# US 11,998,596 B2 · Immunogenic compositions and vaccines comprising African swine fever virus peptides and proteins and uses thereof

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- Number: US 11,998,596 B2
- Document ID: US11998596B2
- Status: Granted
- Kind: B2
- Application number: 18/067,614
- Filed: 2022-12-16
- Published: 2023-09-07
- Granted: 2024-06-04
- Earliest claimed: 2019-03-27
- Applicants: Boehringer Ingelheim Vetmedica GmbH
- Inventors: Veljko Nikolin; Egbert Siegfried Mundt; Fernando Rodriguez Gonzalez; Laia Bosch Camos; Javier Alonso Collado Miguens
- Web page: https://patentgrep.com/patent/US11998596B2

## CPC

- A61K 39/12: Viral antigens
- A61P 31/20: for DNA viruses
- C07K 14/01: DNA viruses
- C12N 15/746: {for lactic acid bacteria (Streptococcus; Lactococcus; Lactobacillus; Pediococcus; Enterococcus; Leuconostoc; Propionibacterium; Bifidobacterium; Sporolactobacillus)}
- C12N 15/86: Viral vectors
- A61K 2039/545: {characterised by the dose, timing or administration schedule}
- A61K 2039/552: {Veterinary vaccine}
- C12N 2710/12022: New viral proteins or individual genes, new structural or functional aspects of known viral proteins or genes
- 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

The present invention relates to African swine fever virus (ASFV) peptides and/or polypeptides as well as immunogenic fragments thereof, corresponding encoding AFSV oligonucleotides and/or polynucleotides as well as immunogenic fragments thereof, immunogenic compositions, vaccines and uses thereof.

## Claims

### Claim 1

An immunogenic composition comprising an adjuvant, and further comprising
two African swine fever virus peptides, polypeptides, and/or full-length proteins, comprising
one amino acid sequence which is at least 95% identical to MGF505-7R (SEQ ID NO: 774) and one amino acid sequence which is at least 95% identical to M448R (SEQ ID NOS: 568, 566).

### Claim 2 (depends on 1)

The immunogenic composition according claim 1, further comprising one or more pharmaceutical- or veterinary-acceptable carriers or excipients, wherein said one or more carriers or excipients are suitable for oral, intradermal, intramuscular or intranasal application.

### Claim 3 (depends on 1)

An immunogenic composition, comprising a viral or bacterial vector, an exogenous and/or heterologous viral or bacterial vector, comprising one or two African swine fever virus oligonucleotides, and/or polynucleotides, encoding the African swine fever virus peptides, polypeptides, and/or full-length proteins, as claimed in claim 1.

### Claim 4 (depends on 3)

The immunogenic composition as claimed in claim 3, wherein the viral or bacterial vector is selected from the group consisting of: avipox virus viral vector, canine morbillivirus viral vector, herpes virus viral vector, varicella virus viral vector, Lawsonia spp., Salmonella spp.

### Claim 5 (depends on 1)

The immunogenic composition as claimed in claim 1, wherein the ASFV polypeptide is an ASFV full-length protein, encoded by a polynucleotide sequence comprising an open reading frame (ORF).

### Claim 6 (depends on 1)

Immunogenic composition as claimed in claim 1, wherein the ASFV is selected from the group consisting of: BA71, BA71ΔCD2 and/or Georgia2007/1 strain(s).

### Claim 7 (depends on 1)

The immunogenic composition as claimed in claim 1, wherein the immunogenicity of the immunogenic composition is indicated by an induced IFN-gamma response when administered to pigs.

### Claim 8 (depends on 1)

A method of reducing or preventing the clinical signs or disease in pigs caused by an infection with at least one pathogenic African swine fever virus or for use in a method of treating and/or preventing an infection with at least one pathogenic African swine fever virus comprising administering the immunogenic composition of claim 1.

### Claim 9 (depends on 1)

A method of immunizing a pig against a clinical disease caused by at least one pathogenic African swine fever virus in said pig comprising the step of administering to the pig the immunogenic composition of claim 1, wherein said immunogenic composition fails to cause significant clinical signs of infection but is capable of inducing an immune response that immunizes the pig against pathogenic forms of said at least one African swine fever virus.

### Claim 10 (depends on 1)

A method of prime-boost immunizing a pig against a clinical disease caused by at least one pathogenic African swine fever virus in said pig comprising the step of administering to the pig once or twice the immunogenic composition of claim 1—as sole immunogenic component (priming step); and subsequently—after priming once or twice—administering to the pig a live attenuated African swine fever virus, such as BA71ΔCD2 (boosting step); wherein said immunogenic composition as well as the live attenuated African swine fever virus independently from each other fail to cause clinical signs of infection but are capable of inducing an immune response that immunizes the pig against pathogenic forms of said at least one African swine fever virus.

### Claim 11 (depends on 1)

A kit for vaccinating a pig against a disease associated with and/or reducing the incidence or the severity of one or more clinical signs associated with or caused by at least one pathogenic African swine fever virus in a pig, comprising:
(a) a dispenser capable of administering a vaccine to said pig; and
(b) the immunogenic composition as claimed in claim 1.
