# US 11,433,146 B2 · Formulations for small intestinal delivery of RSV and norovirus antigens

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 11,433,146 B2
- Document ID: US11433146B2
- Status: Granted
- Kind: B2
- Application number: 15/580,651
- Filed: 2016-06-08
- Published: 2018-06-14
- Granted: 2022-09-06
- Earliest claimed: 2015-06-12
- Assignees: Vaxart, Inc.
- Applicants: Vaxart, Inc.
- Inventors: George Trager; Sean Tucker; Leesun Kim; Ciaran Scallan
- Web page: https://patentgrep.com/patent/US11433146B2

## CPC

- A61K 48/0058: {Nucleic acids adapted for tissue specific expression, e.g. having tissue specific promoters as part of a contruct}
- A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration}
- A61K 9/2009: {Inorganic compounds}
- A61K 9/2054: {Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose}
- A61K 9/2059: {Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin}
- A61K 9/2813: {Inorganic compounds}
- A61K 9/282: {Organic compounds, e.g. fats}
- A61K 9/2846: {Poly(meth)acrylates}
- A61K 39/12: Viral antigens
- A61P 31/14: for RNA viruses
- A61P 31/16: for influenza or rhinoviruses
- A61P 37/04: Immunostimulants
- C12N 2710/10341: Use of virus, viral particle or viral elements as a vector
- C12N 2710/10343: viral genome or elements thereof as genetic vector
- C12N 2760/18534: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- 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)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)

## Abstract

Provided herein are compositions and methods for generating an immunogenic response in humans. Further provided are methods for designing such compositions, e.g., for vaccines.

## Claims

### Claim 1

An immunogenic composition for eliciting serum IgG and intestinal secretory IgA immune responses in a human, the composition comprising:
(i) an E1/E3-deleted replication-incompetent serotype 5 adenoviral vector comprising a nucleic acid sequence encoding a viral protein 1 (VP1) polypeptide of norovirus and a nucleic acid sequence encoding a dsRNA adjuvant, encompassed by (ii) an enteric coating having a threshold pH of 5.8-7.0 that directs delivery and release of the adenoviral vector to the ileum of the human;
wherein the nucleic acid encoding the VP1 polypeptide has at least 90% identity to SEQ ID NO:3 or at least 90% identity to SEQ ID NO:1.

### Claim 2 (depends on 1)

The immunogenic composition of claim 1, wherein the VP1 polypeptide has at least 95% identity to SEQ ID NO:4 or SEQ ID NO:2.

### Claim 3 (depends on 1)

The immunogenic composition of claim 1, wherein the VP1 polypeptide is encoded by a nucleic acid sequence having at least 95% identity to SEQ ID NO:3 or at least 95% identity to SEQ ID NO:1.

### Claim 4 (depends on 1)

The immunogenic composition of claim 1, wherein the VP1 polypeptide is encoded by a nucleic acid sequence having at least 98% identity to SEQ ID NO:3 or at least 98% identity to SEQ ID NO:1.

### Claim 5 (depends on 1)

The immunogenic composition of claim 1, wherein enteric coating has a threshold pH of 5.9-6.1.

### Claim 6 (depends on 1)

The immunogenic composition of claim 1, wherein the dsRNA adjuvant is a TLR3 agonist.

### Claim 7 (depends on 1)

The immunogenic composition of claim 1, wherein the enteric coating comprises poly(methacrylic acid-co-methyl methacrylate) 1:1.

### Claim 8 (depends on 1)

The immunogenic composition of claim 1, wherein the enteric coating comprises a mixture of poly(methacrylic acid-co-methyl methacrylate) 1:1 and poly(methacrylic acid-co-ethyl acrylate) 1:1.

### Claim 9 (depends on 8)

The immunogenic composition of claim 8, wherein the ratio of poly(methacrylic acid-co-methyl methacrylate) 1:1 to poly(methacrylic acid-co-ethyl acrylate) 1:1 is 1:4 to 4:1.

### Claim 10 (depends on 1)

The immunogenic composition of claim 1, wherein the enteric coating comprises poly(methacrylic acid-co-methyl methacrylate) 1:1 and poly(methacrylic acid-co-methyl methacrylate) 1:2.

### Claim 11 (depends on 1)

The immunogenic composition of claim 1, wherein the ratio of poly(methacrylic acid-co-methyl methacrylate) 1:1 to poly(methacrylic acid-co-methyl acrylate) 1:2 is 1:2 to 2:1.

### Claim 12 (depends on 1)

The immunogenic composition of claim 1, wherein the enteric coating comprises a mixture of poly(methacrylic acid-co-methyl methacrylate) 1:2 and poly(methacrylic acid-co-ethyl acrylate) 1:1.

### Claim 13 (depends on 12)

The immunogenic composition of claim 12, wherein the ratio of poly(methacrylic acid-co-methyl methacrylate) 1:2 to poly(methacrylic acid-co-ethyl acrylate) 1:1 is 1:4 to 4:1.

### Claim 14 (depends on 1)

The immunogenic composition of claim 1, wherein the composition is in the form of a compressed tablet.

### Claim 15

An expression vector comprising a heterologous nucleic acid encoding a viral protein 1 (VP1) of norovirus, wherein the heterologous nucleic acid comprises a nucleic acid sequence having at least 90% identity to SEQ ID NO:3 or SEQ ID NO:1.

### Claim 16 (depends on 11)

The expression vector of claim 11, wherein the nucleic acid sequence has at least 95% identity to SEQ ID NO:3 or SEQ ID NO:1.