# US 2025/0082784 A1 · 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 2025/0082784 A1
- Document ID: US20250082784A1
- Status: Published application
- Kind: A1
- Application number: 18/956,413
- Filed: 2024-11-22
- Published: 2025-03-13
- 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/US20250082784A1

## 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

A method for eliciting an immune response to a norovirus viral protein 1(VP1) in a human, the method comprising orally administering an immunogenic composition that elicits serum IgG and intestinal secretory IgA to the norovirus VP1 protein in the human, wherein the immunogenic composition comprises a tablet encompassed in an enteric coating, wherein (i) the tablet comprises a replication-incompetent adenovirus vector comprising a nucleic acid sequence encoding norovirus VP1 polypeptide and a nucleic acid sequence encoding a dsRNA adjuvant; and (ii) the enteric coating has a threshold pH of pH 5.9-6.1 that directs delivery and release of the adenovirus vector to the ileum of the human.

### Claim 2 (depends on 1)

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

### Claim 3 (depends on 1)

The method of claim 1, wherein the enteric coating further comprises triethyl citrate and talc.

### Claim 4 (depends on 3)

The method of claim 3, wherein the enteric coating comprises 4 parts poly(methacrylic acid-co-methyl methacrylate), 1 part triethyl citrate, and 1 part talc.

### Claim 5 (depends on 1)

The method of claim 1, wherein the tablet is coated with 8-12% total solids weight gain of the enteric coating.

### Claim 6 (depends on 1)

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

### Claim 7 (depends on 1)

The method of claim 1, wherein the replication-incompetent adenovirus vector is an E1/E3-deleted serotype 5 adenovirus vector.

### Claim 8 (depends on 1)

The method of claim 1, wherein the nucleic acid sequence 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 9 (depends on 8)

The method of claim 8, wherein the dsRNA adjuvant is a TLR3 agonist.

### Claim 10 (depends on 2)

The method of claim 2, wherein the tablet is coated with 8-12% total solids weight gain of the enteric coating.

### Claim 11 (depends on 10)

The method of claim 10, wherein the replication-incompetent adenovirus vector is an E1/E3-deleted serotype 5 adenovirus vector

### Claim 12 (depends on 11)

The method of claim 11, wherein the dsRNA adjuvant is a TLR3 agonist.

### Claim 13 (depends on 12)

The method of claim 12, 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 14 (depends on 10)

The method of claim 10, wherein the enteric coating further comprises triethyl citrate and talc.

### Claim 15 (depends on 14)

The method of claim 14, wherein the enteric coating comprises 4 parts poly(methacrylic acid-co-methyl methacrylate), 1 part triethyl citrate, and 1 part talc.

### Claim 16 (depends on 14)

The method of claim 14, wherein the replication-incompetent adenovirus vector is an E1/E3-deleted serotype 5 adenovirus vector.

### Claim 17 (depends on 14)

The method of claim 14, wherein the dsRNA adjuvant is a TLR3 agonist.

### Claim 18

A method for eliciting an immune response to a norovirus viral protein 1 (VP1) in a human, the method comprising orally administering an immunogenic composition that elicits serum IgG and intestinal secretory IgA to the norovirus VP1 protein in the human, wherein the immunogenic composition comprises a tablet encompassed in an enteric coating comprising poly(methacrylic acid-co-methyl methacrylate) 1:1; and wherein the tablet is coated with 8-12% total solids weight gain of the enteric coating; and (i) the tablet comprises an E1/E3-deleted serotype 5 adenovirus vector comprising a nucleic acid sequence encoding norovirus VP1 polypeptide and a nucleic acid sequence encoding a TLR3 agonist; and (ii) the enteric coating has a threshold pH of pH 5.9-6.1 that directs delivery and release of the adenovirus vector to the ileum of the human.

### Claim 19 (depends on 18)

The method of claim 18, wherein the enteric coating further comprises triethyl citrate and talc.

### Claim 20 (depends on 19)

The method of claim 19, wherein the enteric coating comprises 4 parts poly(methacrylic acid-co-methyl methacrylate), 1 part triethyl citrate, and 1 part talc.