AU2021352532B2 - Anti-claudin18.2 and cd3 bispecific antibody and use thereof - Google Patents

Anti-claudin18.2 and cd3 bispecific antibody and use thereof

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Publication number
AU2021352532B2
AU2021352532B2 AU2021352532A AU2021352532A AU2021352532B2 AU 2021352532 B2 AU2021352532 B2 AU 2021352532B2 AU 2021352532 A AU2021352532 A AU 2021352532A AU 2021352532 A AU2021352532 A AU 2021352532A AU 2021352532 B2 AU2021352532 B2 AU 2021352532B2
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AU
Australia
Prior art keywords
amino acid
acid sequence
seq
antibody
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.)
Expired - Fee Related
Application number
AU2021352532A
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English (en)
Other versions
AU2021352532A1 (en
AU2021352532A9 (en
Inventor
Yarong GAO
Zhe Guan
Weiwei Wu
Shuaixiang ZHOU
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Fortvita Biologics Singapore Pte Ltd
Original Assignee
Fortvita Biologics Singapore Pte Ltd
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
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Publication of AU2021352532A1 publication Critical patent/AU2021352532A1/en
Assigned to INNOVENT BIOLOGICS (SINGAPORE) PTE. LTD. reassignment INNOVENT BIOLOGICS (SINGAPORE) PTE. LTD. Request for Assignment Assignors: INNOVENT BIOLOGICS (SUZHOU) CO., LTD.
Assigned to Fortvita Biologics (Singapore) Pte.Ltd. reassignment Fortvita Biologics (Singapore) Pte.Ltd. Amend patent request/document other than specification (104) Assignors: INNOVENT BIOLOGICS (SINGAPORE) PTE. LTD.
Publication of AU2021352532A9 publication Critical patent/AU2021352532A9/en
Application granted granted Critical
Publication of AU2021352532B2 publication Critical patent/AU2021352532B2/en
Expired - Fee Related legal-status Critical Current
Anticipated expiration legal-status Critical

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    • 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
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • 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
    • 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
    • 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
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • 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
    • C07K2317/31—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
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • 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
    • C07K2317/73—Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Epidemiology (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Bioinformatics & Cheminformatics (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)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
AU2021352532A 2020-09-29 2021-09-28 Anti-claudin18.2 and cd3 bispecific antibody and use thereof Expired - Fee Related AU2021352532B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
CN202011054428.6 2020-09-29
CN202011054428 2020-09-29
PCT/CN2021/121286 WO2022068810A1 (zh) 2020-09-29 2021-09-28 抗Claudin18.2和CD3的双特异性抗体以及其用途

Publications (3)

Publication Number Publication Date
AU2021352532A1 AU2021352532A1 (en) 2023-05-25
AU2021352532A9 AU2021352532A9 (en) 2025-03-13
AU2021352532B2 true AU2021352532B2 (en) 2026-01-15

Family

ID=80949663

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2021352532A Expired - Fee Related AU2021352532B2 (en) 2020-09-29 2021-09-28 Anti-claudin18.2 and cd3 bispecific antibody and use thereof

Country Status (9)

Country Link
US (1) US20230357389A1 (https=)
EP (1) EP4223778A4 (https=)
JP (1) JP2023544143A (https=)
KR (1) KR20230079165A (https=)
CN (1) CN116323676A (https=)
AU (1) AU2021352532B2 (https=)
CA (1) CA3200865A1 (https=)
TW (1) TWI837517B (https=)
WO (1) WO2022068810A1 (https=)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20240167685A (ko) * 2022-03-28 2024-11-27 포트비타 바이오로직스 (싱가포르) 피티이. 리미티드 항-Claudin18.2 및 CD3 이중특이성 항체를 포함하는 제제 및 이의 제조 방법과 용도
CN117229398A (zh) * 2022-06-15 2023-12-15 中山康方生物医药有限公司 抗cldn18.2抗体、其药物组合物及用途
KR20240101987A (ko) * 2022-12-23 2024-07-03 주식회사 와이바이오로직스 클라우딘-18.2에 특이적으로 결합하는 단클론항체 및 이의 용도
CN116813782B (zh) * 2023-08-10 2024-01-23 北京百普赛斯生物科技股份有限公司 一种Claudin-18.2特异性抗体及其应用
WO2025162454A1 (zh) * 2024-02-02 2025-08-07 北京昌平实验室 双特异性抗体和细胞因子融合蛋白及其应用
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 (3)

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WO2014075697A1 (en) * 2012-11-13 2014-05-22 Biontech Ag Agents for treatment of claudin expressing cancer diseases
WO2019242505A1 (zh) * 2018-06-17 2019-12-26 上海健信生物医药科技有限公司 靶向cldn18.2的抗体、双特异性抗体、adc和car及其应用
WO2020025792A1 (en) * 2018-08-03 2020-02-06 Amgen Research (Munich) Gmbh Antibody constructs for cldn18.2 and cd3

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EP1940881B1 (en) 2005-10-11 2016-11-30 Amgen Research (Munich) GmbH Compositions comprising cross-species-specific antibodies and uses thereof
CN104968367B (zh) * 2012-11-13 2018-04-13 弗·哈夫曼-拉罗切有限公司 抗血凝素抗体和使用方法
EP3766903A3 (en) * 2012-11-13 2021-02-17 BioNTech SE Bispecific anti claudin xcd3 antibodies for treatment of claudin expressing cancer diseases
JP6499079B2 (ja) * 2012-11-13 2019-04-10 バイオエヌテック アーゲーＢｉｏＮＴｅｃｈ ＡＧ クローディンを発現するガン疾患を処置するための剤
CN106589127A (zh) * 2015-10-16 2017-04-26 钜川生物医药 一种pcsk9抗体及其制备方法和应用
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
EP3577137A1 (en) * 2017-02-02 2019-12-11 Merck Patent GmbH Preferred pairing of antibody domains
SG11201907422RA (en) * 2017-02-17 2019-09-27 Denali Therapeutics Inc Anti-tau antibodies and methods of use thereof
EP3409322A1 (en) * 2017-06-01 2018-12-05 F. Hoffmann-La Roche AG Treatment method
EP3694885A1 (en) * 2017-10-14 2020-08-19 CytomX Therapeutics, Inc. Antibodies, activatable antibodies, bispecific antibodies, and bispecific activatable antibodies and methods of use thereof
US12404512B2 (en) * 2018-05-01 2025-09-02 Ambrx, Inc. Method for optimizing antibody expression

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014075697A1 (en) * 2012-11-13 2014-05-22 Biontech Ag Agents for treatment of claudin expressing cancer diseases
WO2019242505A1 (zh) * 2018-06-17 2019-12-26 上海健信生物医药科技有限公司 靶向cldn18.2的抗体、双特异性抗体、adc和car及其应用
WO2020025792A1 (en) * 2018-08-03 2020-02-06 Amgen Research (Munich) Gmbh Antibody constructs for cldn18.2 and cd3

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
GUOYUN ZHU, FOLETTI DAVIDE, LIU XIAOHUI, DING SHENG, MELTON WITT JODY, HASA-MORENO ADELA, RICKERT MATHIAS, HOLZ CHARLES, ASCHENBRE: "Targeting CLDN18.2 by CD3 Bispecific and ADC Modalities for the Treatments of Gastric and Pancreatic Cancer", SCIENTIFIC REPORTS, vol. 9, no. 1, 1 January 2019 (2019-01-01), pages 1 - 11, XP055630964, DOI: 10.1038/s41598-019-44874-0 *

Also Published As

Publication number Publication date
EP4223778A4 (en) 2024-11-06
KR20230079165A (ko) 2023-06-05
CN116323676A (zh) 2023-06-23
AU2021352532A1 (en) 2023-05-25
US20230357389A1 (en) 2023-11-09
JP2023544143A (ja) 2023-10-20
AU2021352532A9 (en) 2025-03-13
EP4223778A1 (en) 2023-08-09
TW202216783A (zh) 2022-05-01
TWI837517B (zh) 2024-04-01
WO2022068810A1 (zh) 2022-04-07
CA3200865A1 (en) 2022-04-07

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Legal Events

Date Code Title Description
PC1 Assignment before grant (sect. 113)

Owner name: INNOVENT BIOLOGICS (SINGAPORE) PTE. LTD.

Free format text: FORMER APPLICANT(S): INNOVENT BIOLOGICS (SUZHOU) CO., LTD.

HB Alteration of name in register

Owner name: FORTVITA BIOLOGICS (SINGAPORE) PTE.LTD.

Free format text: FORMER NAME(S): INNOVENT BIOLOGICS (SINGAPORE) PTE. LTD.

SREP Specification republished