JP2020531523A - 高度に濃縮された低粘度のmasp−2阻害抗体製剤、キット、および非定型溶血性症候群に罹患した対象の治療方法 - Google Patents

高度に濃縮された低粘度のmasp−2阻害抗体製剤、キット、および非定型溶血性症候群に罹患した対象の治療方法 Download PDF

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JP2020531523A
JP2020531523A JP2020511307A JP2020511307A JP2020531523A JP 2020531523 A JP2020531523 A JP 2020531523A JP 2020511307 A JP2020511307 A JP 2020511307A JP 2020511307 A JP2020511307 A JP 2020511307A JP 2020531523 A JP2020531523 A JP 2020531523A
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masp
antibody
formulation
oms646
viscosity
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グレゴリー エイ. デモプロス
グレゴリー エイ. デモプロス
ケネス エム. ファーガソン
ケネス エム. ファーガソン
ウィリアム ジョセフ ランバート
ウィリアム ジョセフ ランバート
ジョン スティーブン ウィタカー
ジョン スティーブン ウィタカー
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オメロス コーポレーション
オメロス コーポレーション
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    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/40Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against enzymes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591Stabilisation, fragmentation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • A61P37/06Immunosuppressants, e.g. drugs for graft rejection
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/54Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/545Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/55Medicinal preparations containing antigens or antibodies characterised by the host/recipient, e.g. newborn with maternal antibodies
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76Antagonist effect on antigen, e.g. neutralization or inhibition of binding

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
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  • Dermatology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Endocrinology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
JP2020511307A 2017-08-25 2018-08-21 高度に濃縮された低粘度のmasp−2阻害抗体製剤、キット、および非定型溶血性症候群に罹患した対象の治療方法 Pending JP2020531523A (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201762550328P 2017-08-25 2017-08-25
US62/550,328 2017-08-25
PCT/US2018/047255 WO2019040453A1 (en) 2017-08-25 2018-08-21 HIGHLY CONCENTRATED MASP-2 INHIBITOR ANTIBODY FORMULATIONS WITH LOW VISCOSITY, KITS AND METHODS FOR TREATING SUBJECTS SUFFERING FROM ATYPICAL HEMOLYTIC SYNDROME

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JP2020531523A true JP2020531523A (ja) 2020-11-05
JP2020531523A5 JP2020531523A5 (enExample) 2021-09-30

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JP2020511307A Pending JP2020531523A (ja) 2017-08-25 2018-08-21 高度に濃縮された低粘度のmasp−2阻害抗体製剤、キット、および非定型溶血性症候群に罹患した対象の治療方法

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US (2) US20190062455A1 (enExample)
EP (1) EP3672994A4 (enExample)
JP (1) JP2020531523A (enExample)
KR (1) KR20200037863A (enExample)
CN (1) CN111278863A (enExample)
AU (1) AU2018322032B2 (enExample)
BR (1) BR112020003632A2 (enExample)
CA (1) CA3072913A1 (enExample)
CL (1) CL2020000397A1 (enExample)
IL (1) IL272673B2 (enExample)
MA (1) MA49960A (enExample)
MX (1) MX2020002077A (enExample)
RU (1) RU2020111574A (enExample)
TW (1) TW201925224A (enExample)
WO (1) WO2019040453A1 (enExample)

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Publication number Priority date Publication date Assignee Title
EP4057980A1 (en) * 2019-11-15 2022-09-21 F. Hoffmann-La Roche AG Prevention of visible particle formation in aqueous protein solutions
TW202135860A (zh) * 2019-12-10 2021-10-01 美商再生元醫藥公司 含有抗cd20x抗cd3雙特異性抗體之穩定調配物
WO2022026914A1 (en) * 2020-07-31 2022-02-03 Alamab Therapeutics, Inc. Anti-connexin antibody formulations
US20230416406A1 (en) * 2022-03-10 2023-12-28 Omeros Corporation Masp-2 and masp-3 inhibitors, and related compositions and methods, for treatment of sickle cell disease

Citations (2)

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JP2014515763A (ja) * 2011-05-02 2014-07-03 ミレニアム ファーマシューティカルズ, インコーポレイテッド 抗α4β7抗体のための製剤
WO2017083371A1 (en) * 2015-11-09 2017-05-18 Omeros Corporation Methods for treating conditions associated with masp-2 dependent complement activation

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Publication number Priority date Publication date Assignee Title
EP2704743B1 (en) * 2011-05-04 2020-03-11 Omeros Corporation Compositions for inhibiting masp-2 dependent complement acitivation
CN118924900A (zh) * 2012-06-18 2024-11-12 奥默罗斯公司 抑制masp-1和/或masp-2和/或masp-3的组合物和方法
WO2015058143A1 (en) * 2013-10-17 2015-04-23 Omeros Corporation Methods for treating conditions associated with masp-2 dependent complement activation
WO2016094834A2 (en) * 2014-12-12 2016-06-16 Alexion Pharmaceuticals, Inc. A method for treating a complement mediated disorder caused by an infectious agent in a patient
JOP20170170B1 (ar) * 2016-08-31 2022-09-15 Omeros Corp صيغ لجسم مضاد تثبيطية لـ masp-2 بتركيز عالي ولزوجة منخفضة وأطقم، وطرق

Patent Citations (2)

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Publication number Priority date Publication date Assignee Title
JP2014515763A (ja) * 2011-05-02 2014-07-03 ミレニアム ファーマシューティカルズ, インコーポレイテッド 抗α4β7抗体のための製剤
WO2017083371A1 (en) * 2015-11-09 2017-05-18 Omeros Corporation Methods for treating conditions associated with masp-2 dependent complement activation

Non-Patent Citations (5)

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Title
HIGHLIGHTS OF PRESCRIBING INFORMATION, SOLIRIS (ECULIZUMAB), 2011, PP.1-24, JPN6022032709, ISSN: 0005220352 *
PHARM. RES., vol. 30, JPN6023016389, 2012, pages 641 - 654, ISSN: 0005220356 *
免疫学イラストレイテッド 第5版, JPN6023016390, 2000, JP, pages 71 - 82, ISSN: 0005220354 *
日本畜産学会報, vol. 61, no. 7, JPN6023016391, 1990, pages 655 - 660, ISSN: 0005220355 *
日腎会誌, 2014, VOL.56, NO.7, PP.1090-1096, JPN6022032710, ISSN: 0005220353 *

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BR112020003632A2 (pt) 2020-10-27
CL2020000397A1 (es) 2020-07-10
US20190062455A1 (en) 2019-02-28
MA49960A (fr) 2021-06-02
IL272673B1 (en) 2024-06-01
RU2020111574A3 (enExample) 2021-11-17
MX2020002077A (es) 2020-03-24
KR20200037863A (ko) 2020-04-09
TW201925224A (zh) 2019-07-01
AU2018322032A1 (en) 2020-03-12
RU2020111574A (ru) 2021-09-27
US20240247078A1 (en) 2024-07-25
IL272673A (en) 2020-03-31
AU2018322032B2 (en) 2025-04-17
WO2019040453A1 (en) 2019-02-28
CN111278863A (zh) 2020-06-12
CA3072913A1 (en) 2019-02-28
IL272673B2 (en) 2024-10-01
EP3672994A4 (en) 2021-06-02
EP3672994A1 (en) 2020-07-01

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