WO2005065717A2 - Formulations liquides de conjugues d'anticorps - Google Patents

Formulations liquides de conjugues d'anticorps Download PDF

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Publication number
WO2005065717A2
WO2005065717A2 PCT/EP2004/014589 EP2004014589W WO2005065717A2 WO 2005065717 A2 WO2005065717 A2 WO 2005065717A2 EP 2004014589 W EP2004014589 W EP 2004014589W WO 2005065717 A2 WO2005065717 A2 WO 2005065717A2
Authority
WO
WIPO (PCT)
Prior art keywords
antibody
cyclodextrin
antibodies
conjugate
cancer
Prior art date
Application number
PCT/EP2004/014589
Other languages
German (de)
English (en)
Other versions
WO2005065717A3 (fr
Inventor
Patrick Garidel
Karoline Bechtold-Peters
Christian Berger
Stefan Bassarab
Original Assignee
Boehringer Ingelheim International Gmbh
Boehringer Ingelheim Pharma Gmbh & Co. Kg
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 Boehringer Ingelheim International Gmbh, Boehringer Ingelheim Pharma Gmbh & Co. Kg filed Critical Boehringer Ingelheim International Gmbh
Publication of WO2005065717A2 publication Critical patent/WO2005065717A2/fr
Publication of WO2005065717A3 publication Critical patent/WO2005065717A3/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/40—Cyclodextrins; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A61K47/6801—Drug-antibody or immunoglobulin conjugates defined by the pharmacologically or therapeutically active agent
    • A61K47/6803—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates
    • A61K47/68033—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates the drug being a maytansine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/69—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit
    • A61K47/6949—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes
    • A61K47/6951—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes using cyclodextrin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B82—NANOTECHNOLOGY
    • B82Y—SPECIFIC USES OR APPLICATIONS OF NANOSTRUCTURES; MEASUREMENT OR ANALYSIS OF NANOSTRUCTURES; MANUFACTURE OR TREATMENT OF NANOSTRUCTURES
    • B82Y5/00—Nanobiotechnology or nanomedicine, e.g. protein engineering or drug delivery

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Inorganic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nanotechnology (AREA)
  • Molecular Biology (AREA)
  • Organic Chemistry (AREA)
  • Crystallography & Structural Chemistry (AREA)
  • General Engineering & Computer Science (AREA)
  • Biotechnology (AREA)
  • Biophysics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Biochemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dermatology (AREA)
  • Immunology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)

Abstract

La présente invention concerne des compositions pharmaceutiques liquides d'anticorps, de préférence d'anticorps qui sont conjugués à un maytansinoïde. L'invention concerne notamment les formulations stables de complexes d'anticorps-DM1.
PCT/EP2004/014589 2003-12-24 2004-12-22 Formulations liquides de conjugues d'anticorps WO2005065717A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE10361599A DE10361599A1 (de) 2003-12-24 2003-12-24 Flüssigformulierung von Antikörperkonjugaten
DE10361599.7 2003-12-24

Publications (2)

Publication Number Publication Date
WO2005065717A2 true WO2005065717A2 (fr) 2005-07-21
WO2005065717A3 WO2005065717A3 (fr) 2006-08-31

Family

ID=34706676

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2004/014589 WO2005065717A2 (fr) 2003-12-24 2004-12-22 Formulations liquides de conjugues d'anticorps

Country Status (3)

Country Link
DE (1) DE10361599A1 (fr)
TW (1) TW200529871A (fr)
WO (1) WO2005065717A2 (fr)

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005065709A2 (fr) * 2003-12-24 2005-07-21 Boehringer Ingelheim International Gmbh Formulation lyophilisee de conjugues d'anticorps
EP2358395A1 (fr) * 2008-11-17 2011-08-24 F. Hoffmann-La Roche AG Procédé et formulation pour réduire l'agrégation d'une macromolécule dans des conditions physiologiques
US9114179B2 (en) 2005-08-03 2015-08-25 Immunogen, Inc. Immunoconjugate formulations
US9610361B2 (en) 2013-03-13 2017-04-04 Seattle Genetics, Inc. Cyclodextrin and antibody-drug conjugate formulations
US20170189536A1 (en) * 2015-12-30 2017-07-06 Genentech, Inc. Formulations with reduced degradation of polysorbate

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8883979B2 (en) 2012-08-31 2014-11-11 Bayer Healthcare Llc Anti-prolactin receptor antibody formulations

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5416064A (en) * 1989-10-25 1995-05-16 Immunogen, Inc. Cytotoxic agents comprising maytansinoids and their therapeutic use
WO2005065709A2 (fr) * 2003-12-24 2005-07-21 Boehringer Ingelheim International Gmbh Formulation lyophilisee de conjugues d'anticorps

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5416064A (en) * 1989-10-25 1995-05-16 Immunogen, Inc. Cytotoxic agents comprising maytansinoids and their therapeutic use
WO2005065709A2 (fr) * 2003-12-24 2005-07-21 Boehringer Ingelheim International Gmbh Formulation lyophilisee de conjugues d'anticorps

Non-Patent Citations (5)

* Cited by examiner, † Cited by third party
Title
LIU C ET AL: "CURE OF LARGE HUMAN COLON XENOGRAFTS BY A C242-MAYTANSINOID CONJUGATE" PROCEEDINGS OF THE ANNUAL MEETING OF THE AMERICAN ASSOCIATION FOR CANCER RESEARCH, NEW YORK, NY, US, Bd. 37, 20. April 1996 (1996-04-20), Seiten 466-467, XP008011025 ISSN: 0197-016X *
LIU CHANGNIAN ET AL: "Eradication of large colon tumor xenografts by targeted delivery of maytansinoids" PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF USA, NATIONAL ACADEMY OF SCIENCE, WASHINGTON, DC, US, Bd. 93, Nr. 16, 1996, Seiten 8618-8623, XP002181060 ISSN: 0027-8424 *
RIGGIN A ET AL: "SOLUTION STABILITY OF THE MONOCLONAL ANTIBODY-VINCA ALKALOID CONJUGATE, KS1/4-DAVLB" PHARMACEUTICAL RESEARCH, NEW YORK, NY, US, Bd. 8, Nr. 10, Oktober 1991 (1991-10), Seiten 1264-1269, XP000986327 ISSN: 0724-8741 *
ROSS S ET AL: "PROSTATE STEM CELL ANTIGEN AS THERAPY TARGET: TISSUE EXPRESSION AND IN VIVO EFFICACY OF AN IMMUNOCONJUGATE" CANCER RESEARCH, AMERICAN ASSOCIATION FOR CANCER RESEARCH, BALTIMORE, MD, US, Bd. 62, Nr. 9, 1. Mai 2002 (2002-05-01), Seiten 2546-2553, XP001191282 ISSN: 0008-5472 *
SMITH S: "TECHNOLOGY EVALUATION: C242-DM1, IMMUNOGEN INC" CURRENT OPINION IN MOLECULAR THERAPEUTICS, CURRENT DRUGS, LONDON,, GB, Bd. 3, Nr. 2, April 2001 (2001-04), Seiten 198-203, XP008011026 ISSN: 1464-8431 *

Cited By (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005065709A3 (fr) * 2003-12-24 2006-08-24 Boehringer Ingelheim Int Formulation lyophilisee de conjugues d'anticorps
WO2005065709A2 (fr) * 2003-12-24 2005-07-21 Boehringer Ingelheim International Gmbh Formulation lyophilisee de conjugues d'anticorps
US9114179B2 (en) 2005-08-03 2015-08-25 Immunogen, Inc. Immunoconjugate formulations
EP2358395A1 (fr) * 2008-11-17 2011-08-24 F. Hoffmann-La Roche AG Procédé et formulation pour réduire l'agrégation d'une macromolécule dans des conditions physiologiques
JP2012509269A (ja) * 2008-11-17 2012-04-19 ジェネンテック， インコーポレイテッド 生理的条件下での高分子の凝集を低減するための方法及び製剤
EP2358395A4 (fr) * 2008-11-17 2013-11-20 Hoffmann La Roche Procédé et formulation pour réduire l'agrégation d'une macromolécule dans des conditions physiologiques
US9987374B2 (en) 2013-03-13 2018-06-05 Seattle Genetics, Inc. Cyclodextrin and antibody-drug conjugate formulations
US9610361B2 (en) 2013-03-13 2017-04-04 Seattle Genetics, Inc. Cyclodextrin and antibody-drug conjugate formulations
US10391181B2 (en) 2013-03-13 2019-08-27 Seattle Genetics, Inc. Cyclodextrin and antibody-drug conjugate formulations
WO2017117311A1 (fr) * 2015-12-30 2017-07-06 Genentech, Inc. Formulations présentant une moindre dégradation des polysorbates
CN108472379A (zh) * 2015-12-30 2018-08-31 豪夫迈·罗氏有限公司 减少聚山梨酯降解的制剂
US20170189536A1 (en) * 2015-12-30 2017-07-06 Genentech, Inc. Formulations with reduced degradation of polysorbate
US10525137B2 (en) 2015-12-30 2020-01-07 Genentech, Inc. Formulations with reduced degradation of polysorbate
US10933141B2 (en) 2015-12-30 2021-03-02 Genentech, Inc. Formulations with reduced degradation of polysorbate
CN108472379B (zh) * 2015-12-30 2022-06-21 豪夫迈·罗氏有限公司 减少聚山梨酯降解的制剂
IL259646B2 (en) * 2015-12-30 2023-06-01 Genentech Inc Formulations with reduced polysorbate dissolution

Also Published As

Publication number Publication date
WO2005065717A3 (fr) 2006-08-31
TW200529871A (en) 2005-09-16
DE10361599A1 (de) 2005-07-28

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