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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WIPO (PCT)
Prior art keywords
bavituximab
methods
glycoprotein
treating cancer
levels
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Application number
PCT/US2017/053370
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French (fr)
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WO2018064013A9 (en
WO2018064013A1 (en
Inventor
Min Tang
Joseph S. SHAN
Steven W. King
Connie Chang
Michael A. Brown
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Oncologie, Inc.
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Application filed by Oncologie, Inc. filed Critical Oncologie, Inc.
Priority to JP2019538088A priority Critical patent/JP2019537619A/en
Priority to AU2017334698A priority patent/AU2017334698A1/en
Priority to EP17791768.9A priority patent/EP3519827A1/en
Priority to US16/336,649 priority patent/US20210032340A1/en
Priority to CA3037008A priority patent/CA3037008A1/en
Priority to KR1020197008828A priority patent/KR20190057303A/en
Priority to CN201780058161.8A priority patent/CN109863402A/en
Priority to MX2019003569A priority patent/MX2019003569A/en
Publication of WO2018064013A1 publication Critical patent/WO2018064013A1/en
Publication of WO2018064013A9 publication Critical patent/WO2018064013A9/en
Publication of WO2018064013A8 publication Critical patent/WO2018064013A8/en

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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
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    • 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
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    • 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
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    • 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
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    • C07—ORGANIC CHEMISTRY
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    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
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    • 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
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    • 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
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K39/00—Medicinal preparations containing antigens or antibodies
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    • C07—ORGANIC CHEMISTRY
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    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
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    • 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)
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  • 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)
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  • Biomedical Technology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Urology & Nephrology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Hematology (AREA)
  • Genetics & Genomics (AREA)
  • Epidemiology (AREA)
  • Microbiology (AREA)
  • Cell Biology (AREA)
  • Biotechnology (AREA)
  • General Physics & Mathematics (AREA)
  • Analytical Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Oncology (AREA)
  • Food Science & Technology (AREA)
  • Hospice & Palliative Care (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Endocrinology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Mycology (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 WO2018064013A1 (en)

Priority Applications (8)

Application Number Priority Date Filing Date Title
JP2019538088A JP2019537619A (en) 2016-09-27 2017-09-26 Method for treating cancer with bavituximab based on β2-glycoprotein 1 levels, 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
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
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
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
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
CN201780058161.8A CN109863402A (en) 2016-09-27 2017-09-26 Based on the horizontal method and its measurement with Ba Wei former times monoclonal antibody treating cancer of beta 2-glycoprotein 1
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.

Applications Claiming Priority (9)

Application Number Priority Date Filing Date Title
US201662400589P 2016-09-27 2016-09-27
US62/400,589 2016-09-27
US62/400,549 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 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)

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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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CN110914300A (en) 2017-04-03 2020-03-24 安康乐济股份有限公司 Methods of treating cancer using PS-targeted antibodies and immunooncology agents
MX2021001777A (en) * 2018-08-13 2021-04-19 Regeneron Pharma Therapeutic protein selection in simulated in vivo conditions.
MX2022006728A (en) * 2020-05-12 2022-06-09 Astrazeneca Ab Methods and combinations for the treatment of cancer using immune checkpoint inhibitor antibodies.
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

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

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