# US 12,214,034 B2 · Vaccines against HPV and HPV-related diseases

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- Number: US 12,214,034 B2
- Document ID: US12214034B2
- Status: Granted
- Kind: B2
- Application number: 18/329,696
- Filed: 2023-06-06
- Published: 2024-02-01
- Granted: 2025-02-04
- Earliest claimed: 2014-01-13
- Assignees: Baylor Research Institute
- Applicants: Baylor Research Institute
- Inventors: Sangkon Oh; Sandra Zurawski; Gerard Zurawski
- Web page: https://patentgrep.com/patent/US12214034B2

## CPC

- A61K 39/12: Viral antigens
- A61K 39/395: Antibodies (agglutinins A61K38/36 {; as drug carriers A61K47/50}); Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K 39/39541: {against normal tissues, cells}
- A61K 39/3955: {against proteinaceous materials, e.g. enzymes, hormones, lymphokines}
- A61P 31/12: Antivirals
- A61P 35/00: Antineoplastic agents
- C07K 14/005: from viruses
- C07K 16/2878: {against the NGF-receptor/TNF-receptor superfamily, e.g. CD27, CD30, CD40, CD95}
- C12N 7/00: Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof (preparing medicinal viral antigen or antibody compositions, e.g. virus vaccines, A61K39/00)
- A61K 2039/505: {comprising antibodies}
- A61K 2039/53: {DNA (RNA) vaccination}
- A61K 2039/55511: {Organic adjuvants}
- A61K 2039/585: {wherein the target is cancer}
- A61K 2039/6056: {Antibodies}
- A61K 2039/70: {Multivalent vaccine}
- C07K 2317/24: containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
- C07K 2317/56: variable (Fv) region, i.e. VH and/or VL
- C07K 2317/565: Complementarity determining region [CDR]
- C07K 2319/00: Fusion polypeptide
- C07K 2319/74: containing a fusion for binding to a cell surface receptor
- C07K 2319/91: containing a motif for glycosylation
- C12N 2710/20022: New viral proteins or individual genes, new structural or functional aspects of known viral proteins or genes
- C12N 2710/20034: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- 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)

## Abstract

Embodiments relate to novel vaccines against human papillomavirus (HPV) and HPV-related diseases, including multiple types of cancers. The HPV vaccines are composed of anti-human dendritic cell (DC) surface receptor antibodies, including CD40, and E6/7 proteins of HPV16 and 18. The technology described is not limited to making vaccines against HPV16- and HPV18-related diseases and can be applied to making vaccines carrying E6/7 from any type of HPV. The HPV vaccines described can target DCs, major and professional antigen presenting cells (APCs), and can induce and activate potent HPV E6/7-specific and strong CD4+ and CD8+ T cell responses. The HPV vaccines can be used for the prevention of HPV infection and HPV-related diseases as well as for the treatment of HPV-related diseases, including cancers.

## Claims

### Claim 1

One or more nucleic acids encoding a fusion protein comprising an anti-CD40antibody or fragment thereof, comprising at least three complementarity determining regions (CDRs) from each of a heavy and light chain of an anti-CD40 antibody, at least one peptide linker and at least one human papillomavirus (HPV) E6 antigen and at least one HPV E7 antigen, wherein the E6 and E7 antigens comprise an antigen with at least 90% sequence identity to SEQ ID NO: 1 and an antigen with at least 90% sequence identity to SEQ ID NO:2; and
wherein the fusion protein comprises an amino acid sequence that has at least 95% sequence identity to SEQ ID NO: 19.

### Claim 2 (depends on 1)

The one or more nucleic acids of claim 1, wherein the anti-CD40 antibody or fragment thereof is humanized.

### Claim 3 (depends on 1)

The one or more nucleic acids of claim 1, wherein the fusion protein comprises peptide linkers comprising the amino acid sequences of SEQ ID NO:5 and SEQ ID NO:6.

### Claim 4 (depends on 1)

The one or more nucleic acids of claim 1, wherein the three CDRs from the heavy chain of the anti-CD40 antibody comprises the amino acid sequences of SEQ ID NOs: 14-16, and wherein the three CDRs from the light chain of the anti-CD40 antibody comprises the amino acid sequences of SEQ ID NOs: 11-13.

### Claim 5

One or more nucleic acids encoding a fusion protein comprising an anti-CD40antibody or fragment thereof, comprising at least three complementarity determining regions (CDRs) from each of a heavy and light chain of an anti-CD40 antibody, at least one peptide linker and at least one human papillomavirus (HPV) E6 antigen and at least one HPV E7 antigen, wherein the E6 and E7 antigens comprise an antigen with at least 90% sequence identity to SEQ ID NO: 3 and an antigen with at least 90% sequence identity to SEQ ID NO:4; and wherein the fusion protein comprises an amino acid sequence that has at least 95% sequence identity to SEQ ID NO:21.

### Claim 6 (depends on 5)

The one or more nucleic acids of claim 5, wherein the anti-CD40 antibody or fragment thereof is humanized.

### Claim 7 (depends on 5)

The one or more nucleic acids of claim 5, wherein the three CDRs from the heavy chain of the anti-CD40 antibody comprises the amino acid sequences of SEQ ID NOs: 14-16, and wherein the three CDRs from the light chain of the anti-CD40 antibody comprises the amino acid sequences of SEQ ID NOs: 11-13.

### Claim 8 (depends on 5)

The one or more nucleic acids of claim 5, wherein the fusion protein comprises peptide linkers comprising the amino acid sequences of SEQ ID NO:5 and SEQ ID NO:6.

### Claim 9 (depends on 5)

The one or more nucleic acids of claim 5, wherein the three CDRs from the heavy chain of the anti-CD40 antibody comprises the amino acid sequences of SEQ ID NOs: 14-16, and wherein the three CDRs from the light chain of the anti-CD40 antibody comprises the amino acid sequences of SEQ ID NOs: 11-13.

### Claim 10 (depends on 1)

A vector comprising the one or more nucleic acids of claim 1.

### Claim 11 (depends on 5)

A vector comprising the one or more nucleic acids of claim 5.

### Claim 12 (depends on 1)

An isolated host cell comprising the one or more nucleic acids of claim 1.

### Claim 13 (depends on 5)

An isolated host cell comprising the one or more nucleic acids of claim 5.

### Claim 14 (depends on 1)

A method of making a fusion protein comprising expressing the one or more nucleic acids of claim 1 in a host cell and isolating the fusion protein.

### Claim 15 (depends on 5)

A method of making a fusion protein comprising expressing the one or more nucleic acids of claim 5 in a host cell and isolating the fusion protein.

### Claim 16 (depends on 1)

A method of making a fusion protein comprising incubating an host cell comprising the one or more nucleic acids of claim 1 and isolating the fusion protein.

### Claim 17 (depends on 5)

A method of making a fusion protein comprising incubating an host cell comprising the one or more nucleic acids of claim 5 and isolating the fusion protein.