# US 12,076,380 B2 · Peptides and combination of peptides for use in immunotherapy against hepatocellular carcinoma (HCC) and other cancers

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- Number: US 12,076,380 B2
- Document ID: US12076380B2
- Status: Granted
- Kind: B2
- Application number: 17/492,112
- Filed: 2021-10-01
- Published: 2022-01-20
- Granted: 2024-09-03
- Earliest claimed: 2014-12-23
- Assignees: Immatics Biotechnologies GmbH
- Applicants: Immatics Biotechnologies GmbH
- Inventors: Toni Weinschenk; Andrea Mahr; Jens Fritsche; Phillip Mueller; Anita Wiebe; Sarah Kutscher
- Web page: https://patentgrep.com/patent/US12076380B2

## CPC

- A61K 38/04: Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof ({enzyme inhibitors A61K38/005;} gastrins {A61K38/2207}, somatostatins A61K38/31, melanotropins A61K38/34 {; protease inhibitors A61K38/55})
- 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 38/20: Interleukins [IL]
- A61K 38/2013: {IL-2}
- A61K 38/2046: {IL-7}
- A61K 38/208: {IL-12}
- A61K 38/212: {IFN-alpha}
- A61K 38/215: {IFN-beta}
- A61K 39/0011: {Cancer antigens}
- A61K 39/00111: {Hepatocyte growth factor receptor [HGFR or c-met]}
- A61K 40/11: T-cells, e.g. tumour infiltrating lymphocytes [TIL] or regulatory T [Treg] cells; Lymphokine-activated killer [LAK] cells
- A61K 40/42: Cancer antigens
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61P 1/04: for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
- A61P 1/16: for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
- A61P 1/18: for pancreatic disorders, e.g. pancreatic enzymes
- A61P 13/12: of the kidneys
- A61P 25/00: Drugs for disorders of the nervous system
- A61P 35/00: Antineoplastic agents
- A61P 35/02: specific for leukemia
- A61P 37/04: Immunostimulants
- C07K 7/00: Peptides having 5 to 20 amino acids in a fully defined sequence; Derivatives thereof
- C07K 7/06: having 5 to 11 amino acids
- C07K 14/435: from animals; from humans
- C07K 14/7051: {T-cell receptor (TcR)-CD3 complex}
- C07K 14/70539: {MHC-molecules, e.g. HLA-molecules}
- C07K 16/18: against material from animals or humans
- C12N 5/0636: {T lymphocytes}
- C12N 15/115: Aptamers, i.e. nucleic acids binding a target molecule specifically and with high affinity without hybridising therewith {; Nucleic acids binding to non-nucleic acids, e.g. aptamers}
- A61K 38/00: Medicinal preparations containing peptides (peptides containing beta-lactam rings A61K31/00; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, A61K31/00; ergot alkaloids of the cyclic peptide type A61K31/48; containing macromolecular compounds having statistically distributed amino acid units A61K31/74; medicinal preparations containing antigens or antibodies A61K39/00; medicinal preparations characterised by the non-active ingredients, e.g. peptides as drug carriers, A61K47/00)
- A61K 51/1057: {the tumor cell being from liver or pancreas}
- A61K 2035/124: {the cells being hematopoietic, bone marrow derived or blood cells}
- A61K 2039/5154: {Antigen presenting cells [APCs], e.g. dendritic cells or macrophages}
- A61K 2039/5158: {Antigen-pulsed cells, e.g. T-cells}
- C07K 7/08: having 12 to 20 amino acids (gastrins C07K14/595; somatostatins C07K14/655; melanotropins C07K14/68)
- C07K 2317/70: characterized by effect upon binding to a cell or to an antigen
- C07K 2319/40: containing a tag for immunodetection, or an epitope for immunisation
- C12N 2310/16: Aptamers
- C12N 2501/998: Proteins not provided for elsewhere
- G01N 33/6803: {General methods of protein analysis not limited to specific proteins or families of proteins}
- 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)
- 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)

## Abstract

A peptide consists of the amino acid sequence ALVEQGFTV (SEQ ID NO: 5) in the form of a pharmaceutically acceptable salt, in which the peptide has the ability to bind to an MHC class-I molecule and, when bound to MHC, is capable of being recognized by CD8+ T cells. A composition contains a peptide consisting of the amino acid sequence ALVEQGFTV (SEQ ID NO: 5), an adjuvant, and a pharmaceutically acceptable carrier.

## Claims

### Claim 1

A peptide consisting of the amino acid sequence ALVEQGFTV (SEQ ID NO: 5) in the form of a pharmaceutically acceptable salt.

### Claim 2 (depends on 1)

The peptide of claim 1, wherein said peptide has the ability to bind to a major histocompatibility complex (MHC) class-I molecule, and wherein said peptide, when bound to said MHC, is capable of being recognized by CD8+ T cells.

### Claim 3 (depends on 1)

The peptide of claim 1, wherein the pharmaceutically acceptable salt is chloride salt.

### Claim 4 (depends on 1)

The peptide of claim 1, wherein the pharmaceutically acceptable salt is acetate salt.

### Claim 5 (depends on 1)

The peptide in the form of a pharmaceutically acceptable salt of claim 1, wherein said peptide is produced by solid phase peptide synthesis or produced by a yeast cell or bacterial cell expression system.

### Claim 6 (depends on 1)

A composition comprising the peptide of claim 1 and a pharmaceutically acceptable carrier.

### Claim 7 (depends on 6)

The composition of claim 6, wherein the peptide is in the form of a chloride salt.

### Claim 8 (depends on 6)

The composition of claim 6, wherein the peptide is in the form of an acetate salt.

### Claim 9 (depends on 6)

The composition of claim 6, further comprising an adjuvant selected from the group consisting of imiquimod, resiquimod, granulocyte-macrophage colony-stimulating factor (GM-CSF), cyclophosphamide, sunitinib, bevacizumab, interferon-alpha, interferon-beta, CpG oligonucleotides, polyinosinic:polycytidylic acid (poly-(I:C)), RNA, sildenafil, particulate formulations with poly(lactide co-glycolide) (PLG), virosomes, interleukin (IL)-1, IL-2, IL-4, IL-7, IL-12, IL-13, IL-15, IL-21, and IL-23.

### Claim 10 (depends on 9)

The composition of claim 9, wherein the adjuvant is IL-2.

### Claim 11 (depends on 9)

The composition of claim 9, wherein the adjuvant is IL-7.

### Claim 12 (depends on 9)

The composition of claim 9, wherein the adjuvant is IL-12.

### Claim 13 (depends on 9)

The composition of claim 9, wherein the adjuvant is IL-15.

### Claim 14 (depends on 9)

The composition of claim 9, wherein the adjuvant is IL-21.

### Claim 15 (depends on 1)

A composition comprising the peptide of claim 1, wherein the composition is a pharmaceutical composition and comprises a buffer.

### Claim 16

A pegylated peptide consisting of the amino acid sequence of ALVEQGFTV (SEQ ID NO: 5) or a pharmaceutically acceptable salt thereof, wherein a polyethylene glycol (PEG) is cross-linked to the amino acid sequence.

### Claim 17 (depends on 16)

The peptide of claim 16, wherein the pharmaceutically acceptable salt is chloride salt.

### Claim 18 (depends on 16)

The peptide of claim 16, wherein the pharmaceutically acceptable salt is acetate salt.

### Claim 19 (depends on 16)

A composition comprising the pegylated peptide of claim 16 or pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable carrier.