AU2020402030A1 - Stabilized formulations containing anti-CD20 x anti-CD3 bispecific antibodies - Google Patents

Stabilized formulations containing anti-CD20 x anti-CD3 bispecific antibodies Download PDF

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Publication number
AU2020402030A1
AU2020402030A1 AU2020402030A AU2020402030A AU2020402030A1 AU 2020402030 A1 AU2020402030 A1 AU 2020402030A1 AU 2020402030 A AU2020402030 A AU 2020402030A AU 2020402030 A AU2020402030 A AU 2020402030A AU 2020402030 A1 AU2020402030 A1 AU 2020402030A1
Authority
AU
Australia
Prior art keywords
antibody
pharmaceutical formulation
seq
amino acid
acid 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
AU2020402030A
Other languages
English (en)
Inventor
Yuan Cheng
Xiaolin Tang
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.)
Regeneron Pharmaceuticals Inc
Original Assignee
Regeneron Pharmaceuticals Inc
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 Regeneron Pharmaceuticals Inc filed Critical Regeneron Pharmaceuticals Inc
Publication of AU2020402030A1 publication Critical patent/AU2020402030A1/en
Pending legal-status Critical Current

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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)
AU2020402030A 2019-12-10 2020-12-09 Stabilized formulations containing anti-CD20 x anti-CD3 bispecific antibodies Pending AU2020402030A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201962946207P 2019-12-10 2019-12-10
US62/946,207 2019-12-10
PCT/US2020/064025 WO2021119135A1 (en) 2019-12-10 2020-12-09 Stabilized formulations containing anti-cd20 x anti-cd3 bispecific antibodies

Publications (1)

Publication Number Publication Date
AU2020402030A1 true AU2020402030A1 (en) 2022-07-28

Family

ID=74141846

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2020402030A Pending AU2020402030A1 (en) 2019-12-10 2020-12-09 Stabilized formulations containing anti-CD20 x anti-CD3 bispecific antibodies

Country Status (15)

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

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
US6659982B2 (en) 2000-05-08 2003-12-09 Sterling Medivations, Inc. Micro infusion drug delivery device
US6629949B1 (en) 2000-05-08 2003-10-07 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
JP2007526220A (ja) * 2003-06-05 2007-09-13 ジェネンテック・インコーポレーテッド Ｂ細胞疾患の併用療法
WO2009070642A1 (en) * 2007-11-28 2009-06-04 Medimmune, Llc Protein formulation
JP2012041317A (ja) * 2010-08-23 2012-03-01 Panasonic Corp フェロセン修飾抗体
PT2691112T (pt) * 2011-03-31 2018-07-10 Merck Sharp & Dohme Formulações estáveis de anticorpos para o recetor pd-1 humano de morte programada e tratamentos relacionados
JOP20200236A1 (ar) 2012-09-21 2017-06-16 Regeneron Pharma الأجسام المضادة لمضاد cd3 وجزيئات ربط الأنتيجين ثنائية التحديد التي تربط cd3 وcd20 واستخداماتها
IL263466B2 (en) * 2013-12-17 2023-10-01 Genentech Inc Anti-CD3 antibodies and methods of using them
KR102614189B1 (ko) * 2014-11-17 2023-12-18 리제너론 파아마슈티컬스, 인크. Cd3xcd20 이특이적 항체를 이용한 종양의 치료 방법
AU2016378573A1 (en) * 2015-12-22 2018-07-19 Regeneron Pharmaceuticals, Inc. Bispecific anti-CD20/anti-CD3 antibodies to treat acute lymphoblastic leukemia
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
KR20200037863A (ko) * 2017-08-25 2020-04-09 오메로스 코포레이션 고도로 농축된 저점도 masp-2 억제 항체 제제, 키트, 및 비정형 용혈성 증후군을 앓고 있는 대상체의 치료 방법
AU2022214319A1 (en) * 2021-01-28 2023-08-03 Regeneron Pharmaceuticals, Inc. Compositions and methods for treating cytokine release syndrome

Also Published As

Publication number Publication date
PH12022551275A1 (en) 2024-01-08
US20250236677A1 (en) 2025-07-24
KR20220113417A (ko) 2022-08-12
CN115003331A (zh) 2022-09-02
CL2024001536A1 (es) 2024-10-18
CL2024003444A1 (es) 2025-04-11
TW202135860A (zh) 2021-10-01
MY210570A (en) 2025-09-30
US20210206870A1 (en) 2021-07-08
CA3161059A1 (en) 2021-06-17
EP4072585A1 (en) 2022-10-19
JP2023507561A (ja) 2023-02-24
JP2026016480A (ja) 2026-02-03
BR112022011150A2 (pt) 2022-08-23
WO2021119135A1 (en) 2021-06-17
CL2022001495A1 (es) 2023-01-13
IL293372A (en) 2022-07-01
JP7813703B2 (ja) 2026-02-13
CO2022008684A2 (es) 2022-06-30

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