# US 2019/0169290 A1 · Compositions and methods for modulating an immune response

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- Number: US 2019/0169290 A1
- Document ID: US20190169290A1
- Status: Published application
- Kind: A1
- Application number: 16/023,682
- Filed: 2018-06-29
- Published: 2019-06-06
- Earliest claimed: 2013-11-26
- Assignees: The Brigham and Women's Hospital, Inc.
- Applicants: The Brigham and Women's Hospital, Inc.
- Inventors: Richard S. Blumberg; Kristi Baker; Timo Rath
- Web page: https://patentgrep.com/patent/US20190169290A1

## CPC

- C07K 16/283: {against Fc-receptors, e.g. CD16, CD32, CD64 (CD23 C07K16/2851)}
- A61K 40/11: T-cells, e.g. tumour infiltrating lymphocytes [TIL] or regulatory T [Treg] cells; Lymphokine-activated killer [LAK] cells
- A61K 40/19: Dendritic cells
- A61K 40/24: Antigen-presenting cells [APC]
- A61K 40/42: Cancer antigens
- A61P 31/00: Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P 35/00: Antineoplastic agents
- A61P 35/04: specific for metastasis
- A61P 37/04: Immunostimulants
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- C07K 16/00: Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
- C07K 16/244: {Interleukins [IL]}
- C12N 15/1138: {against receptors or cell surface proteins}
- G01N 33/564: for pre-existing immune complex or autoimmune disease {, i.e. systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, rheumatoid factors or complement components C1-C9}
- G01N 33/575: for cancer
- G01N 33/6854: {Immunoglobulins}
- G01N 33/6863: {Cytokines, i.e. immune system proteins modifying a biological response such as cell growth proliferation or differentiation, e.g. TNF, CNF, GM-CSF, lymphotoxin, MIF or their receptors}
- G01N 33/6866: {Interferon}
- G01N 33/6869: {Interleukin}
- A61K 2039/505: {comprising antibodies}
- A61K 2039/507: {Comprising a combination of two or more separate antibodies}
- A61K 2239/31: characterized by the route of administration
- A61K 2239/38: characterised by the dose, timing or administration schedule
- A61K 2239/55: Lung
- C07K 2317/21: from primates, e.g. man
- C07K 2317/31: multispecific
- C07K 2317/52: Constant or Fc region; Isotype
- C07K 2317/72: Increased effector function due to an Fc-modification
- C07K 2317/76: Antagonist effect on antigen, e.g. neutralization or inhibition of binding
- C12N 2310/14: interfering nucleic acids [NA]
- G01N 2333/525: Tumor necrosis factor [TNF]
- G01N 2333/5434: IL-12
- G01N 2333/57: IFN-gamma
- G01N 2800/52: Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis
- 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
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)
- 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)

## Abstract

Described herein are compositions for increasing IL-12 production comprising IgG or a fragment thereof or a variant thereof and uses of said compositions for treating cancer and infectious diseases. Also described herein are compositions for decreasing IL-12 production comprising an agent that inhibits signaling mediated by interaction between FcRn and IgG and uses of said compositions for treating autoimmune diseases. Further described herein are methods for assessing efficacy of treatment by monitoring levels of various cytokines in the subject.

## Claims

### Claim 1

A composition for increasing IL-12 production, the composition comprising immunoglobulin G (IgG) or a variant thereof or a fragment thereof.

### Claim 2 (depends on 1)

The composition of claim 1, wherein the composition increases signaling mediated by interaction between IgG and FcRn.

### Claim 3 (depends on 1)

The composition of claim 1, wherein the composition increases an immune response against an antigen.

### Claim 4 (depends on 1)

The composition of claim 1, wherein the variant IgG comprises a methionine to leucine substitution at position 428 and an asparagine to serine substitution at position 434.

### Claim 5 (depends on 1)

The composition of claim 1, further comprising an antigen conjugated to IgG or a variant thereof or a fragment thereof so as to create a monomeric or a multimeric structure which can cross-link FcRn.

### Claim 6 (depends on 1)

The composition of claim 1, further comprising an antigen complexed to IgG or a variant thereof or a fragment thereof so as to create a multimeric structure which can cross-link FcRn.

### Claim 7 (depends on 5)

The composition of claim 5, wherein the antigen is a tumor antigen, an endogenous antigen, a cell-associated antigen, an apoptotic body, a microbial antigen, a viral antigen, a parasitic antigen or a combination thereof.

### Claim 8

The composition of 7, wherein the antigen is a protein or a proteomimetic thereof, a peptide or a peptidomimetic thereof, a lipid or a combination thereof.

### Claim 9 (depends on 1)

The composition of claim 1, wherein the IgG or a variant thereof or a fragment thereof is mammalian.

### Claim 10 (depends on 1)

The composition of claim 1, wherein the IgG or a variant thereof or a fragment thereof is human.

### Claim 11

A composition for decreasing IL-12 production, the composition comprising an agent that inhibits signaling mediated by interaction between FcRn and IgG.

### Claim 12 (depends on 11)

The composition of claim 11, wherein the agent is any one or more of a peptide, protein, small molecule, nucleic acid, aptamer, oligonucleotide, antibody or a combination thereof.

### Claim 13 (depends on 12)

The composition of claim 12, wherein the nucleic acid is siRNA specific to FcRn.

### Claim 14 (depends on 12)

The composition of claim 12, wherein the antibody is selected from the group consisting of a monoclonal antibody or a fragment thereof, a polyclonal antibody or a fragment thereof, chimeric antibody, humanized antibody and single chain antibody.

### Claim 15 (depends on 11)

The composition of claim 11, wherein the agent is a bispecific agent comprising binding sites for IgG and FcRn.

### Claim 16 (depends on 11)

The composition of claim 11, wherein the agent is a recombinant Fc portion of IgG or a biologically active portion thereof or a proteo-mimetic thereof.

### Claim 17 (depends on 16)

The composition of claim 16, wherein the Fc portion of IgG or a biologically active portion thereof is mammalian.

### Claim 18 (depends on 16)

The composition of claim 16, wherein the Fc portion of IgG or a biologically active portion thereof is human.

### Claim 19

A method for modulating the interaction between FcRn and IgG comprising contacting a cell with an agent that binds FcRn and/or IgG and modulates binding of FcRn to IgG.

### Claim 20 (depends on 19)

The method of claim 19, wherein the agent increases signaling mediated by interaction of FcRn and IgG.

### Claim at position 21

-53. (canceled)