# US 2023/0265388 A1 · Methods, kits, and compositions for enhancing cellular therapy

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- Number: US 2023/0265388 A1
- Document ID: US20230265388A1
- Status: Published application
- Kind: A1
- Application number: 18/310,120
- Filed: 2023-05-01
- Published: 2023-08-24
- Earliest claimed: 2016-03-22
- Assignees: University of Florida Research Foundation, Inc.
- Applicants: University of Florida Research Foundation, Incorporated
- Inventors: Maryam Rahman; Duane Mitchell; Rolando Lovaton; Hassan Azari
- Web page: https://patentgrep.com/patent/US20230265388A1

## CPC

- C12N 5/0639: {Dendritic cells, e.g. Langherhans cells in the epidermis}
- 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 40/19: Dendritic cells
- A61K 40/24: Antigen-presenting cells [APC]
- A61K 40/42: Cancer antigens
- A61K 2039/53: {DNA (RNA) vaccination}
- A61K 2039/54: {characterised by the route of administration}
- A61K 2039/57: {characterised by the type of response, e.g. Th1, Th2}
- A61K 2239/31: characterized by the route of administration
- C12N 2500/46: Amines, e.g. putrescine
- C12N 2501/22: Colony stimulating factors (G-CSF, GM-CSF)
- C12N 2501/2304: Interleukin-4 (IL-4)
- C12N 2501/998: Proteins not provided for elsewhere
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)
- 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)

## Abstract

Cell-based compositions and methods for targeting and treating human diseases, including cancers and infectious diseases, are provided, wherein exogenous intracellular sarcosine is used for improved delivery of the composition.

## Claims

### Claim 1

A composition comprising an antigen presenting cell (APC),
wherein the cell comprises a receptor for presenting antigen and antigen bound to the receptor, and wherein the cell contains at least 0.1 pg of sarcosine.

### Claim at position 2

2-20. (Canceled)

### Claim 21

A method for preparing a cell-based pharmaceutical preparation comprising:
providing an antigen presenting cell comprising a receptor for presenting antigen and contacting the cell with a solution containing sarcosine.

### Claim 22

A method of treating a disease in a subject, comprising:
administering to the subject an antigen presenting cell (APC), wherein the cell comprises a receptor for presenting antigen and antigen bound to the receptor and wherein the cell contains at least 0.1 pg of sarcosine.

### Claim 23 (depends on 21)

The method of claim 21, wherein the cell is contacted with sufficient sarcosine such that the cell contains sarcosine above physiological levels.

### Claim 24 (depends on 21)

The method of claim 21, wherein the cell is contacted with sufficient sarcosine such that the cell contains at least 0.1 pg, between about 0.1 and 15 pg, between about 0.2 and 10 pg, between about 0.3 and 5 pg, or between about 0.5 pg and 3.5 pg of sarcosine.

### Claim 25 (depends on 21)

The method of claim 21, wherein the cell is contacted with sarcosine by culturing the cell in medium containing sarcosine.

### Claim 26 (depends on 21)

The method of claim 21, wherein the cell is contacted with sarcosine by electroporation.

### Claim 27 (depends on 21)

The method of claim 21, wherein the APC is a human cell.

### Claim 28 (depends on 21)

The method of claim 21, wherein the APC is a dendritic cell.

### Claim 29 (depends on 21)

The method of claim 21, further comprising contacting the cell with a disease-associated antigen.

### Claim 30 (depends on 29)

The method of claim 29, wherein the antigen is a human cytomegalovirus (CMV) antigen.

### Claim 31 (depends on 29)

The method of claim 29, wherein the disease-associated antigen is a tumor antigen.

### Claim 32 (depends on 29)

The method of claim 29, wherein the antigen is from total tumor RNA.

### Claim 33 (depends on 29)

The method of claim 29, wherein the antigen is a conserved mutation antigen, e.g., IDH1, K27M, BRAF V600E, or EGFRvIII mutation, or a patient-specific mutation antigen.

### Claim 34 (depends on 31)

The method of claim 31, wherein the tumor antigen is an antigen presented on or within brain cancer cells, e.g., glioblastoma, MAGE-1, AIM-2, gp100, or HER2.

### Claim 35 (depends on 31)

The method of claim 31, wherein the tumor antigen is a brain tumor antigen.

### Claim 36 (depends on 35)

The method of claim 35, wherein the brain tumor antigen is a glioblastoma antigen.

### Claim 37 (depends on 29)

The method of claim 29, wherein the disease-associated antigen is an infectious disease antigen.

### Claim 38 (depends on 21)

The method of claim 21, wherein the antigen is presented to the APC by: pulsing the APC (e.g., co-culture or electroporation); fusing cell components with disease tissue components, e.g., tumor components; RNA transfection; viral gene transduction; or DNA transfer.

### Claim 39 (depends on 21)

The method of claim 21, wherein the antigen is a short peptide, a long peptide, mRNA, DNA, recombinant protein, tumor lysate mixture, or carbohydrate antigen expressed within a cancer cell or infected cell.

### Claim 40

(canceled)