CN109415440B - 抗-cd19抗体制剂 - Google Patents

抗-cd19抗体制剂 Download PDF

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Publication number
CN109415440B
CN109415440B CN201780039737.6A CN201780039737A CN109415440B CN 109415440 B CN109415440 B CN 109415440B CN 201780039737 A CN201780039737 A CN 201780039737A CN 109415440 B CN109415440 B CN 109415440B
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concentration
formulation
antibody
sequence
seq
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Chinese (zh)
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CN109415440A (zh
Inventor
P·加里代尔
A·朗格尔
M·黑斯林
D·魏因富特纳
B·布罗克斯
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Incyte Corp
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Morphosys AG
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    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803Immunoglobulins [IGs], 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591Stabilisation, fragmentation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50Medicinal 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
    • A61K47/51Medicinal 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
    • A61K47/54Medicinal 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
    • A61K47/549Sugars, nucleosides, nucleotides or nucleic acids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal 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)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (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)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Proteomics, Peptides & Aminoacids (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)
CN201780039737.6A 2016-06-27 2017-06-27 抗-cd19抗体制剂 Active CN109415440B (zh)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN202211458395.0A CN115998859A (zh) 2016-06-27 2017-06-27 抗-cd19抗体制剂

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
CN202211458395.0A Division CN115998859A (zh) 2016-06-27 2017-06-27 抗-cd19抗体制剂

Publications (2)

Publication Number Publication Date
CN109415440A CN109415440A (zh) 2019-03-01
CN109415440B true CN109415440B (zh) 2022-12-06

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CN201780039737.6A Active CN109415440B (zh) 2016-06-27 2017-06-27 抗-cd19抗体制剂
CN202211458395.0A Pending CN115998859A (zh) 2016-06-27 2017-06-27 抗-cd19抗体制剂

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US (2) US11352423B2 (enExample)
EP (2) EP3475303B1 (enExample)
JP (3) JP2019524671A (enExample)
KR (2) KR102533875B1 (enExample)
CN (2) CN109415440B (enExample)
AU (2) AU2017289085B2 (enExample)
CA (1) CA3029137A1 (enExample)
CY (1) CY1124521T1 (enExample)
DK (1) DK3475303T3 (enExample)
ES (1) ES2874640T3 (enExample)
HR (1) HRP20210945T1 (enExample)
HU (1) HUE054296T2 (enExample)
IL (1) IL263764B2 (enExample)
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MD (1) MD3475303T2 (enExample)
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RU (1) RU2748024C2 (enExample)
SG (2) SG10201912369QA (enExample)
SI (1) SI3475303T1 (enExample)
SM (1) SMT202100317T1 (enExample)
WO (1) WO2018002031A1 (enExample)
ZA (1) ZA201900483B (enExample)

Families Citing this family (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2017032679A1 (en) 2015-08-21 2017-03-02 Morphosys Ag Combinations and uses thereof
AU2017348624B2 (en) 2016-10-28 2024-09-26 Incyte Corporation Combination of anti CD19 antibody with a BCL-2 inhibitor and uses thereof
KR20200030337A (ko) 2018-09-12 2020-03-20 주식회사 녹십자랩셀 종양 치료를 위한 항-cd 19 항체 및 자연살해세포를 포함하는 약학적 조합물
JP7266108B2 (ja) 2019-02-18 2023-04-27 イーライ リリー アンド カンパニー 治療用抗体製剤
JP2022550435A (ja) 2019-10-04 2022-12-01 ウルトラジェニックス ファーマシューティカル インコーポレイテッド 組換えaavの改善された治療的使用のための方法
TWI883067B (zh) 2019-10-31 2025-05-11 美商英塞特公司 包含抗CD19抗體及γδ T細胞之抗腫瘤組合療法
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
JP2024529381A (ja) 2021-07-30 2024-08-06 アフィメド ゲーエムベーハー デュプレックスボディ
WO2023073645A1 (en) 2021-10-29 2023-05-04 Takeda Pharmaceutical Company Limited Therapy comprising anti-cd19 antibody and sumo-activating enzyme inhibitor
EP4426439A1 (en) 2021-11-03 2024-09-11 Affimed GmbH Bispecific cd16a binders
AU2023264582A1 (en) * 2022-05-03 2024-11-21 Incyte Corporation Methods for treating lymphoma
AU2023326589A1 (en) 2022-08-17 2025-02-20 Incyte Corporation Therapy comprising anti-cd19 antibody and ezh2 modulators
WO2024180511A1 (en) * 2023-03-02 2024-09-06 Novetide Ltd. Process for preparation of glp-1 peptides having 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

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2015075201A1 (en) * 2013-11-21 2015-05-28 Genmab A/S Antibody-drug conjugate lyophilised formulation
WO2015157286A1 (en) * 2014-04-07 2015-10-15 Seattle Genetics, Inc. Stable formulations for anti-cd19 antibodies and antibody-drug conjugates
CN105492019A (zh) * 2013-07-04 2016-04-13 普罗塞纳生物科学有限公司 抗体制剂和方法

Family Cites Families (23)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS60500673A (ja) 1983-03-08 1985-05-09 コモンウエルス セラム ラボラトリ−ズ コミツシヨン 抗原活性を有するアミノ酸配列
US7771951B2 (en) 2001-12-03 2010-08-10 Amgen Fremont 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
US7109304B2 (en) 2003-07-31 2006-09-19 Immunomedics, Inc. Humanized anti-CD19 antibodies
JP5215180B2 (ja) 2005-06-20 2013-06-19 メダレックス インコーポレーティッド Cd19抗体およびその使用法
ATE509954T1 (de) 2005-12-30 2011-06-15 Merck Patent Gmbh Anti-cd19-antikörper mit reduzierter immunogenität
ES2402591T3 (es) * 2006-08-14 2013-05-07 Xencor Inc. Anticuerpos optimizados que seleccionan como diana CD19
US8323653B2 (en) 2006-09-08 2012-12-04 Medimmune, Llc Humanized anti-CD19 antibodies and their use in treatment of oncology, transplantation and autoimmune disease
ES2659517T3 (es) 2007-05-30 2018-03-16 Xencor, Inc. Métodos y composiciones para inhibir células que expresan CD32B
CA2700701C (en) * 2007-09-26 2020-12-29 Chugai Seiyaku Kabushiki Kaisha Method of modifying isoelectric point of antibody via amino acid substitution in cdr
SI2211904T1 (sl) 2007-10-19 2016-12-30 Seattle Genetics, Inc. CD19 vezavna sredstva in njihove uporabe
EP2196476A1 (en) * 2008-12-10 2010-06-16 Novartis Ag Antibody formulation
CN102421800A (zh) 2009-02-23 2012-04-18 格兰马克药品股份有限公司 结合cd19的人源化抗体及其用途
AU2010221099A1 (en) * 2009-03-06 2011-09-22 Medimmune, Llc Humanized anti-CD19 antibody formulations
WO2011147834A1 (en) 2010-05-26 2011-12-01 Roche Glycart Ag Antibodies against cd19 and uses thereof
EP2409712A1 (en) 2010-07-19 2012-01-25 International-Drug-Development-Biotech Anti-CD19 antibody having ADCC and CDC functions and improved glycosylation profile
EP2409993A1 (en) 2010-07-19 2012-01-25 International-Drug-Development-Biotech Anti-CD19 antibody having ADCC function with 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
MX365567B (es) 2013-03-13 2019-06-07 Genentech Inc Formulaciones de anticuerpo.
NZ711566A (en) 2013-03-13 2020-06-26 Genentech Inc Formulations with reduced oxidation
EP4285928A3 (en) 2013-09-27 2024-03-13 F. Hoffmann-La Roche AG Anti-pdl1 antibody formulations

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105492019A (zh) * 2013-07-04 2016-04-13 普罗塞纳生物科学有限公司 抗体制剂和方法
WO2015075201A1 (en) * 2013-11-21 2015-05-28 Genmab A/S Antibody-drug conjugate lyophilised formulation
WO2015157286A1 (en) * 2014-04-07 2015-10-15 Seattle Genetics, Inc. Stable formulations for anti-cd19 antibodies and antibody-drug conjugates

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
Formation of Stable Nanobubbles on Reconstituting Lyophilized Formulations Containing Trehalose;Chen Zhou et al;《Journal of Pharmaceutical Sciences》;20160608;第105卷;第2249-2253页 *
Reduced Subvisible Particle Formation in Lyophilized Intravenous Immunoglobulin Formulations Containing Polysorbate 20;Chen Zhou et al;《Journal of Pharmaceutical Sciences》;20160609;第105卷;第2302-2309页 *
The development of stable protein formulations: A close look at protein aggregation, deamidation, and oxidation;Jeffrey L.Cleland et al;《Critical Reviews in Therapeutic Drug Carrier Systems》;19931231;第10卷(第4期);第307-358页 *

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JP2024109816A (ja) 2024-08-14
JP7603201B2 (ja) 2024-12-20
MA45450B1 (fr) 2021-04-30
MX2018016362A (es) 2019-04-22
SG10201912369QA (en) 2020-02-27
IL263764B2 (en) 2024-09-01
JP2019524671A (ja) 2019-09-05
US20190322742A1 (en) 2019-10-24
EP3475303A1 (en) 2019-05-01
IL263764A (en) 2019-01-31
KR20230074823A (ko) 2023-05-31
PL3475303T3 (pl) 2021-12-06
DK3475303T3 (da) 2021-05-31
IL263764B1 (en) 2024-05-01
AU2024205042A1 (en) 2024-08-15
LT3475303T (lt) 2021-06-25
RU2748024C2 (ru) 2021-05-19
US11352423B2 (en) 2022-06-07
RU2019100221A3 (enExample) 2020-11-30
PT3475303T (pt) 2021-06-25
CN109415440A (zh) 2019-03-01
ES2874640T3 (es) 2021-11-05
ZA201900483B (en) 2021-06-30
SG11201810429UA (en) 2018-12-28
RS62035B1 (sr) 2021-07-30
CA3029137A1 (en) 2018-01-04
HUE054296T2 (hu) 2021-08-30
KR20190021373A (ko) 2019-03-05
RU2019100221A (ru) 2020-07-28
CN115998859A (zh) 2023-04-25
JP2022119854A (ja) 2022-08-17
CY1124521T1 (el) 2022-07-22
AU2017289085B2 (en) 2024-07-18
EP3909985A1 (en) 2021-11-17
EP3475303B1 (en) 2021-04-14
HRP20210945T1 (hr) 2021-09-17
NZ748681A (en) 2025-06-27
MD3475303T2 (ro) 2021-09-30
WO2018002031A1 (en) 2018-01-04
SI3475303T1 (sl) 2021-12-31
US20220213190A1 (en) 2022-07-07
SMT202100317T1 (it) 2021-07-12
KR102533875B1 (ko) 2023-05-18
AU2017289085A1 (en) 2018-12-13

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