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 [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/06Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies from serum
    • C07K16/065Purification, fragmentation
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803Immunoglobulins [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
    • C07K16/2809Immunoglobulins [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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803Immunoglobulins [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
    • C07K16/2818Immunoglobulins [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 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)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Organic Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (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 (https=)
EP (1) EP3601338A4 (https=)
JP (1) JP2020512359A (https=)
KR (1) KR20190141658A (https=)
CN (1) CN110678482A (https=)
AU (1) AU2018246252A1 (https=)
BR (1) BR112019018996A2 (https=)
CA (1) CA3055984A1 (https=)
CL (1) CL2019002605A1 (https=)
CO (1) CO2019010230A2 (https=)
EA (1) EA201991912A1 (https=)
EC (1) ECSP19076344A (https=)
IL (1) IL268884A (https=)
MX (1) MX2019010999A (https=)
SG (1) SG11201907948TA (https=)
WO (1) WO2018183459A1 (https=)

Families Citing this family (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114591433A (zh) 2015-07-13 2022-06-07 西托姆克斯治疗公司 抗pd-1抗体、可活化抗pd-1抗体及其使用方法
EA201890790A1 (ru) 2015-09-29 2018-10-31 Селджин Корпорейшн Связывающие pd-1 белки и способы их применения
EP3515943A4 (en) 2016-09-19 2020-05-06 Celgene Corporation METHODS OF TREATING VITILIGO WITH PD-1 BINDING PROTEINS
BR112019004733A2 (pt) 2016-09-19 2019-05-28 Celgene Corp métodos de tratamento de distúrbios imunes usando proteínas de ligação a pd-1
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
KR102735988B1 (ko) 2019-02-18 2024-12-03 일라이 릴리 앤드 캄파니 치료 항체 제제
US20230143066A1 (en) * 2020-04-17 2023-05-11 Ono Pharmaceutical Co., Ltd. Method for removing color from drug substance of protein preparation
BR112022023989A2 (pt) 2020-05-26 2023-02-07 Boehringer Ingelheim Int Anticorpos anti-pd-1
CA3189452A1 (en) * 2020-07-31 2022-02-03 Jiangsu Hengrui Pharmaceuticals Co., Ltd. Anti-pd-1 antibody pharmaceutical composition and use thereof
EP4008345A1 (en) * 2020-12-03 2022-06-08 Hexal AG Novel formulations for antibodies
US20240342083A1 (en) * 2021-07-29 2024-10-17 Shanghai Junshi Biosciences Co., Ltd. Anti-pd-1 antibody pharmaceutical composition and use thereof
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
WO2003011911A1 (fr) * 2001-07-31 2003-02-13 Ono Pharmaceutical Co., Ltd. Substance specifique pour pd-1
RU2494107C2 (ru) * 2005-05-09 2013-09-27 Оно Фармасьютикал Ко., Лтд. Моноклональные антитела человека к белку программируемой смерти 1 (pd-1) и способы лечения рака с использованием анти-pd-1-антител самостоятельно или в комбинации с другими иммунотерапевтическими средствами
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
HRP20131167T1 (hr) * 2007-06-18 2014-01-03 Merck Sharp & Dohme B.V. Antitijela za humani receptor programirane smrti pd-1
WO2009120922A2 (en) * 2008-03-27 2009-10-01 Zymogenetics, Inc. Compositions and methods for inhibiting pdgfrbeta and vegf-a
NZ592420A (en) * 2008-10-02 2012-12-21 Emergent Product Dev Seattle Cd86 antagonist multi-target binding proteins
TW201134488A (en) * 2010-03-11 2011-10-16 Ucb Pharma Sa PD-1 antibodies
MX375378B (es) * 2013-09-27 2025-03-06 Genentech Inc Formulaciones de anticuerpos anti-pdl1.
JP6701079B2 (ja) * 2013-12-20 2020-05-27 インターベット インターナショナル ベー. フェー. ヒトpd−1に対するイヌ化マウス抗体
JP2016530244A (ja) * 2013-12-31 2016-09-29 ディベロップメント センター フォー バイオテクノロジーDevelopment Center For Biotechnology 抗vegf抗体及びその使用
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
TN2017000440A1 (en) * 2015-04-17 2019-04-12 Bristol Myers Squibb Co Compositions comprising a combination of an anti-pd-1 antibody and another antibody
EA201890790A1 (ru) * 2015-09-29 2018-10-31 Селджин Корпорейшн Связывающие pd-1 белки и способы их применения
BR112019004733A2 (pt) * 2016-09-19 2019-05-28 Celgene Corp métodos de tratamento de distúrbios imunes usando proteínas de ligação a pd-1
EP3515943A4 (en) * 2016-09-19 2020-05-06 Celgene Corporation METHODS OF TREATING VITILIGO WITH PD-1 BINDING PROTEINS

Also Published As

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

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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