ANTI FGF23 ANTIBODY AND A PHARMACEUTICAL COMPOSITION COMPRISING THE SAME

• US 20160159895A1
• Filed: 02/10/2016
• Published: 06/09/2016
• Est. Priority Date: 02/14/2007
• Status: Active Grant

• Current Assignee: Kyowa Kirin Co., Ltd. (Kirin Holdings Company Limited)
• Original Assignee: Kyowa Hakko Kirin Company Limited (Kirin Holdings Company Limited)
• Inventors: Yamazaki, Yuji, Urakawa, ltaru, Yoshida, Hitoshi, Aono, Yukiko, Yamashita, Takeyoshi, Shimada, Takashi, Hasegawa, Hisashi
• Granted Patent: US 10,202,446 B2
• Time in Patent Office: Days
• CPC Class Codes: A61K 2039/505 comprising antibodies
• CPC Class Codes: A61P 13/12 of the kidneys
• CPC Class Codes: A61P 17/04 Antipruritics
• CPC Class Codes: A61P 19/00 Drugs for skeletal disorders
• CPC Class Codes: A61P 19/08 for bone diseases, e.g. rachitism, Paget's disease
• CPC Class Codes: A61P 19/10 for osteoporosis
• CPC Class Codes: A61P 21/00 Drugs for disorders of the muscular or neuromuscular system
• CPC Class Codes: A61P 3/00 Drugs for disorders of the metabolism of the blood or the extracellular fluid A61P7/00
• CPC Class Codes: A61P 3/02 Nutrients, e.g. vitamins, minerals
• CPC Class Codes: A61P 3/12 for electrolyte homeostasis
• CPC Class Codes: A61P 3/14 for calcium homeostasis vitamin D A61P3/02; parathyroid hormones A61P5/18; calcitonin A61P5/22; osteoporosis A61P19/10; bone metastasis A61P35/04
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: A61P 5/00 Drugs for disorders of the endocrine system
• CPC Class Codes: A61P 5/18 of the parathyroid hormones
• CPC Class Codes: C07K 16/22 against growth factors ; against growth regulators
• CPC Class Codes: C07K 16/244 Interleukins [IL]
• CPC Class Codes: C07K 2317/24 containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
• CPC Class Codes: C07K 2317/565 Complementarity determining region [CDR]
• CPC Class Codes: C07K 2317/76 Antagonist effect on antigen, e.g. neutralization or inhibition of binding

Abstract

To provide an antibody against FGF23 and a pharmaceutical composition such as a preventive or therapeutic agent which can prevent or treat by suppressing an action of FGF23 by using the antibody. An antibody or its functional fragment against human FGF23 produced by hybridoma C10 (Accession No. FERM BP-10772).

Claims

1. A method for treating a disease having excessive activity of FGF23, comprising administering an antibody or functional fragment thereof to a subject, wherein the antibody or functional fragment thereof binds to FGF23 and comprises:

(a) a heavy chain comprising at least CDR1 shown by SEQ ID NO;

40, CDR2 shown by SEQ ID NO;

41, or CDR3 shown by SEQ ID NO;

42;

or

(b) a light chain comprising at least CDR1 shown by SEQ ID NO;

43, CDR2 shown by SEQ ID NO;

44, or CDR3 shown by SEQ ID NO;

45.

2. The method of claim 1, wherein the antibody or functional fragment thereof comprises a heavy chain comprising CDR1 shown by SEQ ID NO:

40, CDR2 shown by SEQ ID NO;

41, and CDR3 shown by SEQ ID NO;

42.

3. The method of claim 1, wherein the antibody or functional fragment thereof comprises a light chain comprising CDR1 shown by SEQ ID NO:

43, CDR2 shown by SEQ ID NO;

44, and CDR3 shown by SEQ ID NO;

45.

4. The method of claim 1, wherein:

(a) the heavy chain comprises CDR1 shown by SEQ ID NO;

40, CDR2 shown by SEQ ID NO;

41, and CDR3 shown by SEQ ID NO;

42; and

(b) the light chain comprises CDR1 shown by SEQ ID NO;

43, CDR2 shown by SEQ ID NO;

44, and CDR3 shown by SEQ ID NO;

45.

5. The method of claim 1, wherein the antibody or functional fragment thereof comprises:

(a) a heavy chain comprising CDR3 shown by SEQ ID NO;

42;

(b) a light chain comprising CDR3 shown by SEQ ID NO;

45;

or

(c) a combination of (a) and (b).

6. The method of claim 1, wherein the disease is selected from the group consisting of tumor-induced osteomalacia, ADHR, XLH, fibrous dysplasia, McCune-Albright syndrome, autosomal recessive hypophosphataemia, hypophosphataemia, bone mineralization failure, bone pain, muscle weakness, skeletal deformity, growth disorder, low blood 1,25D, osteoporosis, rickets, hypercalcaemia, hypocalcaemia, ectopic calcification, osteosclerosis, Paget'"'"'s disease, hyperparathyroidism, hypoparathyroidism, pruritus, kidney failure and dialysis for kidney failure.

7. A method for increasing serum phosphorous concentration, comprising administering an antibody or functional fragment thereof to a subject, wherein the antibody or functional fragment thereof binds to FGF23 and comprises:

(a) a heavy chain comprising at least CDR1 shown by SEQ ID NO;

40, CDR2 shown by SEQ ID NO;

41, or CDR3 shown by SEQ ID NO;

42;

or

(b) a light chain comprising at least CDR1 shown by SEQ ID NO;

43, CDR2 shown by SEQ ID NO;

44, or CDR3 shown by SEQ ID NO;

45.

8. The method of claim 7, wherein the antibody or functional fragment thereof comprises a heavy chain comprising CDR1 shown by SEQ ID NO:

40, CDR2 shown by SEQ ID NO;

41, and CDR3 shown by SEQ ID NO;

42.

9. The method of claim 7, wherein the antibody or functional fragment thereof comprises a light chain comprising CDR1 shown by SEQ ID NO:

43, CDR2 shown by SEQ ID NO;

44, and CDR3 shown by SEQ ID NO;

45.

10. The method of claim 7, wherein the antibody or functional fragment thereof comprises:

(a) a heavy chain comprising CDR1 shown by SEQ ID NO;

40, CDR2 shown by SEQ ID NO;

41, and CDR3 shown by SEQ ID NO;

42; and

(b) a light chain comprising CDR1 shown by SEQ ID NO;

43, CDR2 shown by SEQ ID NO;

44, and CDR3 shown by SEQ ID NO;

45.

11. The method of claim 7, wherein the antibody or functional fragment thereof comprises:

(a) a heavy chain comprising CDR3 shown by SEQ ID NO;

42;

(b) a light chain comprising CDR3 shown by SEQ ID NO;

45;

or

(c) a combination of (a) and (b).

12. The method of claim 7, wherein the disease is selected from the group consisting of tumor-induced osteomalacia, ADHR, XLH, fibrous dysplasia, McCune-Albright syndrome, autosomal recessive hypophosphataemia, hypophosphataemia, bone mineralization failure, bone pain, muscle weakness, skeletal deformity, growth disorder, low blood 1,25D, osteoporosis, rickets, hypercalcaemia, hypocalcaemia, ectopic calcification, osteosclerosis, Paget'"'"'s disease, hyperparathyroidism, hypoparathyroidism, pruritus, kidney failure and dialysis for kidney failure.