# US 12,311,019 B2 · Vaccine composition and uses thereof

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- Number: US 12,311,019 B2
- Document ID: US12311019B2
- Status: Granted
- Kind: B2
- Application number: 16/966,442
- Filed: 2019-02-07
- Published: 2021-08-05
- Granted: 2025-05-27
- Earliest claimed: 2018-02-07
- Assignees: Imugene Limited
- Applicants: Imugene Limited
- Inventors: Nicholas Ede; Ursula Wiedermann; Joshua Tobias; Christoph Zielinski
- Web page: https://patentgrep.com/patent/US12311019B2

## CPC

- A61K 39/0005: {Vertebrate antigens (from snakes A61K39/38)}
- A61K 39/001111: {Immunoglobulin superfamily}
- A61K 39/00: Medicinal preparations containing antigens or antibodies (materials for immunoassay G01N33/53)
- A61K 39/395: Antibodies (agglutinins A61K38/36 {; as drug carriers A61K47/50}); Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61P 35/00: Antineoplastic agents
- C07K 16/2818: {against CD28 or CD152}
- A61K 2039/505: {comprising antibodies}
- A61K 2039/545: {characterised by the dose, timing or administration schedule}
- A61K 2039/55505: {Inorganic adjuvants}
- A61K 2039/55561: {CpG containing adjuvants; Oligonucleotide containing adjuvants}
- A61K 2039/55566: {Emulsions, e.g. Freund's adjuvant, MF59}
- A61K 2039/55572: {Lipopolysaccharides; Lipid A; Monophosphoryl lipid A}
- A61K 2039/55577: {Saponins; Quil A; QS21; ISCOMS}
- A61K 2039/575: {humoral response}
- A61K 2039/6037: {Bacterial toxins, e.g. diphteria toxoid [DT], tetanus toxoid [TT]}
- A61K 2039/6081: {Albumin; Keyhole limpet haemocyanin [KLH]}
- C07K 2317/33: Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
- C07K 2317/34: Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
- C07K 2317/76: Antagonist effect on antigen, e.g. neutralization or inhibition of binding
- 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

Disclosed herein is a vaccine composition for raising a humoral response to PD1, and uses thereof, for treating a cancer characterised by an involvement of PD1, wherein the vaccine composition comprises an effective amount of an immunogen that induces an antibody response in which the antibody binds to a B cell epitope of PD1.

## Claims

### Claim 1

A method of treating a cancer, the method comprising administering to a human subject having a cancer characterized by an involvement of programmed cell death protein 1 (PD1) a vaccine composition comprising an effective amount of an immunogen that induces an antibody response in which the antibody binds to a B cell epitope of PD1,
wherein the immunogen comprises a B cell epitope of PD1, wherein the B cell epitope of PD1 consists of an amino acid sequence selected from the group consisting of SEQ ID NOs: 9, 10, 14, 24, 28, 29, 42, 43, 49, and a combination of two or more of the foregoing, and wherein the amino acid sequence of the immunogen is not identical to a continuous stretch of at least 50 amino acid residues of PD1.

### Claim 2 (depends on 1)

The method of claim 1, wherein the B cell epitope of PD1 consists of an amino acid sequence selected from the group consisting of SEQ ID NOs: 9, 43, 56 and 57.

### Claim 3 (depends on 1)

The method of claim 1, further comprising administering to the subject an antibody, or an antigen-binding fragment thereof, that specifically binds to a cancer-associated antigen.

### Claim 4 (depends on 1)

The method of claim 1, wherein the immunogen comprises a carrier.

### Claim 5 (depends on 4)

The method of claim 4, wherein the carrier is diphtheria toxin variant CRM-197 (SEQ ID NO:118).

### Claim 6 (depends on 1)

The method of claim 1, wherein the vaccine composition comprises an adjuvant.

### Claim 7 (depends on 6)

The method of claim 6, wherein the adjuvant is a TLR-4 agonist.

### Claim 8 (depends on 6)

The method of claim 6, wherein the adjuvant is a water in oil emulsion.

### Claim 9

A vaccine composition for raising a humoral response to PD1, wherein the vaccine composition comprises an immunogen that induces an antibody response in which the antibody binds to a B cell epitope of PD1, wherein the immunogen comprises a B cell epitope of PD1, wherein the B cell epitope of PD1 consists of an amino acid sequence selected from the group consisting of SEQ ID NOs: 9, 10, 14, 24, 28, 29, 42, 43, and 49, and a combination of two or more of any of the foregoing, wherein the amino acid sequence of the immunogen is not identical to a continuous stretch of at least 50 amino acid residues of PD1, and wherein the vaccine composition further comprises an adjuvant.

### Claim 10 (depends on 9)

The vaccine composition of claim 9, wherein the B cell epitope of PD1 consists of the amino acid sequence selected from the group consisting of SEQ ID NO: 9 and SEQ ID NO: 43.

### Claim 11 (depends on 9)

The vaccine composition of claim 9, wherein the immunogen further comprises a promiscuous T helper cell epitope.

### Claim 12 (depends on 9)

The vaccine composition of claim 9, wherein the B cell epitope of PD1 consists of a fusion of two or more of SEQ ID NOs: 9, 10, 14, 24, 28, 29, 42, 43, and 49.

### Claim 13 (depends on 9)

The vaccine composition of claim 9, wherein the B cell epitope of PD1 consists of an amino acid sequence selected from the group consisting of SEQ ID NO: 56 and SEQ ID NO: 57.

### Claim 14 (depends on 9)

A pharmaceutical composition comprising the vaccine composition of claim 9 and a pharmaceutically acceptable excipient.

### Claim 15 (depends on 9)

A method of treating cancer, the method comprising administering to a subject having a cancer characterised by an involvement of PD1 the vaccine composition of claim 9.

### Claim 16 (depends on 15)

The method of claim 15, further comprising administering to the subject an antibody that specifically binds to a cancer-associated antigen, or an antigen-binding fragment thereof.