# US 11,992,527 B2 · Extracellular vesicles for vaccine delivery

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- Number: US 11,992,527 B2
- Document ID: US11992527B2
- Status: Granted
- Kind: B2
- Application number: 18/050,027
- Filed: 2022-10-26
- Published: 2023-08-24
- Granted: 2024-05-28
- Earliest claimed: 2019-03-21
- Assignees: Lonza Sales AG
- Applicants: Lonza Sales AG
- Inventors: Raymond J. Moniz; Russell E. McConnell; Nikki Ross; Christine McCoy; Timothy J. Soos; Ke Xu
- Web page: https://patentgrep.com/patent/US11992527B2

## CPC

- A61K 39/385: Haptens or antigens, bound to carriers
- A61K 39/39: characterised by the immunostimulating additives, e.g. chemical adjuvants
- A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)}
- A61K 9/0034: {Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants}
- A61K 9/0043: {Nose}
- A61K 9/5176: {Compounds of unknown constitution, e.g. material from plants or animals (oils, fats, waxes, shellac A61K9/5123)}
- A61K 39/00: Medicinal preparations containing antigens or antibodies (materials for immunoassay G01N33/53)
- A61K 39/0005: {Vertebrate antigens (from snakes A61K39/38)}
- A61K 39/0011: {Cancer antigens}
- A61K 39/12: Viral antigens
- A61K 47/6901: {Conjugates being cells, cell fragments, viruses, ghosts, red blood cells or viral vectors}
- A61P 31/00: Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P 31/12: Antivirals
- A61P 33/02: Antiprotozoals, e.g. for leishmaniasis, trichomoniasis, toxoplasmosis
- A61P 35/00: Antineoplastic agents
- A61P 37/04: Immunostimulants
- C07K 14/70503: {Immunoglobulin superfamily}
- C07K 14/70575: {NGF/TNF-superfamily, e.g. CD70, CD95L, CD153, CD154 (NGF C07K14/48, TNF C07K14/525)}
- C07K 14/70596: {Molecules with a "CD"-designation not provided for elsewhere}
- C07K 14/77: Ovalbumin
- C07K 16/2851: {against the lectin superfamily, e.g. CD23, CD72}
- A61K 2039/543: {intranasal}
- A61K 2039/55511: {Organic adjuvants}
- A61K 2039/55516: {Proteins; Peptides}
- A61K 2039/55555: {Liposomes; Vesicles, e.g. nanoparticles; Spheres, e.g. nanospheres; Polymers}
- A61K 2039/55561: {CpG containing adjuvants; Oligonucleotide containing adjuvants}
- A61K 2039/60: {characteristics by the carrier linked to the antigen}
- A61K 2039/70: {Multivalent vaccine}
- C07K 2319/00: Fusion polypeptide
- C07K 2319/60: containing spectroscopic/fluorescent detection, e.g. green fluorescent protein [GFP]
- C12N 2710/16234: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- C12N 2710/16634: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- C12N 2710/20034: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- 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
- 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)
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## Abstract

The present disclosure relates to extracellular vesicles (EVs), e.g., exosomes, comprising a payload (e.g., an antigen, adjuvant, and/or immune modulator) and/or a targeting moiety. Also provided herein are methods for producing the EVs (e.g., exosomes) and methods for using the EVs (e.g., exosomes) to treat and/or prevent diseases or disorders, e.g., cancer, graft-versus-host disease (GvHD), autoimmune disease, infectious diseases, or fibrotic diseases.

## Claims

### Claim 1

An isolated extracellular vesicle (EV) having an exterior surface and a luminal surface and comprising (i) an antigen, (ii) a Scaffold X moiety, and (iii) a Scaffold Y moiety, wherein the antigen is fused to the Scaffold X moiety or the Scaffold Y moiety.

### Claim 2 (depends on 1)

The EV of claim 1, wherein the antigen is fused to the N-terminus of the Scaffold X moiety or wherein the antigen is fused to the C-terminus of the Scaffold X moiety.

### Claim 3 (depends on 1)

The EV of claim 1, wherein the antigen comprises a first antigen and a second antigen, and wherein: (i) the first antigen is fused to the Scaffold X moiety and the second antigen is fused to the Scaffold Y moiety or (ii) the first antigen is fused to the N-terminus of the Scaffold X moiety and the second antigen is fused to the C-terminus of the Scaffold X moiety.

### Claim 4 (depends on 1)

The EV of claim 1, wherein the antigen is derived from a bacterium, virus, fungus, protozoa, or combinations thereof.

### Claim 5 (depends on 4)

The EV of claim 4, wherein the antigen is derived from a human gamma herpes virus 4 (Epstein Barr virus), influenza A virus, influenza B virus, cytomegalovirus, Staphylococcus aureus, Mycobacterium tuberculosis, Chlamydia trachomatis, HIV, corona viruses, filoviruses, Streptococcus pyogenes, Streptococcus pneumoniae, Plasmodia species, Chikungunya virus, Human Papilloma virus (HPV), Hepatitis B, Hepatitis C, human herpes virus 8, Merkel cell polyomavirus (MCV), bunyavirus, arena virus, flavivirus, enterovirus, astrovirus, rhabdoviridae, Borrelia burgdorferi and Burrelia mayonii, herpes simplex virus 2 (HSV2), Klebsiella sp., Pseudomonas aeruginosa, Enterococcus sp., Proteus sp., Enterobacter sp., Actinobacter sp., coagulase-negative staphylococci (CoNS), Mycoplasma sp., Adenovirus, Adeno-associated virus (AAV), or combinations thereof.

### Claim 6 (depends on 1)

The EV of claim 1, which further comprises a payload selected from an adjuvant, immune modulator, targeting moiety, or combinations thereof.

### Claim 7 (depends on 6)

The EV of claim 6, wherein the payload is conjugated to the exterior surface and/or the luminal surface of the EV.

### Claim 8 (depends on 7)

The EV of claim 7, wherein the payload is conjugated to the exterior surface and/or the luminal surface of the EV by a scaffold moiety.

### Claim 9 (depends on 8)

The EV of claim 8, wherein the scaffold moiety comprises a Scaffold X moiety, Scaffold Y moiety, or both.

### Claim 10 (depends on 6)

The EV of claim 6, wherein the payload is encapsulated within a lumen of the EV.

### Claim 11 (depends on 6)

The EV of claim 6, wherein the adjuvant comprises a Stimulator of Interferon Genes (STING) agonist, a toll-like receptor (TLR) agonist, an inflammatory mediator, RIG-I agonists, alpha-gal-cer (NKT agonist), heat shock proteins, C-type lectin agonists, or any combination thereof.

### Claim 12 (depends on 1)

The EV of claim 1, wherein (i) the Scaffold X moiety is a prostaglandin F2 receptor negative regulator (PTGFRN) protein or a fragment thereof, (ii) the Scaffold Y moiety is a brain acid soluble protein 1 (BASP1) protein or a fragment thereof, or (iii) both (i) and (ii).

### Claim 13

An isolated extracellular vesicle (EV) having an exterior surface and a luminal surface and comprising (i) a first antigen, (ii) a second antigen, and (iii) a third antigen, wherein the first antigen, the second antigen, and/or the third antigen is fused to a Scaffold X moiety or a Scaffold Y moiety.

### Claim 14 (depends on 13)

The EV of claim 13, wherein: (i) the first antigen is fused to the N-terminus of the Scaffold X moiety on the exterior surface of the EV, (ii) the second antigen is fused to the C-terminus of the Scaffold X moiety on the luminal surface of the EV, (iii) the third antigen is fused to the Scaffold Y moiety on the luminal surface of the EV, or (iv) any combination of (i) to (iii).

### Claim 15 (depends on 13)

The EV of claim 13, which further comprises a payload selected from an adjuvant, immune modulator, targeting moiety, or combinations thereof.

### Claim 16 (depends on 15)

The EV of claim 15, wherein the adjuvant comprises a STING agonist, a toll-like receptor (TLR) agonist, an inflammatory mediator, RIG-I agonists, alpha-gal-cer (NKT agonist), heat shock proteins, C-type lectin agonists, or any combination thereof.

### Claim 17 (depends on 13)

The EV of claim 13, wherein (i) the Scaffold X moiety is a prostaglandin F2 receptor negative regulator (PTGFRN) protein or a fragment thereof, (ii) the Scaffold Y moiety is a brain acid soluble protein 1 (BASP1) protein or a fragment thereof, or (iii) both (i) and (ii).

### Claim 18 (depends on 13)

The EV of claim 13, wherein the antigen is derived from a bacterium, virus, fungus, protozoa, or combinations thereof.

### Claim 19 (depends on 1)

A pharmaceutical composition comprising the EV of claim 1 and a pharmaceutically acceptable carrier.

### Claim 20 (depends on 1)

A method of treating a coronavirus infection in a subject in need thereof, comprising administering to the subject the EV of claim 1.