# US 12,760,090 B2 · Combination therapy > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,760,090 B2 - Document ID: US12760090B2 - Status: Granted - Kind: B2 - Application number: 18/255,920 - Filed: 2021-12-03 - Published: 2025-09-25 - Granted: 2026-10-13 - Earliest claimed: 2020-12-07 - Assignees: ViiV Healthcare Company - Applicants: ViiV Healthcare Company - Inventors: Zhi Hong; Jerry Lee Jeffrey; Brian Alvin Johns; Andrew Spaltenstein; Emile Johann Velthuisen - Web page: https://patentgrep.com/patent/US12760090B2 ## CPC - C07K 16/1145: {Env proteins, e.g. gp41, gp110/120, gp160, V3, principal neutralising domain [PND] or CD4-binding site} - A61K 31/4985: Pyrazines or piperazines ortho- or peri-condensed with heterocyclic ring systems - A61P 31/18: for HIV - A61K 2039/505: {comprising antibodies} - 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) - 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 ## Abstract The present invention relates to a combination of cabotegravir or a pharmaceutically acceptable salt thereof and a gp120 binding protein. The present invention also provides a method of treatment human immunodeficiency virus (HIV) with the co-administration of a therapeutically effective amount of cabotegravir or a pharmaceutically acceptable salt thereof and a therapeutically effective amount of a gp120 binding protein. ## Claims ### Claim 1 A method of treating an HIV infection in a human in need thereof comprising: administering to a human a therapeutically effective amount of cabotegravir or a pharmaceutically acceptable salt thereof and a therapeutically effective amount of an HIV gp120 binding protein or an antigen binding fragment thereof, wherein the gp120 binding protein comprises an isolated monoclonal antibody which comprises: a heavy chain variable region (VH) comprising a heavy chain complementarity determining region (HCDR) 1, a HCDR2, and a HCDR3 set forth as SEQ ID NOs: 15, 16, and 17, respectively; and a light chain variable region (VL) comprising a light chain complementarity determining region (LCDR) 1, a LCDR2, and a LCDR3 set forth as SEQ ID NOs: 18, 19, and 20, respectively. wherein the VH comprises an amino acid sequence that is at least 80%, 85%, 90%, 95%, 98%, or 99% identical to SEQ ID NO: 1 and the VL comprises an amino acid sequence that is at least 80%, 85%, 90%, 95%, 98%, or 99% identical to SEQ ID NO: 2. ### Claim 2 (depends on 1) The method according to claim 1, wherein the HIV gp120 binding protein neutralizes HIV-1. ### Claim 3 (depends on 1) The method according to claim 1, wherein the HIV gp120 binding protein comprises a recombinant constant domain comprising one or more amino acid modifications that increase the half-life of the antibody. ### Claim 4 (depends on 1) The method according to claim 1, wherein the VH comprises the amino acid sequence having at least 95% sequence identity to SEQ ID NO: 1. ### Claim 5 (depends on 1) The method according to claim 1, wherein the VH comprises the amino acid sequence of SEQ ID NO: 1. ### Claim 6 (depends on 1) The method according to claim 1, wherein the VL comprises the amino acid sequence having at least 95% sequence identity to SEQ ID NO: 2. ### Claim 7 (depends on 1) The method according to claim 1, wherein the VL comprises the amino acid sequence of SEQ ID NO: 2. ### Claim 8 (depends on 3) The method according to claim 3, wherein the recombinant constant domain comprises one or more mutations from the group consisting of: M252Y/S254T/T256E, M428L/N434S, T250Q/M428L, V259I/V308F/M428L, E380A/N434A, T307A/E380A/N434A, and H433K/N434F. ### Claim 9 (depends on 3) The method according to claim 3, wherein the recombinant constant domain comprises M428L and N434S mutations. ### Claim 10 (depends on 1) The method according to claim 1, wherein the antibody is an IgG, IgA or IgM antibody. ### Claim 11 (depends on 1) The method according to claim 1, wherein the cabotegravir or the pharmaceutically acceptable salt thereof and the HIV gp120 binding protein are administered separately. ### Claim 12 (depends on 1) The method according to claim 1, the cabotegravir or the pharmaceutically acceptable salt thereof and the HIV gp120 binding protein are administered simultaneously. ### Claim 13 (depends on 1) The method according to claim 1, wherein the cabotegravir or the pharmaceutically acceptable salt thereof and the HIV gp120 binding protein are administered parenterally. ### Claim 14 (depends on 1) The method according to claim 1, wherein the cabotegravir or the pharmaceutically acceptable salt thereof and the HIV gp120 binding protein are administered once every month, once every 2 months, once every 3 months, or once every 6 months. ### Claim 15 (depends on 1) The method according to claim 1, wherein the VH comprises the amino acid sequence of SEQ ID NO: 1 and wherein the VL comprises the amino acid sequence of SEQ ID NO: 2.