# US 11,077,130 B2 · Methods for reducing HIV-1 mother-to-child transmission by inducing V3-specific or CD4 binding site-specific antibodies

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- Number: US 11,077,130 B2
- Document ID: US11077130B2
- Status: Granted
- Kind: B2
- Application number: 15/025,031
- Filed: 2014-09-26
- Published: 2016-11-24
- Granted: 2021-08-03
- Earliest claimed: 2013-09-27
- Assignees: Duke University
- Applicants: Duke University
- Inventors: Barton F. Haynes; Sallie Permar; M. Anthony Moody; Feng Gao; Hua-Xin Liao; Georgia Tomaras; David C. Montefiori
- Web page: https://patentgrep.com/patent/US11077130B2

## CPC

- A61K 31/7088: Compounds having three or more nucleosides or nucleotides
- A61K 39/21: Retroviridae, e.g. equine infectious anemia virus
- A61K 39/395: Antibodies (agglutinins A61K38/36 {; as drug carriers A61K47/50}); Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61P 31/18: for HIV
- C07K 14/005: from viruses
- C07K 14/162: {env, e.g. gp160, gp110/120, gp41, V3, peptid T, CD4-Binding site}
- C07K 16/1145: {Env proteins, e.g. gp41, gp110/120, gp160, V3, principal neutralising domain [PND] or CD4-binding site}
- G01N 33/56988: {HIV or HTLV}
- A61K 2039/505: {comprising antibodies}
- C07K 2317/21: from primates, e.g. man
- C07K 2317/33: Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
- C07K 2317/76: Antagonist effect on antigen, e.g. neutralization or inhibition of binding
- C12N 2740/16111: concerning HIV env
- C12N 2770/00041: Use of virus, viral particle or viral elements as a vector
- G01N 2800/50: Determining the risk of developing a disease
- 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)
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)

## Abstract

The invention provides compositions and methods to induce and boost antibody response, including but not limited to IgG responses binding to HIV-1 in a subject in need thereof, wherein the induced/boosted plasma level of the antibody responses, for example V3 and/or CD4 binding site antibody responses, is over a threshold level and is associated with reduced risk of maternal-to-child-transmission (MTCT) of HIV-1.

## Claims

### Claim 1

A method for reducing maternal to child HIV-1 transmission by inducing or boosting V3-specific or CD4 binding site-specific HIV-1 antibody responses in a pregnant female subject infected with HIV-1 comprising administering to the subject an immunogenic composition comprising an HIV-1 envelope in an amount sufficient to effect such induction, wherein the composition comprises clade B gp120 HIV-1 envelope and clade C gp120 HIV-1 envelope and wherein the subject's anti-V3 IgG concentration above 37 micorgram/ml in plasma is correlated with reduced risk of maternal to child transmission.

### Claim 2 (depends on 1)

The method of claim 1, wherein the HIV-1 antibody responses are V3-specific antibodies able to neutralize tier 1 and tier 2 autologous HIV-1 strains.

### Claim 3 (depends on 1)

The method of claim 1, wherein the composition comprises clade B gp120 HIV-1 envelope B.63521 and clade C gp120 envelope CH505 T/F.

### Claim 4 (depends on 1)

The method of claim 1, wherein the composition comprises clade B gp120 HIV-1 envelope B.63521 and clade C gp120 envelope 1086.C.

### Claim 5 (depends on 1)

The method of claim 1, wherein the HIV-1 antibody response is CD4 binding_site antibodies able to neutralize tier 1 and tier 2 autologous HIV-1 strains.

### Claim 6 (depends on 1)

The method of claim 1, further comprising administering HIV-1 Clade M envelope CON-S.

### Claim 7 (depends on 1)

The method of claim 1, wherein each Clade B HIV-1 envelope and Clade C HIV-1 envelope is administered as a recombinant protein.

### Claim 8 (depends on 1)

The method of claim 1, where wherein each Clade B HIV-1 envelope and Clade C HIV-1 envelope is administered as a nucleic acid encoding the envelope.

### Claim 9 (depends on 6)

The method of claim 6, wherein the HIV-1 Clade M envelope CON-S is administered as a recombinant protein.

### Claim 10 (depends on 6)

The method of claim 6, wherein the HIV-1 Clade M envelope CON-S is administered as a nucleic acid encoding the envelope.

### Claim 11 (depends on 1)

The method of claim 1, further comprising administering an adjuvant.

### Claim 12 (depends on 1)

The method of claim 1, wherein the composition comprises an adjuvant.

### Claim 13 (depends on 3)

The method of claim 3, wherein the composition comprises an adjuvant.

### Claim 14 (depends on 4)

The method of claim 4, wherein the composition comprises an adjuvant.

### Claim 15 (depends on 6)

The method of claim 6, wherein the composition comprises an adjuvant.

### Claim 16 (depends on 7)

The method of claim 7, wherein the composition comprises an adjuvant.

### Claim 17 (depends on 9)

The method of claim 9, wherein the composition comprises an adjuvant.