WO2022022464A8 - 新型双特异性抗cd3/cd20多肽复合物配制剂 - Google Patents

新型双特异性抗cd3/cd20多肽复合物配制剂 Download PDF

Info

Publication number
WO2022022464A8
WO2022022464A8 PCT/CN2021/108455 CN2021108455W WO2022022464A8 WO 2022022464 A8 WO2022022464 A8 WO 2022022464A8 CN 2021108455 W CN2021108455 W CN 2021108455W WO 2022022464 A8 WO2022022464 A8 WO 2022022464A8
Authority
WO
WIPO (PCT)
Prior art keywords
formulation
polypeptide complex
bispecific anti
novel bispecific
antigen
Prior art date
Application number
PCT/CN2021/108455
Other languages
English (en)
French (fr)
Other versions
WO2022022464A1 (zh
Inventor
朱友伟
李盈淳
程艳菊
Original Assignee
正大天晴药业集团股份有限公司
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 正大天晴药业集团股份有限公司 filed Critical 正大天晴药业集团股份有限公司
Priority to CN202180041422.1A priority Critical patent/CN115715200A/zh
Priority to EP21849910.1A priority patent/EP4190352A1/en
Priority to CA3217391A priority patent/CA3217391A1/en
Priority to US18/007,012 priority patent/US20230279138A1/en
Publication of WO2022022464A1 publication Critical patent/WO2022022464A1/zh
Publication of WO2022022464A8 publication Critical patent/WO2022022464A8/zh

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • 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
    • C07K16/2887Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against CD20
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/545Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • 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
    • C07K2317/50Immunoglobulins 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
    • C07K2317/53Hinge
    • 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
    • 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
    • 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)
  • General Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)
  • Dermatology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)

Abstract

本发明提供一种含有第一抗原结合部分和第二抗原结合部分的新型双特异性抗CD3/CD20多肽复合物配制剂,具体而言,其包括液体配制剂和冻干配制剂。
PCT/CN2021/108455 2020-07-27 2021-07-26 新型双特异性抗cd3/cd20多肽复合物配制剂 WO2022022464A1 (zh)

Priority Applications (4)

Application Number Priority Date Filing Date Title
CN202180041422.1A CN115715200A (zh) 2020-07-27 2021-07-26 新型双特异性抗cd3/cd20多肽复合物配制剂
EP21849910.1A EP4190352A1 (en) 2020-07-27 2021-07-26 Formulation of novel bispecific anti-cd3/cd20 polypeptide complex
CA3217391A CA3217391A1 (en) 2020-07-27 2021-07-26 Formulation of novel bispecific anti-cd3/cd20 polypeptide complex
US18/007,012 US20230279138A1 (en) 2020-07-27 2021-07-26 Novel bispecific anti-cd3/cd20 polypeptide complex formulation

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN202010733597 2020-07-27
CN202010733597.6 2020-07-27

Publications (2)

Publication Number Publication Date
WO2022022464A1 WO2022022464A1 (zh) 2022-02-03
WO2022022464A8 true WO2022022464A8 (zh) 2022-03-03

Family

ID=80037593

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CN2021/108455 WO2022022464A1 (zh) 2020-07-27 2021-07-26 新型双特异性抗cd3/cd20多肽复合物配制剂

Country Status (5)

Country Link
US (1) US20230279138A1 (zh)
EP (1) EP4190352A1 (zh)
CN (1) CN115715200A (zh)
CA (1) CA3217391A1 (zh)
WO (1) WO2022022464A1 (zh)

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MX2011007589A (es) 2009-01-16 2011-08-17 Glaxosmithkline Llc Tratamiento de un cancer usando una combinacion de bendamustine y un anticuerpo anti-cd20.
US20140004037A1 (en) 2012-01-19 2014-01-02 Therapeutic Proteins, Inc. Stabilization of the anti-cd20 antibody rituximab
TWI701042B (zh) 2014-03-19 2020-08-11 美商再生元醫藥公司 用於腫瘤治療之方法及抗體組成物
CA3074130A1 (en) * 2017-09-21 2019-03-28 WuXi Biologics Ireland Limited Novel anti-cd3epsilon antibodies
JP7337079B2 (ja) * 2018-02-15 2023-09-01 マクロジェニクス,インコーポレーテッド 変異型cd3結合ドメイン、及び疾患の治療のための併用療法におけるその使用
WO2019228406A1 (en) * 2018-05-29 2019-12-05 Wuxi Biologics (Shanghai) Co., Ltd. A novel anti-cd3/anti-cd20 bispecific antibody
WO2020084608A1 (en) * 2018-10-22 2020-04-30 Explore Bio 1 Ltd Precursor bispecific antibody constructs and methods of use thereof
CA3118397A1 (en) * 2018-11-01 2020-05-07 Shandong Newtime Pharmaceutical Co., Ltd. Bispecific antibody targeting cd3 and bcma, and uses thereof

Also Published As

Publication number Publication date
US20230279138A1 (en) 2023-09-07
CA3217391A1 (en) 2022-02-03
EP4190352A1 (en) 2023-06-07
CN115715200A (zh) 2023-02-24
WO2022022464A1 (zh) 2022-02-03

Similar Documents

Publication Publication Date Title
WO2019074973A3 (en) Anti-cd38 antibodies and combinations with anti-cd3 and anti-cd28 antibodies
IL299221A (en) CD3 binding antibodies
WO2020016662A3 (en) Antibodies specific to trophoblast antigen 2 (trop2)
MX2019007719A (es) Anticuerpo anti-receptor de transferrina humana novedoso capaz de penetrar la barrera hematoencefalica.
AU2018258045A1 (en) Chimeric antibody/T-cell receptor constructs and uses thereof
DE69429095D1 (de) Humanisierte antikoerper
WO2021183839A3 (en) Novel anti-lilrb4 antibodies and derivative products
WO2003078468A3 (de) Verwendung einer an cd28 bindenden wirksubstanz zur herstellung einer pharmazeutischen zusammensetzung
RS53120B (en) ANTAGONISTIC HUMAN MONOCLONAL ANTIBODIES SPECIFIC TO THE HUMAN LIGHT
MX2021005396A (es) Anticuerpo anti-cd73, fragmento de union a antigeno y aplicacion del mismo.
Piazza et al. Internalization and recycling of ALCAM/CD166 detected by a fully human single-chain recombinant antibody
WO2019136300A3 (en) Anti-mct1 antibodies and uses thereof
WO2019117685A3 (ko) 항-igf1r 항체 및 그 용도
EP4249511A3 (en) Anti-pd-l1/anti-lag3 bispecific antibodies and uses thereof
MX2021005048A (es) Anticuerpos anti-ctla4, fragmentos de anticuerpos, sus inmunoconjugados y usos.
WO2021207433A3 (en) Epitopes of sars-cov-2 neutralizing antibodies
EP3917969A4 (en) NEW BISPECIFIC CD3/CD20 POLYPEPTIDIC COMPLEXES
MX2021012365A (es) Anticuerpos biespecificos.
WO2020223392A3 (en) Cancer associated antibody compositions and methods of use
MX2021015763A (es) Polipeptidos.
WO2022022464A8 (zh) 新型双特异性抗cd3/cd20多肽复合物配制剂
WO2021031784A9 (zh) 靶向cd3和cd20的双特异性抗体及其应用
WO2021118930A3 (en) Anti-pd-l1 antibody formulations
WO2022032073A3 (en) Trpml modulators
WO2020176871A8 (en) Kawasaki disease antibodies identify hepacivirus peptides

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 21849910

Country of ref document: EP

Kind code of ref document: A1

WWE Wipo information: entry into national phase

Ref document number: 2021849910

Country of ref document: EP

NENP Non-entry into the national phase

Ref country code: DE

ENP Entry into the national phase

Ref document number: 2021849910

Country of ref document: EP

Effective date: 20230227

WWE Wipo information: entry into national phase

Ref document number: 3217391

Country of ref document: CA

WWE Wipo information: entry into national phase

Ref document number: 202393060

Country of ref document: EA