# US 11,298,414 B2 · Cellular adjuvants for viral infection

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- Number: US 11,298,414 B2
- Document ID: US11298414B2
- Status: Granted
- Kind: B2
- Application number: 16/536,962
- Filed: 2019-08-09
- Published: 2020-04-02
- Granted: 2022-04-12
- Earliest claimed: 2018-08-10
- Assignees: NantBio, Inc.
- Applicants: Nantbio, Inc.
- Inventors: Kayvan Niazi; Raymond Wong; Peter Sieling; Philip T. Liu
- Web page: https://patentgrep.com/patent/US11298414B2

## CPC

- A61K 39/0258: {Escherichia}
- C12N 15/86: Viral vectors
- A61K 39/0002: {Fungal antigens, e.g. Trichophyton, Aspergillus, Candida}
- A61K 39/39: characterised by the immunostimulating additives, e.g. chemical adjuvants
- C12N 15/861: Adenoviral vectors
- 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 2039/5256: {expressing foreign proteins}
- A61K 2039/605: {MHC molecules or ligands thereof}
- C12N 2710/10343: viral genome or elements thereof as genetic vector
- C12N 2770/16034: 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)
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)

## Abstract

Two-component vaccine formulations and methods are contemplated where the vaccine has an adjuvant component and a therapeutic component. The therapeutic component comprises preferably a recombinant therapeutic virus encoding a therapeutic antigen while the adjuvant component comprises a non-host cell or immune stimulating portion thereof. Notably, use of the adjuvant component will result in significant uptake of the therapeutic component into immune competent cells, even in the absence of receptors for entry of the therapeutic component. In addition, such adjuvant also stimulates expression of the therapeutic antigen.

## Claims

### Claim 1

A method of increasing expression of a recombinant antigen in a dendritic host cell, comprising:
providing an adenovirus having a genome that includes a recombinant sequence encoding an antigen, wherein the sequence is operably linked to a promoter to drive expression of the antigen in the dendritic host cell;
providing a non-host cell selected from a group consisting of Escherichia coli and Saccharomyces cerevisiae; and
concurrently exposing the dendritic host cell with both the adenovirus and the non-host cell under conditions to allow uptake of the virus into the host cell and to allow for expression of the recombinant sequence in the host cell; and wherein the exposure of the dendritic host cell with the non-host cell is in an amount that increases expression of the antigen.

### Claim 2 (depends on 1)

The method of claim 1 wherein the antigen includes a patient and tumor specific neoepitope or a tumor associated antigen.

### Claim 3 (depends on 1)

The method of claim 1 wherein the step of concurrently exposing is performed in vivo or in vitro.

### Claim 4

A method of treating a patient using an immune therapy, comprising:
administering a two-component vaccine formulation to the patient, wherein the vaccine formulation has an adjuvant component and a therapeutic component;
wherein the therapeutic component comprises an adenovirus having a genome that includes a recombinant sequence encoding an antigen, wherein the sequence is operably linked to a promoter to drive expression of the antigen in a cell of a patient; and
wherein the adjuvant component comprises a non-host cell selected from a group consisting of E coli and S. cerevisiae.

### Claim 5 (depends on 4)

The method of claim 4 wherein the antigen is patient and tumor specific neoepitope or a tumor associated antigen.

### Claim 6

A vaccine composition, comprising:
an adjuvant component and a therapeutic component;
wherein the therapeutic component comprises an adenovirus having a genome that includes a recombinant sequence encoding an antigen, wherein the sequence is operably linked to a promoter to drive expression of the antigen in a cell of the patient; and
wherein the adjuvant component comprises a non-host cell selected from a group consisting of E. coli and S. cerevisiae.

### Claim 7 (depends on 6)

The vaccine composition of claim 6 wherein the antigen includes a patient and tumor specific neoepitope or a tumor associated antigen.

### Claim 8 (depends on 6)

The vaccine composition of claim 6 wherein the composition is formulated for injection.
