# US 11,999,789 B2 · Humanized antibodies to TNF-like ligand 1A (TL1A) and uses thereof

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- Number: US 11,999,789 B2
- Document ID: US11999789B2
- Status: Granted
- Kind: B2
- Application number: 17/682,922
- Filed: 2022-02-28
- Published: 2022-08-18
- Granted: 2024-06-04
- Earliest claimed: 2019-10-24
- Assignees: Prometheus Biosciences, Inc.; Cedars-Sinai Medical Center
- Applicants: Prometheus Biosciences, Inc.; Cedars-Sinai Medical Center
- Inventors: Jeffry D. Watkins; Cindy T. Dickerson; Rafael Rojas; Matthew Reissman; Patricia McNeeley; Janine Bilsborough; Bradley Henkle; Stephan R. Targan
- Web page: https://patentgrep.com/patent/US11999789B2

## CPC

- C07K 16/2875: {against the NGF/TNF superfamily, e.g. CD70, CD95L, CD153, CD154 (against NGF C07K16/22, against TNF C07K16/241)}
- A61P 1/00: Drugs for disorders of the alimentary tract or the digestive system
- A61P 1/04: for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
- C07K 16/241: {Tumor Necrosis Factors}
- A61K 2039/505: {comprising antibodies}
- C07K 2317/21: from primates, e.g. man
- C07K 2317/24: containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
- C07K 2317/40: characterized by post-translational modification
- C07K 2317/51: Complete heavy chain or Fd fragment, i.e. VH + CH1
- C07K 2317/515: Complete light chain, i.e. VL + CL
- C07K 2317/52: Constant or Fc region; Isotype
- C07K 2317/524: CH2 domain
- C07K 2317/526: CH3 domain
- C07K 2317/53: Hinge
- C07K 2317/56: variable (Fv) region, i.e. VH and/or VL
- C07K 2317/70: characterized by effect upon binding to a cell or to an antigen
- C07K 2317/71: Decreased effector function due to an Fc-modification
- C07K 2317/734: Complement-dependent cytotoxicity [CDC]
- C07K 2317/76: Antagonist effect on antigen, e.g. neutralization or inhibition of binding
- C07K 2317/90: characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
- C07K 2317/92: Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
- C07K 2317/94: Stability, e.g. half-life, pH, temperature or enzyme-resistance
- 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)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- 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)

## Abstract

Described herein are humanized anti-TL1A antibodies and pharmaceutical compositions for the treatment of inflammatory bowel disease (IBD), such as Crohn's Disease (CD) and ulcerative colitis (UC).

## Claims

### Claim 1

An antibody or antigen binding fragment thereof that binds to tumor necrosis factor ligand 1A (TL1A), wherein the antibody or antigen binding fragment thereof comprises: (a) a heavy chain variable region comprising the amino acid sequence of SEQ ID NO: 104 and (b) a light chain variable region comprising the amino acid sequence of SEQ ID NO: 201.

### Claim 2 (depends on 1)

The antibody or antigen binding fragment of claim 1, wherein the antibody or antigen binding fragment thereof is a humanized antibody or humanized antigen binding fragment.

### Claim 3 (depends on 1)

The antibody or antigen binding fragment of claim 1, wherein the antibody or antigen binding fragment comprises a human IgG1 heavy chain constant region.

### Claim 4 (depends on 3)

The antibody or antigen binding fragment of claim 3, wherein the heavy chain constant region comprises one amino acid deletion.

### Claim 5 (depends on 1)

The antibody or antigen binding fragment of claim 1, wherein the antibody or antigen binding fragment comprises a human kappa light chain constant region.

### Claim 6

An antibody that binds to tumor necrosis factor ligand 1A (TL1A), wherein the antibody comprises: (a) a heavy chain comprising the amino acid sequence of SEQ ID NO: 505 and (b) a light chain comprising the amino acid sequence of SEQ ID NO: 514.

### Claim 7 (depends on 6)

The antibody of claim 6, wherein the heavy chain comprises one amino acid deletion.