IP Library › Granted Patent US 12,606,615
Granted Patent B2
US 12,606,615 · App. 18/964,217 · Granted Apr 21, 2026

Anti-FGF23 antibody or antibody fragment thereof

Inventors: Hikaru Miyagi (Tokyo, JP); Taiji Oashi (Tokyo, JP); Kenta Nakajima (Tokyo, JP); Sari Ogasawara (Tokyo, JP)
Assignee: KYOWA KIRIN CO., LTD.
C07K16/22A61K2039/505C07K2317/76C07K2317/92C07K2317/94
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Quick Facts
Patent No.
US 12,606,615
App. No.
18/964,217
Granted
Apr 21, 2026
Kind
B2
Abstract

The present invention relates to an antibody or an antibody fragment thereof which binds to FGF23. The antibody comprises a heavy chain variable region (hereinafter, described as VH) comprising the amino acid sequence represented by SEQ ID NO: 1 and a light chain variable region (hereinafter, described as VL) comprising the amino acid sequence represented by SEQ ID NO: 2. At least the amino acid residue at position 100 or the amino acid residue at position 105 of the amino acid sequence represented by SEQ ID NO: 1 in the VH is substituted with another amino acid residue.

Claims (12)

1 . An antibody or an antibody fragment thereof which binds to FGF23, wherein the antibody comprises a heavy chain variable region (VH) comprising the amino acid sequence represented by SEQ ID NO: 39 and a light chain variable region (VL) comprising the amino acid sequence represented by SEQ ID NO: 2.

2 . The antibody or the antibody fragment thereof according to claim 1 , wherein the subclass of the antibody is IgG1, IgG2, IgG3 or IgG4.

3 . The antibody or the antibody fragment thereof according to claim 1 , wherein the Fc region of the antibody is one selected from the following (a) to (e):

(a) an Fc region comprising substitution of the amino acid residue at position 252 with tyrosine residue, substitution of the amino acid residue at position 254 with threonine residue, and substitution of the amino acid residue at position 256 with glutamic acid residue according to the EU index,

(b) an Fc region comprising substitution of the amino acid residue at position 428 with leucine residue, and substitution of the amino acid residue at position 434 with serine residue according to the EU index,

(c) an Fc region comprising substitution of the amino acid residue at position 308 with proline residue according to the EU index,

(d) an Fc region comprising substitution of the amino acid residue at position 250 with glutamine residue, and substitution of the amino acid residue at position 428 with leucine residue according to the EU index, and

(e) an Fc region comprising substitution of the amino acid residue at position 434 with alanine residue according to the EU index.

4 . The antibody or the antibody fragment thereof according to claim 1 , wherein the heavy chain constant region of the antibody comprises the amino acid sequence represented by SEQ ID NO: 48, 49, 50, 51 or 52.

5 . The antibody or the antibody fragment thereof according to claim 1 , wherein the antibody fragment is one selected from Fab, Fab′, (Fab′) 2 , scFv, diabody, and dsFv.

6 . A composition comprising:

the antibody or the antibody fragment thereof according to claim 1 and a pharmacologically acceptable carrier.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 14, 2025
From: MIYAGI, HIKARU; OASHI, TAIJI; NAKAJIMA, KENTA; OGASAWARA, SARI
To: KYOWA KIRIN CO., LTD.
Reel/Frame 069856/0021 →
Priority Claims (2)
JP 2022-128011 · Aug 10, 2022 · national
JP 2022-164256 · Oct 12, 2022 · national
Continuity (2)
Continuation PCTJP2023029098 · Aug 9, 2023
Related Publication 20250163140A1 · May 22, 2025
References Cited (31)
US 10202446B2 · Yamazaki · 2019 [cited by examiner]
US 20050171339A1 · Sugo et al. · 2005 [cited by applicant]
US 20060287508A1 · Sugo et al. · 2006 [cited by applicant]
US 20080138860A1 · Torikai et al. · 2008 [cited by applicant]
US 20090148461A1 · Yamazaki et al. · 2009 [cited by applicant]
US 20100298542A1 · Igawa et al. · 2010 [cited by applicant]
US 20110182913A1 · Yamazaki et al. · 2011 [cited by applicant]
US 20160159895A1 · Yamazaki et al. · 2016 [cited by applicant]
US 20170342154A1 · Igawa et al. · 2017 [cited by applicant]
US 20180118813A1 · Torikai et al. · 2018 [cited by applicant]
US 20190106485A1 · Yamazaki et al. · 2019 [cited by applicant]
US 20220185876A1 · Jayaraman et al. · 2022 [cited by applicant]
US 20220251225A1 · Igawa et al. · 2022 [cited by applicant]
JP 2022527790 · 2022 [cited by applicant]
WO 03057881 · 2003 [cited by applicant]
WO 2006085518 · 2006 [cited by applicant]
WO 2008099969 · 2008 [cited by applicant]
WO 2009041613 · 2009 [cited by applicant]
WO WO2020205523A1 · 2020 [cited by examiner]
WO WO2024034638A1 · 2024 [cited by examiner]
International Search Report issued Oct. 10, 2023 in International (PCT) Application No. PCT/JP2023/029098. [cited by applicant]
Ornitz, Daivd M. et al., “The Fibroblast Growth Factor signaling pathway”, Wires Dev Biol, 2015, vol. 4, pp. 215-266. [cited by applicant]
Itoh, Nobuyuki et al., “Fibroblast growth factors: from molecular evolution to roles in development, metabolism and disease”, The Journal of Biochemistry, 2011, vol. 149, No. 2, pp. 121-130. [cited by applicant]
Yamashita, Tetsuo et al., “Identification of a Novel Fibroblast Growth Factor, FGF-23, Preferentially Expressed in the Ventrolateral Thalamic Nucleus of the Brain”, Biochemical and Biophysical Research Communications, 2… [cited by applicant]
Hori, Michiko et al., “Minireview: Fibroblast Growth Factor 23 in Phosphate Homeostasis and Bone Metabolism”, Endocrinology, Jan. 2011, vol. 152, No. 1, pp. 4-10. [cited by applicant]
Sabbagh, Yves et al., “PHEXdb, a Locus-Specific Database for Mutations Causing X-Linked Hypophosphatemia”, Human Mutation, 2000, vol. 16, pp. 1-6. [cited by applicant]
Yuan, Baozhi et al., “Aberrant Phex function in osteoblasts and osteocytes alone underlies murine X-linked hypophosphatemia”, The Journal of Clinical Investigation, Feb. 2008, vol. 118, No. 2, pp. 722-734. [cited by applicant]
Beck, L. et al., “Pex/PEX tissue distribution and evidence for a deletion in the 3′ region of the PEX gene in X-linked hypophosphatemic mice”, The Journal of Clinical Investigation, Mar. 1997, vol. 99, No. 6, pp. 1200-1… [cited by applicant]
Beck-Nielsen, Signe Sparre et al., “FGF23 and its role in X-linked hypophosphatemia-related morbidity”, Orphanet Journal of Rare Diseases, 2019, vol. 14, No. 58, 25 pages. [cited by applicant]
Imel, Erik A. et al., “Burosumab versus continuation of conventional therapy in children with X-linked hypophosphatemia: a randomised, active-controlled, open-label, phase 3 trial”, Lancet, 2019, Jun. 2020, vol. 393, No… [cited by applicant]
Carpenter, Thomas O. et al., “A Clinician's Guide to X-Linked Hypophosphatemia”, J Bone Miner Res, Jul. 2011, vol. 26, No. 7, pp. 1381-1388. [cited by applicant]