BR112022011150A2 - Formulações estabilizadas contendo anticorpos biespecíficos anti-cd20 x anti-cd3 - Google Patents

Formulações estabilizadas contendo anticorpos biespecíficos anti-cd20 x anti-cd3

Info

Publication number
BR112022011150A2
BR112022011150A2 BR112022011150A BR112022011150A BR112022011150A2 BR 112022011150 A2 BR112022011150 A2 BR 112022011150A2 BR 112022011150 A BR112022011150 A BR 112022011150A BR 112022011150 A BR112022011150 A BR 112022011150A BR 112022011150 A2 BR112022011150 A2 BR 112022011150A2
Authority
BR
Brazil
Prior art keywords
antibodies
formulations containing
human
stabilized formulations
containing bispecific
Prior art date
Application number
BR112022011150A
Other languages
English (en)
Inventor
Cheng Yuan
Tang Xiaolin
Original Assignee
Regeneron Pharma
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 Pharma filed Critical Regeneron Pharma
Publication of BR112022011150A2 publication Critical patent/BR112022011150A2/pt

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 [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
    • C07K16/2809—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 against the T-cell receptor (TcR)-CD3 complex
    • 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
    • C07K16/2887—Immunoglobulins [IGs], 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 [IGs], 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)
  • Life Sciences & Earth Sciences (AREA)
  • Organic Chemistry (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)

Abstract

A presente invenção refere-se a formulações farmacêuticas líquidas estáveis compreendendo um anticorpo biespecífico humano que se liga especificamente a CD20 humano e CD3 humano. Em certas modalidades, as formulações contêm, além do anticorpo biespecífico, um tampão, um tensoativo e um açúcar. As formulações farmacêuticas da presente invenção exibem um grau substancial de estabilidade do anticorpo sob estresse e armazenamento.
BR112022011150A 2019-12-10 2020-12-09 Formulações estabilizadas contendo anticorpos biespecíficos anti-cd20 x anti-cd3 BR112022011150A2 (pt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201962946207P 2019-12-10 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
BR112022011150A2 true BR112022011150A2 (pt) 2022-08-23

Family

ID=74141846

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112022011150A BR112022011150A2 (pt) 2019-12-10 2020-12-09 Formulações estabilizadas contendo anticorpos biespecíficos anti-cd20 x anti-cd3

Country Status (13)

Country Link
US (1) US20210206870A1 (pt)
EP (1) EP4072585A1 (pt)
JP (1) JP2023507561A (pt)
KR (1) KR20220113417A (pt)
CN (1) CN115003331A (pt)
AU (1) AU2020402030A1 (pt)
BR (1) BR112022011150A2 (pt)
CA (1) CA3161059A1 (pt)
CL (1) CL2022001495A1 (pt)
CO (1) CO2022008684A2 (pt)
IL (1) IL293372A (pt)
TW (1) TW202135860A (pt)
WO (1) WO2021119135A1 (pt)

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 (15)

* 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
KR20060027801A (ko) * 2003-06-05 2006-03-28 제넨테크, 인크. Ｂ 세포 장애에 대한 조합 요법
US9308257B2 (en) * 2007-11-28 2016-04-12 Medimmune, Llc Protein formulation
MX341076B (es) * 2011-03-31 2016-08-04 Merck Sharp & Dohme Formulaciones estables de anticuerpos para el receptor humano pd-1 de meurte programada y tratamientos 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
UA120753C2 (uk) * 2013-12-17 2020-02-10 Дженентек, Інк. Біспецифічне антитіло до сd3 та cd20
PL3221359T3 (pl) * 2014-11-17 2020-11-16 Regeneron Pharmaceuticals, Inc. Sposoby leczenia nowotworów przy użyciu dwuswoistego przeciwciała CD3XCD20
BR112018012929A2 (pt) * 2015-12-22 2018-12-11 Regeneron Pharma anticorpos anti-cd20/anti-cd3 biespecíficos para tratar leucemia linfoblástica aguda
CN116963774A (zh) * 2021-01-28 2023-10-27 瑞泽恩制药公司 用于治疗细胞因子释放综合征的组合物和方法

Also Published As

Publication number Publication date
JP2023507561A (ja) 2023-02-24
CO2022008684A2 (es) 2022-06-30
IL293372A (en) 2022-07-01
WO2021119135A1 (en) 2021-06-17
CN115003331A (zh) 2022-09-02
EP4072585A1 (en) 2022-10-19
KR20220113417A (ko) 2022-08-12
AU2020402030A1 (en) 2022-07-28
CA3161059A1 (en) 2021-06-17
US20210206870A1 (en) 2021-07-08
TW202135860A (zh) 2021-10-01
CL2022001495A1 (es) 2023-01-13

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