luft
- Web page: https://patentgrep.com/patent/US11305000B2

## CPC

- A61K 39/0225: {Spirochetes, e.g. Treponema, Leptospira, Borrelia}
- A61P 31/00: Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P 31/04: Antibacterial agents
- A61P 31/14: for RNA viruses
- A61P 33/00: Antiparasitic agents
- A61P 33/14: Ectoparasiticides, e.g. scabicides
- A61P 37/04: Immunostimulants
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- C07K 14/20: from Spirochaetales (O), e.g. Treponema, Leptospira
- A61K 2039/575: {humoral response}
- A61K 2039/6018: {Lipids, e.g. in lipopeptides}
- A61K 2039/70: {Multivalent vaccine}
- 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
- 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)
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## Abstract

The invention relates to the development of chimeric OspA molecules for use in a new Lyme vaccine. More specifically, the chimeric OspA molecules comprise the proximal portion from one OspA serotype, together with the distal portion from another OspA serotype, while retaining antigenic properties of both of the parent polypeptides. The chimeric OspA molecules are delivered alone or in combination to provide protection against a variety of Borrelia genospecies. The invention also provides methods for administering the chimeric OspA molecules to a subject in the prevention and treatment of Lyme disease or borreliosis.

## Claims

### Claim 1

An isolated polypeptide comprising an amino acid sequence having at least about 90 percent sequence identity to the amino acid sequence set forth in SEQ ID NO: 12, wherein the polypeptide maintains the following mutations: methionine (M) at amino acid 121, tyrosine (Y) at amino acid 142, and methionine (M) at amino acid 172.

### Claim 2 (depends on 1)

A composition comprising the isolated polypeptide of claim 1 and a pharmaceutically acceptable carrier.

### Claim 3 (depends on 2)

The composition of claim 2, wherein the composition further comprises at least one additional polypeptide comprising an amino acid sequence having at least about 85 percent sequence identity to an amino acid sequence set forth in SEQ ID NO:2, SEQ ID NO:4, or SEQ ID NO: 6, SEQ ID NO: 8, or SEQ ID NO: 10.

### Claim 4 (depends on 2)

An immunogenic composition comprising the composition of claim 2 and an adjuvant.

### Claim 5 (depends on 2)

The composition of claim 2, in combination with at least a second composition.

### Claim 6 (depends on 5)

The composition of claim 5 wherein the second composition protects against a tick-borne disease.

### Claim 7 (depends on 6)

The composition of claim 6 wherein the tick-borne disease is Rocky Mountain Spotted Fever, Babesiosis, Relapsing Fever, Colorado tick fever, Human monocytic ehrlichiosis (HME), Human granulocytic ehrlichiosis (HGE), Southern Tick-Associated Rash Illness (STARI), Tularemia, Tick paralysis, Powassan encephalitis, Q fever, Crimean-Congo hemorrhagic fever, Cytauxzoonosis, boutonneuse fever, or tick-borne encephalitis.

### Claim 8 (depends on 6)

The composition of claim 6 wherein the second composition is a tick-borne encephalitis vaccine.

### Claim 9 (depends on 2)

A method for inducing an immunological response in a subject, the method comprising the step of administering the composition of claim 2 to the subject in an amount effective to induce an immunological response.

### Claim 10 (depends on 9)

The method of claim 9 wherein the immunological response comprises production of an anti-OspA antibody and wherein the isolated polypeptide comprises the amino acid sequence set forth in SEQ ID NO: 12.

### Claim 11 (depends on 1)

A composition comprising at least two of the isolated polypeptides of claim 1 and a pharmaceutically acceptable carrier, wherein the polypeptides have different sequences.

### Claim 12 (depends on 1)

The isolated polypeptide of claim 1 comprising an amino acid sequence having at least 91 percent sequence identity to the amino acid sequence set forth in SEQ ID NO: 12.

### Claim 13 (depends on 1)

The isolated polypeptide of claim 1 comprising an amino acid sequence having at least 92 percent sequence identity to the amino acid sequence set forth in SEQ ID NO: 12.

### Claim 14 (depends on 1)

The isolated polypeptide of claim 1 comprising an amino acid sequence having at least 93 percent sequence identity to the amino acid sequence set forth in SEQ ID NO: 12.

### Claim 15 (depends on 1)

The isolated polypeptide of claim 1 comprising an amino acid sequence having at least 94 percent sequence identity to the amino acid sequence set forth in SEQ ID NO: 12.

### Claim 16 (depends on 1)

The isolated polypeptide of claim 1 comprising an amino acid sequence having at least 95 percent sequence identity to the amino acid sequence set forth in SEQ ID NO: 12.

### Claim 17 (depends on 1)

The isolated polypeptide of claim 1 comprising an amino acid sequence having at least 96 percent sequence identity to the amino acid sequence set forth in SEQ ID NO: 12.

### Claim 18 (depends on 1)

The isolated polypeptide of claim 1 comprising an amino acid sequence having at least 97 percent sequence identity to the amino acid sequence set forth in SEQ ID NO: 12.

### Claim 19 (depends on 1)

The isolated polypeptide of claim 1 comprising an amino acid sequence having at least 98 percent sequence identity to the amino acid sequence set forth in SEQ ID NO: 12.

### Claim 20 (depends on 1)

The isolated polypeptide of claim 1 comprising an amino acid sequence having at least 99 percent sequence identity to the amino acid sequence set forth in SEQ ID NO: 12.

### Claim 21

An isolated polypeptide comprising the amino acid sequence set forth in SEQ ID NO: 12.

### Claim 22 (depends on 21)

The isolated polypeptide of claim 21, wherein the polypeptide consists of the amino acid sequence set forth in SEQ ID NO: 12.

### Claim 23 (depends on 21)

A composition comprising the isolated polypeptide of claim 21 and a pharmaceutically acceptable carrier.

### Claim 24 (depends on 23)

An immunogenic composition comprising the composition of claim 23 and an adjuvant.