WO2018217638A1 - Dosage and administration of anti-c5 antibodies for treatment of protein-losing enteropathy in patients - Google Patents

Dosage and administration of anti-c5 antibodies for treatment of protein-losing enteropathy in patients Download PDF

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Publication number
WO2018217638A1
WO2018217638A1 PCT/US2018/033678 US2018033678W WO2018217638A1 WO 2018217638 A1 WO2018217638 A1 WO 2018217638A1 US 2018033678 W US2018033678 W US 2018033678W WO 2018217638 A1 WO2018217638 A1 WO 2018217638A1
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Prior art keywords
fold
antibody
weeks
per week
patient
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PCT/US2018/033678
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English (en)
French (fr)
Inventor
Orly Eshach ADIV
Camille Bedrosian
Hagit Baris FELDMAN
Alina KUROLAP
Susan Faas MCKNIGHT
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Alexion Pharmaceuticals Inc
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Alexion Pharmaceuticals Inc
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Priority to JP2019563123A priority Critical patent/JP7194698B2/ja
Priority to ES18731616T priority patent/ES2967965T3/es
Priority to EP18731616.1A priority patent/EP3630819B1/en
Priority to US16/614,582 priority patent/US11459382B2/en
Publication of WO2018217638A1 publication Critical patent/WO2018217638A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/40—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against enzymes
    • 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
    • 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
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6893—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids related to diseases not provided for elsewhere
    • 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
    • A61K2039/54—Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • 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
    • A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • 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
    • C07K2317/50—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
    • C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/68—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving nucleic acids
    • C12Q1/6876—Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes
    • C12Q1/6883—Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for diseases caused by alterations of genetic material
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q2600/00—Oligonucleotides characterized by their use
    • C12Q2600/156—Polymorphic or mutational markers

Definitions

  • PLE e.g., lymphangiectasia
  • PLE lymphangiectasia
  • the patient has not previously been treated with a complement inhibitor (e.g., the patient is a complement inhibitor treatment-naive patient).
  • An exemplary anti-C5 antibody is eculizumab (Soliris ® ).
  • the antibody comprises the heavy and light chain CDRs or variable regions of eculizumab.
  • the antibody comprises the CDRl , CDR2 and CDR3 domains of the VH region of eculizumab having the sequence set forth in SEQ ID NO:7, and the CDRl, CDR2 and CDR3 domains of the VL region of eculizumab having the sequence set forth in SEQ ID NO: 8.
  • the antibody comprises heavy chain CDRl , CDR2 and CDR3 domains having the sequences set forth in SEQ ID NOs: l , 2 and 3, respectively, and light chain CDRl , CDR2 and CDR3 domains having the sequences set forth in SEQ ID NOs:4, 5 and 6, respectively.
  • the antibody comprises a VH region having the amino acid sequence set forth in SEQ ID NO:7. In another embodiment, the antibody comprises a VL region having the amino acid sequence set forth in SEQ ID NO:8. In another embodiment, the antibody comprises VH and VL regions having the amino acid sequences set forth in SEQ ID NO:7 and SEQ ID NO:8, respectively. In another embodiment, the antibody comprises the heavy chain constant region of eculizumab having the sequence set forth in SEQ ID NO:9. In another embodiment, the antibody comprises a heavy chain having the amino acid sequence set forth in SEQ ID NO: 10. In another embodiment, the antibody comprises a light chain having the amino acid sequence set forth in SEQ ID NO: l 1. In another embodiment, the antibody comprises heavy and light chains having the amino acid sequences set forth in SEQ ID NO: 10 and SEQ ID NO: 11, respectively.
  • 600 mg of the anti-C5 antibody, or antigen binding fragment thereof is administered to a patient weighing 20 kg to ⁇ 30 kg.
  • 900 mg of the anti-C5 antibody, or antigen binding fragment thereof is administered to a patient weighing 30 kg to ⁇ 40 kg.
  • 1200 mg of the anti-C5 antibody, or antigen binding fragment thereof is administered to a patient weighing >40 kg.
  • dosage regimens are adjusted to provide the optimum desired response (e.g., an effective response).
  • the anti-C5 antibody, or antigen binding fragment thereof is administered for one or more administration cycles. In one embodiment, the administration cycle is 27 weeks.
  • lymphangiectasia comprising administering to the patient during an administration cycle an effective amount of an anti-C5 antibody, or antigen binding fragment thereof, comprising CDR1, CDR2 and CDR3 heavy chain sequences as set forth in SEQ ID NOs: l, 2 and 3, respectively, and CDR1, CDR2 and CDR3 light chain sequences as set forth in SEQ ID NOs:4, 5 and 6, respectively, wherein the anti-C5 antibody, or antigen binding fragment thereof, is administered at a dose of: i) 600 mg to a patient weighing 10 kg to ⁇ 20 kg twice per week during weeks 1 and 2 of the administration cycle and once during week 3, followed by 300 mg or 600 mg once per week during weeks 4 and 5 and every two weeks thereafter; ii) 600 mg to a patient weighing 20 kg to ⁇ 30 kg twice per week during weeks 1 and 2 of the administration cycle, followed by 600 mg once per week during weeks 3, 4 and 5 and every two weeks thereafter; iii) 900 mg to a patient weighing 30 kg to ⁇
  • 600 mg of the anti-C5 antibody, or antigen binding fragment thereof is administered to a patient weighing 10 kg to ⁇ 30 kg.
  • the anti-C5 antibody, or antigen binding fragment thereof is administered to a patient weighing 10 kg to ⁇ 20 kg at a dose of 600 mg twice per week during weeks 1 and 2 of the administration cycle and once during week 3, followed by 300 mg or 600 mg once per week during weeks 4 and 5 and every two weeks thereafter.
  • the anti-C5 antibody, or antigen binding fragment thereof is administered to a patient weighing 20 kg to ⁇ 30 kg at a dose of 600 mg twice per week during weeks 1 and 2 of the administration cycle, followed by 600 mg once per week during weeks 3, 4 and 5 and every two weeks thereafter.
  • the anti-C5 antibody, or antigen binding fragment thereof is administered on a monthly basis or every other month basis for a year after completion of the administration cycle. In another embodiment, the anti-C5 antibody, or antigen binding fragment thereof, is administered on a monthly basis or every other month basis for two, three, four or five years after completion of the administration cycle. In a particular embodiment, the anti-C5 antibody, or antigen binding fragment thereof, is
  • the treatment regimens described are sufficient to maintain particular serum trough concentrations of the anti-C5 antibody, or antigen binding fragment thereof.
  • the treatment maintains a serum trough concentration of the anti-C5 antibody, or antigen binding fragment thereof, of 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 105, 1 10, 1 15, 120, 125, 130, 135, 140, 145, 150, 155, 160, 165, 170, 175, 180, 185, 190, 200, 205, 210, 215, 220, 225, 230, 240, 245, 250, 255, 260, 265, 270, 280, 290, 300, 305, 310, 315, 320, 325, 330, 335, 340, 345, 350, 355, 360, 365, 370, 375, 380, 385, 390, 395 or
  • the anti-C5 antibody is administered to the patient in an amount and with a frequency to maintain at least 50 ⁇ g, 55 ⁇ g, 60 ⁇ & 65 ⁇ & 70 ⁇ g, 75 ig, 80 ⁇ g, 85 ⁇ g, 90 ⁇ g, 95 ⁇ g, 100 ⁇ ⁇ , 105 110 ⁇ g, 115 ⁇ g, 120 ⁇ g, 125 ⁇ g, 130 ⁇ g, 135 ⁇ g, 140 ⁇ g, 145 ⁇ g, 150 ⁇ 155 ⁇ g, 160 ⁇ g 5 165 ⁇ & 170 ⁇ g 1 175 ⁇ 180 ⁇ ⁇ , 185 ⁇ ⁇ , 190 ⁇ g, 195 ⁇ ⁇ , 200 ⁇ ⁇ , 205 ⁇ ⁇ , 210 ⁇ ⁇ , 215 ⁇ ⁇ , 220 ⁇ ⁇ , 225 ⁇ ⁇ , 230 ⁇ ⁇ , 235 ⁇ g, 240
  • the patient has been vaccinated with a Neisseria meningococcal vaccine prior to receiving the treatment methods described herein.
  • Patients who receive treatment less than two weeks after receiving a meningococcal vaccine can receive treatment with appropriate prophylactic antibiotics until two weeks after vaccination.
  • Vaccines against serotypes A, C, Y, W 135, and B, where available, are recommended to prevent common pathogenic meningococcal serotypes.
  • the efficacy of the treatment methods provided herein can be assessed using any suitable means.
  • the treatment produces a shift toward normal serum albumin levels.
  • patients treated according to the disclosed methods experience an increase in serum albumin levels to near normal levels or to within about 10% or within about 20% above or below what is considered the normal level of serum albumin.
  • the treatment results in at least a 1.0-fold, 1.1-fold, 1.2-fold, 1.3-fold,
  • the kit comprises a dose of an anti-C5 antibody, or antigen binding fragment thereof, is administered to a patient weighing >40 kg at a dose of 1200 mg twice per week during weeks 1 and 2 of the administration cycle, followed by 1200 mg once per week during weeks 3, 4 and 5 and every two weeks thereafter.
  • Monoclonal antibodies can be obtained by various techniques familiar to those skilled in the art. Briefly, for example, spleen cells from an animal immunized with a desired antigen are immortalized, commonly by fusion with a myeloma cell (Kohler, G. & Milstein, C, Eur. J. Immunol. , 6:511-9, 1976). Alternative methods of immortalization include, but are not limited to, transformation with Epstein Barr Virus, oncogenes, or retroviruses, or other methods known in the art.
  • compositions comprising an anti-C5 antibody, or antigen binding fragment thereof.
  • the composition comprises an antibody comprising the CDRl, CDR2 and CDR3 domains of the VH region of eculizumab having the sequence set forth in SEQ ID NO:7, and the CDRl, CDR2 and CDR3 domains of the VL region of eculizumab having the sequence set forth in SEQ ID NO: 8.
  • the antibody comprises heavy chain CDRl, CDR2 and CDR3 domains having the sequences set forth in SEQ ID NOs: l, 2 and 3, respectively, and light chain CDRl, CDR2 and CDR3 domains having the sequences set forth in SEQ ID NOs:4, 5 and 6, respectively.
  • Parenteral administration refers to modes of administration other than enteral and topical administration, usually by injection, and include, without limitation, intravenous, intranasal, intraocular, pulmonary, intramuscular, intraarterial, intrathecal, intracapsular, intraorbital, intracardiac, intradermal, intrapulmonary, intraperitoneal, transtracheal, subcutaneous, subcuticular, intraarticular, subcapsular, subarachnoid, intraspinal, epidural, intracerebral, intracranial, intracarotid and intrasternal injection and infusion.
  • the kit comprises a dose of an anti-C5 antibody, or antigen binding fragment thereof, is administered to a patient weighing >40 kg at a dose of 1200 mg twice per week during weeks 1 and 2 of the administration cycle, followed by 1200 mg once per week during weeks 3, 4 and 5 and every two weeks thereafter.
  • Table 2 Schedule of Dosing and Assessments for Patient Between 10 and ⁇ 20 kg !

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PCT/US2018/033678 2017-05-22 2018-05-21 Dosage and administration of anti-c5 antibodies for treatment of protein-losing enteropathy in patients Ceased WO2018217638A1 (en)

Priority Applications (4)

Application Number Priority Date Filing Date Title
JP2019563123A JP7194698B2 (ja) 2017-05-22 2018-05-21 患者においてタンパク質漏出性腸症を処置するための抗ｃ５抗体の投薬量および投与
ES18731616T ES2967965T3 (es) 2017-05-22 2018-05-21 Dosis y administración de anticuerpos anti-C5 para el tratamiento de enteropatía pierde-proteínas en pacientes
EP18731616.1A EP3630819B1 (en) 2017-05-22 2018-05-21 Dosage and administration of anti-c5 antibodies for treatment of protein-losing enteropathy in patients
US16/614,582 US11459382B2 (en) 2017-05-22 2018-05-21 Dosage and administration of anti-C5 antibodies for treatment of protein-losing enteropathy in patients

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US201762509576P 2017-05-22 2017-05-22
US62/509,576 2017-05-22

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WO (1) WO2018217638A1 (enExample)

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Publication number Priority date Publication date Assignee Title
US11459382B2 (en) 2017-05-22 2022-10-04 Alexion Pharmaceuticals, Inc. Dosage and administration of anti-C5 antibodies for treatment of protein-losing enteropathy in patients

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Publication number Priority date Publication date Assignee Title
WO2021081277A1 (en) * 2019-10-25 2021-04-29 Regeneron Pharmaceuticals, Inc. Dosing regimens for treating or preventing c5-associated diseases

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HUE066795T2 (hu) 2006-03-15 2024-09-28 Alexion Pharma Inc Paroxysmalis nocturnalis haemoglobinuriában szenvedõ betegek kezelése egy komplement inhibitorral
CA2742802C (en) * 2008-11-10 2019-11-26 Alexion Pharmaceuticals, Inc. Methods and compositions for treating complement-associated disorders
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US11459382B2 (en) 2017-05-22 2022-10-04 Alexion Pharmaceuticals, Inc. Dosage and administration of anti-C5 antibodies for treatment of protein-losing enteropathy in patients

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