CA3029137A1 - Anti-cd19 antibody formulations - Google Patents

Anti-cd19 antibody formulations Download PDF

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Publication number
CA3029137A1
CA3029137A1 CA3029137A CA3029137A CA3029137A1 CA 3029137 A1 CA3029137 A1 CA 3029137A1 CA 3029137 A CA3029137 A CA 3029137A CA 3029137 A CA3029137 A CA 3029137A CA 3029137 A1 CA3029137 A1 CA 3029137A1
Authority
CA
Canada
Prior art keywords
formulation
concentration
antibody
seq
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.)
Pending
Application number
CA3029137A
Other languages
English (en)
French (fr)
Inventor
Patrick Garidel
Andreas Langer
Martin Hessling
Daniel WEINFURTNER
Bodo Brocks
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Morphosys GmbH
Original Assignee
Morphosys GmbH
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Morphosys GmbH filed Critical Morphosys GmbH
Publication of CA3029137A1 publication Critical patent/CA3029137A1/en
Pending legal-status Critical Current

Links

Classifications

    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803Immunoglobulins [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
    • 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

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)
  • Biophysics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Genetics & Genomics (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)
CA3029137A 2016-06-27 2017-06-27 Anti-cd19 antibody formulations Pending CA3029137A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP16176322 2016-06-27
EP16176322.2 2016-06-27
PCT/EP2017/065819 WO2018002031A1 (en) 2016-06-27 2017-06-27 Anti-cd19 antibody formulations

Publications (1)

Publication Number Publication Date
CA3029137A1 true CA3029137A1 (en) 2018-01-04

Family

ID=56368805

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3029137A Pending CA3029137A1 (en) 2016-06-27 2017-06-27 Anti-cd19 antibody formulations

Country Status (26)

Country Link
US (2) US11352423B2 (https=)
EP (2) EP3909985A1 (https=)
JP (3) JP2019524671A (https=)
KR (2) KR102533875B1 (https=)
CN (2) CN115998859A (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) SG11201810429UA (https=)
SI (1) SI3475303T1 (https=)
SM (1) SMT202100317T1 (https=)
WO (1) WO2018002031A1 (https=)
ZA (1) ZA201900483B (https=)

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RU2767063C2 (ru) 2015-08-21 2022-03-16 МорфоСис АГ Комбинации и их использование
US12358983B2 (en) 2016-10-28 2025-07-15 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
CN120241997A (zh) 2019-02-18 2025-07-04 伊莱利利公司 治疗性抗体制剂
WO2021067598A1 (en) 2019-10-04 2021-04-08 Ultragenyx Pharmaceutical Inc. Methods for improved therapeutic use of recombinant aav
CN115151565A (zh) 2019-10-31 2022-10-04 莫佛塞斯公司 包含抗CD19抗体和γδT细胞的抗肿瘤组合疗法
WO2021259902A1 (en) 2020-06-22 2021-12-30 Morphosys Ag Anti-tumor combination therapy comprising anti-cd19 antibody and polypeptides blocking the sirpα-cd47 innate immune checkpoint
CN116368154A (zh) 2020-10-08 2023-06-30 阿菲姆德股份有限公司 三特异性结合剂
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
US20260070986A1 (en) 2021-11-03 2026-03-12 Affimed Gmbh Bispecific cd16a binders
AU2023264582A1 (en) * 2022-05-03 2024-11-21 Incyte Corporation Methods for treating lymphoma
KR20250052388A (ko) 2022-08-17 2025-04-18 인사이트 코포레이션 항-cd19 항체 및 ezh2 조절제를 포함하는 요법
EP4673177A1 (en) * 2023-03-02 2026-01-07 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

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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
CA2534639C (en) 2003-07-31 2013-07-30 Immunomedics, Inc. Anti-cd19 antibodies
US7902338B2 (en) 2003-07-31 2011-03-08 Immunomedics, Inc. Anti-CD19 antibodies
CA2611814A1 (en) 2005-06-20 2007-01-04 Medarex, Inc. Cd19 antibodies and their uses
ES2365046T3 (es) 2005-12-30 2011-09-21 Merck Patent Gmbh Anticuerpos anti-cd19 con inmunogenicidad reducida.
PL2383297T3 (pl) * 2006-08-14 2013-06-28 Xencor Inc Zoptymalizowane przeciwciała ukierunkowane na CD19
RU2495882C2 (ru) 2006-09-08 2013-10-20 Медиммун, Ллк. Гуманизированные антитела к cd19 и их применение для лечения онкологического, связанного с трансплантацией и аутоиммунного заболевания
EP2176298B1 (en) 2007-05-30 2017-11-15 Xencor, Inc. Methods and compositions for inhibiting cd32b expressing cells
ES2595638T3 (es) 2007-09-26 2017-01-02 Chugai Seiyaku Kabushiki Kaisha Método para modificar el punto isoeléctrico de un anticuerpo mediante la sustitución de aminoácidos en una CDR
DK2211904T3 (en) 2007-10-19 2016-10-24 Seattle Genetics Inc Cd19-binding agents and uses thereof
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
CN102413839A (zh) * 2009-03-06 2012-04-11 医学免疫有限责任公司 人源化抗cd19抗体制剂
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EP2409712A1 (en) 2010-07-19 2012-01-25 International-Drug-Development-Biotech Anti-CD19 antibody having ADCC and CDC functions and improved glycosylation profile
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MY175472A (en) 2013-09-27 2020-06-29 Genentech Inc Anti-pdl1 antibody formulations
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Also Published As

Publication number Publication date
CN109415440A (zh) 2019-03-01
ES2874640T3 (es) 2021-11-05
KR20190021373A (ko) 2019-03-05
JP2019524671A (ja) 2019-09-05
CN109415440B (zh) 2022-12-06
US20190322742A1 (en) 2019-10-24
IL263764B2 (en) 2024-09-01
JP2022119854A (ja) 2022-08-17
HRP20210945T1 (hr) 2021-09-17
LT3475303T (lt) 2021-06-25
IL263764B1 (en) 2024-05-01
US11352423B2 (en) 2022-06-07
EP3909985A1 (en) 2021-11-17
MA45450B1 (fr) 2021-04-30
RU2748024C2 (ru) 2021-05-19
MX2018016362A (es) 2019-04-22
JP2024109816A (ja) 2024-08-14
JP7603201B2 (ja) 2024-12-20
EP3475303A1 (en) 2019-05-01
EP3475303B1 (en) 2021-04-14
PT3475303T (pt) 2021-06-25
HUE054296T2 (hu) 2021-08-30
CN115998859A (zh) 2023-04-25
MD3475303T2 (ro) 2021-09-30
SMT202100317T1 (it) 2021-07-12
KR102533875B1 (ko) 2023-05-18
JP7824990B2 (ja) 2026-03-05
DK3475303T3 (da) 2021-05-31
ZA201900483B (en) 2021-06-30
RU2019100221A (ru) 2020-07-28
SI3475303T1 (sl) 2021-12-31
AU2024205042A1 (en) 2024-08-15
WO2018002031A1 (en) 2018-01-04
AU2017289085B2 (en) 2024-07-18
NZ748681A (en) 2025-06-27
KR20230074823A (ko) 2023-05-31
PL3475303T3 (pl) 2021-12-06
US20220213190A1 (en) 2022-07-07
CY1124521T1 (el) 2022-07-22
SG11201810429UA (en) 2018-12-28
SG10201912369QA (en) 2020-02-27
RU2019100221A3 (https=) 2020-11-30
IL263764A (en) 2019-01-31
RS62035B1 (sr) 2021-07-30
AU2017289085A1 (en) 2018-12-13

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