# US 11,993,647 B2 · Antibody or an antigen-binding fragment thereof capable of binding to a human receptor of interleukin-6

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- Number: US 11,993,647 B2
- Document ID: US11993647B2
- Status: Granted
- Kind: B2
- Application number: 16/325,528
- Filed: 2017-08-03
- Published: 2019-06-27
- Granted: 2024-05-28
- Earliest claimed: 2016-08-17
- Applicants: Joint Stock Company “Biocad”
- Inventors: Stanislav Rudolfovich Evdokimov; Andrei Borisovich Ulitin; Valery Vladimirovich Solovyev; Aleksei Aleksandrovich Aleksandrov; Yulia Sergeevna Chernykh; Timofey Aleksandrovich Nemankin; Anna Konstantinovna Vladimirova; Oleg Igorevich Smotrov; Tatiana Veniaminovna Chernovskaya; Aleksandr Aleksandrovich Moshchenko; Viktoriia Evgenevna Nalobina; Roman Alekseevich Ivanov; Dmitry Valentinovich Morozov
- Web page: https://patentgrep.com/patent/US11993647B2

## CPC

- C07K 16/248: {IL-6}
- A61K 9/0073: {Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy; (nasal sprays A61K9/0043; inhalation of vapours of volatile or heated drugs, e.g. essential oils or nicotine, A61K9/007; devices A61M)}
- A61K 9/19: lyophilised {, i.e. freeze-dried, solutions or dispersions (lyophilised products with subsequent particle size reduction A61K9/14; granules or pellets made by lyphilisation A61K9/1682; solid oral dosage forms made by lyophilisation A61K9/2095; lyophilisation additives A61K47/00)}
- A61K 39/395: Antibodies (agglutinins A61K38/36 {; as drug carriers A61K47/50}); Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61P 37/00: Drugs for immunological or allergic disorders
- A61P 37/06: Immunosuppressants, e.g. drugs for graft rejection
- A61P 37/08: Antiallergic agents (antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14)
- C07K 16/065: {Purification, fragmentation}
- C07K 16/18: against material from animals or humans
- C07K 16/24: against cytokines, lymphokines or interferons
- C07K 16/2866: {against receptors for cytokines, lymphokines, interferons}
- C12N 15/00: Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor (mutants or genetically engineered microorganisms, per se C12N1/00, C12N5/00, C12N7/00; new plants per se A01H; plant reproduction by tissue culture techniques A01H4/00; new animals per se A01K67/00; use of medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases, gene therapy A61K48/00)
- C12N 15/63: Introduction of foreign genetic material using vectors; Vectors; Use of hosts therefor; Regulation of expression
- A61K 2039/505: {comprising antibodies}
- C07K 2317/21: from primates, e.g. man
- C07K 2317/52: Constant or Fc region; Isotype
- 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
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)

## Abstract

The invention relates to medicine. The problem addressed by the present invention consists in creating alternative antibodies or fragments thereof which are capable of specifically binding to a human receptor of interleukin-6 and which would be useful as drugs for treating or diagnosing diseases, or for relieving symptoms, mediated by interleukin-6.

## Claims

### Claim 1

An antibody or antigen-binding fragment thereof having the ability to bind to a human interleukin-6 receptor (IL-6) comprising:
a binding domain comprises a heavy chain that comprises CDR1 comprising the amino acid sequence of SEQ ID NO:1, CDR2 comprising the amino acid sequence of SEQ ID NO:2, and CDR3 comprising the amino acid sequence of SEQ ID NO: 3, and
a light chain that comprises CDR1 comprising the amino acid sequence of SEQ ID NO:4, CDR2 comprising the amino acid sequence of SEQ ID NO:5, and CDR3 comprising the amino acid sequence of SEQ ID NO: 6.

### Claim 2 (depends on 1)

The antibody or fragment thereof according to claim 1, comprising a heavy chain with an amino acid sequence that is at least 95% identical to the sequence of SEQ ID NO: 9.

### Claim 3 (depends on 1)

The antibody or fragment thereof according to claim 1, comprising a light chain sequence that is at least 95% identical to the sequence of SEQ ID NO: 10.

### Claim 4 (depends on 1)

The antibody or fragment thereof according to claim 1 that is one of the following human isotypes: IgG1, IgG2, IgG3 and IgG4.

### Claim 5 (depends on 1)

The antibody or fragment thereof according to claim 1, wherein the antibody or fragment thereof is of an IgG1 isotype with an Fc constant region, comprising E233P, L234A, L235A, E236P, L237V and/or L238A mutations.

### Claim 6 (depends on 1)

The antibody or fragment thereof according to claim 1, wherein the antibody or fragment thereof is of an IgG1 isotype with an Fc constant region comprising M255Y, S257T and/or T259E mutations that increase the value of animal or human pharmacokinetic parameters.

### Claim 7 (depends on 1)

A pharmaceutical composition comprising an effective amount of an antibody or antigen-binding fragment thereof according to claim 1, in combination with one or more pharmaceutically acceptable excipients, diluents or carriers.

### Claim 8 (depends on 7)

The pharmaceutical composition according to claim 7 wherein it is a solution for parenteral administration.

### Claim 9 (depends on 7)

The pharmaceutical composition according to claim 7 in a form of lyophilized powder.

### Claim 10 (depends on 1)

The antibody or fragment thereof according to claim 1, comprising a heavy chain with an amino acid sequence that is SEQ ID NO: 9.

### Claim 11 (depends on 1)

The antibody or fragment thereof according to claim 1, comprising a light chain with an amino acid sequence that is SEQ ID NO: 10.