# US 12,215,141 B2 · Anti-respiratory syncytial virus antibodies, and methods of their generation and use

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- Number: US 12,215,141 B2
- Document ID: US12215141B2
- Status: Granted
- Kind: B2
- Application number: 17/931,629
- Filed: 2022-09-13
- Published: 2023-09-28
- Granted: 2025-02-04
- Earliest claimed: 2016-10-21
- Assignees: Adimab, LLC
- Applicants: Adimab, LLC
- Inventors: Laura M. Walker
- Web page: https://patentgrep.com/patent/US12215141B2

## CPC

- C07K 16/11: Paramyxoviridae (F); Pneumoviridae (F), e.g. respiratory syncytial virus [RSV]
- A61K 39/42: viral
- A61P 31/14: for RNA viruses
- A61P 31/16: for influenza or rhinoviruses
- C07K 2317/33: Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
- C07K 2317/34: Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
- C07K 2317/92: Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
- 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

Anti-RSV antibodies with neutralizing potency against RSV subtype A and RSV subtype B are provided, as well as nucleic acid sequences encoding such antibodies, methods for their identification, isolation, generation, and methods for their preparation and use are provided.

## Claims

### Claim 1

An isolated antibody or an antigen-binding fragment thereof that specifically binds to Respiratory Syncytial Virus (RSV) F protein (F) (“anti-RSV F antibody”), wherein said antibody:
(i) comprises a heavy chain (HC) polypeptide comprising a variable heavy (V H) chain polypeptide comprising VH CDR1, 2 and 3 polypeptides respectively comprising the amino acid sequences of SEQ ID NO: 51, 53 and 55; and a light chain (LC) polypeptide comprising a variable light (VL) chain polypeptide comprising VL CDR1, 2 and 3 polypeptides respectively comprising the amino acid sequences of SEQ ID NO: 59, 61 and 63; or
(ii) comprises a HC polypeptide comprising a VH chain polypeptide comprising VH CDR1, 2 and 3 polypeptides respectively comprising the amino acid sequences of SEQ ID NO: 979, 981 and 983; and a LC polypeptide comprising a VL chain polypeptide comprising VL CDR1, 2 and 3 polypeptides respectively comprising the amino acid sequences of SEQ ID NO:987, 989 and 991.

### Claim 2 (depends on 1)

The isolated anti-RSV F antibody of claim 1, which comprises either:
(i)
(1) a VH chain polypeptide comprising the same VH CDRs as recited in claim 1 (i) and possessing at least 90% sequence identity or at least 95% sequence identity to the VH chain polypeptide of SEQ ID NO: 50; and
(2) a VL chain polypeptide comprising the same VL CDRs as recited in claim 1 (i), and possessing at least 90% sequence identity, or at least 95% sequence identity to SEQ ID NO: 58: or
(ii)
(1) a VH chain polypeptide comprising the same VH CDRs as recited in claim 1 (ii), and possessing at least 90% sequence identity, or at least 95% sequence identity to the VH chain polypeptide of SEQ ID NO: 978; and
(2) a VL chain polypeptide comprising the same VL CDRs as recited in claim 1 (ii), and possessing at least 90% sequence identity to the VL chain polypeptide of SEQ ID NO: 986.

### Claim 3 (depends on 1)

The isolated anti-RSV F antibody of claim 1, which comprises either:
(i) a VH chain polypeptide comprising the amino acid sequence of SEQ ID NO: 50; and a VL chain polypeptide comprising the amino acid sequence of SEQ ID NO: 58: or
(ii) a VH chain polypeptide comprising the amino acid sequence of SEQ ID NO: 978; and a variable light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 986.

### Claim 4 (depends on 1)

A pharmaceutical composition comprising the anti-RSV F antibody of claim 1; and a pharmaceutically acceptable carrier and/or excipient.

### Claim 5 (depends on 1)

A method for (i) preventing a respiratory syncytial virus (RSV) infection in a patient in need thereof or suspected of being in need thereof, or for treating a patient suffering from an RSV infection, or for ameliorating at least one symptom or complication associated with the infection, wherein the infection is either prevented, or at least one symptom or complication associated with the infection is prevented, ameliorated, or lessened in severity and/or duration as a result of such use; or (ii) treating or preventing either a RSV infection or a human metapneumovirus (HMPV) infection, or at least one symptom associated with the RSV infection or the HMPV infection, in a patient in need thereof or suspected of being in need thereof, by administering an anti-RSV F antibody according to claim 1.

### Claim 6 (depends on 5)

The method according to claim 5, which further comprises administering to the patient a second therapeutic agent optionally selected from the group consisting of an antiviral agent; a vaccine specific for RSV, a vaccine specific for influenza virus, or a vaccine specific for metapneumovirus (MPV); an siRNA specific for an RSV antigen or a metapneumovirus (MPV) antigen; a second antibody specific for an RSV antigen or a metapneumovirus (MPV) antigen; an anti-IL4R antibody, an antibody specific for an influenza virus antigen, an anti-RSV-G antibody, and a NSAID.

### Claim 7 (depends on 2)

A pharmaceutical composition comprising the anti-RSV F antibody of claim 2; and a pharmaceutically acceptable carrier and/or excipient.

### Claim 8 (depends on 3)

A pharmaceutical composition comprising the anti-RSV F antibody of claim 3; and a pharmaceutically acceptable carrier and/or excipient.

### Claim 9 (depends on 2)

A method for (i) preventing a respiratory syncytial virus (RSV) infection in a patient in need thereof or suspected of being in need thereof, or for treating a patient suffering from an RSV infection, or for ameliorating at least one symptom or complication associated with the infection, wherein the infection is either prevented, or at least one symptom or complication associated with the infection is prevented, ameliorated, or lessened in severity and/or duration as a result of such use; or (ii) treating or preventing either a RSV infection or a human metapneumovirus (HMPV) infection, or at least one symptom associated with the RSV infection or the HMPV infection, in a patient in need thereof or suspected of being in need thereof, by administering an anti-RSV F antibody according to claim 2.

### Claim 10 (depends on 3)

A method for (i) preventing a respiratory syncytial virus (RSV) infection in a patient in need thereof or suspected of being in need thereof, or for treating a patient suffering from an RSV infection, or for ameliorating at least one symptom or complication associated with the infection, wherein the infection is either prevented, or at least one symptom or complication associated with the infection is prevented, ameliorated, or lessened in severity and/or duration as a result of such use; or (ii) treating or preventing either a RSV infection or a human metapneumovirus (HMPV) infection, or at least one symptom associated with the RSV infection or the HMPV infection, in a patient in need thereof or suspected of being in need thereof, by administering an anti-RSV F antibody according to claim 3.