RU2019100221A - Составы на основе антитела к CD19 - Google Patents
Составы на основе антитела к CD19 Download PDFInfo
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- RU2019100221A RU2019100221A RU2019100221A RU2019100221A RU2019100221A RU 2019100221 A RU2019100221 A RU 2019100221A RU 2019100221 A RU2019100221 A RU 2019100221A RU 2019100221 A RU2019100221 A RU 2019100221A RU 2019100221 A RU2019100221 A RU 2019100221A
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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
- A61K39/39591—Stabilisation, fragmentation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
-
- 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
- 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
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- 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
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
-
- 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
- A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
- A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
- A61K47/54—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic compound
- A61K47/549—Sugars, nucleosides, nucleotides or nucleic acids
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
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- 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
- C07K16/2803—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
-
- 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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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Immunology (AREA)
- Engineering & Computer Science (AREA)
- Organic Chemistry (AREA)
- Molecular Biology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Biochemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Mycology (AREA)
- Microbiology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Genetics & Genomics (AREA)
- Biophysics (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Inorganic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Endocrinology (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicinal Preparation (AREA)
- Peptides Or Proteins (AREA)
Claims (19)
1. Стабильный лиофилизированный фармацевтический состав, при этом состав содержит антитело к CD19 в концентрации, составляющей от 20 мг/мл до 125 мг/мл, буфер, полисорбат в концентрации, составляющей от 0,005% (вес/об.) до 0,06% (вес/об.), и с показателем рН, составляющим 6,0, где состав дополнительно содержит
a) трегалозу в концентрации, составляющей от 180 мМ до 240 мМ, или
b) маннит в концентрации, составляющей от 180 мМ до 240 мМ, и сахарозу в концентрации, составляющей от 10 мМ до 50 мМ,
и где указанное антитело к CD19 содержит константный домен тяжелой цепи с последовательностью
ASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSWTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGGPDVFLFPPKPKDTLMISRTPEVTCVWDVSHEDPEVQFNWYVDGVEVHNAKTKPREEQFNSTFRWSVLTWHQDWLNGKEYKCKVSNKALPAPEEKTISKTKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPMLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK (SEQ ID NO: 8) и константный домен легкой цепи с последовательностью RTVAAPSVFIFPPSDEQLKSGTASWCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC (SEQ ID NO: 9).
2. Состав по п. 1, где концентрация указанного антитела к CD19 в составе составляет 40 мг/мл.
3. Состав по любому из п. 1 или 2, где указанный буфер представляет собой цитратный буфер или фосфатный буфер.
4. Состав по п. 3, где концентрация указанного цитратного буфера или фосфатного буфера составляет от 20 до 50 мМ.
5. Состав по п. 4, где концентрация указанного цитратного буфера или фосфатного буфера составляет 25 мМ.
6. Состав по любому из пп. 1-5, где концентрация указанной трегалозы в составе составляет 200 мМ.
7. Состав по любому из пп. 1-5, где концентрация указанного маннита в составе составляет 219 мМ, и концентрация указанной сахарозы в составе составляет 29 мМ.
8. Состав по любому из пп. 1-7, где указанный полисорбат в составе представляет собой полисорбат 20.
9. Состав по любому из пп. 1-8, где концентрация указанного полисорбата в составе составляет 0,02%.
10. Состав по любому из пп. 1-9, где указанное антитело к CD19 представляет собой антитело lgG1, lgG2, lgG3 или lgG4.
11. Состав по любому из пп. 1-10, где состав является стабильным при 2-8°С в течение по меньшей мере 6 месяцев, по меньшей мере 12 месяцев, по меньшей мере 18 месяцев, по меньшей мере 24 месяцев или по меньшей мере 36 месяцев.
12. Состав по любому из пп. 1-5, где количество указанного антитела к CD19 составляет 40 мг/мл, концентрация указанного цитратного буфера составляет 25 мМ, концентрация указанной трегалозы составляет 200 мМ, концентрация полисорбата составляет 0,02% (вес/об.), и указанный состав характеризуется показателем рН, составляющим 6,0.
13. Состав по любому из пп. 1-5, где количество указанного антитела к CD19 составляет 40 мг/мл, концентрация указанного цитратного буфера составляет 25 мМ, концентрация указанного маннита составляет 219 мМ, и концентрация указанной сахарозы составляет 29 мМ, концентрация полисорбата составляет 0,02% (вес/об.), и указанный состав характеризуется показателем рН, составляющим 6,0.
14. Изделие, содержащее контейнер, в котором содержится стабильный лиофилизированный фармацевтический состав по любому из пп. 1-13.
15. Способ лечения заболевания или нарушения у субъекта, включающий введение субъекту эффективного количества состава по любому из пп. 1-13, где заболевание или нарушение представляет собой рак.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP16176322.2 | 2016-06-27 | ||
| EP16176322 | 2016-06-27 | ||
| PCT/EP2017/065819 WO2018002031A1 (en) | 2016-06-27 | 2017-06-27 | Anti-cd19 antibody formulations |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2021110291A Division RU2848327C1 (ru) | 2016-06-27 | 2017-06-27 | Составы на основе антитела к CD19 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| RU2019100221A true RU2019100221A (ru) | 2020-07-28 |
| RU2019100221A3 RU2019100221A3 (ru) | 2020-11-30 |
| RU2748024C2 RU2748024C2 (ru) | 2021-05-19 |
Family
ID=56368805
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2019100221A RU2748024C2 (ru) | 2016-06-27 | 2017-06-27 | Составы на основе антитела к CD19 |
Country Status (26)
| Country | Link |
|---|---|
| US (2) | US11352423B2 (ru) |
| EP (2) | EP3475303B1 (ru) |
| JP (3) | JP2019524671A (ru) |
| KR (2) | KR102533875B1 (ru) |
| CN (2) | CN109415440B (ru) |
| AU (2) | AU2017289085B2 (ru) |
| CA (1) | CA3029137A1 (ru) |
| CY (1) | CY1124521T1 (ru) |
| DK (1) | DK3475303T3 (ru) |
| ES (1) | ES2874640T3 (ru) |
| HR (1) | HRP20210945T1 (ru) |
| HU (1) | HUE054296T2 (ru) |
| IL (1) | IL263764B2 (ru) |
| LT (1) | LT3475303T (ru) |
| MA (1) | MA45450B1 (ru) |
| MD (1) | MD3475303T2 (ru) |
| MX (1) | MX2018016362A (ru) |
| PL (1) | PL3475303T3 (ru) |
| PT (1) | PT3475303T (ru) |
| RS (1) | RS62035B1 (ru) |
| RU (1) | RU2748024C2 (ru) |
| SG (2) | SG10201912369QA (ru) |
| SI (1) | SI3475303T1 (ru) |
| SM (1) | SMT202100317T1 (ru) |
| WO (1) | WO2018002031A1 (ru) |
| ZA (1) | ZA201900483B (ru) |
Families Citing this family (15)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| SMT202100541T1 (it) | 2015-08-21 | 2021-11-12 | Morphosys Ag | Combinazioni e loro usi |
| IL301786B2 (en) | 2016-10-28 | 2025-09-01 | Morphosys Ag | Combination of anti-CD19 antibody with BCL-2 inhibitor and their uses |
| KR20200030337A (ko) | 2018-09-12 | 2020-03-20 | 주식회사 녹십자랩셀 | 종양 치료를 위한 항-cd 19 항체 및 자연살해세포를 포함하는 약학적 조합물 |
| KR102735988B1 (ko) | 2019-02-18 | 2024-12-03 | 일라이 릴리 앤드 캄파니 | 치료 항체 제제 |
| US12544437B2 (en) | 2019-10-04 | 2026-02-10 | Ultragenyx Pharmaceutical Inc. | Methods for improved therapeutic use of recombinant AAV |
| US20210130461A1 (en) | 2019-10-31 | 2021-05-06 | Morphosys Ag | Anti-tumor combination therapy comprising anti-cd19 antibody and gamma delta t-cells |
| US20230014026A1 (en) | 2020-06-22 | 2023-01-19 | Morphosys Ag | Anti-Tumor Combination Therapy comprising Anti-CD19 Antibody and Polypeptides Blocking the SIRPalpha-CD47 Innate Immune Checkpoint |
| JP2023545099A (ja) | 2020-10-08 | 2023-10-26 | アフィメド ゲーエムベーハー | 三重特異性バインダー |
| CA3216098A1 (en) | 2021-07-30 | 2023-02-02 | Uwe Reusch | Duplexbodies |
| WO2023073645A1 (en) | 2021-10-29 | 2023-05-04 | Takeda Pharmaceutical Company Limited | Therapy comprising anti-cd19 antibody and sumo-activating enzyme inhibitor |
| AU2022382368A1 (en) | 2021-11-03 | 2024-05-02 | Affimed Gmbh | Bispecific cd16a binders |
| IL316747A (en) * | 2022-05-03 | 2025-01-01 | Xencor Inc | Lymphoma treatment methods |
| IL318787A (en) | 2022-08-17 | 2025-04-01 | Incyte Corp | Treatment including ANTI-CD19 antibodies and EZH2 modulators |
| IL322510A (en) * | 2023-03-02 | 2025-10-01 | Novetide Ltd | Method for preparing GLP-1 peptides with controlled particle size |
| CN120754244B (zh) * | 2025-09-10 | 2025-12-12 | 江苏豪森药业集团有限公司 | 一种含抗cd19抗体的药物组合物及其用途 |
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| AU2006332155B2 (en) | 2005-12-30 | 2013-01-10 | Cancer Research Technology Limited | Anti-CD19 antibodies with reduced immunogenicity |
| PL2383297T3 (pl) * | 2006-08-14 | 2013-06-28 | Xencor Inc | Zoptymalizowane przeciwciała ukierunkowane na CD19 |
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2017
- 2017-06-27 SI SI201730801T patent/SI3475303T1/sl unknown
- 2017-06-27 HR HRP20210945TT patent/HRP20210945T1/hr unknown
- 2017-06-27 AU AU2017289085A patent/AU2017289085B2/en active Active
- 2017-06-27 JP JP2018567742A patent/JP2019524671A/ja active Pending
- 2017-06-27 HU HUE17735440A patent/HUE054296T2/hu unknown
- 2017-06-27 SG SG10201912369QA patent/SG10201912369QA/en unknown
- 2017-06-27 WO PCT/EP2017/065819 patent/WO2018002031A1/en not_active Ceased
- 2017-06-27 PT PT177354404T patent/PT3475303T/pt unknown
- 2017-06-27 MX MX2018016362A patent/MX2018016362A/es unknown
- 2017-06-27 LT LTEP17735440.4T patent/LT3475303T/lt unknown
- 2017-06-27 ES ES17735440T patent/ES2874640T3/es active Active
- 2017-06-27 IL IL263764A patent/IL263764B2/en unknown
- 2017-06-27 MA MA45450A patent/MA45450B1/fr unknown
- 2017-06-27 SG SG11201810429UA patent/SG11201810429UA/en unknown
- 2017-06-27 CN CN201780039737.6A patent/CN109415440B/zh active Active
- 2017-06-27 KR KR1020197002043A patent/KR102533875B1/ko active Active
- 2017-06-27 PL PL17735440T patent/PL3475303T3/pl unknown
- 2017-06-27 DK DK17735440.4T patent/DK3475303T3/da active
- 2017-06-27 EP EP17735440.4A patent/EP3475303B1/en active Active
- 2017-06-27 KR KR1020237016157A patent/KR20230074823A/ko not_active Ceased
- 2017-06-27 MD MDE20190533T patent/MD3475303T2/ro unknown
- 2017-06-27 CA CA3029137A patent/CA3029137A1/en active Pending
- 2017-06-27 US US16/310,555 patent/US11352423B2/en active Active
- 2017-06-27 EP EP21167818.0A patent/EP3909985A1/en active Pending
- 2017-06-27 CN CN202211458395.0A patent/CN115998859A/zh active Pending
- 2017-06-27 SM SM20210317T patent/SMT202100317T1/it unknown
- 2017-06-27 RU RU2019100221A patent/RU2748024C2/ru active
- 2017-06-27 RS RS20210748A patent/RS62035B1/sr unknown
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2019
- 2019-01-23 ZA ZA2019/00483A patent/ZA201900483B/en unknown
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2021
- 2021-06-14 CY CY20211100532T patent/CY1124521T1/el unknown
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2022
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