# US 2019/0167789 A1 · Immunotherapy treatments and compositions

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- Number: US 2019/0167789 A1
- Document ID: US20190167789A1
- Status: Published application
- Kind: A1
- Application number: 15/537,731
- Filed: 2015-12-17
- Published: 2019-06-06
- Earliest claimed: 2014-12-19
- Assignees: Susavion Biosciences, Inc.
- Applicants: Susavion Biosciences, Inc.
- Inventors: Laura L. Eggink; J. Kenneth Hoober
- Web page: https://patentgrep.com/patent/US20190167789A1

## CPC

- A61K 39/3955: {against proteinaceous materials, e.g. enzymes, hormones, lymphokines}
- A61K 38/10: Peptides having 12 to 20 amino acids {(A61K38/043 - A61K38/046 take precedence)}
- A61K 39/0011: {Cancer antigens}
- A61P 31/04: Antibacterial agents
- A61P 31/12: Antivirals
- A61P 33/00: Antiparasitic agents
- A61P 35/00: Antineoplastic agents
- A61P 37/04: Immunostimulants
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- A61K 2039/507: {Comprising a combination of two or more separate antibodies}
- A61K 2039/585: {wherein the target is cancer}
- A61K 2039/6056: {Antibodies}
- A61K 2039/64: {characterised by the architecture of the carrier-antigen complex, e.g. repetition of carrier-antigen units}
- Y02A 50/30: Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
- 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
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## Abstract

The present invention relates to compositions and kits comprising a peptide that activate the immune response and methods of using the composition for immunotherapy and cancer treatments. The peptide comprises an active peptide sequence of VQATQSNQHTPR. In some embodiments, the peptide may be tetravalent. For example, the peptide has the structure [(VQATQSNQHTPRGGGS)2K]2K-NH2. In some embodiments, the compositions and methods are directed to the treatment of cancer and/or infections.

## Claims

### Claim 1

A pharmaceutical composition, comprising a therapeutically effective amount of a peptide and a therapeutically effective amount of a first antibody, wherein the peptide has an active sequence represented by SEQ ID NO:1, and the first antibody is against a first immune checkpoint protein.

### Claim 2 (depends on 1)

The pharmaceutical composition of claim 1, wherein the peptide has a structure set forth in SEQ ID NO:3.

### Claim 3 (depends on 1)

The pharmaceutical composition of claim 1, further comprising a pharmaceutically acceptable carrier.

### Claim 4 (depends on 1)

The pharmaceutical composition of claim 1, further comprising a second antibody, wherein the second antibody is against a second immune checkpoint protein of a different immune checkpoint pathway as the first immune checkpoint protein.

### Claim 5 (depends on 1)

The pharmaceutical composition of claim 1, wherein the therapeutically effective amount is selected from the group consisting of: an amount sufficient to activate an immune response in a subject, an amount sufficient to treat infections arising from viruses, mycobacteria, or parasites, and an amount sufficient to increase the population of effector T cells.

### Claim 6 (depends on 1)

The pharmaceutical composition of claim 1, wherein the therapeutically effective amount is selected from the group consisting of: an amount sufficient to treat cancer in a subject having cancer, an amount sufficient to suppress the population of regulatory T cells within tumors, and an amount sufficient to increase the levels of at least one anti-cancer cytokines selected from the group consisting of: IL-2, IL-12p70, IL-21, IL-27, TNFα, and IFNγ.

### Claim 7 (depends on 6)

The pharmaceutical composition of claim 6, wherein cancer is selected from the group consisting of: bladder cancer, brain cancer, breast cancer, colon cancer, head and neck cancer, liver cancer, lung cancer, pancreatic cancer, prostate cancer, ovarian cancer, kidney cancer, and skin cancer.

### Claim 8 (depends on 7)

The pharmaceutical composition of claim 7, wherein cancer is selected from the group consisting of: colorectal adenocarcinoma, glioblastoma, hepatocellular carcinoma, hormone-refractory prostate cancer, epithelial ovarian carcinoma, ovarian adenocarcinoma, melanoma, mesothelioma, non-small cell lung cancer, small cell lung cancer, and renal cell carcinoma.

### Claim at position 9

9-25. (canceled)

### Claim 26 (depends on 1)

The pharmaceutical composition of claim 1, wherein the first immune checkpoint protein is selected from the group consisting of: CTLA-4, PD-1, PD-L1, and PD-L2.

### Claim 27

(canceled)

### Claim 28

A method of activating the immune response in a subject, the method comprising:
administering a therapeutically effective amount of a peptide to the subject, wherein the peptide has an active sequence represented by SEQ ID NO:1; and
administering a therapeutically effective amount of a first antibody to the subject, wherein the first antibody is against a first immune checkpoint protein.

### Claim 29 (depends on 28)

The method of claim 28, wherein the first antibody is selected from the group consisting of: α-CTLA-4, α-PD-1, α-PD-L1, α-PD-L2, and a combination thereof.

### Claim 30 (depends on 28)

The method of claim 28, wherein the peptide is administered before the first antibody.

### Claim at position 15

31-34. (canceled)

### Claim 35 (depends on 28)

The method of claim 28, further comprising administering a second antibody against a second immune checkpoint protein, wherein the second immune checkpoint protein and the first immune checkpoint protein are of two distinct immune checkpoint pathways.

### Claim 36 (depends on 28)

The method of claim 28, wherein the subject has cancer, and the method further comprising administering radiation treatment to the subject.

### Claim 37

A kit for activating the immune response, the kit comprising:
a therapeutically effective amount of a peptide, wherein the peptide has an active sequence represented by SEQ ID NO:1; and
a therapeutically effective amount of one or more antibodies, wherein the antibodies are against immune checkpoint proteins.

### Claim 38 (depends on 37)

The kit of claim 37, wherein the one or more antibodies are selected from the group consisting of: α-CTLA-4, α-PD-1, α-PD-L1, and α-PD-L2.

### Claim 39 (depends on 37)

The kit of claim 37, wherein the peptide has a structure set forth in SEQ ID NO:3.

### Claim 40 (depends on 28)

The method of claim 28, wherein the therapeutic amount of the peptide is between about 0.1 nmol/kg body weight to about 1500 nmol/kg body weight.

### Claim 41 (depends on 40)

The method of claim 40, wherein the therapeutic amount of the peptide is between about 1 nmol/kg body weight to about 1000 nmol/kg body weight.

### Claim 42 (depends on 40)

The method of claim 40, wherein the therapeutic amount of the peptide is about 1 nmol/kg body weight.