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WO2017064615A1 - Utilisation d'inhibiteurs de c5 dans la microangiopathies associée à une greffe - Google Patents

Utilisation d'inhibiteurs de c5 dans la microangiopathies associée à une greffe Download PDF

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Publication number
WO2017064615A1
WO2017064615A1 PCT/IB2016/056073 IB2016056073W WO2017064615A1 WO 2017064615 A1 WO2017064615 A1 WO 2017064615A1 IB 2016056073 W IB2016056073 W IB 2016056073W WO 2017064615 A1 WO2017064615 A1 WO 2017064615A1
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WO
WIPO (PCT)
Prior art keywords
antibody
tam
inhibitor
tesidolumab
weeks
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/IB2016/056073
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English (en)
Inventor
Irina BALTCHEVA
Christoph Bucher
Izabela ROZENBERG
Hans-Ulrich HOCKEY
Mark MILTON
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Novartis AG
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Novartis AG
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Filing date
Publication date
Application filed by Novartis AG filed Critical Novartis AG
Publication of WO2017064615A1 publication Critical patent/WO2017064615A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • 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
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
    • 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
    • A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
    • 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
    • A61K2039/545—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
    • C07K2317/70—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

Definitions

  • TAM-SCT Stem Cell Transplantation
  • TAM-HSCT Hematopoietic Stem Cell Transplantation
  • a C5 inhibitor e.g. anti-C5 antibody, e.g. Coversin, for use in prevention or treatment of Transplant Associated Microangiopathy (TAM), e.g. TAM after cell transplantation, in a patient in need thereof.
  • TAM Transplant Associated Microangiopathy
  • the C5 inhibitor as defined under 1.1 wherein the C5 inhibitor is administered to a patient in need thereof at doses of about 30mg/kg, e.g. lOmg/kg; or at doses of about 400mg to about lOOOmg, e.g. about 500mg to about lOOOmg.
  • TAM Precursor Cell Transplantation
  • TAM-HPCT Hematopoietic Precursor Cell Transplantation
  • TAM-HSCT allogeneic Hematopoietic Stem cCell Transplantation
  • a method for monitoring the efficacy of treatment against TAM-PCT or TAM-HSCT or allogeneic TAM-HSCT in a subject that has undergone transplantation such as HSCT comprising the steps of
  • an C5 inhibitor e.g. an anti-C5 antibody
  • TAM e.g. TAM after cell transplantation
  • a method for treating or preventing TAM comprising administering to the patient in need thereof a therapeutic amount of tesidolumab or a homologous antibody thereof as herein defined.
  • a C5 inhibitor e.g. Coversin or an anti-C5 antibody
  • the C5 inhibitor is selected from the group consisting of tesidolumab, eculizumab, a 305 variant antibody and a homologous antibody thereof as herein defined, e.g. an antibody homologous to tesidolumab, e.g. is tesidolumab.
  • treating means the administration of a composition to a subject, who has a disorder as described herein, with the purpose to cure, alleviate, relieve, remedy, prevent, or ameliorate the disorder, the symptom of the disorder, the disease state secondary to the disorder, or the predisposition toward the disorder.
  • the terms “individual”, “host”, “subject”, and “patient” are used interchangeably to refer to an animal that is the object of treatment, observation and/or experiment. In general, such individual, host, subject or patient is a human, though other mammals are within the scope of the invention.
  • the antibodies of the invention are isolated human or humanized monoclonal antibodies that specifically bind to a C5 protein. In some embodiments, the antibodies of the invention are isolated chimeric antibodies that specifically bind to a C5 protein. In some embodiments, the anti-C5 antibodies are single chain antibodies, e.g. Fab fragments, e.g. scFv.
  • the invention provides an isolated recombinant antibody (or a functional protein comprising an antigen binding portion thereof) comprising a heavy chain variable region and a light chain variable region, wherein: the heavy chain variable region comprises an amino acid sequence that is at least 80%, 90%, 95%, 96%, 97%, 98% or 99% identical to an amino acid sequence of SEQ ID NO: 7; the light chain variable region comprises an amino acid sequence that is at least 80%, 90%, 95%, 96%, 97%, 98% or 99% identical to an amino acid sequence of SEQ ID NO: 8, as herein above defined.
  • the invention provides isolated anti-C5 monoclonal antibodies, or a functional antigen binding portion thereof, consisting of a heavy chain variable region having: a VH CDR1 region having an amino acid sequence of SEQ I D NO: 1 or an amino acid sequence having one, two, three or four amino acid substitutions, deletions or additions as compared to SEQ ID NO: 1; a VH CDR2 region having an amino acid sequence of SEQ ID NO: 2, or an amino acid sequence having one, two, three, four or five amino acid substitutions, deletions or additions as compared to SEQ ID NO:2; a VH CDR3 region having an amino acid sequence of SEQ I D NO: 3 , or an amino acid sequence having one, two, three, four or five amino acid substitutions, deletions or additions as compared to SEQ ID NO: 3; a VL CDR1 region having an amino acid sequence of SEQ ID NO: 4, or an amino acid sequence having one, two, three, four or five amino acid substitutions, deletions or additions as compared to
  • the drug e.g. the antibody, e.g. the anti-C5 antibody as herein defined, may be used in at least one dose, or at least two doses, or at least three doses, or at least four doses, or at least five doses, or at least six doses, or at least seven doses, or at least eight doses, or at least nine doses, or at least 10 doses, or at least 11 doses, or at least 12 doses, or at least 13 doses, or at least 14 doses, or at least 15 doses, or at least 16 doses, or at least 17 doses, or at least 18 doses, or at least 19 doses, or at least 20 doses, or in certain aspects, even more doses.
  • the use may be carried out until a hematological response or a complete disease response is achieved in the subject.
  • the induction dose of the C5 inhibitor e.g. anti-C5 antibody, e.g. an anti-C5 antibody selected from the group selected from eculizumab, tesidolumab, a 305 variant antibody and a homologous antibody thereof as herein above defined, e.g. eculizumab, tesidolumab, or a 305 variant antibody, may be comprised in a range of about lOmg/kg to 40mg/kg, e.g. about lOmg/kg to 35mg/kg, e.g. about lOmg/kg to 30mg/kg, e.g.
  • an C5 inhibitor that is an anti-C5 antibody selected from the group selected from eculizumab, tesidolumab or a 305 variant antibody, and a homologous antibody thereof as herein above defined, e.g. eculizumab, tesidolumab or a 305 variant antibody.
  • the induction dose is about 20mg/kg, e.g. for an C5 inhibitor that is an anti-C5 antibody selected from the group selected from eculizumab, tesidolumab or a 305 variant antibody, and a homologous antibody thereof as herein above defined, e.g. eculizumab, tesidolumab or a 305 variant antibody.
  • the administration step may be carried out in a manner sufficient to achieve a therapeutic level of the C5 inhibitor, in particular of anti-C5 antibody e.g. selected from the group selected from eculizumab, tesidolumab, or a 305 variant antibody and a homologous antibody thereof as herein above defined, e.g. eculizumab, tesidolumab or a 305 variant antibody in the subject.
  • the administration step may comprise at least one dose, or at least two doses, or at least three doses, or at least four doses, or, in some aspects, more than four doses.
  • a method for treating or preventing TAM e.g. TAM-PCT, e.g. TAM- SCT, e.g. TAM-HPCT, e.g. TAM-HSCT, which comprises the step of administering the C5 inhibitor, e.g. the anti-C5 antibody, e.g. eculizumab, tesidolumab, a 305 variant antibody or a homologous antibody thereof as hereinabove described.
  • the C5 inhibitor e.g. the anti-C5 antibody, e.g. eculizumab, tesidolumab, a 305 variant antibody or a homologous antibody thereof as hereinabove described.
  • TAM-PCT e.g. TAM-SCT
  • TAM-HPCT e.g. TAM-HSCT
  • homologous antibody thereof as herein above defined to obtain an initial CH50 measurement; b) administering said complement inhibitor as defined in a); and c) measuring total CH50 activity after administration of said complement inhibitor to obtain a post-treatment CH50 measurement, wherein said complement inhibitor is administered until said post-treatment CH50 measurement is from about 0-3 CAE units as measured by enzyme immunoassay, or wherein the CH50 measurement is 0-15 CH50 units as measured using a hemolytic method using standardized sheep erythrocytes.
  • the administration step may comprise administering an anti-C5 antibody, e.g. tesidolumab, eculizumab, a 305 variant antibody or a homologous antibody thereof as herein above defined, and the
  • the study consists of up to 28 days of screening period, 16 weeks treatment period that can be extended to maximum of total 45 weeks (in case of inadequate suppression of serum complement after 16 weeks), 36 weeks follow up, and end of study visit (EOS) at week 52 (Figure 1). Duration of follow up depends on duration of treatment. Patients who are treated for more than 41 weeks proceed directly to EOS visit.
  • SoC standard of care treatment
  • immunosuppressive drugs such as rituximab, and plasmapheresis
  • tesidolumab plus SoC excluding plasmapheresis and prohibited treatments such as eculizumab, high dose IVIG, plasmapheresis in the tesidolumab treatment arm or live vaccinations in the tesidolumab treatment arm.
  • Patients are included in the study if they have diagnosis of TAM and poor prognostic markers. Inclusion of pediatric patients > 2 years old are allowed only after 5 patients > 12 years old have been dosed with tesidolumab and interim analysis reveals no safety issues after 4 weeks of treatment.

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • General Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Transplantation (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)

Abstract

La présente invention concerne des méthodes d'utilisation de médicaments, par exemple des anticorps tels que par exemple des anticorps anti-C5, qui sont capables d'inhiber la voie du complément pour traiter une microangiopathie associée à une greffe, en particulier après une transplantation de cellules hématopoïétiques.
PCT/IB2016/056073 2015-10-12 2016-10-11 Utilisation d'inhibiteurs de c5 dans la microangiopathies associée à une greffe Ceased WO2017064615A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201562240150P 2015-10-12 2015-10-12
US62/240,150 2015-10-12

Publications (1)

Publication Number Publication Date
WO2017064615A1 true WO2017064615A1 (fr) 2017-04-20

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TW (1) TW201718014A (fr)
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Cited By (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2017212391A1 (fr) * 2016-06-07 2017-12-14 Novartis Ag Schéma posologique d'un anticorps anti-c5
WO2017212392A1 (fr) * 2016-06-07 2017-12-14 Novartis Ag Tésidolumab pour utilisation dans le traitement du rejet de greffe
US10385122B2 (en) 2014-12-19 2019-08-20 Chugai Seiyaku Kabushiki Kaisha Nucleic acids encoding anti-C5 antibodies
US10472623B2 (en) 2008-04-11 2019-11-12 Chugai Seiyaku Kabushiki Kaisha Antigen-binding molecule capable of binding two or more antigen molecules repeatedly
WO2019246293A3 (fr) * 2018-06-19 2020-02-20 Atarga, Llc Molécules d'anticorps se liant au composant du complément 5 et leurs utilisations
US10633434B2 (en) 2016-06-14 2020-04-28 Regeneron Pharmaceuticals, Inc. Anti-C5 antibodies
WO2021058117A1 (fr) * 2019-09-27 2021-04-01 Volution Immuno Pharmaceuticals Sa Méthode de traitement de la microangiopathie thrombotique associée à une transplantation de cellules souches hématopoïétiques (hsct-tma)
US11046784B2 (en) 2006-03-31 2021-06-29 Chugai Seiyaku Kabushiki Kaisha Methods for controlling blood pharmacokinetics of antibodies
US11248053B2 (en) 2007-09-26 2022-02-15 Chugai Seiyaku Kabushiki Kaisha Method of modifying isoelectric point of antibody via amino acid substitution in CDR
US11365265B2 (en) 2017-12-13 2022-06-21 Regeneron Pharmaceuticals, Inc. Anti-C5 antibody combinations and uses thereof
US11891434B2 (en) 2010-11-30 2024-02-06 Chugai Seiyaku Kabushiki Kaisha Antigen-binding molecule capable of binding to plurality of antigen molecules repeatedly
WO2024054408A1 (fr) * 2022-09-06 2024-03-14 Alexion Pharmaceuticals, Inc. Dosage supplémentaire et administration d'anticorps anti-c5 pour le traitement de la microangiopathie thrombotique associée à une greffe de cellules souches hématopoïétiques (hsct-tma)
US12169205B2 (en) 2014-12-19 2024-12-17 Chugai Seiyaku Kabushiki Kaisha Anti-myostatin antibodies, polypeptides containing variant fc regions, and methods of use

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WO2015039126A1 (fr) * 2013-09-16 2015-03-19 Children hospital medical center Compositions et procédés pour le traitement de la microangiopathie thrombotique associée à la transplantation de cellules souches hématopoïétiques (tcsh)
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WO2015039126A1 (fr) * 2013-09-16 2015-03-19 Children hospital medical center Compositions et procédés pour le traitement de la microangiopathie thrombotique associée à la transplantation de cellules souches hématopoïétiques (tcsh)
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Cited By (27)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11046784B2 (en) 2006-03-31 2021-06-29 Chugai Seiyaku Kabushiki Kaisha Methods for controlling blood pharmacokinetics of antibodies
US12473375B2 (en) 2006-03-31 2025-11-18 Chugai Seiyaku Kabushiki Kaisha Methods for controlling blood pharmacokinetics of antibodies
US12122840B2 (en) 2007-09-26 2024-10-22 Chugai Seiyaku Kabushiki Kaisha Method of modifying isoelectric point of antibody via amino acid substitution in CDR
US12116414B2 (en) 2007-09-26 2024-10-15 Chugai Seiyaku Kabushiki Kaisha Method of modifying isoelectric point of antibody via amino acid substitution in CDR
US11248053B2 (en) 2007-09-26 2022-02-15 Chugai Seiyaku Kabushiki Kaisha Method of modifying isoelectric point of antibody via amino acid substitution in CDR
US10472623B2 (en) 2008-04-11 2019-11-12 Chugai Seiyaku Kabushiki Kaisha Antigen-binding molecule capable of binding two or more antigen molecules repeatedly
US11371039B2 (en) 2008-04-11 2022-06-28 Chugai Seiyaku Kabushiki Kaisha Antigen-binding molecule capable of binding to two or more antigen molecules repeatedly
US11359194B2 (en) 2008-04-11 2022-06-14 Chugai Seiyaku Kabushiki Kaisha Antigen-binding molecule capable of binding two or more antigen molecules repeatedly
US11891434B2 (en) 2010-11-30 2024-02-06 Chugai Seiyaku Kabushiki Kaisha Antigen-binding molecule capable of binding to plurality of antigen molecules repeatedly
US11597760B2 (en) 2014-12-19 2023-03-07 Chugai Seiyaku Kabushiki Kaisha Method of detecting the presence of complement C5
US12169205B2 (en) 2014-12-19 2024-12-17 Chugai Seiyaku Kabushiki Kaisha Anti-myostatin antibodies, polypeptides containing variant fc regions, and methods of use
US10385122B2 (en) 2014-12-19 2019-08-20 Chugai Seiyaku Kabushiki Kaisha Nucleic acids encoding anti-C5 antibodies
WO2017212392A1 (fr) * 2016-06-07 2017-12-14 Novartis Ag Tésidolumab pour utilisation dans le traitement du rejet de greffe
WO2017212391A1 (fr) * 2016-06-07 2017-12-14 Novartis Ag Schéma posologique d'un anticorps anti-c5
US10633434B2 (en) 2016-06-14 2020-04-28 Regeneron Pharmaceuticals, Inc. Anti-C5 antibodies
US11479602B2 (en) 2016-06-14 2022-10-25 Regeneren Pharmaceuticals, Inc. Methods of treating C5-associated diseases comprising administering anti-C5 antibodies
US11492392B2 (en) 2016-06-14 2022-11-08 Regeneran Pharmaceuticals, Inc. Polynucleotides encoding anti-C5 antibodies
US11365265B2 (en) 2017-12-13 2022-06-21 Regeneron Pharmaceuticals, Inc. Anti-C5 antibody combinations and uses thereof
US12084516B2 (en) 2017-12-13 2024-09-10 Regeneron Pharmaceuticals, Inc. Anti-C5 antibody combinations and uses thereof
EP3810269A2 (fr) * 2018-06-19 2021-04-28 Atarga, LLC Molécules d'anticorps se liant au composant du complément 5 et leurs utilisations
JP7472119B2 (ja) 2018-06-19 2024-04-22 アターガ，エルエルシー 補体第５成分に対する抗体分子およびその使用
WO2019246293A3 (fr) * 2018-06-19 2020-02-20 Atarga, Llc Molécules d'anticorps se liant au composant du complément 5 et leurs utilisations
CN112654394A (zh) * 2018-06-19 2021-04-13 阿塔盖有限责任公司 针对补体成分5的抗体分子和其用途
CN112654394B (zh) * 2018-06-19 2025-07-11 阿塔盖有限责任公司 针对补体成分5的抗体分子和其用途
JP2021528996A (ja) * 2018-06-19 2021-10-28 アターガ，エルエルシー 補体第５成分に対する抗体分子およびその使用
WO2021058117A1 (fr) * 2019-09-27 2021-04-01 Volution Immuno Pharmaceuticals Sa Méthode de traitement de la microangiopathie thrombotique associée à une transplantation de cellules souches hématopoïétiques (hsct-tma)
WO2024054408A1 (fr) * 2022-09-06 2024-03-14 Alexion Pharmaceuticals, Inc. Dosage supplémentaire et administration d'anticorps anti-c5 pour le traitement de la microangiopathie thrombotique associée à une greffe de cellules souches hématopoïétiques (hsct-tma)

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