CN115998859A - 抗-cd19抗体制剂 - Google Patents

抗-cd19抗体制剂 Download PDF

Info

Publication number
CN115998859A
CN115998859A CN202211458395.0A CN202211458395A CN115998859A CN 115998859 A CN115998859 A CN 115998859A CN 202211458395 A CN202211458395 A CN 202211458395A CN 115998859 A CN115998859 A CN 115998859A
Authority
CN
China
Prior art keywords
concentration
formulation
antibody
sequence
seq
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
CN202211458395.0A
Other languages
English (en)
Chinese (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
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.)
Incyte Corp
Original Assignee
Morphosys AG
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 AG filed Critical Morphosys AG
Publication of CN115998859A publication Critical patent/CN115998859A/zh
Pending legal-status Critical Current

Links

Images

Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [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
    • 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
    • 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)
  • 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)
CN202211458395.0A 2016-06-27 2017-06-27 抗-cd19抗体制剂 Pending CN115998859A (zh)

Applications Claiming Priority (4)

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
CN201780039737.6A CN109415440B (zh) 2016-06-27 2017-06-27 抗-cd19抗体制剂

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
CN201780039737.6A Division CN109415440B (zh) 2016-06-27 2017-06-27 抗-cd19抗体制剂

Publications (1)

Publication Number Publication Date
CN115998859A true CN115998859A (zh) 2023-04-25

Family

ID=56368805

Family Applications (2)

Application Number Title Priority Date Filing Date
CN202211458395.0A Pending CN115998859A (zh) 2016-06-27 2017-06-27 抗-cd19抗体制剂
CN201780039737.6A Active CN109415440B (zh) 2016-06-27 2017-06-27 抗-cd19抗体制剂

Family Applications After (1)

Application Number Title Priority Date Filing Date
CN201780039737.6A Active CN109415440B (zh) 2016-06-27 2017-06-27 抗-cd19抗体制剂

Country Status (26)

Country Link
US (2) US11352423B2 (enExample)
EP (2) EP3909985A1 (enExample)
JP (3) JP2019524671A (enExample)
KR (2) KR102533875B1 (enExample)
CN (2) CN115998859A (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)
LT (1) LT3475303T (enExample)
MA (1) MA45450B1 (enExample)
MD (1) MD3475303T2 (enExample)
MX (1) MX2018016362A (enExample)
PL (1) PL3475303T3 (enExample)
PT (1) PT3475303T (enExample)
RS (1) RS62035B1 (enExample)
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
AU2016311136B2 (en) 2015-08-21 2022-02-17 Incyte Corporation Combinations and uses thereof
LT3532098T (lt) 2016-10-28 2021-06-25 Morphosys Ag Anti cd19 antikūno derinys su bcl-2 inhibitoriumi, ir jo naudojimas
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
AU2020372646A1 (en) 2019-10-31 2022-05-12 Incyte Corporation Anti-tumor combination therapy comprising anti-CD19 antibody and gamma delta T-cells
JP2023530499A (ja) 2020-06-22 2023-07-18 モルフォシス・アーゲー 抗ＣＤ１９抗体及びＳＩＲＰα－ＣＤ４７自然免疫チェックポイントを遮断するポリペプチドを含む抗腫瘍組み合わせ療法
AU2021357841A1 (en) 2020-10-08 2023-06-15 Affimed Gmbh Trispecific binders
AU2022320948A1 (en) 2021-07-30 2024-01-18 Affimed Gmbh Duplexbodies
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
EP4572756A1 (en) 2022-08-17 2025-06-25 Incyte Corporation Therapy comprising anti-cd19 antibody 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

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102245639A (zh) * 2008-12-10 2011-11-16 诺瓦提斯公司 抗体制剂
CN104302320A (zh) * 2012-05-04 2015-01-21 诺华股份有限公司 冻干以及水性抗cd40抗体制剂
WO2015157286A1 (en) * 2014-04-07 2015-10-15 Seattle Genetics, Inc. Stable formulations for anti-cd19 antibodies and antibody-drug conjugates

Family Cites Families (23)

* Cited by examiner, † Cited by third party
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
ATE395413T1 (de) 2001-12-03 2008-05-15 Amgen Fremont Inc Antikörperkategorisierung auf der grundlage von bindungseigenschaften
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
JP4733635B2 (ja) 2003-07-31 2011-07-27 イミューノメディクス、インコーポレイテッド 抗ｃｄ１９抗体
WO2007002223A2 (en) 2005-06-20 2007-01-04 Medarex, Inc. Cd19 antibodies and their uses
PT1966245E (pt) 2005-12-30 2011-08-31 Merck Patent Gmbh Anticorpos anti-cd19 com imunogenicidade reduzida
RS53263B (sr) * 2006-08-14 2014-08-29 Xencor Inc. Optimizovana antitela usmerena 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
LT2176298T (lt) 2007-05-30 2018-04-10 Xencor, Inc. Būdai ir kompozicijos, skirti cd32b ekspresuojančių ląstelių slopinimui
CN106519025B (zh) 2007-09-26 2021-04-23 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
SI2211904T1 (sl) 2007-10-19 2016-12-30 Seattle Genetics, Inc. CD19 vezavna sredstva in njihove uporabe
WO2010095031A2 (en) 2009-02-23 2010-08-26 Glenmark Pharmaceuticals S.A. Humanized antibodies that bind to cd19 and their uses
JP2012519712A (ja) * 2009-03-06 2012-08-30 メディミューン，エルエルシー ヒト化抗ｃｄ１９抗体製剤
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
WO2014160490A1 (en) 2013-03-13 2014-10-02 Genetech, Inc. Antibody formulations
RU2707092C2 (ru) 2013-03-13 2019-11-22 Дженентек, Инк. Составы со сниженным окислением
US10513555B2 (en) * 2013-07-04 2019-12-24 Prothena Biosciences Limited Antibody formulations and methods
LT3049441T (lt) 2013-09-27 2020-02-10 F. Hoffmann-La Roche Ag Anti-pdl1 antikūnų kompozicija
JP6590803B2 (ja) * 2013-11-21 2019-10-16 ゲンマブ エー／エス 抗体−薬物コンジュゲート凍結乾燥製剤

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102245639A (zh) * 2008-12-10 2011-11-16 诺瓦提斯公司 抗体制剂
CN104302320A (zh) * 2012-05-04 2015-01-21 诺华股份有限公司 冻干以及水性抗cd40抗体制剂
WO2015157286A1 (en) * 2014-04-07 2015-10-15 Seattle Genetics, Inc. Stable formulations for anti-cd19 antibodies and antibody-drug conjugates

Also Published As

Publication number Publication date
ZA201900483B (en) 2021-06-30
AU2017289085B2 (en) 2024-07-18
WO2018002031A1 (en) 2018-01-04
IL263764B1 (en) 2024-05-01
ES2874640T3 (es) 2021-11-05
NZ748681A (en) 2025-06-27
KR20190021373A (ko) 2019-03-05
KR20230074823A (ko) 2023-05-31
IL263764B2 (en) 2024-09-01
EP3475303B1 (en) 2021-04-14
HUE054296T2 (hu) 2021-08-30
EP3909985A1 (en) 2021-11-17
HRP20210945T1 (hr) 2021-09-17
PT3475303T (pt) 2021-06-25
RU2019100221A3 (enExample) 2020-11-30
AU2024205042A1 (en) 2024-08-15
MD3475303T2 (ro) 2021-09-30
MX2018016362A (es) 2019-04-22
AU2017289085A1 (en) 2018-12-13
SMT202100317T1 (it) 2021-07-12
US11352423B2 (en) 2022-06-07
CA3029137A1 (en) 2018-01-04
CN109415440A (zh) 2019-03-01
LT3475303T (lt) 2021-06-25
SG11201810429UA (en) 2018-12-28
IL263764A (en) 2019-01-31
SG10201912369QA (en) 2020-02-27
RS62035B1 (sr) 2021-07-30
SI3475303T1 (sl) 2021-12-31
RU2019100221A (ru) 2020-07-28
US20220213190A1 (en) 2022-07-07
KR102533875B1 (ko) 2023-05-18
CN109415440B (zh) 2022-12-06
CY1124521T1 (el) 2022-07-22
EP3475303A1 (en) 2019-05-01
PL3475303T3 (pl) 2021-12-06
MA45450B1 (fr) 2021-04-30
US20190322742A1 (en) 2019-10-24
JP2019524671A (ja) 2019-09-05
JP7603201B2 (ja) 2024-12-20
DK3475303T3 (da) 2021-05-31
JP2022119854A (ja) 2022-08-17
RU2748024C2 (ru) 2021-05-19
JP2024109816A (ja) 2024-08-14

Similar Documents

Publication Publication Date Title
JP7603201B2 (ja) 抗ｃｄ１９抗体製剤
CN118924895A (zh) 用于癌症治疗的结合her2、nkg2d和cd16的多特异性结合蛋白的药物制剂和剂量方案
CN110960490A (zh) 一种抗egfr抗体偶联药物组合物及其用途
CN110732023A (zh) 一种her2抗体药物组合物及其用途
WO2018223958A1 (zh) 一种含c-Met抗体药物偶联物的药物组合物及其用途
RU2848327C1 (ru) Составы на основе антитела к CD19
HK40064043A (en) Anti-cd19 antibody formulations
US20230090868A1 (en) Anti-cd30 antibody-drug conjugates and their use for the treatment of non-hodgkin lymphoma
HK40004117A (en) Anti-cd19 antibody formulations
HK40004117B (zh) 抗-cd19抗体制剂
HK40004579A (en) Anti-cd19 antibody formulations
HK40004579B (en) Anti-cd19 antibody formulations
NZ789731A (en) Anti-CD19 antibody formulations
CA3250813A1 (en) PHARMACEUTICAL FORMULATIONS OF AN ANTI-ILT4 ANTIBODY OR AN ANTIGEN-BINDING FRAGMENT OF IT AND METHODS OF USE
WO2025162364A1 (zh) 抗CD79b抗体药物偶联物联合免疫治疗剂、化疗剂治疗肿瘤
WO2025108438A1 (zh) 抗her3抗体药物偶联物和抗vegf抗体治疗肿瘤的方法
JP2020055830A (ja) 慢性リンパ球性白血病（ｃｌｌ）の処置

Legal Events

Date Code Title Description
PB01 Publication
PB01 Publication
SE01 Entry into force of request for substantive examination
SE01 Entry into force of request for substantive examination
TA01 Transfer of patent application right
TA01 Transfer of patent application right

Effective date of registration: 20250305

Address after: Delaware, USA

Applicant after: INCYTE Corp.

Country or region after: U.S.A.

Address before: Praneger, Germany

Applicant before: MORPHOSYS AG

Country or region before: Germany