# US 10,869,921 B2 · Compositions and methods to treat AIDS

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- Number: US 10,869,921 B2
- Document ID: US10869921B2
- Status: Granted
- Kind: B2
- Application number: 16/180,519
- Filed: 2018-11-05
- Published: 2019-05-30
- Granted: 2020-12-22
- Earliest claimed: 2013-03-15
- Assignees: University of Massachusetts
- Applicants: University of Massachusetts
- Inventors: Shan Lu; Shixia Wang
- Web page: https://patentgrep.com/patent/US10869921B2

## CPC

- A61K 39/21: Retroviridae, e.g. equine infectious anemia virus
- A61K 39/12: Viral antigens
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- C07K 14/005: from viruses
- C12N 7/00: Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof (preparing medicinal viral antigen or antibody compositions, e.g. virus vaccines, A61K39/00)
- A61K 2039/53: {DNA (RNA) vaccination}
- A61K 2039/54: {characterised by the route of administration}
- A61K 2039/545: {characterised by the dose, timing or administration schedule}
- A61K 2039/575: {humoral response}
- A61K 2039/70: {Multivalent vaccine}
- C12N 2740/16134: 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)
- 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)

## Abstract

Polyvalent, primary isolate nucleic acid compositions for inducing an immune response against HIV are disclosed. The compositions and methods described herein are for the use of a nucleic acid composition that encodes one or more different HIV envelope glycoproteins. The synthetic, codon-optimized DNAs encoding one or more HIV proteins are a combination of different nucleic acids, such as DNA plasmids, generated from primary isolate DNA of different HIV major group genetic clades and/or different proteins. HIV polypeptide compositions for inducing an immune response against HIV are also disclosed. Methods for using the polypeptide compositions before, at the same time as, and/or after administration of the DNA compositions are provided.

## Claims

### Claim 1

A composition comprising:
a first synthetic nucleic acid molecule comprising a nucleotide sequence that has at least 90% identity to the nucleotide sequence of SEQ ID NO:1; and
a second synthetic nucleic acid molecule comprising a nucleotide sequence that has at least 90% identity to the nucleotide sequence of SEQ ID NO:7.

### Claim 2

A composition comprising:
a first polypeptide comprising an amino acid sequence that has at least 90% identity to the amino acid sequence of SEQ ID NO: 2;
a second polypeptide comprising an amino acid sequence that has at least 90% identity to the amino acid sequence of SEQ ID NO: 8; and
an adjuvant.

### Claim 3 (depends on 1)

The composition of claim 1, wherein the first synthetic nucleic acid molecule comprises a nucleotide sequence that has at least 92% identity to the nucleotide sequence of SEQ ID NO:1 and the second synthetic nucleic acid molecule comprises a nucleotide sequence that has at least 92% identity to the nucleotide sequence of SEQ ID NO:7.

### Claim 4 (depends on 1)

The composition of claim 1, wherein the first synthetic nucleic acid molecule comprises a nucleotide sequence that has at least 95% identity to the nucleotide sequence of SEQ ID NO:1 and the second synthetic nucleic acid molecule comprises a nucleotide sequence that has at least 95% identity to the nucleotide sequence of SEQ ID NO:7.

### Claim 5 (depends on 1)

The composition of claim 1, wherein the first synthetic nucleic acid molecule comprises a nucleotide sequence that has at least 97% identity to the nucleotide sequence of SEQ ID NO:1 and the second synthetic nucleic acid molecule comprises a nucleotide sequence that has at least 97% identity to the nucleotide sequence of SEQ ID NO:7.

### Claim 6 (depends on 1)

The composition of claim 1, wherein the first synthetic nucleic acid molecule comprises a nucleotide sequence that has at least 99% identity to the nucleotide sequence of SEQ ID NO:1 and the second synthetic nucleic acid molecule comprises a nucleotide sequence that has at least 99% identity to the nucleotide sequence of SEQ ID NO:7.

### Claim 7 (depends on 1)

The composition of claim 1, wherein one of the synthetic nucleic acid molecules comprises a nucleotide sequence that has at least 95% identity to the nucleotide sequence of SEQ ID NO: 7.

### Claim 8 (depends on 1)

The composition of claim 1, wherein one of the synthetic nucleic acid molecules comprises a nucleotide sequence that has at least 97% identity to the nucleotide sequence of SEQ ID NO: 7.

### Claim 9 (depends on 1)

The composition of claim 1, wherein one of the synthetic nucleic acid molecules comprises a nucleotide sequence that has at least 99% identity to the nucleotide sequence of SEQ ID NO: 7.

### Claim 10 (depends on 1)

The composition of claim 1, wherein the composition further comprises a carrier or an adjuvant.

### Claim 11 (depends on 2)

The composition of claim 2, wherein the first polypeptide comprises an amino acid sequence that has at least 92% identity to the amino acid sequence of SEQ ID NO: 2 and the second polypeptide comprises an amino acid sequence that has at least 92% identity to the amino acid sequence of SEQ ID NO: 8.

### Claim 12 (depends on 2)

The composition of claim 2, wherein the first polypeptide comprises an amino acid sequence that has at least 95% identity to the amino acid sequence of SEQ ID NO: 2 and the second polypeptide comprises an amino acid sequence that has at least 95% identity to the amino acid sequence of SEQ ID NO: 8.

### Claim 13 (depends on 2)

The composition of claim 2, wherein the first polypeptide comprises an amino acid sequence that has at least 97% identity to the amino acid sequence of SEQ ID NO: 2 and the second polypeptide comprises an amino acid sequence that has at least 97% identity to the amino acid sequence of SEQ ID NO: 8.

### Claim 14 (depends on 2)

The composition of claim 2, wherein the first polypeptide comprises an amino acid sequence that has at least 99% identity to the amino acid sequence of SEQ ID NO: 2 and the second polypeptide comprises an amino acid sequence that has at least 99% identity to the amino acid sequence of SEQ ID NO: 8.

### Claim 15 (depends on 2)

The composition of claim 2, wherein the composition further comprises a carrier.

### Claim 16 (depends on 2)

The composition of claim 2, wherein the adjuvant is QS-21, incomplete Freund's adjuvant, aluminum phosphate, aluminum hydroxide, or alum.

### Claim 17 (depends on 16)

The composition of claim 16, wherein the adjuvant is incomplete Freund's adjuvant.

### Claim 18 (depends on 2)

The composition of claim 2, wherein the composition further comprises one or more nucleoside reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors, protease inhibitors, entry inhibitors, CCR5 receptor antagonists, integrase inhibitors, or maturation inhibitors.

### Claim 19 (depends on 18)

The composition of claim 18, wherein the protease inhibitor comprises one or more of atazanavir, darunavir, fosamprenavir, or ritonavir.

### Claim 20 (depends on 2)

The composition of claim 2, wherein one or both of the first or the second polypeptide comprises a conservative amino acid substitution in the amino acid sequence of SEQ ID NO: 2 or SEQ ID NO: 8, respectively.
