# US 9,435,804 B2 · Detection, prevention, and treatment of anthrax and other infectious diseases

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- Number: US 9,435,804 B2
- Document ID: US9435804B2
- Status: Granted
- Kind: B2
- Application number: 13/967,259
- Filed: 2013-08-14
- Published: 2015-02-19
- Granted: 2016-09-06
- Earliest claimed: 2003-09-12
- Assignees: Board of Regents of the Nevada System of Higher Education, on behalf of the University of Nevada, Reno; Regents of the University of Minnesota; Stc. Unm
- Applicants: Board of Regents of the Nevada System of Higher Education, on behalf of the University of Nevada; Stc.Unm; Regents of the University of Minnesota
- Inventors: Thomas Kozel; William Murphy; Suzanne Brandt; Bruce R Blazar; Julie A Lovchik; Peter Thorkildson; Ann Percival; C. Rick Lyons
- Web page: https://patentgrep.com/patent/US9435804B2

## CPC

- G01N 33/56911: {Bacteria}
- A61K 39/07: Bacillus
- A61K 39/3955: {against proteinaceous materials, e.g. enzymes, hormones, lymphokines}
- C07K 16/1278: Bacillus (G)
- C07K 16/2878: {against the NGF-receptor/TNF-receptor superfamily, e.g. CD27, CD30, CD40, CD95}
- A61K 2039/505: {comprising antibodies}
- A61K 2039/54: {characterised by the route of administration}
- A61K 2039/55566: {Emulsions, e.g. Freund's adjuvant, MF59}
- A61K 2039/575: {humoral response}
- A61K 2039/6081: {Albumin; Keyhole limpet haemocyanin [KLH]}
- C07K 2317/75: Agonist effect on antigen
- C07K 2317/92: Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
- G01N 2333/32: from Bacillus (G)
- 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)
- 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

Compositions and methods for the detection, prevention, or treatment of anthrax or other infectious diseases. In one aspect, the present invention provides methods for immunizing humans or animals against Bacillus anthracis or other capsulated pathogens. The methods include administering a capsular polypeptide of a pathogen of interest and a CD40 agonist to a human or animal. The capsular polypeptide or the CD40 agonist is administered in such an amount or frequency that an immunoprotective response can be elicited in the human or animal against the pathogen of interest. In another aspect, the present invention provides methods of using passive immunization with anti-capsular polypeptide antibodies to prevent or treat infections caused by Bacillus anthracis or other pathogens. In yet another aspect, the present invention provides methods useful for diagnosis of anthrax by detection of capsular polypeptide in serum or other biological samples.

## Claims

### Claim 1

A method of diagnosing infection by a PGA producing pathogen in a subject from a vertebrate species, comprising:
assaying soluble PGA in a biological sample obtained from the subject using an anti-PGA antibody, the assay generating a detectable signal if the level of soluble PGA in the sample exceeds a predetermined amount, the predetermined amount is 140 pg/ml.

### Claim 2 (depends on 1)

The method of claim 1 wherein the subject is a human.

### Claim 3 (depends on 1)

The method of claim 1, further comprising administering antibiotics to the subject if the soluble PGA in the sample exceeds the predetermined amount.

### Claim 4 (depends on 1)

The method of claim 1, wherein assaying the soluble PGA in a biological sample comprises subjecting the sample to a lateral flow assay.

### Claim 5 (depends on 4)

The method of claim 4, wherein the lateral flow assay comprises the anti-PGA antibody coupled to a colloidal metal.

### Claim 6 (depends on 1)

The method of claim 1, wherein the anti-PGA antibody comprises an IgG3 isotype anti-PGA antibody.

### Claim 7 (depends on 1)

The method of claim 1, wherein the anti-PGA antibody is from a species other than the species of the subject.

### Claim 8 (depends on 1)

The method of claim 1, wherein the anti-PGA antibody is obtained by immunizing a vertebrate with PGA under conditions of enhanced immunogenicity.

### Claim 9 (depends on 8)

The method of claim 8, further comprising isolating the antibody for use in the assay.

### Claim 10 (depends on 1)

The method of claim 1, wherein the perceptible indication comprises a visually perceptible indication.

### Claim 11

A method of diagnosing a subject as being infected by a PGA producing pathogen, comprising detecting soluble PGA exceeding a predetermined amount, the predetermined amount is 140 pg/ml, in a sample obtained from a subject known to be at risk for acquiring anthrax.

### Claim 12 (depends on 1)

The method of claim 1, wherein the detectable signal is a visual indicator.

### Claim 13 (depends on 11)

The method of claim 11, further comprising administering antibiotics to the subject if the soluble PGA in the sample exceeds the predetermined amount.