AU2017289085B2 - Anti-CD19 antibody formulations - Google Patents
Anti-CD19 antibody formulations Download PDFInfo
- Publication number
- AU2017289085B2 AU2017289085B2 AU2017289085A AU2017289085A AU2017289085B2 AU 2017289085 B2 AU2017289085 B2 AU 2017289085B2 AU 2017289085 A AU2017289085 A AU 2017289085A AU 2017289085 A AU2017289085 A AU 2017289085A AU 2017289085 B2 AU2017289085 B2 AU 2017289085B2
- Authority
- AU
- Australia
- Prior art keywords
- concentration
- seq
- formulation
- antibody
- sequence
- 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.)
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Classifications
-
- 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
- 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
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- 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
Landscapes
- 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)
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| AU2024205042A AU2024205042A1 (en) | 2016-06-27 | 2024-07-24 | Anti-CD19 antibody formulations |
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 |
|---|---|---|---|
| AU2024205042A Division AU2024205042A1 (en) | 2016-06-27 | 2024-07-24 | Anti-CD19 antibody formulations |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| AU2017289085A1 AU2017289085A1 (en) | 2018-12-13 |
| AU2017289085B2 true AU2017289085B2 (en) | 2024-07-18 |
Family
ID=56368805
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| AU2017289085A Active 2038-06-20 AU2017289085B2 (en) | 2016-06-27 | 2017-06-27 | Anti-CD19 antibody formulations |
| AU2024205042A Pending AU2024205042A1 (en) | 2016-06-27 | 2024-07-24 | Anti-CD19 antibody formulations |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| AU2024205042A Pending AU2024205042A1 (en) | 2016-06-27 | 2024-07-24 | Anti-CD19 antibody formulations |
Country Status (26)
| Country | Link |
|---|---|
| US (2) | US11352423B2 (https=) |
| EP (2) | EP3475303B1 (https=) |
| JP (3) | JP2019524671A (https=) |
| KR (2) | KR102533875B1 (https=) |
| CN (2) | CN109415440B (https=) |
| AU (2) | AU2017289085B2 (https=) |
| CA (1) | CA3029137A1 (https=) |
| CY (1) | CY1124521T1 (https=) |
| DK (1) | DK3475303T3 (https=) |
| ES (1) | ES2874640T3 (https=) |
| HR (1) | HRP20210945T1 (https=) |
| HU (1) | HUE054296T2 (https=) |
| IL (1) | IL263764B2 (https=) |
| LT (1) | LT3475303T (https=) |
| MA (1) | MA45450B1 (https=) |
| MD (1) | MD3475303T2 (https=) |
| MX (1) | MX2018016362A (https=) |
| PL (1) | PL3475303T3 (https=) |
| PT (1) | PT3475303T (https=) |
| RS (1) | RS62035B1 (https=) |
| RU (1) | RU2748024C2 (https=) |
| SG (2) | SG10201912369QA (https=) |
| SI (1) | SI3475303T1 (https=) |
| SM (1) | SMT202100317T1 (https=) |
| WO (1) | WO2018002031A1 (https=) |
| ZA (1) | ZA201900483B (https=) |
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 |
Family Cites Families (26)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4708871A (en) | 1983-03-08 | 1987-11-24 | Commonwealth Serum Laboratories Commission | Antigenically active amino acid sequences |
| CA2467633C (en) | 2001-12-03 | 2012-03-27 | Abgenix, Inc. | Antibody categorization based on binding characteristics |
| US20080260731A1 (en) * | 2002-03-01 | 2008-10-23 | Bernett Matthew J | Optimized antibodies that target cd19 |
| US7902338B2 (en) | 2003-07-31 | 2011-03-08 | Immunomedics, Inc. | Anti-CD19 antibodies |
| EP2216342B1 (en) | 2003-07-31 | 2015-04-22 | Immunomedics, Inc. | Anti-CD19 antibodies |
| WO2007002223A2 (en) | 2005-06-20 | 2007-01-04 | Medarex, Inc. | Cd19 antibodies and their uses |
| 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 |
| KR101456728B1 (ko) | 2006-09-08 | 2014-10-31 | 메디뮨 엘엘씨 | 인간화 항-ｃｄ19 항체, 및 이것의 종양학, 이식 및 자가면역 질환의 치료에서의 용도 |
| CA2693053C (en) | 2007-05-30 | 2021-01-05 | Xencor, Inc. | Methods and compositions for inhibiting cd32b expressing cells |
| CN101874042B9 (zh) | 2007-09-26 | 2019-01-01 | 中外制药株式会社 | 利用cdr的氨基酸取代来改变抗体等电点的方法 |
| RU2476441C2 (ru) | 2007-10-19 | 2013-02-27 | Сиэтл Дженетикс, Инк. | Cd19-связывающие средства и их применение |
| EP2196476A1 (en) * | 2008-12-10 | 2010-06-16 | Novartis Ag | Antibody formulation |
| EP2398829A2 (en) | 2009-02-23 | 2011-12-28 | Glenmark Pharmaceuticals S.A. | Humanized antibodies that bind to cd19 and their uses |
| MX2011009312A (es) * | 2009-03-06 | 2012-02-29 | Medimmune Llc | Formulaciones de anticuerpos humanizados anti-cd19. |
| WO2011147834A1 (en) | 2010-05-26 | 2011-12-01 | Roche Glycart Ag | Antibodies against cd19 and uses thereof |
| EP2409993A1 (en) | 2010-07-19 | 2012-01-25 | International-Drug-Development-Biotech | Anti-CD19 antibody having ADCC function with improved glycosylation profile |
| EP2409712A1 (en) | 2010-07-19 | 2012-01-25 | International-Drug-Development-Biotech | Anti-CD19 antibody having ADCC and CDC functions and improved glycosylation profile |
| EP2524929A1 (en) | 2011-05-17 | 2012-11-21 | Sanofi | Use of anti-CD19 maytansinoid immunoconjugate antibody for the treatment of CD19+ B-cell malignancies syptoms |
| US20140004131A1 (en) * | 2012-05-04 | 2014-01-02 | Novartis Ag | Antibody formulation |
| CN110538322A (zh) | 2013-03-13 | 2019-12-06 | 豪夫迈·罗氏有限公司 | 抗体配制剂 |
| IL269947B (en) | 2013-03-13 | 2022-08-01 | Genentech Inc | Formulations with reduced oxidation |
| US10513555B2 (en) * | 2013-07-04 | 2019-12-24 | Prothena Biosciences Limited | Antibody formulations and methods |
| MX375378B (es) | 2013-09-27 | 2025-03-06 | Genentech Inc | Formulaciones de anticuerpos anti-pdl1. |
| KR102372245B1 (ko) * | 2013-11-21 | 2022-03-08 | 젠맵 에이/에스 | 항체-약물 접합체 동결건조 제제 |
| CN106132434A (zh) * | 2014-04-07 | 2016-11-16 | 西雅图基因公司 | 抗‑cd19抗体和抗体‑药物偶联物的稳定制剂 |
-
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
-
2019
- 2019-01-23 ZA ZA2019/00483A patent/ZA201900483B/en unknown
-
2021
- 2021-06-14 CY CY20211100532T patent/CY1124521T1/el unknown
-
2022
- 2022-03-22 US US17/700,809 patent/US20220213190A1/en active Pending
- 2022-05-18 JP JP2022081779A patent/JP7603201B2/ja active Active
-
2024
- 2024-05-23 JP JP2024083988A patent/JP7824990B2/ja active Active
- 2024-07-24 AU AU2024205042A patent/AU2024205042A1/en active Pending
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PC1 | Assignment before grant (sect. 113) |
Owner name: INCYTE CORPORATION Free format text: FORMER APPLICANT(S): MORPHOSYS AG |
|
| FGA | Letters patent sealed or granted (standard patent) | ||
| NC | Extension of term for standard patent requested (sect. 70) |
Free format text: PRODUCT NAME: MINJUVI TAFASITAMAB Filing date: 20230620 |
|
| NDA | Extension of term for standard patent accepted (sect.70) |
Free format text: PRODUCT NAME: MINJUVI TAFASITAMAB Filing date: 20230620 |
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| NDB | Extension of term for standard patent granted (sect.76) |
Free format text: PRODUCT NAME: MINJUVI TAFASITAMAB Filing date: 20230620 Extension date: 20380620 |