# US 8,465,740 B2 · Regulatory T cell mediator proteins and uses thereof

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- Number: US 8,465,740 B2
- Document ID: US8465740B2
- Status: Granted
- Kind: B2
- Application number: 13/326,792
- Filed: 2011-12-15
- Published: 2012-08-02
- Granted: 2013-06-18
- Earliest claimed: 2005-04-25
- Assignees: Trustees of Dartmouth College
- Applicants: Randolph J. Noelle; Li-Fan Lu; Sergio Quezada; David Gondek
- Inventors: Randolph J. Noelle; Li-Fan Lu; Sergio Quezada; David Gondek
- Web page: https://patentgrep.com/patent/US8465740B2

## CPC

- G01N 33/505: {involving T-cells}
- A01K 67/0278: Knock-in vertebrates, e.g. humanised vertebrates
- A61K 38/1709: {from mammals}
- A61P 31/00: Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P 37/00: Drugs for immunological or allergic disorders
- C07K 14/4702: {Regulators; Modulating activity}
- 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)
- A01K: ANIMAL HUSBANDRY; AVICULTURE; APICULTURE; PISCICULTURE; FISHING; REARING OR BREEDING ANIMALS, NOT OTHERWISE PROVIDED FOR; NEW BREEDS OF ANIMALS
- 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)

## Abstract

The present invention relates to novel regulatory T cell proteins. One protein, designated PD-L3, resembles members of the PD-L1 family, and co-stimulates αCD3 proliferation of T cells in vitro. A second, TNF-like, protein has also been identified as being upregulated upon αCD3/αGITR stimulation. This protein has been designated Treg-sTNF. Proteins, antibodies, activated T cells and methods for using the same are disclosed.

## Claims

### Claim 1

A method of promoting T cell immunity against a viral infectious agent comprising administering an effective amount of an anti-PD-L3 antibody or antibody fragment that specifically binds to the extracellular region of the human PD-L3 protein having the sequence in SEQ ID NO:4, wherein said anti-PD-L3 antibody or antibody fragment antagonizes the immunosuppressive effect of PD-L3 on T cell immunity in vivo, and thereby potentiates T cell immune response against the viral infectious agent.

### Claim 2 (depends on 1)

The method of claim 1, wherein the anti-PD-L3 antibody or antibody fragment antagonizes one or more of the following effects of PD-L3 on T cell function in vivo:
(1) suppression of T cell activation or differentiation;
(2) suppression of CD4+T cell proliferation,
(3) suppression of CD8+T cell proliferation and
(4) suppression of cytokine production by T cells.

### Claim 3 (depends on 1)

The method of claim 1, wherein the antibody or antibody fragment is a chimeric, human or humanized antibody or fragment thereof.

### Claim 4 (depends on 1)

The method of claim 1, wherein the antibody fragment is selected from a Fab, F(ab′)2, Fv, Fd, and a scFv.

### Claim 5 (depends on 1)

The method of claim 1, wherein the antibody is an IgG1.

### Claim 6 (depends on 1)

The method of claim 1, which promotes T cell-mediated killing of virally infected cells.