# US 8,771,666 B2 · Ex-vivo treatment of T-cells with IFN-λ

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- Number: US 8,771,666 B2
- Document ID: US8771666B2
- Status: Granted
- Kind: B2
- Application number: 13/713,457
- Filed: 2012-12-13
- Published: 2014-02-20
- Granted: 2014-07-08
- Earliest claimed: 2007-10-27
- Assignees: Medical Diagnostics Laboratories, LLC
- Applicants: Grant Gallagher; Joyce Gallagher; Sshekar Srinivas; Jihong Dai; Nicholas Megjugorac; Grant E. Gallagher
- Inventors: Grant Gallagher; Joyce Gallagher; Sshekar Srinivas; Jihong Dai; Nicholas Megjugorac; Grant E. Gallagher
- Web page: https://patentgrep.com/patent/US8771666B2

## CPC

- A61K 38/217: {IFN-gamma}
- A61K 35/15: Cells of the myeloid line, e.g. granulocytes, basophils, eosinophils, neutrophils, leucocytes, monocytes, macrophages or mast cells; Myeloid precursor cells; Antigen-presenting cells, e.g. dendritic cells (presenting a specific antigen A61K39/00; therapeutic combinations of antibodies, or fragments thereof, and blood-derived cells A61K39/00)
- A61K 35/17: Lymphocytes; B-cells; T-cells; Natural killer cells; Interferon-activated or cytokine-activated lymphocytes (when activated by a specific antigen A61K39/00)
- A61P 11/06: Antiasthmatics
- A61P 31/12: Antivirals
- A61P 37/08: Antiallergic agents (antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14)
- 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

## Abstract

The present invention provides a method of treating Th2-associated diseases and disorders by modulating the expression or secretion of IL-4, IL-5 and IL-13 using interferon lambda (IFN-λ). For Th2-associated diseases and disorders, cells of a patient having a Th2-associated disease or disorder are treated ex vivo, with IFN-λ and returned to the patient. The present invention also provides a method of ex vivo treatment, in conjunction with co-administration of IFN-λ.

## Claims

### Claim 1

A method of ex vivo treatment of T-cells, comprising the steps:
(a) obtaining peripheral blood from a human subject suffering from asthma;
(b) isolating mononuclear cells from said peripheral blood;
(c) purifying T-cells from said isolated mononuclear cells;
(d) exposing said purified T-cells to IFN-λ; and
(e) administering said exposed cells to said human subject,
wherein said IFN-λ is present in an amount sufficient to inhibit stimulus-induced cytokine release, and
wherein said stimulus is selected from the group consisting of Concanavalin A and anti-CD2/3/28 beads and said cytokine is at least one compound selected from the group consisting of IL-4 and IL-5.

### Claim 2 (depends on 1)

The method of claim 1, wherein said purified T-cells are naïve T-cells.

### Claim 3 (depends on 1)

The method of claim 1, wherein said purified T-cells are memory T-cells.

### Claim 4 (depends on 1)

The method of claim 1, wherein said IFN-λ is at least one compound selected from the group consisting of IFN-λ1, IFN-λ2, and IFN-λ3.

### Claim 5 (depends on 1)

The method of claim 1, wherein said amount is in the range about 1 ng/mL to about 200 μg/mL.

### Claim 6 (depends on 1)

The method of claim 1, wherein said amount is in the range of about 100 ng/mL to about 10 μg/mL.

### Claim 7 (depends on 1)

The method of claim 1, wherein said exposing step is performed for about 1 hour to about 24 hours.

### Claim 8 (depends on 1)

The method of claim 1, wherein said exposing step is performed for about 6 hours to about 12 hours.

### Claim 9 (depends on 1)

The method of claim 1, wherein said asthma is virus-induced or allergen-induced.

### Claim 10 (depends on 1)

The method of claim 1, wherein said mononuclear cells are in the range of about 1×107 cells to about 1×109 cells.

### Claim 11 (depends on 1)

The method of claim 1, wherein said mononuclear cells are about 1×108 cells.

### Claim 12 (depends on 1)

The method of claim 1, further comprising the step of repeating the step (a) through step (e).

### Claim 13 (depends on 1)

The method of claim 1, further comprising the step (f) of administering a composition comprising IFN-λ to the human subject.

### Claim 14 (depends on 13)

The method of claim 13, wherein said IFN-λ composition is administered nasally, intravenously, or orally.

### Claim 15 (depends on 13)

The method of claim 13, wherein said step (f) is performed simultaneously or sequentially with step (e).
