# US 11,168,307 B2 · Poxvirus-Plasmodium recombinants, compositions containing such recombinants, uses thereof, and methods of making and using the same

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- Number: US 11,168,307 B2
- Document ID: US11168307B2
- Status: Granted
- Kind: B2
- Application number: 16/567,531
- Filed: 2019-09-11
- Published: 2020-04-02
- Granted: 2021-11-09
- Earliest claimed: 2013-12-30
- Assignees: V-Core Technologies, Inc.
- Applicants: V-Core Technologies, Inc.
- Inventors: Enzo Paoletti; Randall L. Weinberg; Scott J. Goebel
- Web page: https://patentgrep.com/patent/US11168307B2

## CPC

- 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 39/015: Hemosporidia antigens, e.g. Plasmodium antigens
- A61K 39/275: Poxviridae, e.g. avipoxvirus
- A61P 33/06: Antimalarials
- A61P 37/00: Drugs for immunological or allergic disorders
- A61P 37/04: Immunostimulants
- C12N 15/86: Viral vectors
- A61K 2039/5256: {expressing foreign proteins}
- C12N 2710/24021: Viruses as such, e.g. new isolates, mutants or their genomic sequences
- C12N 2710/24034: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- C12N 2710/24122: New viral proteins or individual genes, new structural or functional aspects of known viral proteins or genes
- C12N 2710/24134: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- C12N 2710/24143: viral genome or elements thereof as genetic vector
- Y02A 50/30: Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)
- 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
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## Abstract

The invention provides a recombinant or synthetic or engineered or non-naturally occurring poxvirus that contains and expresses DNA encoding a heterologous or exogenous antigen, epitope or immunogen and Flagellin or an operable binding portion thereof. The poxvirus can contain or be engineered to contain and express vaccinia host range gene K1L. The poxvirus can be attenuated as to mammals, e.g., NYVAC, NYVAC.1, NYVAC.2, avipox, canarypox, fowlpox, ALVAC, TROVAC, MVA, or MVA-BN. The invention also provides methods for inducing an immunological response involving the poxvirus, and compositions containing the poxvirus. The antigen, epitope or immunogen that the poxvirus expresses can be at least one Plasmodium antigen. The Plasmodium antigen(s), epitope(s) or immunogen(s) can be SERA, ABRA, Pfhsp70, AMA-1, Pfs25, Pfs16, CSP, PfSSP2, LSA-1 repeatless, MSA-1, AMA-1 or combination(s) thereof. Advantageously the poxvirus contains DNA coding for and expresses Plasmodium antigen(s) CSP, PfSSP2, LSA-1-repeatless, MSA-1, SERA, AMA-1 and Pfs25. Also, advantageously, the poxvirus is a NYVAC poxvirus. The invention thus also provides an anti-malarial immunogenic or immunological compositions comprising the poxvirus, and methods for inducing an immunogenic or immunological response against malaria or Plasmodium in a mammal comprising administering to the mammal the poxvirus or an immunological or immunogenic composition containing the poxvirus. The mammal can be a human.

## Claims

### Claim 1

A recombinant or engineered poxvirus that contains DNA encoding, for expression of each of:
Plasmodium circumsporozoite protein (CSP),
Plasmodium sporozoite surface protein 2 (PfSSP2),
Plasmodium liver stage antigen 1 (LSA-1)-repeatless,
Plasmodium merozoite surface antigen 1 (MSA-1),
Plasmodium serine repeat antigen (SERA),
Plasmodium apical membrane antigen 1 (AMA-1),
Plasmodium 25-kDa sexual-stage antigen (Pfs25), and
Flagellin,
wherein:
the Plasmodium antigen AMA-1 is coded for by a nucleotide sequence comprising the AMA-1 coding sequence contained in SEQ ID NO:19;
the Flagellin is expressed as a peptide and not as a fusion; and
the poxvirus is a NYVAC virus, an ALVAC virus, a TROVAC virus, a MVA virus, a MVA-BN virus, an avipox virus, a canarypox virus, or a fowlpox virus.

### Claim 2 (depends on 1)

The recombinant or engineered poxvirus of claim 1, further comprising DNA encoding, for expression of
vaccinia host range gene K1L.

### Claim 3 (depends on 1, 2)

The recombinant or engineered poxvirus of claim 1 or 2, wherein the poxvirus comprises a NYVAC virus.

### Claim 4 (depends on 1, 2)

The recombinant or engineered poxvirus of claim 1 or 2, wherein the poxvirus comprises a MVA virus, or MVA-BN virus.

### Claim 5 (depends on 1, 2)

The recombinant or engineered poxvirus of claim 1 or 2, wherein the poxvirus comprises a fowlpox virus.

### Claim 6 (depends on 1, 2)

A method of inducing an immunological response against malaria, Plasmodium or a Plasmodium antigens in a mammal comprising administering to the mammal the recombinant or engineered poxvirus of claim 1 or 2, or an immunological or immunogenic composition containing the recombinant or engineered poxvirus.

### Claim 7 (depends on 1, 2)

An immunological or immunogenic composition containing the recombinant or engineered poxvirus of claim 1 or 2.

### Claim 8 (depends on 1, 2)

The recombinant or engineered poxvirus of claim 1 or 2, wherein the poxvirus comprises an ALVAC virus.

### Claim 9 (depends on 1, 2)

The recombinant or engineered poxvirus of claim 1 or 2, wherein the poxvirus comprises an avipox virus.

### Claim 10 (depends on 1, 2)

The recombinant or engineered poxvirus of claim 1 or 2, wherein the poxvirus comprises a TROVAC virus.

### Claim 11 (depends on 1, 2)

The recombinant or engineered poxvirus of claim 1 or 2, wherein the poxvirus comprises a canarypox virus.

### Claim 12 (depends on 1, 2)

The recombinant or engineered poxvirus of claim 1 or 2, wherein the Flagellin is coded for by a nucleotide sequence comprising the Flagellin coding sequence contained in SEQ ID NO:19.

### Claim 13 (depends on 1, 2)

An anti-malarial immunogenic or immunological composition comprising a recombinant or engineered poxvirus of claim 1 or 2.

### Claim 14 (depends on 3)

An immunogenic or immunological composition comprising a poxvirus of claim 3.

### Claim 15 (depends on 4)

An immunogenic or immunological composition comprising a poxvirus of claim 4.

### Claim 16 (depends on 12)

The recombinant or engineered poxvirus of claim 12, wherein the poxvirus comprises a NYVAC virus.

### Claim 17 (depends on 16)

A method for inducing an immunogenic or immunological response against malaria or Plasmodium or a Plasmodium antigen in a mammal comprising administering to the mammal the recombinant or engineered poxvirus of claim 16 or an immunological or immunogenic composition containing the recombinant or engineered poxvirus.

### Claim 18 (depends on 3)

A method for inducing an immunogenic or immunological response against malaria or Plasmodium or a Plasmodium antigen in a mammal comprising administering to the mammal the recombinant or engineered poxvirus of claim 3 or an immunological or immunogenic composition containing the recombinant or engineered poxvirus.

### Claim 19 (depends on 4)

A method for inducing an immunogenic or immunological response against malaria or Plasmodium or a Plasmodium antigen in a mammal comprising administering to the mammal the recombinant or engineered poxvirus of claim 4 or an immunological or immunogenic composition containing the recombinant or engineered poxvirus.