# US 2024/0189356 A1 · Active donor t cell stat6

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- Number: US 2024/0189356 A1
- Document ID: US20240189356A1
- Status: Published application
- Kind: A1
- Application number: 18/535,619
- Filed: 2023-12-11
- Published: 2024-06-13
- Earliest claimed: 2022-12-09
- Inventors: Mirac Nedim Ince; David Elliott
- Web page: https://patentgrep.com/patent/US20240189356A1

## CPC

- 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)
- A61K 35/28: Bone marrow; Haematopoietic stem cells; Mesenchymal stem cells of any origin, e.g. adipose-derived stem cells
- A61K 40/11: T-cells, e.g. tumour infiltrating lymphocytes [TIL] or regulatory T [Treg] cells; Lymphokine-activated killer [LAK] cells
- A61K 40/34: Antigenic peptides
- A61K 40/4238: {Regulators of development}
- A61K 40/4242: {Transcription factors, e.g. SOX or c-MYC}
- A61P 37/04: Immunostimulants
- A61P 37/06: Immunosuppressants, e.g. drugs for graft rejection
- C07K 14/4705: {stimulating, promoting or activating activity}
- C12N 15/86: Viral vectors
- 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)
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)

## Abstract

Provided herein is the use of donor T cells that express a continuously active form of STAT6, e.g., before or during BMT/HCT or after BMT/HCT, the use of autologous T cells genetically engineered to express a continuously active form of STAT6 to prevent, inhibit or treat immune diseases including autoimmune diseases and the use of T cells genetically engineered to express a continuously active form of STAT6 to enhance an immune response to a vaccine.

## Claims

### Claim 1

A method to enhance the efficacy of a bone marrow transplant (BMT) in a mammal comprising administering to a mammal in need thereof an amount of a population of hematopoietic stem cells (HSCs) and an amount of isolated T cells that express constitutively active STAT6.

### Claim 2 (depends on 1)

The method of claim 1, wherein the hematopoietic stem cells are allogeneic or autologous.

### Claim 3 (depends on 1)

The method of claim 1, wherein the T cells are allogeneic or autologous.

### Claim 4 (depends on 1)

The method of claim 1, wherein the STAT6 is a human STAT6.

### Claim 5 (depends on 1)

The method of claim 1, wherein the immune system of the mammal prior to administering is inactivated.

### Claim 6 (depends on 1)

The method of claim 1, wherein the mammal has cancer.

### Claim 7 (depends on 6)

The method of claim 6, wherein the cancer is leukemia, myeloma or lymphoma.

### Claim 8 (depends on 1)

The method of claim 1, wherein the T cells comprise a viral vector expressing the STAT6.

### Claim 9

A method to prevent, inhibit or treat an autoimmune disease or to enhance memory cell generation in a mammal comprising administering to a mammal in need thereof an amount of isolated T cells that express constitutively active STAT6, a vector that expresses constitutively active STAT6 or isolated constitutively active STAT6.

### Claim 10 (depends on 9)

The method of claim 9, wherein the T cells are allogeneic or autologous.

### Claim 11 (depends on 9)

The method of claim 9, wherein the STAT6 is a human STAT6.

### Claim 12

A method to enhance the immune response to a pathogen in a mammal comprising administering to a mammal in need thereof an amount of isolated T cells that express constitutively active STAT6, a vector that expresses constitutively active STAT6 or isolated constitutively active STAT6 and an immunogen of the pathogen.

### Claim 13 (depends on 12)

The method of claim 12, wherein the pathogen is a virus or a bacterium or a coronavirus.

### Claim 14 (depends on 1)

The method of claim 1, wherein the STAT6 has at least 86% amino acid sequence identity to SEQ ID NO: 1 or SEQ ID NO: 2.

### Claim 15 (depends on 14)

The method of claim 14, wherein the residue at position 548 is alanine, glycine, leucine or isoleucine.

### Claim 16

A population of isolated human T cells the genome of which comprises a nucleic acid sequence encoding a constitutively active form of human STAT6.