# US 10,369,205 B2 · Immunomodulatory compositions and methods of use thereof

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- Number: US 10,369,205 B2
- Document ID: US10369205B2
- Status: Granted
- Kind: B2
- Application number: 15/108,744
- Filed: 2015-01-07
- Published: 2016-11-03
- Granted: 2019-08-06
- Earliest claimed: 2014-01-07
- Applicants: Babita Agrawal; Rakesh Kumar
- Inventors: Babita Agrawal; Rakesh Kumar
- Web page: https://patentgrep.com/patent/US10369205B2

## CPC

- A61K 39/02: Bacterial antigens
- A61K 39/0011: {Cancer antigens}
- A61K 39/015: Hemosporidia antigens, e.g. Plasmodium antigens
- A61K 39/04: Mycobacterium, e.g. Mycobacterium tuberculosis
- A61K 39/12: Viral antigens
- A61K 39/35: Allergens
- A61K 39/39: characterised by the immunostimulating additives, e.g. chemical adjuvants
- A61K 39/395: Antibodies (agglutinins A61K38/36 {; as drug carriers A61K47/50}); Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61P 35/00: Antineoplastic agents
- A61P 37/02: Immunomodulators
- A61P 37/04: Immunostimulants
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- A61K 2039/505: {comprising antibodies}
- A61K 2039/521: {inactivated (killed)}
- A61K 2039/55516: {Proteins; Peptides}
- A61K 2039/55572: {Lipopolysaccharides; Lipid A; Monophosphoryl lipid A}
- A61K 2039/58: {raising an immune response against a target which is not the antigen used for immunisation}
- C12N 2710/10343: viral genome or elements thereof as genetic vector
- C12N 2730/10134: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- C12N 2760/16134: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- C12N 2760/16234: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- C12N 2770/24234: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- 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
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## Abstract

The present disclosure provides immunomodulatory compositions comprising heat-killed Caulobacter crescentus (HKCC). Immunomodulatory compositions of the present disclosure are useful for modulating an immune response in an individual. The present disclosure thus provides methods of modulating an immune response in an individual, involving administering an immunomodulatory composition comprising HKCC to the individual.

## Claims

### Claim 1

A method of modulating an antigen-specific immune response in an individual, the method comprising administering to the individual an effective amount of an immunomodulatory composition comprising:
a) heat-killed Caulobacter crescentus;
b) a pathogen-derived antigen, or a tumor-associated antigen; and
c) a pharmaceutically acceptable excipient;
wherein the composition is administered via an oral, nasal, subcutaneous, intramuscular, topical or mucosal route of administration.

### Claim 2 (depends on 1)

The method of claim 1, wherein the immune response comprises a humoral immune response, a cellular immune response, an innate immune response, and/or production of one or more cytokines.

### Claim 3 (depends on 1)

The method of claim 1, further comprising administering to the individual a cancer chemotherapeutic agent, an anti-bacterial agent, an anti-mycobacterial agent, an anti-viral agent, an anti-protozoan agent, an anti-malarial agent, an anti-helminth agent, or a therapeutic treatment for cancer selected from the group consisting of radiation therapy, laser therapy, photodynamic therapy, and surgery.

### Claim 4 (depends on 1)

The method of claim 1, further comprising administering to the individual an antibody.

### Claim 5 (depends on 1)

The method of claim 1, further comprising administering to the individual a cytokine, an additional adjuvant, or an immunomodulatory agent.

### Claim 6 (depends on 1)

The method of claim 1, wherein the individual is a human, a non-human mammal, or a non-mammal animal.

### Claim 7

A method of reducing tumor progression or an infection in an individual having a disease selected from the group consisting of cancer and an infectious disease, wherein the infectious disease is caused by a virus, a bacterium, a fungus, a parasite, or a mycobacterium, the method comprising administering to the individual a composition comprising:
a) heat-killed Caulobacter crescentus; and
b) a pharmaceutically acceptable excipient;
wherein the composition is administered via an oral, nasal, subcutaneous, intramuscular, topical or mucosal route of administration.

### Claim 8 (depends on 7)

The method of claim 7, further comprising administering an anti-bacterial agent, an anti-mycobacterial agent, an anti-viral agent, an anti-protozoan agent, an anti-malarial agent, an anti-helminth agent, an immunomodulatory agent, an antibody, a cytokine, an adjuvant, a vaccine, a cancer chemotherapeutic agent, or a therapeutic treatment for cancer selected from the group consisting of radiation therapy, laser therapy, photodynamic therapy, and surgery.

### Claim 9 (depends on 7)

The method of claim 7, wherein the Caulobacter is selected from the group consisting of S-layer negative Caulobacter crescentus and lipopolysaccharide negative Caulobacter crescentus.

### Claim 10 (depends on 7)

The method of claim 7, wherein the individual is a human, a non-human mammal, or a non-mammal animal.

### Claim 11

A method of enhancing the efficacy and/or reducing the toxicity of a therapeutic treatment in an individual, the method comprising administering to the individual an effective amount of an immunomodulatory composition comprising:
a) heat-killed Caulobacter crescentus; and
b) a pharmaceutically acceptable excipient;
wherein the composition is administered via an oral, nasal, subcutaneous, intramuscular, topical or mucosal route of administration,
wherein the therapeutic treatment is an anticancer treatment.

### Claim 12 (depends on 11)

The method of claim 11, wherein the immunomodulatory composition further comprises a pathogen-derived antigen or a tumor-associated antigen.