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WO2018064013A8 - METHODS FOR TREATING CANCER WITH BAVITUXIMAB BASED ON LEVELS OF β2-GLYCOPROTEIN 1, AND ASSAYS THEREFOR - Google Patents

METHODS FOR TREATING CANCER WITH BAVITUXIMAB BASED ON LEVELS OF β2-GLYCOPROTEIN 1, AND ASSAYS THEREFOR Download PDF

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Publication number
WO2018064013A8
WO2018064013A8 PCT/US2017/053370 US2017053370W WO2018064013A8 WO 2018064013 A8 WO2018064013 A8 WO 2018064013A8 US 2017053370 W US2017053370 W US 2017053370W WO 2018064013 A8 WO2018064013 A8 WO 2018064013A8
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WO
WIPO (PCT)
Prior art keywords
bavituximab
methods
glycoprotein
treating cancer
levels
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
PCT/US2017/053370
Other languages
French (fr)
Other versions
WO2018064013A1 (en
WO2018064013A9 (en
Inventor
Min Tang
Joseph S. SHAN
Steven W. King
Connie Chang
Michael A. Brown
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.)
Feng Biosciences Inc
Original Assignee
Oncologie Inc
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
Priority to CN201780058161.8A priority Critical patent/CN109863402A/en
Application filed by Oncologie Inc filed Critical Oncologie Inc
Priority to AU2017334698A priority patent/AU2017334698A1/en
Priority to US16/336,649 priority patent/US20210032340A1/en
Priority to JP2019538088A priority patent/JP2019537619A/en
Priority to CA3037008A priority patent/CA3037008A1/en
Priority to KR1020197008828A priority patent/KR20190057303A/en
Priority to EP17791768.9A priority patent/EP3519827A1/en
Priority to MX2019003569A priority patent/MX2019003569A/en
Publication of WO2018064013A1 publication Critical patent/WO2018064013A1/en
Publication of WO2018064013A9 publication Critical patent/WO2018064013A9/en
Anticipated expiration legal-status Critical
Publication of WO2018064013A8 publication Critical patent/WO2018064013A8/en
Ceased legal-status Critical Current

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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/574—Immunoassay; Biospecific binding assay; Materials therefor for cancer
    • G01N33/57484—Immunoassay; Biospecific binding assay; Materials therefor for cancer involving compounds serving as markers for tumor, cancer, neoplasia, e.g. cellular determinants, receptors, heat shock/stress proteins, A-protein, oligosaccharides, metabolites
    • G01N33/57488—Immunoassay; Biospecific binding assay; Materials therefor for cancer involving compounds serving as markers for tumor, cancer, neoplasia, e.g. cellular determinants, receptors, heat shock/stress proteins, A-protein, oligosaccharides, metabolites involving compounds identifable in body fluids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/337—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having four-membered rings, e.g. taxol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/555—Heterocyclic compounds containing heavy metals, e.g. hemin, hematin, melarsoprol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7052—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
    • A61K31/706—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom
    • A61K31/7064—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines
    • A61K31/7068—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines having oxo groups directly attached to the pyrimidine ring, e.g. cytidine, cytidylic acid
    • 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
    • A61K39/39558—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against tumor tissues, cells, antigens
    • 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 [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], 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 [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [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
    • C07K16/2818—Immunoglobulins [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 CD28 or CD152
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [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
    • C07K16/2827—Immunoglobulins [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 B7 molecules, e.g. CD80, CD86
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/44—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material not provided for elsewhere, e.g. haptens, metals, DNA, RNA, amino acids
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/92—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving lipids, e.g. cholesterol, lipoproteins, or their receptors
    • 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
    • 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
    • A61K2039/507—Comprising a combination of two or more separate antibodies
    • 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
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2400/00—Assays, e.g. immunoassays or enzyme assays, involving carbohydrates
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00—Detection or diagnosis of diseases
    • G01N2800/52—Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Immunology (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Molecular Biology (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Biochemistry (AREA)
  • Biomedical Technology (AREA)
  • Biophysics (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Hematology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Urology & Nephrology (AREA)
  • Genetics & Genomics (AREA)
  • Epidemiology (AREA)
  • Microbiology (AREA)
  • Cell Biology (AREA)
  • General Physics & Mathematics (AREA)
  • Food Science & Technology (AREA)
  • Oncology (AREA)
  • Pathology (AREA)
  • Analytical Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Biotechnology (AREA)
  • Hospice & Palliative Care (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Mycology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Endocrinology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

Disclosed are surprising new methods and kits for identifying and treating patients treatable with PS-targeting antibodies, particularly for identifying and treating cancer patients using bavituximab and bavituximab combination therapies. The methods and kits are based on the surprising finding that defined ranges of pre-treatment blood concentrations of β2-glycoprotein 1 (β2GΡΙ), particularly functional β2GPI, act as an indicator to accurately predict patients with better treatment outcomes.
PCT/US2017/053370 2016-09-27 2017-09-26 METHODS FOR TREATING CANCER WITH BAVITUXIMAB BASED ON LEVELS OF β2-GLYCOPROTEIN 1, AND ASSAYS THEREFOR Ceased WO2018064013A1 (en)

Priority Applications (8)

Application Number Priority Date Filing Date Title
MX2019003569A MX2019003569A (en) 2016-09-27 2017-09-26 Methods for treating cancer with bavituximab based on levels of î²2-glycoprotein 1, and assays therefor.
AU2017334698A AU2017334698A1 (en) 2016-09-27 2017-09-26 Methods for treating cancer with bavituximab based on levels of β2-glycoprotein 1, and assays therefor
US16/336,649 US20210032340A1 (en) 2016-09-27 2017-09-26 Methods for treating cancer with bavituximab based on levels of beta2-glycoprotein 1, and assays therefor
JP2019538088A JP2019537619A (en) 2016-09-27 2017-09-26 Method for treating cancer with bavituximab based on β2-glycoprotein 1 levels, and assays therefor
CA3037008A CA3037008A1 (en) 2016-09-27 2017-09-26 Methods for treating cancer with bavituximab based on levels of .beta.2-glycoprotein 1, and assays therefor
CN201780058161.8A CN109863402A (en) 2016-09-27 2017-09-26 Methods of treating cancer with baviximab based on β2-glycoprotein 1 levels and assays thereof
EP17791768.9A EP3519827A1 (en) 2016-09-27 2017-09-26 Methods for treating cancer with bavituximab based on levels of 2-glycoprotein 1, and assays therefor
KR1020197008828A KR20190057303A (en) 2016-09-27 2017-09-26 a method for treating cancer by bovituximab based on the level of? 2-glycoprotein 1, and an essay therefor

Applications Claiming Priority (9)

Application Number Priority Date Filing Date Title
US201662400589P 2016-09-27 2016-09-27
US62/400,549 2016-09-27
US62/400,589 2016-09-27
US201662406727P 2016-10-11 2016-10-11
US62/406,727 2016-10-11
US201762480994P 2017-04-03 2017-04-03
US62/480,994 2017-04-03
US201762507580P 2017-05-17 2017-05-17
US62/507,580 2017-05-17

Publications (3)

Publication Number Publication Date
WO2018064013A1 WO2018064013A1 (en) 2018-04-05
WO2018064013A9 WO2018064013A9 (en) 2018-07-05
WO2018064013A8 true WO2018064013A8 (en) 2019-05-23

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PCT/US2017/053370 Ceased WO2018064013A1 (en) 2016-09-27 2017-09-26 METHODS FOR TREATING CANCER WITH BAVITUXIMAB BASED ON LEVELS OF β2-GLYCOPROTEIN 1, AND ASSAYS THEREFOR

Country Status (8)

Country Link
EP (1) EP3519827A1 (en)
JP (1) JP2019537619A (en)
KR (1) KR20190057303A (en)
CN (1) CN109863402A (en)
AU (1) AU2017334698A1 (en)
CA (1) CA3037008A1 (en)
MX (1) MX2019003569A (en)
WO (1) WO2018064013A1 (en)

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CN112698033A (en) * 2020-12-09 2021-04-23 复旦大学附属中山医院 Detection method and application of blood-borne exosome HER2
CN114716547B (en) * 2022-05-18 2023-11-21 珠海丽禾医疗诊断产品有限公司 Binding proteins comprising antigen binding domains and methods of production and use thereof
WO2024065243A1 (en) * 2022-09-28 2024-04-04 University Of Macau Drug for treatment of breast cancer and application thereof
CN119555937B (en) * 2025-01-26 2025-05-20 杭州奥泰生物技术股份有限公司 Canine insect vector disease quintuplet antibody detection card, preparation method and kit thereof

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Publication number Publication date
JP2019537619A (en) 2019-12-26
EP3519827A1 (en) 2019-08-07
KR20190057303A (en) 2019-05-28
CA3037008A1 (en) 2018-04-05
CN109863402A (en) 2019-06-07
WO2018064013A1 (en) 2018-04-05
MX2019003569A (en) 2020-07-22
WO2018064013A9 (en) 2018-07-05
AU2017334698A1 (en) 2019-03-21

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