TW202135860A - 含有抗cd20x抗cd3雙特異性抗體之穩定調配物 - Google Patents

含有抗cd20x抗cd3雙特異性抗體之穩定調配物 Download PDF

Info

Publication number
TW202135860A
TW202135860A TW109143208A TW109143208A TW202135860A TW 202135860 A TW202135860 A TW 202135860A TW 109143208 A TW109143208 A TW 109143208A TW 109143208 A TW109143208 A TW 109143208A TW 202135860 A TW202135860 A TW 202135860A
Authority
TW
Taiwan
Prior art keywords
pharmaceutical formulation
antibody
seq
amino acid
acid sequence
Prior art date
Application number
TW109143208A
Other languages
English (en)
Chinese (zh)
Inventor
遠 程
曉林 湯
Original Assignee
美商再生元醫藥公司
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=74141846&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=TW202135860(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by 美商再生元醫藥公司 filed Critical 美商再生元醫藥公司
Publication of TW202135860A publication Critical patent/TW202135860A/zh

Links

Classifications

    • 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
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • 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
    • C07K16/2809—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 against the T-cell receptor (TcR)-CD3 complex
    • 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
    • C07K16/2887—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against CD20
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/46—Hybrid immunoglobulins
    • C07K16/468—Immunoglobulins having two or more different antigen binding sites, e.g. multifunctional antibodies
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/10—Immunoglobulins specific features characterized by their source of isolation or production
    • C07K2317/14—Specific host cells or culture conditions, e.g. components, pH or temperature
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/31—Immunoglobulins specific features characterized by aspects of specificity or valency multispecific
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant or Fc region; Isotype
    • C07K2317/526—CH3 domain
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565—Complementarity determining region [CDR]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/72—Increased effector function due to an Fc-modification
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
TW109143208A 2019-12-10 2020-12-08 含有抗cd20x抗cd3雙特異性抗體之穩定調配物 TW202135860A (zh)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201962946207P 2019-12-10 2019-12-10
US62/946,207 2019-12-10

Publications (1)

Publication Number Publication Date
TW202135860A true TW202135860A (zh) 2021-10-01

Family

ID=74141846

Family Applications (1)

Application Number Title Priority Date Filing Date
TW109143208A TW202135860A (zh) 2019-12-10 2020-12-08 含有抗cd20x抗cd3雙特異性抗體之穩定調配物

Country Status (15)

Country Link
US (2) US20210206870A1 (cg-RX-API-DMAC10.html)
EP (1) EP4072585A1 (cg-RX-API-DMAC10.html)
JP (2) JP7813703B2 (cg-RX-API-DMAC10.html)
KR (1) KR20220113417A (cg-RX-API-DMAC10.html)
CN (1) CN115003331A (cg-RX-API-DMAC10.html)
AU (1) AU2020402030A1 (cg-RX-API-DMAC10.html)
BR (1) BR112022011150A2 (cg-RX-API-DMAC10.html)
CA (1) CA3161059A1 (cg-RX-API-DMAC10.html)
CL (3) CL2022001495A1 (cg-RX-API-DMAC10.html)
CO (1) CO2022008684A2 (cg-RX-API-DMAC10.html)
IL (1) IL293372A (cg-RX-API-DMAC10.html)
MY (1) MY210570A (cg-RX-API-DMAC10.html)
PH (1) PH12022551275A1 (cg-RX-API-DMAC10.html)
TW (1) TW202135860A (cg-RX-API-DMAC10.html)
WO (1) WO2021119135A1 (cg-RX-API-DMAC10.html)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TW202400228A (zh) 2022-02-25 2024-01-01 美商再生元醫藥公司 減輕細胞激素釋放症候群的給藥方案

Family Cites Families (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0747045B2 (ja) 1986-10-15 1995-05-24 株式会社大協精工 積層した注射器用滑栓
JP3100727B2 (ja) 1992-01-23 2000-10-23 株式会社大協精工 変性ポリシロキサン組成物及び該組成物を被覆した衛生ゴム製品
JP3172057B2 (ja) 1995-04-05 2001-06-04 株式会社大協精工 ラミネートゴム栓
JP3512349B2 (ja) 1999-01-29 2004-03-29 株式会社大協精工 柱状ゴム要素の成形型
US6629949B1 (en) 2000-05-08 2003-10-07 Sterling Medivations, Inc. Micro infusion drug delivery device
US6659982B2 (en) 2000-05-08 2003-12-09 Sterling Medivations, Inc. Micro infusion drug delivery device
JP2002209975A (ja) 2001-01-19 2002-07-30 Daikyo Seiko Ltd 医薬バイアル用ラミネートゴム栓
ES2537738T3 (es) * 2003-06-05 2015-06-11 Genentech, Inc. Terapia de combinación para trastornos de células B
EP2225275A4 (en) * 2007-11-28 2013-04-03 Medimmune Llc PROTEIN FORMULATION
JP2012041317A (ja) * 2010-08-23 2012-03-01 Panasonic Corp フェロセン修飾抗体
WO2012135408A1 (en) * 2011-03-31 2012-10-04 Merck Sharp & Dohme Corp. Stable formulations of antibodies to human programmed death receptor pd-1 and related treatments
JOP20200236A1 (ar) 2012-09-21 2017-06-16 Regeneron Pharma الأجسام المضادة لمضاد cd3 وجزيئات ربط الأنتيجين ثنائية التحديد التي تربط cd3 وcd20 واستخداماتها
HUE050159T2 (hu) * 2013-12-17 2020-11-30 Genentech Inc Anti-CD3 antitestek és alkalmazási eljárások
ES2809455T3 (es) * 2014-11-17 2021-03-04 Regeneron Pharma Métodos para tratamiento tumoral usando anticuerpo biespecífico CD3xCD20
CN108602889A (zh) * 2015-12-22 2018-09-28 瑞泽恩制药公司 医治急性成淋巴细胞性白血病的双特异性抗cd20/抗cd3抗体
TWI865430B (zh) * 2017-07-24 2024-12-11 美商再生元醫藥公司 穩定化之抗體組合物及其製法
MA49960A (fr) * 2017-08-25 2021-06-02 Omeros Corp Formulations d'anticorps inhibiteurs de masp-2 hautement concentrées à faible viscosité, kits et méthodes de traitement de sujets souffrant d'un syndrome hémolytique atypique
CA3202891A1 (en) * 2021-01-28 2022-08-04 Kara Olson Compositions and methods for treating cytokine release syndrome

Also Published As

Publication number Publication date
CA3161059A1 (en) 2021-06-17
MY210570A (en) 2025-09-30
WO2021119135A1 (en) 2021-06-17
US20210206870A1 (en) 2021-07-08
CN115003331A (zh) 2022-09-02
EP4072585A1 (en) 2022-10-19
JP2026016480A (ja) 2026-02-03
IL293372A (en) 2022-07-01
JP7813703B2 (ja) 2026-02-13
US20250236677A1 (en) 2025-07-24
KR20220113417A (ko) 2022-08-12
BR112022011150A2 (pt) 2022-08-23
PH12022551275A1 (en) 2024-01-08
JP2023507561A (ja) 2023-02-24
AU2020402030A1 (en) 2022-07-28
CL2022001495A1 (es) 2023-01-13
CL2024001536A1 (es) 2024-10-18
CL2024003444A1 (es) 2025-04-11
CO2022008684A2 (es) 2022-06-30

Similar Documents

Publication Publication Date Title
JP6053886B2 (ja) 抗インターロイキン6受容体(il−6r)抗体を含有する安定化製剤
TWI861073B (zh) 含有抗il-33抗體之穩定調配物
AU2018247501A1 (en) Stable antibody formulation
JP2026016480A (ja) 抗cd20×抗cd3二重特異性抗体を含有する安定化製剤
US20220332849A1 (en) Stabilized Formulations Containing Anti-MUC16 x Anti-CD3 Bispecific Antibodies
WO2022010988A1 (en) Stabilized formulations containing anti-ctla-4 antibodies
EA048191B1 (ru) СТАБИЛИЗИРОВАННЫЕ СОСТАВЫ, СОДЕРЖАЩИЕ БИСПЕЦИФИЧНЫЕ АНТИТЕЛА ПРОТИВ CD20 х CD3
TW202517293A (zh) 含有抗bcmax抗cd3雙特異性抗體之穩定化配製物
CN117320700A (zh) 含有抗muc16 x抗cd3双特异性抗体的稳定制剂
EA051038B1 (ru) Стабилизированные составы, содержащие биспецифические антитела к muc16 и к cd3
EA045976B1 (ru) Стабилизированные составы, содержащие антитела к il-33