# US 12,214,012 B2 · Combined preparations for the treatment of cancer

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- Number: US 12,214,012 B2
- Document ID: US12214012B2
- Status: Granted
- Kind: B2
- Application number: 16/918,527
- Filed: 2020-07-01
- Published: 2020-10-15
- Granted: 2025-02-04
- Earliest claimed: 2013-12-19
- Assignees: Immutep S.A.S.
- Applicants: Immutep S.A.S.
- Inventors: Frederic Triebel
- Web page: https://patentgrep.com/patent/US12214012B2

## CPC

- A61K 38/1774: {Immunoglobulin superfamily (e.g. CD2, CD4, CD8, ICAM molecules, B7 molecules, Fc-receptors, MHC-molecules)}
- A61K 31/282: Platinum compounds
- A61K 31/4745: condensed with ring systems having nitrogen as a ring hetero atom, e.g. phenantrolines (yohimbine derivatives, vinblastine A61K31/475; ergoline derivatives A61K31/48)
- A61K 31/555: containing heavy metals, e.g. hemin, hematin, melarsoprol
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61P 35/00: Antineoplastic agents
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- C07K 14/70503: {Immunoglobulin superfamily}
- C07K 2319/30: Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto
- 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)

## Abstract

Combined preparations for the treatment of cancer are described. The combined preparations comprise: (a) LAG-3 protein, or a derivative thereof that is able to bind to MHC class II molecules; and (b) an anti-neoplastic agent, wherein the anti-neoplastic agent is a platinum-based anti-neoplastic agent or a topoisomerase I inhibitor. Methods for the treatment of cancer using the combined preparations are also described.

## Claims

### Claim 1

A method of treating or ameliorating a cancer, which comprises:
administering to a subject in need of such treatment or amelioration an effective amount of:
a derivative of LAG-3 protein that is able to bind to MHC class II molecules, wherein the derivative comprises domains D1 and D2 of human LAG-3 protein, and wherein the derivative is fused to an Immunoglobulin Fc sequence; and
an anti-neoplastic agent, wherein the anti-neoplastic agent is a platinum-based anti-neoplastic agent or a topoisomerase I inhibitor; and
synergistically reducing tumor growth in the subject, the synergistic reduction of tumor growth being more than a sum of a reduction of tumor growth caused by administration to the subject of the derivative alone and the anti-neoplastic agent alone.

### Claim 2 (depends on 1)

A method according to claim 1, wherein the derivative and the anti-neoplastic agent are administered sequentially to the subject.

### Claim 3 (depends on 1)

A method according to claim 1, wherein the derivative is administered after the anti-neoplastic agent.

### Claim 4 (depends on 2)

A method according to claim 2, wherein the derivative and the anti-neoplastic agent are administered to the subject within 96 hours of each other.

### Claim 5 (depends on 1)

A method according to claim 1, wherein the derivative and the anti-neoplastic agent are co-administered to the subject.

### Claim 6 (depends on 1)

A method according to claim 1, wherein the derivative is administered to the subject at a dose which is a molar equivalent of 0.25-30 mg of LAG-3Ig fusion protein IMP321 per individual.

### Claim 7 (depends on 1)

A method according to claim 1, wherein a plurality of doses of the derivative is administered to the subject.

### Claim 8 (depends on 1)

A method according to claim 1, wherein a plurality of doses of the anti-neoplastic agent is administered to the subject.

### Claim 9 (depends on 1)

A method according to claim 1, wherein a dose of the derivative is administered before, with, or after each administration of two or more doses of the anti-neoplastic agent.

### Claim 10 (depends on 1)

A method according to claim 1, wherein the derivative comprises domains D1, D2, D3, and optionally D4 of human LAG-3 protein.

### Claim 11 (depends on 1)

A method according to claim 1, wherein the derivative of LAG-3 protein is IMP321.

### Claim 12 (depends on 1)

A method according to claim 1, wherein the anti-neoplastic agent is selected from the group consisting of oxaliplatin, carboplatin, and topotecan.
