# US 12,600,792 B2 · Monoclonal antibodies and methods of use

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- Number: US 12,600,792 B2
- Document ID: US12600792B2
- Status: Granted
- Kind: B2
- Application number: 17/703,542
- Filed: 2022-03-24
- Published: 2022-08-11
- Granted: 2026-04-14
- Earliest claimed: 2011-10-26
- Assignees: Elanco Tiergesundheit AG
- Applicants: Elanco Tiergesundheit AG
- Inventors: Sarah Rue; Brendan Eckelman; Quinn L. Deveraux; Marc Nasoff
- Web page: https://patentgrep.com/patent/US12600792B2

## CPC

- C07K 16/2887: {against CD20}
- A61K 39/3955: {against proteinaceous materials, e.g. enzymes, hormones, lymphokines}
- A61K 39/39558: {against tumor tissues, cells, antigens}
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61P 35/00: Antineoplastic agents
- C07K 16/2896: {against molecules with a "CD"-designation, not provided for elsewhere}
- C07K 16/3061: {Blood cells}
- G01N 33/57505: of the blood, e.g. leukaemia
- C07K 2317/20: characterized by taxonomic origin
- C07K 2317/24: containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
- C07K 2317/33: Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
- C07K 2317/52: Constant or Fc region; Isotype
- C07K 2317/56: variable (Fv) region, i.e. VH and/or VL
- 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
- 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)

## Abstract

This disclosure relates to immunogens and monoclonal antibodies useful in the identification and/or treatment of cancer cells, including those of the dog. In one example, chimeric anti-canine CD20 antibodies are provided. The antibodies can be used therapeutically to treat lymphoma in dogs.

## Claims

### Claim 1

An antibody comprising at least one heavy chain variable region polypeptide comprising
a heavy chain (H) complementary determining region (CDR) 1 (CDRH1) comprising DYGML (SEQ ID NO.: 20), a CDRH2 comprising YISSGSSTIYYADRVKG (SEQ ID NO.: 22), a CDRH3 comprising GTFAY (SEQ ID NO.: 24), and
a light chain (L) CDR 1 (CDRL1) comprising RSSQSLIYNNGNTYLH (SEQ ID NO.: 70), a CDRL2 comprising KVSNRFS (SEQ ID NO.: 27), and a CDRL3 comprising SQSTHVPFT (SEQ ID NO.: 29).

### Claim 2 (depends on 1)

The antibody of claim 1, which is a chimeric canine antibody.

### Claim 3 (depends on 1)

The antibody of claim 1, which is a canine-mouse chimeric antibody.

### Claim 4 (depends on 1)

The antibody of claim 1, which comprises a canine constant region.

### Claim 5 (depends on 1)

The antibody of claim 1, wherein the antibody further comprises a detectable label or an effector moiety attached thereto.

### Claim 6

A chimeric antibody comprising a light chain variable region (VL) sequence and a heavy chain variable region (VH) sequence consisting of:
a. a light chain variable region (VL) sequence SEQ ID NO.:3 having an amino acid substitution of N33K, and a heavy chain variable region sequence (VH) SEQ ID NO.:6; and
wherein the antibody binds canine CD20.

### Claim 7 (depends on 6)

The derivative antibody of claim 6, which comprises a canine constant region.

### Claim 8 (depends on 6)

The derivative antibody of claim 6, wherein the antibody further comprises a detectable label or an effector moiety attached thereto.

### Claim 9

An isolated nucleic acid encoding an antibody comprising:
a. a heavy chain (H) complementary determining region (CDR) 1 (CDRH1) comprising DYGML (SEQ ID NO.: 20), a CDRH2 comprising YISSGSSTIYYADRVKG (SEQ ID NO.: 22), a CDRH3 comprising GTFAY (SEQ ID NO.: 24), and
a light chain (L) CDR 1 (CDRL1) comprising RSSQSLIYNKGNTYLH (SEQ ID NO.: 70), a CDRL2 comprising KVSNRFS (SEQ ID NO.: 27), and a CDRL3 comprising SQSTHVPFT (SEQ ID NO.: 29),
wherein the antibody binds canine CD20.

### Claim 10

A kit for identifying, detecting or targeting cells expressing canine CD20 comprising
a heavy chain (H) complementary determining region (CDR) 1 (CDRH1) comprising DYGML (SEQ ID NO.: 20), a CDRH2 comprising YISSGSSTIYYADRVKG (SEQ ID NO.: 22), a CDRH3 comprising GTFAY (SEQ ID NO.: 24), and
a light chain (L) CDR 1 (CDRL1) comprising RSSQSLIYNKGNTYLH (SEQ ID NO.: 70), a CDRL2 comprising KVSNRFS (Seq ID NO.: 27), and a CDRL3 comprising SQSTHVPFT (SEQ ID NO.: 29),
wherein the antibody binds canine CD20;
and instructions for use and/or one or more other reagents selected from buffers, blocking agents and detection reagents.

### Claim 11 (depends on 10)

The kit of claim 10 wherein the detection reagents are selected from biotin, streptavidin, peroxidase and other detectable labels.

### Claim 12 (depends on 10)

The kit of claim 10 wherein a detectable label is attached to the antibody.

### Claim 13 (depends on 1)

A method for treating a canine CD20-expressing lymphoma in a canine animal comprising administering to the animal at least one effective dose of the antibody of claim 1.

### Claim 14 (depends on 13)

The method of claim 13 wherein the monoclonal antibody is administered in a dosage amount of about 1 to 50 mg/kg of body weight of the animal.

### Claim 15 (depends on 13)

The method of claim 13 wherein multiple doses are administered to the animal.

### Claim 16 (depends on 13)

The method of claim 13 wherein the monoclonal antibody is administered in conjunction with one or more chemotherapeutic agents.

### Claim 17 (depends on 6)

A method for treating a canine CD20-expressing lymphoma in a canine animal comprising administering to the animal at least one effective dose of the antibody of claim 6.

### Claim 18 (depends on 17)

The method of claim 17 wherein the monoclonal antibody is administered in a dosage amount of about 1 to 50 mg/kg of body weight of the animal.

### Claim 19 (depends on 17)

The method of claim 17 wherein multiple doses are administered to the animal.

### Claim 20 (depends on 17)

The method of claim 17 wherein the monoclonal antibody is administered in conjunction with one or more chemotherapeutic agents.

### Claim 21 (depends on 1)

The antibody of claim 1, wherein the antibody binds canine CD20.

### Claim 22 (depends on 1)

The antibody of claim 1, wherein the antibody is a chimeric antibody, bi-specific antibody, antibody comprising a canine Fc, caninized antibody, CDR-grafted antibody, camelid antibody, or a nanobody comprising a single monomeric variable domain consisting of the heavy chain variable region polypeptide comprising a CDRH1, a CDRH2, and a CDRH3.