# US 11,098,114 B2 · Ovine derived human TNFα polyclonal antibody composition for oral administration

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- Number: US 11,098,114 B2
- Document ID: US11098114B2
- Status: Granted
- Kind: B2
- Application number: 16/481,439
- Filed: 2018-01-29
- Published: 2019-11-07
- Granted: 2021-08-24
- Earliest claimed: 2017-01-27
- Assignees: MicroPharm Limited
- Applicants: Micropharm Limited
- Inventors: John Landon; Ruth Elizabeth Coxon
- Web page: https://patentgrep.com/patent/US11098114B2

## CPC

- C07K 16/241: {Tumor Necrosis Factors}
- A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration}
- A61K 39/39591: {Stabilisation, fragmentation}
- A61K 47/42: Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein (oligopeptides having up to five amino acids {A61K47/183}; polyamino acids A61K47/34)
- A61K 47/46: Ingredients of undetermined constitution or reaction products thereof, e.g. skin, bone, milk, cotton fibre, eggshell, oxgall or plant extracts
- A61P 1/04: for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
- A61P 9/10: for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
- A61P 25/32: Alcohol-abuse
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61P 31/00: Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P 31/04: Antibacterial agents
- A61P 37/06: Immunosuppressants, e.g. drugs for graft rejection
- A61P 37/08: Antiallergic agents (antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14)
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- C07K 16/248: {IL-6}
- A61K 2039/505: {comprising antibodies}
- A61K 2039/542: {oral/gastrointestinal}
- C07K 2317/12: isolated from milk
- C07K 2317/20: characterized by taxonomic origin
- C07K 2317/23: from birds
- C07K 2317/33: Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
- C07K 2317/55: Fab or Fab'
- C07K 2317/76: Antagonist effect on antigen, e.g. neutralization or inhibition of binding
- 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)
- 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 is directed to an antibody composition for oral administration comprising intact blood-derived polyclonal antibodies that bind to a human tumour necrosis factor α (TNFα), and means for protecting the antibodies during gastrointestinal transit, as well as methods for manufacturing, kits, and therapeutic uses of the same.

## Claims

### Claim 1

An antibody composition for oral administration comprising:
a. intact blood-derived polyclonal antibodies that bind to a human tumour necrosis factor a (TNFα); and
b. a protease inhibitor and/or an antacid,
wherein the intact blood-derived polyclonal antibodies are derived from serum or plasma of an ovine mammal administered TNFα or a fragment thereof.

### Claim 2 (depends on 1)

The antibody composition of claim 1, wherein the antibody composition and the intact blood-derived polyclonal antibodies therein have not been affinity purified.

### Claim 3 (depends on 1)

The antibody composition of claim 1, wherein the intact blood-derived polyclonal antibodies are purified using sodium sulphate precipitation or caprylic acid precipitation, and optionally, filtration.

### Claim 4 (depends on 1)

The antibody composition of claim 1, wherein the protease inhibitor is selected from the Bowman-Birk inhibitor family of proteins.

### Claim 5 (depends on 1)

The antibody composition of claim 1, wherein the protease inhibitor comprises one or more of:
a. a polypeptide which binds specifically to and suppresses or inactivates the proteolytic activity of trypsin and/or chymotrypsin; and/or b. an antibody that binds to trypsin and/or chymotrypsin and suppresses or inactivates the protease activity of said trypsin and/or chymotrypsin.

### Claim 6 (depends on 1)

The antibody composition of claim 1, wherein the protease inhibitor comprises egg whites.

### Claim 7 (depends on 6)

The antibody composition of claim 6, wherein the egg whites comprise powdered egg whites.

### Claim 8 (depends on 1)

The antibody composition of claim 1, wherein the protease inhibitor comprises ovomucoid, ovostatin, ovomacroglobulin, or combinations thereof.

### Claim 9 (depends on 1)

The antibody composition of claim 1, formulated as a liquid.

### Claim 10 (depends on 1)

The antibody composition of claim 1, wherein at least 5% of the total antibodies present in the composition bind to TNFα.

### Claim 11 (depends on 1)

The antibody composition of claim 1, wherein at least 10% of the total antibodies present in the composition bind to TNFα.

### Claim 12

A method for manufacturing an antibody composition for oral administration, said method comprising:
a. obtaining a blood sample from an ovine mammal that has been administered an immunogen comprising human tumour necrosis factor a (TNFα) or a fragment thereof, thereby providing a sample comprising intact blood-derived polyclonal antibodies that bind to TNFα;
b. admixing the intact blood-derived polyclonal antibodies that bind to human TNFα with a protease inhibitor and/or an antacid.

### Claim 13 (depends on 12)

The method of claim 12, wherein the obtaining further comprises obtaining serum from the blood sample.