KR20190141658A - Pd-1 결합 단백질을 포함하는 제제 및 이의 제조 방법 - Google Patents

Pd-1 결합 단백질을 포함하는 제제 및 이의 제조 방법 Download PDF

Info

Publication number
KR20190141658A
KR20190141658A KR1020197028673A KR20197028673A KR20190141658A KR 20190141658 A KR20190141658 A KR 20190141658A KR 1020197028673 A KR1020197028673 A KR 1020197028673A KR 20197028673 A KR20197028673 A KR 20197028673A KR 20190141658 A KR20190141658 A KR 20190141658A
Authority
KR
South Korea
Prior art keywords
antibody
seq
amino acid
pharmaceutical formulation
antigen
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.)
Ceased
Application number
KR1020197028673A
Other languages
English (en)
Korean (ko)
Inventor
샤오-핑 다이
더글라스 뱅크스
윌라드 알. 포스
Original Assignee
셀진 코포레이션
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=63678296&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=KR20190141658(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by 셀진 코포레이션 filed Critical 셀진 코포레이션
Publication of KR20190141658A publication Critical patent/KR20190141658A/ko
Ceased legal-status Critical Current

Links

Images

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
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/06—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies from serum
    • C07K16/065—Purification, fragmentation
    • 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
    • C07K16/2803—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
    • C07K16/2818—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 CD28 or CD152
    • 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
    • A61K2039/57—Medicinal preparations containing antigens or antibodies characterised by the type of response, e.g. Th1, Th2
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • 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
    • C07K2317/33—Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
    • 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
    • C07K2317/34—Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/515—Complete light chain, i.e. VL + CL
    • 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
    • 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
    • C07K2317/50—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
    • C07K2317/567—Framework region [FR]
    • 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
    • C07K2317/71—Decreased effector function due to an Fc-modification
    • 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
    • C07K2317/73—Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
    • C07K2317/732—Antibody-dependent cellular cytotoxicity [ADCC]
    • 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
    • C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
    • 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)
  • 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)
KR1020197028673A 2017-03-29 2018-03-28 Pd-1 결합 단백질을 포함하는 제제 및 이의 제조 방법 Ceased KR20190141658A (ko)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201762478524P 2017-03-29 2017-03-29
US62/478,524 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
KR20190141658A true KR20190141658A (ko) 2019-12-24

Family

ID=63678296

Family Applications (1)

Application Number Title Priority Date Filing Date
KR1020197028673A Ceased KR20190141658A (ko) 2017-03-29 2018-03-28 Pd-1 결합 단백질을 포함하는 제제 및 이의 제조 방법

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
BR112019018996A2 (pt) 2020-04-14
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
JP2020512359A (ja) 2020-04-23

Similar Documents

Publication Publication Date Title
US20230272076A1 (en) PD-1 Binding Proteins and Methods of Use Thereof
US12084499B2 (en) SIRP-α binding proteins and methods of use thereof
US10751414B2 (en) Methods of treating psoriasis using PD-1 binding antibodies
US20210163595A1 (en) Methods of treating vitiligo using pd-1 binding antibodies
KR20190141658A (ko) Pd-1 결합 단백질을 포함하는 제제 및 이의 제조 방법
US11591390B2 (en) SIRP-α binding proteins and methods of use thereof

Legal Events

Date Code Title Description
PA0105 International application

Patent event date: 20190930

Patent event code: PA01051R01D

Comment text: International Patent Application

PG1501 Laying open of application
A201 Request for examination
PA0201 Request for examination

Patent event code: PA02012R01D

Patent event date: 20210323

Comment text: Request for Examination of Application

E902 Notification of reason for refusal
PE0902 Notice of grounds for rejection

Comment text: Notification of reason for refusal

Patent event date: 20230825

Patent event code: PE09021S01D

E601 Decision to refuse application
PE0601 Decision on rejection of patent

Patent event date: 20231124

Comment text: Decision to Refuse Application

Patent event code: PE06012S01D

Patent event date: 20230825

Comment text: Notification of reason for refusal

Patent event code: PE06011S01I