# US 10,370,679 B2 · Modified immunization vectors

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- Number: US 10,370,679 B2
- Document ID: US10370679B2
- Status: Granted
- Kind: B2
- Application number: 15/289,297
- Filed: 2016-10-10
- Published: 2017-08-31
- Granted: 2019-08-06
- Earliest claimed: 2009-04-30
- Assignees: Arizona Board of Regents, a body corporate of the State of Arizona, acting for and on behalf of Ariz; Consejo Superior De Investgaciones Cientrificas; IPPOX Foundation
- Applicants: Arizona Board of Regents, a body corporate of the State of Arizona acting for and on behalf of Arizona State University; Consejo Superior De Investigaciones Cientificas; IPPOX Foundation
- Inventors: Giuseppe Pantaleo; Thierry Calandra; Alexandre Harari; Thierry Roger; Mariano Esteban; Bertram Jacobs; Karen Kibler; Cornelius Melief; Rafick-Pierre Sekaly; Elias El Haddad; James Tartaglia
- Web page: https://patentgrep.com/patent/US10370679B2

## CPC

- C12N 15/86: Viral vectors
- A61K 39/275: Poxviridae, e.g. avipoxvirus
- A61K 39/295: Polyvalent viral antigens (vaccinia virus or variola virus A61K39/285); Mixtures of viral and bacterial antigens
- A61P 37/02: Immunomodulators
- A61K 39/12: Viral antigens
- A61K 49/00: Preparations for testing in vivo
- A61K 2039/5256: {expressing foreign proteins}
- 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 disclosure relates to recombinant vectors and methods for using the same. In certain embodiments, the recombinant vectors are immunogenic.

## Claims

### Claim 1

A recombinant NYVAC vector encoding within its genome C7L (SEQ ID NO. 17) and K1L (SEQ ID NO. 27), and optionally at least one of C1L (SEQ ID NO. 5), C2L (SEQ ID NO. 7), C3L (SEQ ID NO. 9), C4L (SEQ ID NO. 11), C5L (SEQ ID NO. 13), C6L (SEQ ID NO. 15), N1L (SEQ ID NO. 19), N2L (SEQ ID NO. 21), M1L (SEQ ID NO. 23), and M2L (SEQ ID NO. 25); wherein the C7L (SEQ ID NO. 17) and the and K1L (SEQ ID NO. 27) are positioned adjacent to C8L and K2L, respectively, in the NYVAC genome.

### Claim 2 (depends on 1)

The recombinant NYVAC vector of claim 1 encoding at least one of C1L (SEQ ID NO. 5), C2L (SEQ ID NO. 7), C3L (SEQ ID NO. 9), C4L (SEQ ID NO. 11), C5L (SEQ ID NO. 13), C6L (SEQ ID NO. 15), N1L (SEQ ID NO. 19), N2L (SEQ ID NO. 21), M1L (SEQ ID NO. 23), and M2L (SEQ ID NO. 25).

### Claim 3 (depends on 1)

The recombinant NYVAC vector of claim 1, further comprising a polynucleotide encoding Ambystoma tigrinum virus Eukaryotic Translation Initiation Factor (ATV eIF2αH) (SEQ ID NO. 29).

### Claim 4 (depends on 1)

The recombinant NYVAC vector of claim 1 wherein the recombinant NYVAC vector further encodes an immunogen that directs an immune response against an antigen selected from the group consisting of a viral target antigen, a bacterial target antigen, a parasitic target antigen, or a tumor target antigen.

### Claim 5 (depends on 4)

The recombinant NYVAC vector of claim 4 wherein the viral target antigen is derived from a virus selected from the group consisting of an adenovirus, herpes virus, Epstein-Barr virus, human cytomegalovirus, varicella-zoster virus, poxvirus, parvovirus, papillomavirus, reovirus, picornavirus, coxsackie virus, hepatitis A virus, poliovirus, togavirus, rubella virus, flavivirus, hepatitis C virus, yellow fever virus, dengue virus, West Nile virus, orthomyxovirus, influenza virus, rhabdovirus, paramyxovirus, measles virus, mumps virus, parainfluenza virus, respiratory syncytial virus, rhabdovirus, rabies virus, retrovirus, human immunodeficiency virus (HIV), hepadnavirus, and hepatitis B virus.

### Claim 6 (depends on 5)

The recombinant NYVAC vector of claim 5 wherein the virus is human immunodeficiency virus (HIV).

### Claim 7 (depends on 6)

The recombinant NYVAC vector of claim 6 wherein the viral target antigen is selected from the group consisting of Env, Gag, Nef, and Pol.

### Claim 8 (depends on 7)

The recombinant NYVAC vector of claim 7 wherein the viral target antigen is provided by a GAG-POL-NEF fusion protein.

### Claim 9 (depends on 6)

The recombinant NYVAC vector of claim 6 wherein the viral target antigen has the amino acid sequence selected from the group consisting of ENV, GAG, POL, NEF, VGNLWVTVYYGVPVW (SEQ ID NO. 56), WVTVYYGVPVWKGAT (SEQ ID NO. 57), GATTTLFCASDAKAY (SEQ ID NO. 58), TTLFCASDAKAYDTE (SEQ ID NO. 59), THACVPADPNPQEMV (SEQ ID NO. 60), ENVTENFNMWKNEMV (SEQ ID NO. 61), ENFNMWKNEMVNQMQ (SEQ ID NO. 62), EMVNQMQEDVISLWD (SEQ ID NO. 63), CVKLTPLCVTLECRN (SEQ ID NO. 64), NCSFNATTVVRDRKQ (SEQ ID NO. 65), NATTVVRDRKQTVYA (SEQ ID NO. 66), VYALFYRLDIVPLTK (SEQ ID NO. 67), FYRLDIVPLTKKNYS (SEQ ID NO. 68), INCNTSAITQACPKV (SEQ ID NO. 69), PKVTFDPIPIHYCTP (SEQ ID NO. 70), FDPIPIHYCTPAGYA (SEQ ID NO. 71), TGDIIGDIRQAHCNI (SEQ ID NO. 72), SSSIITIPCRIKQII (SEQ ID NO. 73), ITIPCRIKQIINMWQ (SEQ ID NO. 74), CRIKQIINMWQEVGR (SEQ ID NO. 75), VGRAMYAPPIKGNIT (SEQ ID NO. 76), MYAPPIKGNITCKSN (SEQ ID NO. 77), PIKGNITCKSNITGL (SEQ ID NO. 78), ETFRPGGGDMRNNWR (SEQ ID NO. 79), ELYKYKVVEIKPLGV (SEQ ID NO. 80), YKVVEIKPLGVAPTT (SEQ ID NO. 81), EIKPLGVAPTTTKRR (SEQ ID NO. 82), LGVAPTTTKRRVVER (SEQ ID NO. 83), and YSENSSEYY (SEQ ID NO. 84).

### Claim 10 (depends on 4)

The recombinant NYVAC vector of claim 4 wherein the bacterial target antigen is derived from a bacterial organism selected from the group consisting of Bacillus anthracis, Bordetella pertussis, Borrelia burgdorferi, Brucella abortus, Brucella canis, Brucella melitensis, Brucella suis, Campylobacter jejuni, Chlamydia pneumoniae, Chlamydia psittaci, Chlamydia trachomatis, Clostridium botulinum, Clostridium difficile, Clostridium perfringens, Clostridium tetani, Corynebacterium diptheriae, Enterococcus faecalis, enterococcus faecum, Escherichia coli, Francisella tularensis, Haemophilus influenza, Helicobacter pylori, Legionella pneumophila, Leptospira interrogans, Listeria monocytogenes, Mycobacterium leprae, Mycobacterium tuberculosis, Mycoplasma pneumoniae, Neisseria gonorrhea, Neisseria meningitidis, Pseudomonas aeruginosa, Rickettsia rickettsii, Salmonella typhi, Salmonella typhinurium, Shigella sonnei, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus saprophyticus, coagulase negative Staphylococcus, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyrogenes, Treponema pallidum, Vibrio cholerae, and Yersinia pestis.

### Claim 11 (depends on 4)

The NYVAC recombinant vector of claim 4 wherein the parasite target antigen is derived from an organism selected from the group consisting of Ancylostoma duodenale, Anisakis spp., Ascaris lumbricoides, Balantidium coli, Cestoda spp., Cimicidae spp., Clonorchis sinensis, Dicrocoelium dendriticum, Dicrocoelium hospes, Diphyllobothrium latum, Dracunculus spp., Echinococcus granulosus, Echinococcus multilocularis, Entamoeba histolytica, Enterobius vermicularis, Fasciola hepatica, Fasciola magna, Fasciola gigantica, Fasciola jacksoni, Fasciolopsis buski, Giardia lamblia, Gnathostoma spp., Hymenolepis nana, Hymenolepis diminuta, Leishmania spp., Loa boa, Metorchis conjunctus, Metorchis albidus, Necator americanus, Oestroidea spp., Onchocercidae spp., Opisthorchis viverrini, Opisthorchis felineus, Opisthorchis guayaquilensis, Opisthorchis noverca, Plasmodium falciparum, Protofasciola robusta, Parafasciolopsis fasciomorphae, Paragonimus westermani, Schistosoma mansoni, Schistosoma japonicum, Schistosoma mekongi, Schistosoma haematobium, Spirometra erinaceieuropaei, Strongyloides stercoralis, Taenia saginata, Taenia solium, Toxocara canis, Toxocara cati, Toxoplasma gondii, Trichobilharzia regenti, Trichinella spiralis, Trichuris trichiura, Trombiculidae spp., Trypanosoma spp., Tunga penetrans, and Wuchereria bancrofti.

### Claim 12 (depends on 4)

The recombinant NYVAC vector of claim 4 wherein the tumor target antigen is selected from the group consisting of a gp100 MART-1/Melan A, gp75 (TRP-1), tyrosinase, NY-ESO-1, melanoma proteoglycan a MAGE family antigen, a BAGE family antigen, a GAGE family antigen, a RAGE family antigens, N-acetylglucosaminyltransferase-V, p15, ß-catenin, MUM-1, cyclin dependent kinase-4 (CDK4), p21-ras, BCR-abl, p53, p185 HER2/neu, epidermal growth factor receptor (EGFR), carcinoembryonic antigen (CEA), a carcinoma-associated mutated mucin, MUC-1, prostate specific antigen (PSA), prostate specific membrane antigen (PSMA), KSA, kinesin 2, HIP-55, TGFβ-1 anti-apoptotic factor, tumor protein D52, H1FT, NY-BR-1, NY-BR-62, NY-BR-75, NY-BR-85, NY-BR-87, NY-BR-96, and a pancreatic cancer antigen.

### Claim 13 (depends on 1)

A composition comprising a recombinant NYVAC vector of claim 1 and a pharmaceutically acceptable carrier.

### Claim 14 (depends on 4)

A method of inducing an immune response in a host against a viral target antigen, a bacterial target antigen, a parasitic target antigen, or a tumor target antigen comprising administering a therapeutically effective amount of the recombinant NYVAC vector of claim 4 to the host.

### Claim 15 (depends on 14)

The method of claim 14 wherein the host is a human being.