RU2015101113A - Антитела против pcsk9, составы, дозы и способы применения - Google Patents
Антитела против pcsk9, составы, дозы и способы применения Download PDFInfo
- Publication number
- RU2015101113A RU2015101113A RU2015101113A RU2015101113A RU2015101113A RU 2015101113 A RU2015101113 A RU 2015101113A RU 2015101113 A RU2015101113 A RU 2015101113A RU 2015101113 A RU2015101113 A RU 2015101113A RU 2015101113 A RU2015101113 A RU 2015101113A
- Authority
- RU
- Russia
- Prior art keywords
- seq
- hvr
- amino acid
- acid sequence
- antibody
- Prior art date
Links
- 239000000203 mixture Substances 0.000 title claims 43
- 238000000034 method Methods 0.000 title claims 26
- 101001098868 Homo sapiens Proprotein convertase subtilisin/kexin type 9 Proteins 0.000 title claims 14
- 102100038955 Proprotein convertase subtilisin/kexin type 9 Human genes 0.000 title claims 14
- 125000003275 alpha amino acid group Chemical group 0.000 claims abstract 83
- 229910052739 hydrogen Inorganic materials 0.000 claims abstract 8
- FWMNVWWHGCHHJJ-SKKKGAJSSA-N 4-amino-1-[(2r)-6-amino-2-[[(2r)-2-[[(2r)-2-[[(2r)-2-amino-3-phenylpropanoyl]amino]-3-phenylpropanoyl]amino]-4-methylpentanoyl]amino]hexanoyl]piperidine-4-carboxylic acid Chemical compound C([C@H](C(=O)N[C@H](CC(C)C)C(=O)N[C@H](CCCCN)C(=O)N1CCC(N)(CC1)C(O)=O)NC(=O)[C@H](N)CC=1C=CC=CC=1)C1=CC=CC=C1 FWMNVWWHGCHHJJ-SKKKGAJSSA-N 0.000 claims abstract 4
- HVYWMOMLDIMFJA-DPAQBDIFSA-N cholesterol Chemical compound C1C=C2C[C@@H](O)CC[C@]2(C)[C@@H]2[C@@H]1[C@@H]1CC[C@H]([C@H](C)CCCC(C)C)[C@@]1(C)CC2 HVYWMOMLDIMFJA-DPAQBDIFSA-N 0.000 claims 14
- 239000003814 drug Substances 0.000 claims 13
- 210000004027 cell Anatomy 0.000 claims 10
- 238000008214 LDL Cholesterol Methods 0.000 claims 8
- 238000007920 subcutaneous administration Methods 0.000 claims 8
- 235000012000 cholesterol Nutrition 0.000 claims 7
- 208000035150 Hypercholesterolemia Diseases 0.000 claims 6
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 6
- 229940079593 drug Drugs 0.000 claims 6
- 238000004519 manufacturing process Methods 0.000 claims 5
- 229940071643 prefilled syringe Drugs 0.000 claims 5
- 150000007523 nucleic acids Chemical class 0.000 claims 4
- 102000039446 nucleic acids Human genes 0.000 claims 4
- 108020004707 nucleic acids Proteins 0.000 claims 4
- 239000013598 vector Substances 0.000 claims 4
- 230000002401 inhibitory effect Effects 0.000 claims 3
- QTBSBXVTEAMEQO-UHFFFAOYSA-M Acetate Chemical compound CC([O-])=O QTBSBXVTEAMEQO-UHFFFAOYSA-M 0.000 claims 2
- 229940121710 HMGCoA reductase inhibitor Drugs 0.000 claims 2
- 102000008394 Immunoglobulin Fragments Human genes 0.000 claims 2
- 108010021625 Immunoglobulin Fragments Proteins 0.000 claims 2
- OZBJWQQAAQSQPL-WCCKRBBISA-N acetic acid;(2s)-2-amino-5-(diaminomethylideneamino)pentanoic acid Chemical compound CC(O)=O.OC(=O)[C@@H](N)CCCN=C(N)N OZBJWQQAAQSQPL-WCCKRBBISA-N 0.000 claims 2
- 150000001413 amino acids Chemical class 0.000 claims 2
- 238000012258 culturing Methods 0.000 claims 2
- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 claims 2
- 239000008194 pharmaceutical composition Substances 0.000 claims 2
- FJLGEFLZQAZZCD-MCBHFWOFSA-N (3R,5S)-fluvastatin Chemical compound C12=CC=CC=C2N(C(C)C)C(\C=C\[C@@H](O)C[C@@H](O)CC(O)=O)=C1C1=CC=C(F)C=C1 FJLGEFLZQAZZCD-MCBHFWOFSA-N 0.000 claims 1
- XUKUURHRXDUEBC-KAYWLYCHSA-N Atorvastatin Chemical compound C=1C=CC=CC=1C1=C(C=2C=CC(F)=CC=2)N(CC[C@@H](O)C[C@@H](O)CC(O)=O)C(C(C)C)=C1C(=O)NC1=CC=CC=C1 XUKUURHRXDUEBC-KAYWLYCHSA-N 0.000 claims 1
- XUKUURHRXDUEBC-UHFFFAOYSA-N Atorvastatin Natural products C=1C=CC=CC=1C1=C(C=2C=CC(F)=CC=2)N(CCC(O)CC(O)CC(O)=O)C(C(C)C)=C1C(=O)NC1=CC=CC=C1 XUKUURHRXDUEBC-UHFFFAOYSA-N 0.000 claims 1
- PCZOHLXUXFIOCF-UHFFFAOYSA-N Monacolin X Natural products C12C(OC(=O)C(C)CC)CC(C)C=C2C=CC(C)C1CCC1CC(O)CC(=O)O1 PCZOHLXUXFIOCF-UHFFFAOYSA-N 0.000 claims 1
- 108091007491 NSP3 Papain-like protease domains Proteins 0.000 claims 1
- 229920001213 Polysorbate 20 Polymers 0.000 claims 1
- TUZYXOIXSAXUGO-UHFFFAOYSA-N Pravastatin Natural products C1=CC(C)C(CCC(O)CC(O)CC(O)=O)C2C(OC(=O)C(C)CC)CC(O)C=C21 TUZYXOIXSAXUGO-UHFFFAOYSA-N 0.000 claims 1
- RYMZZMVNJRMUDD-UHFFFAOYSA-N SJ000286063 Natural products C12C(OC(=O)C(C)(C)CC)CC(C)C=C2C=CC(C)C1CCC1CC(O)CC(=O)O1 RYMZZMVNJRMUDD-UHFFFAOYSA-N 0.000 claims 1
- AJLFOPYRIVGYMJ-UHFFFAOYSA-N SJ000287055 Natural products C12C(OC(=O)C(C)CC)CCC=C2C=CC(C)C1CCC1CC(O)CC(=O)O1 AJLFOPYRIVGYMJ-UHFFFAOYSA-N 0.000 claims 1
- 229960005370 atorvastatin Drugs 0.000 claims 1
- 239000003937 drug carrier Substances 0.000 claims 1
- 210000003527 eukaryotic cell Anatomy 0.000 claims 1
- 239000013604 expression vector Substances 0.000 claims 1
- 229960003765 fluvastatin Drugs 0.000 claims 1
- 239000012634 fragment Substances 0.000 claims 1
- 229960004844 lovastatin Drugs 0.000 claims 1
- PCZOHLXUXFIOCF-BXMDZJJMSA-N lovastatin Chemical compound C([C@H]1[C@@H](C)C=CC2=C[C@H](C)C[C@@H]([C@H]12)OC(=O)[C@@H](C)CC)C[C@@H]1C[C@@H](O)CC(=O)O1 PCZOHLXUXFIOCF-BXMDZJJMSA-N 0.000 claims 1
- QLJODMDSTUBWDW-UHFFFAOYSA-N lovastatin hydroxy acid Natural products C1=CC(C)C(CCC(O)CC(O)CC(O)=O)C2C(OC(=O)C(C)CC)CC(C)C=C21 QLJODMDSTUBWDW-UHFFFAOYSA-N 0.000 claims 1
- 229950009116 mevastatin Drugs 0.000 claims 1
- AJLFOPYRIVGYMJ-INTXDZFKSA-N mevastatin Chemical compound C([C@H]1[C@@H](C)C=CC2=CCC[C@@H]([C@H]12)OC(=O)[C@@H](C)CC)C[C@@H]1C[C@@H](O)CC(=O)O1 AJLFOPYRIVGYMJ-INTXDZFKSA-N 0.000 claims 1
- BOZILQFLQYBIIY-UHFFFAOYSA-N mevastatin hydroxy acid Natural products C1=CC(C)C(CCC(O)CC(O)CC(O)=O)C2C(OC(=O)C(C)CC)CCC=C21 BOZILQFLQYBIIY-UHFFFAOYSA-N 0.000 claims 1
- 229960002797 pitavastatin Drugs 0.000 claims 1
- VGYFMXBACGZSIL-MCBHFWOFSA-N pitavastatin Chemical compound OC(=O)C[C@H](O)C[C@H](O)\C=C\C1=C(C2CC2)N=C2C=CC=CC2=C1C1=CC=C(F)C=C1 VGYFMXBACGZSIL-MCBHFWOFSA-N 0.000 claims 1
- 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 claims 1
- 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 claims 1
- 229920000136 polysorbate Polymers 0.000 claims 1
- 229950008882 polysorbate Drugs 0.000 claims 1
- 229940068977 polysorbate 20 Drugs 0.000 claims 1
- 229960002965 pravastatin Drugs 0.000 claims 1
- TUZYXOIXSAXUGO-PZAWKZKUSA-N pravastatin Chemical compound C1=C[C@H](C)[C@H](CC[C@@H](O)C[C@@H](O)CC(O)=O)[C@H]2[C@@H](OC(=O)[C@@H](C)CC)C[C@H](O)C=C21 TUZYXOIXSAXUGO-PZAWKZKUSA-N 0.000 claims 1
- 229960000672 rosuvastatin Drugs 0.000 claims 1
- BPRHUIZQVSMCRT-VEUZHWNKSA-N rosuvastatin Chemical compound CC(C)C1=NC(N(C)S(C)(=O)=O)=NC(C=2C=CC(F)=CC=2)=C1\C=C\[C@@H](O)C[C@@H](O)CC(O)=O BPRHUIZQVSMCRT-VEUZHWNKSA-N 0.000 claims 1
- 229960002855 simvastatin Drugs 0.000 claims 1
- RYMZZMVNJRMUDD-HGQWONQESA-N simvastatin Chemical compound C([C@H]1[C@@H](C)C=CC2=C[C@H](C)C[C@@H]([C@H]12)OC(=O)C(C)(C)CC)C[C@@H]1C[C@@H](O)CC(=O)O1 RYMZZMVNJRMUDD-HGQWONQESA-N 0.000 claims 1
Classifications
-
- 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
-
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/06—Antihyperlipidemics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
-
- 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
-
- 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
- C07K2317/34—Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
-
- 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
- C07K2317/70—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
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Organic Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Immunology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biochemistry (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Molecular Biology (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Epidemiology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Obesity (AREA)
- Diabetes (AREA)
- Hematology (AREA)
- Peptides Or Proteins (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
- Micro-Organisms Or Cultivation Processes Thereof (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201261660605P | 2012-06-15 | 2012-06-15 | |
| US61/660,605 | 2012-06-15 | ||
| US201361786280P | 2013-03-14 | 2013-03-14 | |
| US61/786,280 | 2013-03-14 | ||
| PCT/US2013/046032 WO2013188855A1 (en) | 2012-06-15 | 2013-06-14 | Anti-pcsk9 antibodies, formulations, dosing, and methods of use |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| RU2015101113A true RU2015101113A (ru) | 2016-08-10 |
Family
ID=48746111
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2015101113A RU2015101113A (ru) | 2012-06-15 | 2013-06-14 | Антитела против pcsk9, составы, дозы и способы применения |
Country Status (13)
| Country | Link |
|---|---|
| US (2) | US9266961B2 (enExample) |
| EP (1) | EP2861624A1 (enExample) |
| JP (1) | JP2015530867A (enExample) |
| KR (1) | KR20150023711A (enExample) |
| CN (1) | CN104364266A (enExample) |
| AR (1) | AR091462A1 (enExample) |
| BR (1) | BR112014031310A2 (enExample) |
| CA (1) | CA2875096A1 (enExample) |
| HK (1) | HK1205141A1 (enExample) |
| MX (1) | MX2014014830A (enExample) |
| RU (1) | RU2015101113A (enExample) |
| TW (1) | TW201410706A (enExample) |
| WO (1) | WO2013188855A1 (enExample) |
Families Citing this family (20)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JOP20080381B1 (ar) | 2007-08-23 | 2023-03-28 | Amgen Inc | بروتينات مرتبطة بمولدات مضادات تتفاعل مع بروبروتين كونفيرتاز سيتيليزين ككسين من النوع 9 (pcsk9) |
| US9255154B2 (en) | 2012-05-08 | 2016-02-09 | Alderbio Holdings, Llc | Anti-PCSK9 antibodies and use thereof |
| EP3169710A1 (en) * | 2014-07-14 | 2017-05-24 | Amgen Inc. | Crystalline antibody formulations |
| CN105461809B (zh) * | 2015-02-11 | 2018-10-12 | 康融东方（广东）医药有限公司 | Pcsk9抗体、其药物组合物及其用途 |
| CN106810609A (zh) * | 2015-11-27 | 2017-06-09 | 苏州君盟生物医药科技有限公司 | 抗pcsk9抗体及其应用 |
| WO2017114230A1 (zh) * | 2015-12-31 | 2017-07-06 | 江苏恒瑞医药股份有限公司 | Pcsk9抗体、其抗原结合片段及其医药用途 |
| CN107531795B (zh) * | 2016-01-05 | 2021-01-19 | 江苏恒瑞医药股份有限公司 | Pcsk9抗体、其抗原结合片段及其医药用途 |
| CN107266575B (zh) | 2016-04-07 | 2021-12-24 | 天士力生物医药股份有限公司 | 前蛋白转化酶枯草溶菌素kexin 9型的结合蛋白及其应用 |
| CN107474140B (zh) * | 2016-06-08 | 2022-06-03 | 常州博嘉生物医药科技有限公司 | Pcsk9特异性的结合蛋白mv072及其应用 |
| BR112018076242A2 (pt) * | 2016-06-24 | 2019-03-26 | Hoffmann La Roche | inibidores de pcsk9, pcsk9 inibido, composição farmacêutica, métodos para modular a atividade de pcsk9, para inibir a ligação de pcsk9 a ldlr, para aumentar a disponibilidade de ldlr, para reduzir um nível de ldl-c, para reduzir o nível sérico de ldl-c, para o tratamento de um distúrbio relacionado com colesterol, métodos para o tratamento de um distúrbio associado a um nível anormal de ldl-c, de uma condição associada a um nível elevado de ldl-c, de dislipidemia, de hipercolesterolemia, usos de um inibidor de pcsk9 e método para identificar um composto candidato como um inibidor de pcsk9 que liga um epítopo da seq id nº 1 |
| EP3515949A4 (en) * | 2016-09-20 | 2020-10-28 | Wuxi Biologics Ireland Limited. | NEW ANTI-PCSK9 ANTIBODIES |
| CN107698679B (zh) * | 2017-01-22 | 2019-03-01 | 北京东方百泰生物科技有限公司 | 抗pcsk9单克隆抗体 |
| US11325945B2 (en) | 2017-04-12 | 2022-05-10 | Cadila Healthcare Limited | Peptide based PCSK9 vaccine |
| CN107177003A (zh) * | 2017-06-27 | 2017-09-19 | 上海海玫生物科技有限公司 | 一种特异性抗人pcsk9的抗体及其应用 |
| US20200223941A1 (en) | 2017-06-30 | 2020-07-16 | Jiangsu Hengrui Medicine Co., Ltd. | Pharmaceutical composition comprising pcsk-9 antibody and use thereof |
| GB201820687D0 (en) * | 2018-12-19 | 2019-01-30 | Kymab Ltd | Antagonists |
| BR112021013807A2 (pt) | 2019-01-18 | 2021-11-30 | Astrazeneca Ab | Inibidores de pcsk9 e seus métodos de uso |
| CN109776680B (zh) * | 2019-01-25 | 2020-05-12 | 浙江蓝盾药业有限公司 | 抗人pcsk9单克隆抗体及其用途 |
| EP4640848A2 (en) | 2019-05-17 | 2025-10-29 | Regeneron Pharmaceuticals, Inc. | Genome-based methods for reducing cardiovascular risk |
| US20230167188A1 (en) * | 2020-07-02 | 2023-06-01 | Biolojic Design Ltd. | Anti-tumor necrosis factor receptor (tnfr2) antibodies and uses thereof |
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-
2013
- 2013-06-14 CA CA2875096A patent/CA2875096A1/en not_active Abandoned
- 2013-06-14 BR BR112014031310A patent/BR112014031310A2/pt active Search and Examination
- 2013-06-14 EP EP13733479.3A patent/EP2861624A1/en not_active Withdrawn
- 2013-06-14 CN CN201380031599.9A patent/CN104364266A/zh active Pending
- 2013-06-14 KR KR20157000680A patent/KR20150023711A/ko not_active Withdrawn
- 2013-06-14 HK HK15105650.3A patent/HK1205141A1/xx unknown
- 2013-06-14 US US13/918,755 patent/US9266961B2/en not_active Expired - Fee Related
- 2013-06-14 TW TW102121268A patent/TW201410706A/zh unknown
- 2013-06-14 RU RU2015101113A patent/RU2015101113A/ru not_active Application Discontinuation
- 2013-06-14 MX MX2014014830A patent/MX2014014830A/es unknown
- 2013-06-14 AR ARP130102123 patent/AR091462A1/es unknown
- 2013-06-14 WO PCT/US2013/046032 patent/WO2013188855A1/en not_active Ceased
- 2013-06-14 JP JP2015517471A patent/JP2015530867A/ja active Pending
-
2015
- 2015-12-28 US US14/981,853 patent/US20160355606A1/en not_active Abandoned
Also Published As
| Publication number | Publication date |
|---|---|
| TW201410706A (zh) | 2014-03-16 |
| US20160355606A1 (en) | 2016-12-08 |
| MX2014014830A (es) | 2015-05-11 |
| EP2861624A1 (en) | 2015-04-22 |
| KR20150023711A (ko) | 2015-03-05 |
| BR112014031310A2 (pt) | 2017-07-25 |
| JP2015530867A (ja) | 2015-10-29 |
| US20130344085A1 (en) | 2013-12-26 |
| WO2013188855A1 (en) | 2013-12-19 |
| CN104364266A (zh) | 2015-02-18 |
| US9266961B2 (en) | 2016-02-23 |
| AR091462A1 (es) | 2015-02-04 |
| CA2875096A1 (en) | 2013-12-19 |
| HK1205141A1 (en) | 2015-12-11 |
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