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

Info

Publication number
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
Authority
JP
Japan
Prior art keywords
masp
antibody
formulation
oms646
viscosity
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
JP2020511307A
Other languages
English (en)
Japanese (ja)
Other versions
JP2020531523A5 (enExample
Inventor
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
Original Assignee
オメロス コーポレーション
オメロス コーポレーション
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by オメロス コーポレーション, オメロス コーポレーション filed Critical オメロス コーポレーション
Publication of JP2020531523A publication Critical patent/JP2020531523A/ja
Publication of JP2020531523A5 publication Critical patent/JP2020531523A5/ja
Pending legal-status Critical Current

Links

Images

Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/40—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against enzymes
    • 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
    • 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
    • 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
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • 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
    • 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
    • A61K2039/54—Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • 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
    • A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • 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
    • A61K2039/55—Medicinal preparations containing antigens or antibodies characterised by the host/recipient, e.g. newborn with maternal antibodies
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Immunology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Transplantation (AREA)
  • 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

Publications (2)

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

Family

ID=65436837

Family Applications (1)

Application Number Title Priority Date Filing Date
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

Country Status (15)

Country Link
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)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114641270A (zh) * 2019-11-15 2022-06-17 豪夫迈·罗氏有限公司 防止水性蛋白质溶液中可见颗粒的形成
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
IL300245A (en) * 2020-07-31 2023-03-01 Alamab Therapeutics Inc Anti-connexin antibody formulations
EP4489782A4 (en) * 2022-03-10 2026-03-25 Omeros Corp MASP-2 and MASP-3 inhibitors, and associated compositions and methods for the treatment of sickle cell disease

Citations (2)

* Cited by examiner, † Cited by third party
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

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
HUE049154T2 (hu) * 2011-05-04 2020-09-28 Omeros Corp Készítmények a MASP-2-függõ komplement-aktiválás gátlására
PT2861246T (pt) * 2012-06-18 2021-04-05 Univ Leicester Composições e métodos para inibir masp-1 e/ou masp-2 e/ou masp-3 para o tratamento de várias doenças e perturbações
RS61351B1 (sr) * 2013-10-17 2021-02-26 Omeros Corp Postupci za lečenje stanja udruženih sa aktivacijom komplementa zavisnom od masp-2
US20160168237A1 (en) * 2014-12-12 2016-06-16 Alexion Pharmaceuticals, Inc. 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)

* Cited by examiner, † Cited by third party
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)

* Cited by examiner, † Cited by third party
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 *

Also Published As

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

Similar Documents

Publication Publication Date Title
US20230226178A1 (en) Highly concentrated low viscosity masp-2 inhibitory antibody formulations, kits, and methods
US20240247078A1 (en) Highly concentrated low viscosity masp-2 inhibitory antibody formulations, kits, and methods of treating subjects suffering from atypical hemolytic syndrome
HK40117196A (en) Highly concentrated low viscosity masp-2 inhibitory antibody formulations, kits, and methods
HK40093811A (en) Highly concentrated low viscosity masp-2 inhibitory antibody formulations, kits, and methods
HK40093808A (en) Highly concentrated low viscosity masp-2 inhibitory antibody formulations, kits, and methods
HK40031101A (en) Highly concentrated low viscosity masp-2 inhibitory antibody formulations, kits, and methods of treating subjects suffering from atypical hemolytic syndrome
HK40009867A (en) Highly concentrated low viscosity masp-2 inhibitory antibody formulations, kits, and methods
HK40009867B (en) Highly concentrated low viscosity masp-2 inhibitory antibody formulations, kits, and methods
OA19221A (en) Highly concentrated low viscosity MASP-2 inhibitory antibody formulations, kits, and methods
EA043928B1 (ru) Высококонцентрированные низковязкие препараты ингибирующего masp-2 антитела, наборы и способы

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A821

Effective date: 20200226

RD04 Notification of resignation of power of attorney

Free format text: JAPANESE INTERMEDIATE CODE: A7424

Effective date: 20210319

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20210819

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20210819

A977 Report on retrieval

Free format text: JAPANESE INTERMEDIATE CODE: A971007

Effective date: 20220728

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20220808

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20221107

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20230206

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20230424

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20230718

A02 Decision of refusal

Free format text: JAPANESE INTERMEDIATE CODE: A02

Effective date: 20231218