JP2018518461A - 進行性骨化性線維異形成症の治療 - Google Patents
進行性骨化性線維異形成症の治療 Download PDFInfo
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
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- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/22—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against growth factors ; against growth regulators
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- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
- A61K31/138—Aryloxyalkylamines, e.g. propranolol, tamoxifen, phenoxybenzamine
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- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
- A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P21/00—Drugs for disorders of the muscular or neuromuscular system
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
- A61K2039/507—Comprising a combination of two or more separate antibodies
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- A—HUMAN NECESSITIES
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- A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
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- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
- C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
- C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
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Abstract
Description
本発明は、進行性骨化性線維異形成症(FOP)を治療するための薬剤の製造における、アクチビンB、BMP9又はBMP10に対する抗体の使用を更に提供する。任意選択的に、この抗体は、キメラ抗体、ベニヤ化抗体、ヒト化抗体、又はヒト抗体である。任意選択的に、この抗体は、インタクトな抗体である。任意選択的に、この抗体は、ヒトκIgG1抗体である。任意選択的に、アクチビンB、BMP9及びBMP10のうち2つ又はそれ以上に対する抗体の組み合わせが投与される。任意選択的に、抗体は、ACVR1、ACVR2A、若しくはACVR2Bの細胞外ドメイン−Fc融合タンパク質、又は、アクチビンAに対する抗体との併用療法で投与される。
抗体又はECD−Fc融合タンパク質などの治療薬は、典型的には単離形態で提供される。つまり、薬物は、通常、干渉タンパク質及びその産物又精製から生じた他の混入物質に対し少なくとも50w/w%純度であるが、薬物が過度の薬学的に許容可能な担体又はその使用を促進することを意図する他のビヒクルと組み合わされる可能性を排除しない。場合によっては、薬物は、干渉タンパク質及び産生又は精製から生じた混入物質に対し少なくとも60、70、80、90、95、又は99w/w%の純度である。
I.概要
本開示は、有効なレジメンのアクチビンB、BMP9又はBMP10に対する抗体を進行性骨化性線維異形成症(FOP)の症状を有する被験者に投与する、この疾患を治療する方法を提供する。本開示は、特にこれらのリガンドが、それぞれACVR1H206変異細胞において、FOPの異所性骨化を誘発できるという結果に一部基づいている。アクチビンBは野生型ACVR1のリガンドではないため、アクチビンBによる活性化は、特に驚きである。
II.ACVR1、ACVR2A、ACVR2B、アクチビンA、アクチビンB、BMP9及びBMP10
III.アクチビンB、BMP9及びBMP10に対する抗体
IV.進行性骨化性線維異形成症(FOP)
V.治療方法
A.投与法
B.併用療法
C.医薬組成物
材料及び方法
ACVR1発現細胞を選択するためのFACS分類
HEK293/Bre−Lucレポーター株におけるシグナル伝達アッセイ
結果:
最大倍率変化=Cmaxにおける倍率変化
イタリック=シグナルがACVR1[R206H]発現細胞にのみ観察された
薄灰=同一のシグナルが両株に観察された
濃灰=ACVR1[R206H]発現細胞がより応答する
Claims (6)
- 進行性骨化性線維異形成症(FOP)を治療するための薬剤の製造における、アクチビンB、BMP9又はBMP10に対する抗体の使用。
- 前記抗体が、キメラ抗体、ベニヤ化抗体、ヒト化抗体、又はヒト抗体である、請求項1に記載の使用。
- 前記抗体がインタクトな抗体である、請求項1又は2に記載の使用。
- 前記抗体がヒトκIgG1抗体である、請求項1〜3のいずれか一項に記載の使用。
- アクチビンB、BMP9及びBMP10のうち2つ又はそれ以上に対する抗体の組み合わせが投与される、請求項1〜4のいずれか一項に記載の使用。
- 前記抗体が、ACVR1、ACVR2A、若しくはACVR2Bの細胞外ドメイン−Fc融合タンパク質、又は、アクチビンAに対する抗体との併用療法で投与される、請求項1〜4のいずれか一項に記載の使用。
Applications Claiming Priority (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201562154617P | 2015-04-29 | 2015-04-29 | |
US62/154,617 | 2015-04-29 | ||
US201562155427P | 2015-04-30 | 2015-04-30 | |
US62/155,427 | 2015-04-30 | ||
PCT/US2016/029585 WO2016176341A1 (en) | 2015-04-29 | 2016-04-27 | Treatment of fibrodysplasia ossificans progressiva |
Publications (1)
Publication Number | Publication Date |
---|---|
JP2018518461A true JP2018518461A (ja) | 2018-07-12 |
Family
ID=55911125
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2017556598A Pending JP2018518461A (ja) | 2015-04-29 | 2016-04-27 | 進行性骨化性線維異形成症の治療 |
Country Status (9)
Country | Link |
---|---|
US (3) | US20160319009A1 (ja) |
EP (1) | EP3288976B1 (ja) |
JP (1) | JP2018518461A (ja) |
KR (1) | KR20170140318A (ja) |
AU (1) | AU2016255768B2 (ja) |
CA (1) | CA2984249A1 (ja) |
HK (1) | HK1251898A1 (ja) |
TW (1) | TW201713361A (ja) |
WO (1) | WO2016176341A1 (ja) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2021534430A (ja) * | 2018-08-17 | 2021-12-09 | エフ.ホフマン−ラ ロシュ アーゲーF. Hoffmann−La Roche Aktiengesellschaft | 心房細動の評価における循環bmp10(骨形成タンパク質10) |
Families Citing this family (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20160075772A1 (en) | 2014-09-12 | 2016-03-17 | Regeneron Pharmaceuticals, Inc. | Treatment of Fibrodysplasia Ossificans Progressiva |
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2016
- 2016-04-27 TW TW105113027A patent/TW201713361A/zh unknown
- 2016-04-27 AU AU2016255768A patent/AU2016255768B2/en not_active Ceased
- 2016-04-27 CA CA2984249A patent/CA2984249A1/en active Pending
- 2016-04-27 WO PCT/US2016/029585 patent/WO2016176341A1/en active Application Filing
- 2016-04-27 EP EP16720685.3A patent/EP3288976B1/en active Active
- 2016-04-27 KR KR1020177033896A patent/KR20170140318A/ko not_active Application Discontinuation
- 2016-04-27 JP JP2017556598A patent/JP2018518461A/ja active Pending
- 2016-04-27 US US15/140,411 patent/US20160319009A1/en not_active Abandoned
-
2018
- 2018-08-31 HK HK18111218.3A patent/HK1251898A1/zh unknown
- 2018-11-19 US US16/195,679 patent/US20190153085A1/en not_active Abandoned
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2020
- 2020-09-14 US US17/020,493 patent/US20210061898A1/en not_active Abandoned
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WO2011158924A1 (ja) * | 2010-06-18 | 2011-12-22 | 独立行政法人国立精神・神経医療研究センター | 優性アレル発現抑制剤 |
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WO2015152183A1 (ja) * | 2014-03-31 | 2015-10-08 | 大日本住友製薬株式会社 | 進行性骨化性線維異形成症の予防剤及び治療剤 |
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Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2021534430A (ja) * | 2018-08-17 | 2021-12-09 | エフ.ホフマン−ラ ロシュ アーゲーF. Hoffmann−La Roche Aktiengesellschaft | 心房細動の評価における循環bmp10(骨形成タンパク質10) |
JP7232434B2 (ja) | 2018-08-17 | 2023-03-03 | エフ. ホフマン-ラ ロシュ アーゲー | 心房細動の評価における循環bmp10(骨形成タンパク質10) |
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Publication number | Publication date |
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US20190153085A1 (en) | 2019-05-23 |
TW201713361A (zh) | 2017-04-16 |
EP3288976B1 (en) | 2020-04-08 |
KR20170140318A (ko) | 2017-12-20 |
HK1251898A1 (zh) | 2019-04-26 |
US20210061898A1 (en) | 2021-03-04 |
EP3288976A1 (en) | 2018-03-07 |
CA2984249A1 (en) | 2016-11-03 |
AU2016255768B2 (en) | 2022-03-10 |
US20160319009A1 (en) | 2016-11-03 |
AU2016255768A1 (en) | 2017-11-16 |
WO2016176341A1 (en) | 2016-11-03 |
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