RU2020111211A - Способы лечения состояний, ассоциированных с masp-2-зависимой активацией комплемента - Google Patents
Способы лечения состояний, ассоциированных с masp-2-зависимой активацией комплемента Download PDFInfo
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- 230000000295 complement effect Effects 0.000 title claims 2
- 238000000034 method Methods 0.000 title claims 2
- 230000004913 activation Effects 0.000 title 1
- 101710117460 Mannan-binding lectin serine protease 2 Proteins 0.000 claims 14
- 102100026046 Mannan-binding lectin serine protease 2 Human genes 0.000 claims 14
- 230000002401 inhibitory effect Effects 0.000 claims 12
- 125000003275 alpha amino acid group Chemical group 0.000 claims 6
- 239000012634 fragment Substances 0.000 claims 6
- 239000000427 antigen Substances 0.000 claims 5
- 102000036639 antigens Human genes 0.000 claims 5
- 108091007433 antigens Proteins 0.000 claims 5
- 230000024203 complement activation Effects 0.000 claims 4
- 239000003112 inhibitor Substances 0.000 claims 4
- 239000003795 chemical substances by application Substances 0.000 claims 3
- 208000029713 Catastrophic antiphospholipid syndrome Diseases 0.000 claims 2
- 108010028773 Complement C5 Proteins 0.000 claims 2
- 238000003776 cleavage reaction Methods 0.000 claims 2
- 230000008021 deposition Effects 0.000 claims 2
- 239000003814 drug Substances 0.000 claims 2
- 230000007017 scission Effects 0.000 claims 2
- 210000002966 serum Anatomy 0.000 claims 2
- 102100023661 Coiled-coil domain-containing protein 115 Human genes 0.000 claims 1
- 101710155594 Coiled-coil domain-containing protein 115 Proteins 0.000 claims 1
- 102100031506 Complement C5 Human genes 0.000 claims 1
- 102000000989 Complement System Proteins Human genes 0.000 claims 1
- 101001056015 Homo sapiens Mannan-binding lectin serine protease 2 Proteins 0.000 claims 1
- 102000008394 Immunoglobulin Fragments Human genes 0.000 claims 1
- 108010021625 Immunoglobulin Fragments Proteins 0.000 claims 1
- 230000001419 dependent effect Effects 0.000 claims 1
- 229960002224 eculizumab Drugs 0.000 claims 1
- 239000012636 effector Substances 0.000 claims 1
- 102000054960 human MASP2 Human genes 0.000 claims 1
- 238000000338 in vitro Methods 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 230000035772 mutation Effects 0.000 claims 1
- 230000037361 pathway Effects 0.000 claims 1
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/40—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against enzymes
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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
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
-
- 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
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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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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
- C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
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- C—CHEMISTRY; METALLURGY
- 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
- C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
- C07K2317/33—Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/54—F(ab')2
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/55—Fab or Fab'
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
- C07K2317/565—Complementarity determining region [CDR]
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/60—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments
- C07K2317/62—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments comprising only variable region components
- C07K2317/622—Single chain antibody (scFv)
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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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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
- C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
- C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Organic Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
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- Diabetes (AREA)
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- Genetics & Genomics (AREA)
- Biochemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Endocrinology (AREA)
- Epidemiology (AREA)
- Mycology (AREA)
- Microbiology (AREA)
- Dermatology (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Peptides Or Proteins (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
- Photoreceptors In Electrophotography (AREA)
- Saccharide Compounds (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
Claims (22)
1. Применение агента, ингибирующего MASP-2, который ингибирует MASP-2-зависимую активацию комплемента, для получения лекарственного средства для лечения субъекта, страдающего от катастрофического антифосфолипидного синдрома (CAPS).
2. Применение по п. 1, где агент, ингибирующий MASP-2 представляет собой антитело против MASP-2 или его антигенсвязывающий фрагмент.
3. Применение по п. 2, где антитело против MASP-2 представляет собой моноклональное антитело или его антигенсвязывающий фрагмент, которое специфически связывается с частью последовательности SEQ ID NO:6.
4. Применение по п. 1, где субъект ранее подвергался или подвергается на текущий момент лечению ингибитором терминального пути комплемента, который ингибирует расщепление белка C5 комплемента.
5. Применение по п. 1, где способ дополнительно включает в себя введение субъекту ингибитора терминала комплемента, который ингибирует расщепление белка комплемента C5.
6. Применение по п.5, где ингибитор терминального пути комплемента представляет собой гуманизированное антитело против C5 или его антигенсвязывающий фрагмент.
7. Применение по п. 5, где ингибитор терминального пути комплемента представляет собой экулизумаб.
8. Применение по п. 2, где антитело или его фрагмент выбраны из группы, состоящей из рекомбинантного антитела, антитела, имеющего сниженную эффекторную функцию, химерного антитела, гуманизированного антитела и антитела человека.
9. Применение по п. 1, где лекарственное средство составлено для ее доставки подкожно, внутримышечно, артериально, внутривенно или в качестве ингалируемого средства.
10. Применение по п.2, где указанное ингибирующее MASP-2 антитело связывает MASP-2 человека с KD, равным 10 нМ или менее.
11. Применение по п.2, где указанное ингибирующее MASP-2 антитело связывает эпитоп в домене CCP1 MASP-2.
12. Применение по п.2, где указанное ингибирующее MASP-2 антитело ингибирует депонирование C3b in vitro в 1% сыворотке человека с IC50 10 нМ или менее.
13. Применение по п.2, где указанное ингибирующее MASP-2 антитело ингибирует депонирование C3b в 90% сыворотке человека с IC50 30 нМ или менее.
14. Применение по п.2, где указанное ингибирующее MASP-2 антитело представляет собой фрагмент антитела, выбранный из группы, состоящей из Fv, Fab, Fab', F(ab)2 и F(ab')2.
15. Применение по п.2, где указанное ингибирующее MASP-2 антитело выбрано из группы, состоящей из молекулы IgG1, молекулы IgG2 и молекулы IgG4.
16. Применение по п.15, где молекула IgG4 содержит мутацию S228P.
17. Применение по п.2, где указанное ингибирующее MASP-2 антитело по существу не ингибирует классический путь.
18. Применение по п.2, где ингибирующее MASP-2 моноклональное антитело или его антигенсвязывающий фрагмент содержит:
(а) вариабельную область тяжелой цепи, содержащую: i) CDR-H1 тяжелой цепи, содержащую аминокислотную последовательность положений 31-35 последовательности SEQ ID NO:67; и ii) CDR-H2 тяжелой цепи, содержащую аминокислотную последовательность положений 50-65 последовательности SEQ ID NO:67; и iii) CDR-H3 тяжелой цепи, содержащую аминокислотную последовательность положений 95-102 SEQ ID NO:67 и
(b) вариабельную область легкой цепи, содержащую: i) CDR-L1 легкой цепи, содержащую аминокислотную последовательность положений 24-34 последовательности SEQ ID NO:70; и ii) CDR-L2 легкой цепи, содержащую аминокислотную последовательность положений 50-56 последовательности SEQ ID NO:70; и iii) CDR-L3 легкой цепи, содержащую аминокислотную последовательность положений 89-97 SEQ ID NO:70.
19. Применение по п.2, где ингибирующее MASP-2 моноклональное антитело содержит вариабельную область тяжелой цепи, указанную в качестве SEQ ID NO:67, и вариабельную область легкой цепи, обозначенную как SEQ ID NO:70.
20. Применение по п.2, где ингибирующее MASP-2 антитело или его антигенсвязывающий фрагмент специфически распознают по меньшей мере часть эпитопа, распознаваемого эталонным антителом, содержащим вариабельную область тяжелой цепи, как указано в SEQ ID NO:67 и вариабельную область легкой цепи, как указано в SEQ ID NO: 70.
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201361892283P | 2013-10-17 | 2013-10-17 | |
| US61/892,283 | 2013-10-17 | ||
| US201462020845P | 2014-07-03 | 2014-07-03 | |
| US62/020,845 | 2014-07-03 |
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| Application Number | Title | Priority Date | Filing Date |
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| RU2016118769A Division RU2718850C2 (ru) | 2013-10-17 | 2014-10-17 | Способы лечения состояний, ассоциированных с masp-2-зависимой активацией комплемента |
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| RU2020111211A true RU2020111211A (ru) | 2021-11-08 |
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| RU2016118769A RU2718850C2 (ru) | 2013-10-17 | 2014-10-17 | Способы лечения состояний, ассоциированных с masp-2-зависимой активацией комплемента |
| RU2020111211A RU2020111211A (ru) | 2013-10-17 | 2014-10-17 | Способы лечения состояний, ассоциированных с masp-2-зависимой активацией комплемента |
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| RU2016118769A RU2718850C2 (ru) | 2013-10-17 | 2014-10-17 | Способы лечения состояний, ассоциированных с masp-2-зависимой активацией комплемента |
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| Country | Link |
|---|---|
| US (3) | US20150166675A1 (ru) |
| EP (2) | EP3057993B1 (ru) |
| JP (3) | JP2016539919A (ru) |
| KR (1) | KR20160062186A (ru) |
| CN (2) | CN105683219B (ru) |
| AU (2) | AU2014337047B2 (ru) |
| BR (1) | BR112016008409B1 (ru) |
| CA (1) | CA2926385A1 (ru) |
| CL (2) | CL2016000908A1 (ru) |
| CY (1) | CY1123776T1 (ru) |
| DK (1) | DK3057993T3 (ru) |
| ES (1) | ES2829913T3 (ru) |
| HR (1) | HRP20201733T1 (ru) |
| HU (1) | HUE051746T2 (ru) |
| IL (2) | IL283373B1 (ru) |
| LT (1) | LT3057993T (ru) |
| MX (2) | MX2016005017A (ru) |
| NZ (2) | NZ719476A (ru) |
| PL (1) | PL3057993T3 (ru) |
| PT (1) | PT3057993T (ru) |
| RS (1) | RS61351B1 (ru) |
| RU (2) | RU2718850C2 (ru) |
| SI (1) | SI3057993T1 (ru) |
| WO (1) | WO2015058143A1 (ru) |
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| US8840893B2 (en) | 2004-06-10 | 2014-09-23 | Omeros Corporation | Methods for treating conditions associated with MASP-2 dependent complement activation |
| EP2694108B1 (en) | 2011-04-08 | 2018-06-06 | University Of Leicester | Methods for treating conditions associated with masp-2 dependent complement activation |
| US9644035B2 (en) | 2011-04-08 | 2017-05-09 | Omeros Corporation | Methods for treating conditions associated with MASP-2 dependent complement activation |
| JP2016539919A (ja) | 2013-10-17 | 2016-12-22 | オメロス コーポレーション | Ｍａｓｐ−２依存性補体活性化に関連した状態を治療するための方法 |
| GEP20247583B (en) * | 2015-11-09 | 2024-01-10 | Univ Leicester | Methods for treating condi tions associated with masp-2 dependent complement activation |
| IL294411A (en) | 2016-01-05 | 2022-08-01 | Omeros Corp | masp-2 suppressors for use in suppressing fibrosis |
| CA3018774C (en) * | 2016-03-31 | 2023-02-28 | Omeros Corporation | Methods for inhibiting angiogenesis in a subject in need thereof |
| JOP20170170B1 (ar) * | 2016-08-31 | 2022-09-15 | Omeros Corp | صيغ لجسم مضاد تثبيطية لـ masp-2 بتركيز عالي ولزوجة منخفضة وأطقم، وطرق |
| JOP20190068A1 (ar) * | 2016-10-13 | 2019-04-01 | Omeros Corp | طرق لتقليل البول البروتيني في خاضع بشري يعاني من الاعتلال الكلوي a الناتج عن الجلوبيولين المناعي |
| TW202402809A (zh) * | 2017-08-15 | 2024-01-16 | 美商歐米諾斯公司 | 用於治療和／或預防與造血幹細胞移植有關的移植物抗宿主病和／或瀰漫性肺泡出血和／或靜脈閉塞性病的方法 |
| MX2020002077A (es) * | 2017-08-25 | 2020-03-24 | Omeros Corp | Formulaciones de anticuerpos inhibidores de masp-2 de baja viscosidad altamente concentradas, kits y metodos para el tratamiento de sujetos que padecen sindrome hemolitico atipico. |
| CN108171772B (zh) * | 2017-12-28 | 2021-11-19 | 中国地质调查局西安地质调查中心 | 利用mapGIS、CJKCOOR_Ver和DELF3D提取河流边界的方法 |
| KR20210024003A (ko) * | 2018-06-22 | 2021-03-04 | 오메로스 코포레이션 | 다양한 혈전성 질환 및 장애의 치료를 위한 masp-2 억제 조성물 및 방법 |
| WO2020121282A1 (en) * | 2018-12-13 | 2020-06-18 | Argenx Bvba | Antibodies to human complement factor c2b and methods of use |
| CN111134250A (zh) * | 2019-12-03 | 2020-05-12 | 海南大学 | 一种草地贪夜蛾幼虫食用人工饲料的配方和制作方法 |
| JP2023504544A (ja) | 2019-12-04 | 2023-02-03 | オメロス コーポレーション | Ｍａｓｐ－２阻害剤および使用方法 |
| IL293551A (en) | 2019-12-04 | 2022-08-01 | Omeros Corp | 2-masp inhibitor compounds, preparations containing them and their uses |
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