JP7513854B2 - Cldn18.2及びcd3に結合する二重特異性結合剤 - Google Patents

Cldn18.2及びcd3に結合する二重特異性結合剤 Download PDF

Info

Publication number
JP7513854B2
JP7513854B2 JP2023577405A JP2023577405A JP7513854B2 JP 7513854 B2 JP7513854 B2 JP 7513854B2 JP 2023577405 A JP2023577405 A JP 2023577405A JP 2023577405 A JP2023577405 A JP 2023577405A JP 7513854 B2 JP7513854 B2 JP 7513854B2
Authority
JP
Japan
Prior art keywords
amino acid
seq
polypeptide chain
cells
binding
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.)
Active
Application number
JP2023577405A
Other languages
English (en)
Japanese (ja)
Other versions
JPWO2022263508A5 (https=
JP2024520868A5 (https=
JP2024520868A (ja
Inventor
ベネット,マシュー
ニスタル,アレックス
ムーア,グレゴリー
Original Assignee
アステラス・ファーマ・ヨーロッパ・ベスローデン・フェンノートシャップ
ゼンコア インコーポレイテッド
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 アステラス・ファーマ・ヨーロッパ・ベスローデン・フェンノートシャップ, ゼンコア インコーポレイテッド filed Critical アステラス・ファーマ・ヨーロッパ・ベスローデン・フェンノートシャップ
Publication of JP2024520868A publication Critical patent/JP2024520868A/ja
Priority to JP2024093451A priority Critical patent/JP2024116283A/ja
Publication of JPWO2022263508A5 publication Critical patent/JPWO2022263508A5/ja
Publication of JP2024520868A5 publication Critical patent/JP2024520868A5/ja
Application granted granted Critical
Publication of JP7513854B2 publication Critical patent/JP7513854B2/ja
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • 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
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • 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
    • C07K2317/31Immunoglobulins specific features characterized by aspects of specificity or valency multispecific
    • 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
    • C07K2317/35Valency
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/51Complete heavy chain or Fd fragment, i.e. VH + CH1
    • 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
    • C07K2317/522CH1 domain
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52Constant or Fc region; Isotype
    • C07K2317/526CH3 domain
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/55Fab or Fab'
    • 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
    • C07K2317/60Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/60Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments
    • C07K2317/62Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments comprising only variable region components
    • C07K2317/622Single chain antibody (scFv)
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/60Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments
    • C07K2317/64Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments comprising a combination of variable region and constant region components
    • 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
    • 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
    • C07K2319/00Fusion polypeptide

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • General Chemical & Material Sciences (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
JP2023577405A 2021-06-15 2022-06-15 Cldn18.2及びcd3に結合する二重特異性結合剤 Active JP7513854B2 (ja)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2024093451A JP2024116283A (ja) 2021-06-15 2024-06-10 Cldn18.2及びcd3に結合する二重特異性結合剤

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EPPCT/EP2021/066141 2021-06-15
PCT/EP2021/066141 WO2022262959A1 (en) 2021-06-15 2021-06-15 Bispecific binding agents binding to cldn18.2 and cd3
PCT/EP2022/066299 WO2022263508A1 (en) 2021-06-15 2022-06-15 Bispecific binding agents binding to cldn18.2 and cd3

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2024093451A Division JP2024116283A (ja) 2021-06-15 2024-06-10 Cldn18.2及びcd3に結合する二重特異性結合剤

Publications (4)

Publication Number Publication Date
JP2024520868A JP2024520868A (ja) 2024-05-24
JPWO2022263508A5 JPWO2022263508A5 (https=) 2024-06-18
JP2024520868A5 JP2024520868A5 (https=) 2024-06-18
JP7513854B2 true JP7513854B2 (ja) 2024-07-09

Family

ID=77519090

Family Applications (2)

Application Number Title Priority Date Filing Date
JP2023577405A Active JP7513854B2 (ja) 2021-06-15 2022-06-15 Cldn18.2及びcd3に結合する二重特異性結合剤
JP2024093451A Pending JP2024116283A (ja) 2021-06-15 2024-06-10 Cldn18.2及びcd3に結合する二重特異性結合剤

Family Applications After (1)

Application Number Title Priority Date Filing Date
JP2024093451A Pending JP2024116283A (ja) 2021-06-15 2024-06-10 Cldn18.2及びcd3に結合する二重特異性結合剤

Country Status (15)

Country Link
US (3) US11739145B2 (https=)
EP (1) EP4355428A1 (https=)
JP (2) JP7513854B2 (https=)
KR (1) KR20240032847A (https=)
CN (1) CN117858906A (https=)
AR (1) AR126154A1 (https=)
AU (1) AU2022292895A1 (https=)
BR (1) BR112023026566A2 (https=)
CA (1) CA3222300A1 (https=)
CL (1) CL2023003725A1 (https=)
CO (1) CO2023017378A2 (https=)
IL (1) IL308072A (https=)
MX (1) MX2023014666A (https=)
TW (1) TW202317624A (https=)
WO (2) WO2022262959A1 (https=)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018054484A1 (en) * 2016-09-23 2018-03-29 Biontech Ag Bispecific trivalent antibodies binding to claudin 6 or claudin18.2 and cd3 for treatment of claudin expressing cancer diseases
KR20250120305A (ko) * 2022-12-14 2025-08-08 아스텔라스 파마 유럽 비.브이. Cldn18.2 및 cd3에 결합하는 2중 특이성 결합제와 면역 체크포인트 저해제를 수반한 조합 요법
WO2025120867A1 (en) * 2023-12-08 2025-06-12 Astellas Pharma Inc. Combination therapy involving bispecific binding agents binding to cldn18.2 and cd3 and anti-vegfr2 antibodies
AR134560A1 (es) * 2023-12-08 2026-01-28 Astellas Pharma Inc Terapia de combinación que implica agentes de unión biespecíficos que se unen a cldn18.2 y cd3 y agentes que estabilizan o aumentan la expresión de cldn18.2
WO2025120866A1 (en) * 2023-12-08 2025-06-12 Astellas Pharma Inc. Combination therapy involving bispecific binding agents binding to cldn18.2 and cd3 and agents stabilizing or increasing expression of cldn18.2
CN120829517A (zh) * 2024-04-22 2025-10-24 鲁南新时代生物技术有限公司 抗cldn18.2/cd3双特异性抗体及用途

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016086189A2 (en) 2014-11-26 2016-06-02 Xencor, Inc. Heterodimeric antibodies that bind cd3 and tumor antigens
WO2018054484A1 (en) 2016-09-23 2018-03-29 Biontech Ag Bispecific trivalent antibodies binding to claudin 6 or claudin18.2 and cd3 for treatment of claudin expressing cancer diseases
WO2020025792A1 (en) 2018-08-03 2020-02-06 Amgen Research (Munich) Gmbh Antibody constructs for cldn18.2 and cd3
CN111518214A (zh) 2019-02-03 2020-08-11 上海健信生物医药科技有限公司 靶向cldn18.2的双特异性抗体及其制备方法和应用
WO2021237717A1 (zh) 2020-05-29 2021-12-02 武汉友芝友生物制药有限公司 抗cldn18.2和cd3的双特异性抗体

Family Cites Families (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB8601597D0 (en) 1986-01-23 1986-02-26 Wilson R H Nucleotide sequences
GB8717430D0 (en) 1987-07-23 1987-08-26 Celltech Ltd Recombinant dna product
GB8809129D0 (en) 1988-04-18 1988-05-18 Celltech Ltd Recombinant dna methods vectors and host cells
EP1400536A1 (en) 1991-06-14 2004-03-24 Genentech Inc. Method for making humanized antibodies
GB9203459D0 (en) 1992-02-19 1992-04-08 Scotgen Ltd Antibodies with germ-line variable regions
US5731168A (en) 1995-03-01 1998-03-24 Genentech, Inc. Method for making heteromultimeric polypeptides
US7754208B2 (en) 2001-01-17 2010-07-13 Trubion Pharmaceuticals, Inc. Binding domain-immunoglobulin fusion proteins
US20030133939A1 (en) 2001-01-17 2003-07-17 Genecraft, Inc. Binding domain-immunoglobulin fusion proteins
CN101928344B (zh) 2002-10-17 2014-08-13 根马布股份公司 抗cd20的人单克隆抗体
CA2548817A1 (en) 2003-12-04 2005-06-23 Xencor, Inc. Methods of generating variant proteins with increased host string content and compositions thereof
EP1790664A1 (en) 2005-11-24 2007-05-30 Ganymed Pharmaceuticals AG Monoclonal antibodies against claudin-18 for treatment of cancer
US20090004213A1 (en) 2007-03-26 2009-01-01 Immatics Biotechnologies Gmbh Combination therapy using active immunotherapy
CN113967253A (zh) 2012-05-15 2022-01-25 百时美施贵宝公司 通过破坏pd-1/pd-l1信号传输的免疫治疗
CA2898100C (en) 2013-01-14 2023-10-10 Xencor, Inc. Novel heterodimeric proteins

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016086189A2 (en) 2014-11-26 2016-06-02 Xencor, Inc. Heterodimeric antibodies that bind cd3 and tumor antigens
WO2018054484A1 (en) 2016-09-23 2018-03-29 Biontech Ag Bispecific trivalent antibodies binding to claudin 6 or claudin18.2 and cd3 for treatment of claudin expressing cancer diseases
WO2020025792A1 (en) 2018-08-03 2020-02-06 Amgen Research (Munich) Gmbh Antibody constructs for cldn18.2 and cd3
CN111518214A (zh) 2019-02-03 2020-08-11 上海健信生物医药科技有限公司 靶向cldn18.2的双特异性抗体及其制备方法和应用
WO2021237717A1 (zh) 2020-05-29 2021-12-02 武汉友芝友生物制药有限公司 抗cldn18.2和cd3的双特异性抗体

Also Published As

Publication number Publication date
EP4355428A1 (en) 2024-04-24
MX2023014666A (es) 2024-01-12
CL2023003725A1 (es) 2024-05-17
TW202317624A (zh) 2023-05-01
AR126154A1 (es) 2023-09-13
CN117858906A (zh) 2024-04-09
US12378313B2 (en) 2025-08-05
US20230137677A1 (en) 2023-05-04
BR112023026566A2 (pt) 2024-03-05
KR20240032847A (ko) 2024-03-12
CA3222300A1 (en) 2022-12-22
WO2022262959A1 (en) 2022-12-22
AU2022292895A1 (en) 2024-01-04
US11739145B2 (en) 2023-08-29
JP2024116283A (ja) 2024-08-27
CO2023017378A2 (es) 2024-02-05
WO2022263508A1 (en) 2022-12-22
IL308072A (en) 2023-12-01
JP2024520868A (ja) 2024-05-24
US20260035458A1 (en) 2026-02-05
US20240018234A1 (en) 2024-01-18

Similar Documents

Publication Publication Date Title
JP7791916B2 (ja) クローディン発現がん疾患の処置のためのクローディン6又はクローディン18.2とcd3とに結合する二重特異的三価抗体
US20240228616A1 (en) Agents for Treatment of Claudin Expressing Cancer Diseases
JP7513854B2 (ja) Cldn18.2及びcd3に結合する二重特異性結合剤
EP3766903A2 (en) Bispecific anti claudin xcd3 antibodies for treatment of claudin expressing cancer diseases
TW202436336A (zh) 涉及結合至cldn18.2和cd3及免疫檢查點抑制劑的雙特異性結合劑之組合療法
EA051393B1 (ru) Биспецифические связывающие агенты, связывающиеся с cldn18.2 и cd3
RU2798988C2 (ru) Биспецифические трехвалентные антитела, связывающиеся с клаудином 6 или клаудином 18.2, и cd3, для лечения онкологических заболеваний с экспрессией клаудина
HK40078730A (en) Bispecific trivalent antibodies binding to claudin 6 or claudin 18.2 and cd3 for treatment of claudin expressing cancer diseases
HK40010154B (zh) 用於治疗表达密蛋白之癌症疾病的与密蛋白6或密蛋白18 .2和cd3结合的双特异性三价抗体

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20240610

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20240610

A871 Explanation of circumstances concerning accelerated examination

Free format text: JAPANESE INTERMEDIATE CODE: A871

Effective date: 20240610

TRDD Decision of grant or rejection written
A01 Written decision to grant a patent or to grant a registration (utility model)

Free format text: JAPANESE INTERMEDIATE CODE: A01

Effective date: 20240625

A61 First payment of annual fees (during grant procedure)

Free format text: JAPANESE INTERMEDIATE CODE: A61

Effective date: 20240627

R150 Certificate of patent or registration of utility model

Ref document number: 7513854

Country of ref document: JP

Free format text: JAPANESE INTERMEDIATE CODE: R150