BR112019018996A2 - formulações compreendendo proteínas de ligação de pd-1 e métodos para produzir as mesmas - Google Patents

formulações compreendendo proteínas de ligação de pd-1 e métodos para produzir as mesmas Download PDF

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Publication number
BR112019018996A2
BR112019018996A2 BR112019018996A BR112019018996A BR112019018996A2 BR 112019018996 A2 BR112019018996 A2 BR 112019018996A2 BR 112019018996 A BR112019018996 A BR 112019018996A BR 112019018996 A BR112019018996 A BR 112019018996A BR 112019018996 A2 BR112019018996 A2 BR 112019018996A2
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BR
Brazil
Prior art keywords
antibody
pharmaceutical formulation
seq
antigen
amino acid
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BR112019018996A
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English (en)
Portuguese (pt)
Inventor
Banks Douglas
R Foss Willard
Dai Xiao-Ping
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Celgene Corp
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Application filed by Celgene Corp filed Critical Celgene Corp
Publication of BR112019018996A2 publication Critical patent/BR112019018996A2/pt

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    • 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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/06Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies from serum
    • C07K16/065Purification, fragmentation
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803Immunoglobulins [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
    • C07K16/2809Immunoglobulins [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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803Immunoglobulins [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
    • C07K16/2818Immunoglobulins [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 CD28 or CD152
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/57Medicinal preparations containing antigens or antibodies characterised by the type of response, e.g. Th1, Th2
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/30Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/33Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/30Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/34Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/515Complete light chain, i.e. VL + CL
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52Constant or Fc region; Isotype
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565Complementarity determining region [CDR]
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/567Framework region [FR]
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/71Decreased effector function due to an Fc-modification
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/73Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
    • C07K2317/732Antibody-dependent cellular cytotoxicity [ADCC]
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/92Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94Stability, e.g. half-life, pH, temperature or enzyme-resistance

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Organic Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Mycology (AREA)
  • Veterinary Medicine (AREA)
  • Microbiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Endocrinology (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
BR112019018996A 2017-03-29 2018-03-28 formulações compreendendo proteínas de ligação de pd-1 e métodos para produzir as mesmas BR112019018996A2 (pt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201762478524P 2017-03-29 2017-03-29
PCT/US2018/024787 WO2018183459A1 (en) 2017-03-29 2018-03-28 Formulations comprising pd-1 binding proteins and methods of making thereof

Publications (1)

Publication Number Publication Date
BR112019018996A2 true BR112019018996A2 (pt) 2020-04-14

Family

ID=63678296

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112019018996A BR112019018996A2 (pt) 2017-03-29 2018-03-28 formulações compreendendo proteínas de ligação de pd-1 e métodos para produzir as mesmas

Country Status (16)

Country Link
US (1) US20180289802A1 (enExample)
EP (1) EP3601338A4 (enExample)
JP (1) JP2020512359A (enExample)
KR (1) KR20190141658A (enExample)
CN (1) CN110678482A (enExample)
AU (1) AU2018246252A1 (enExample)
BR (1) BR112019018996A2 (enExample)
CA (1) CA3055984A1 (enExample)
CL (1) CL2019002605A1 (enExample)
CO (1) CO2019010230A2 (enExample)
EA (1) EA201991912A1 (enExample)
EC (1) ECSP19076344A (enExample)
IL (1) IL268884A (enExample)
MX (1) MX2019010999A (enExample)
SG (1) SG11201907948TA (enExample)
WO (1) WO2018183459A1 (enExample)

Families Citing this family (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
BR112018000768A2 (pt) 2015-07-13 2018-09-25 Cytomx Therapeutics Inc anticorpos anti-pd-1, anticorpos anti-pd-1 ativáveis e métodos de uso dos mesmos
KR20180054824A (ko) 2015-09-29 2018-05-24 셀진 코포레이션 Pd-1 결합 단백질 및 이의 사용 방법
BR112019004733A2 (pt) 2016-09-19 2019-05-28 Celgene Corp métodos de tratamento de distúrbios imunes usando proteínas de ligação a pd-1
US10766958B2 (en) 2016-09-19 2020-09-08 Celgene Corporation Methods of treating vitiligo using PD-1 binding antibodies
TWI849895B (zh) 2018-02-09 2024-07-21 日商小野藥品工業股份有限公司 雙特異性抗體
TWI871300B (zh) * 2019-01-28 2025-02-01 美商安進公司 藉由將藥物物質和藥物產品過程整體化的生物製劑製造之連續製造過程
CN120241997A (zh) 2019-02-18 2025-07-04 伊莱利利公司 治疗性抗体制剂
JP7686180B2 (ja) * 2020-04-17 2025-06-02 小野薬品工業株式会社 タンパク質製剤原薬の着色除去方法
CR20220596A (es) 2020-05-26 2023-01-23 Boehringer Ingelheim Int Anticuerpos anti-pd-1
BR112023001471A2 (pt) * 2020-07-31 2023-03-14 Jiangsu Hengrui Pharmaceuticals Co Ltd Composição farmacêutica de anticorpo anti-pd-1 e uso da mesma
EP4008345A1 (en) * 2020-12-03 2022-06-08 Hexal AG Novel formulations for antibodies
CN116019907A (zh) * 2021-07-29 2023-04-28 上海君实生物医药科技股份有限公司 抗pd-1抗体药物组合物及其用途
CN117088981B (zh) * 2023-08-15 2024-09-10 福建医科大学附属协和医院 抗b7-h3的单链抗体

Family Cites Families (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1445264B1 (en) * 2001-07-31 2011-09-14 Ono Pharmaceutical Co., Ltd. Substance specific to pd-1
EP2418278A3 (en) * 2005-05-09 2012-07-04 Ono Pharmaceutical Co., Ltd. Human monoclonal antibodies to programmed death 1(PD-1) and methods for treating cancer using anti-PD-1 antibodies alone or in combination with other immunotherapeutics
WO2008047914A1 (fr) * 2006-10-20 2008-04-24 Forerunner Pharma Research Co., Ltd. Agent anticancéreux comprenant un anticorps anti-hb-egf en tant qu'ingrédient actif
EP2535354B1 (en) * 2007-06-18 2017-01-11 Merck Sharp & Dohme B.V. Antibodies to human programmed death receptor pd-1
WO2009120922A2 (en) * 2008-03-27 2009-10-01 Zymogenetics, Inc. Compositions and methods for inhibiting pdgfrbeta and vegf-a
EA024877B1 (ru) * 2008-10-02 2016-10-31 Эмерджент Продакт Дивелопмент Сиэтл, Ллс Связывающие множество мишеней белки, обладающие антагонистическими свойствами по отношению к cd86
TW201134488A (en) * 2010-03-11 2011-10-16 Ucb Pharma Sa PD-1 antibodies
LT3049441T (lt) * 2013-09-27 2020-02-10 F. Hoffmann-La Roche Ag Anti-pdl1 antikūnų kompozicija
RU2732604C2 (ru) * 2013-12-20 2020-09-21 Интервет Интернэшнл Б.В. Антитела к pd-1 собак
KR20150132581A (ko) * 2013-12-31 2015-11-25 재단법인 생물기술개발중심 항-vegf 항체 및 그것의 용도
TWI681969B (zh) * 2014-01-23 2020-01-11 美商再生元醫藥公司 針對pd-1的人類抗體
TWI595006B (zh) * 2014-12-09 2017-08-11 禮納特神經系統科學公司 抗pd-1抗體類和使用彼等之方法
KR20250004095A (ko) * 2015-04-17 2025-01-07 브리스톨-마이어스 스큅 컴퍼니 항-pd-1 항체 및 또 다른 항체의 조합물을 포함하는 조성물
KR20180054824A (ko) * 2015-09-29 2018-05-24 셀진 코포레이션 Pd-1 결합 단백질 및 이의 사용 방법
BR112019004733A2 (pt) * 2016-09-19 2019-05-28 Celgene Corp métodos de tratamento de distúrbios imunes usando proteínas de ligação a pd-1
US10766958B2 (en) * 2016-09-19 2020-09-08 Celgene Corporation Methods of treating vitiligo using PD-1 binding antibodies

Also Published As

Publication number Publication date
WO2018183459A1 (en) 2018-10-04
CN110678482A (zh) 2020-01-10
EP3601338A4 (en) 2020-12-16
CA3055984A1 (en) 2018-10-04
ECSP19076344A (es) 2019-10-31
CL2019002605A1 (es) 2020-05-29
AU2018246252A1 (en) 2019-09-19
JP2020512359A (ja) 2020-04-23
EP3601338A1 (en) 2020-02-05
IL268884A (en) 2019-10-31
SG11201907948TA (en) 2019-09-27
US20180289802A1 (en) 2018-10-11
MX2019010999A (es) 2020-02-05
KR20190141658A (ko) 2019-12-24
CO2019010230A2 (es) 2020-01-17
EA201991912A1 (ru) 2020-03-10

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B350 Update of information on the portal [chapter 15.35 patent gazette]
B06W Patent application suspended after preliminary examination (for patents with searches from other patent authorities) chapter 6.23 patent gazette]
B11B Dismissal acc. art. 36, par 1 of ipl - no reply within 90 days to fullfil the necessary requirements