WO2005065717A3 - Liquid formulations of antibody conjugates - Google Patents

Liquid formulations of antibody conjugates Download PDF

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Publication number
WO2005065717A3
WO2005065717A3 PCT/EP2004/014589 EP2004014589W WO2005065717A3 WO 2005065717 A3 WO2005065717 A3 WO 2005065717A3 EP 2004014589 W EP2004014589 W EP 2004014589W WO 2005065717 A3 WO2005065717 A3 WO 2005065717A3
Authority
WO
WIPO (PCT)
Prior art keywords
liquid formulations
antibodies
antibody
antibody conjugates
relates
Prior art date
Application number
PCT/EP2004/014589
Other languages
German (de)
French (fr)
Other versions
WO2005065717A2 (en
Inventor
Patrick Garidel
Karoline Bechtold-Peters
Christian Berger
Stefan Bassarab
Original Assignee
Boehringer Ingelheim Int
Boehringer Ingelheim Pharma
Patrick Garidel
Karoline Bechtold-Peters
Christian Berger
Stefan Bassarab
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 Int, Boehringer Ingelheim Pharma, Patrick Garidel, Karoline Bechtold-Peters, Christian Berger, Stefan Bassarab filed Critical Boehringer Ingelheim Int
Publication of WO2005065717A2 publication Critical patent/WO2005065717A2/en
Publication of WO2005065717A3 publication Critical patent/WO2005065717A3/en

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

Abstract

The invention relates to liquid pharmaceutical antibody compositions, preferably of antibodies that are conjugated to a maytansinoid. The invention especially relates to stable formulations of antibody DM1 complexes. The invention also relates to preparations of antibodies. The stability of the product, preferably of antibodies, that are conjugated to an effector molecule can be increased by adding cyclodextrins and/or by reducing the pH. The invention especially relates to stable liquid formulations of antibody DM1 complexes and to methods for producing the same.
PCT/EP2004/014589 2003-12-24 2004-12-22 Liquid formulations of antibody conjugates WO2005065717A2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE10361599A DE10361599A1 (en) 2003-12-24 2003-12-24 Liquid formulation of antibody conjugates
DE10361599.7 2003-12-24

Publications (2)

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

Family

ID=34706676

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2004/014589 WO2005065717A2 (en) 2003-12-24 2004-12-22 Liquid formulations of antibody conjugates

Country Status (3)

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

Cited By (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

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AR046774A1 (en) * 2003-12-24 2005-12-21 Boehringer Ingelheim Pharma LIOFILIZED FORMULATION OF ANTIBODY CONJUGATES
EA014513B1 (en) 2005-08-03 2010-12-30 Иммьюноджен, Инк. Immunoconjugate formulations
EP2358395A4 (en) * 2008-11-17 2013-11-20 Hoffmann La Roche Method and formulation for reducing aggregation of a macromolecule under physiological conditions
EA201591710A1 (en) 2013-03-13 2016-03-31 Сиэтл Дженетикс, Инк. COMPOSITIONS CONTAINING CYCLODEXTRIN AND CONJUGATE ANTIBODY AND MEDICINE
IL299759A (en) 2015-12-30 2023-03-01 Genentech Inc Formulations with reduced degradation of polysorbate

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 (en) * 2003-12-24 2005-07-21 Boehringer Ingelheim International Gmbh Lyophilized antibody conjugate formulation

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 (en) * 2003-12-24 2005-07-21 Boehringer Ingelheim International Gmbh Lyophilized antibody conjugate formulation

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, vol. 37, 20 April 1996 (1996-04-20), pages 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, vol. 93, no. 16, 1996, pages 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, vol. 8, no. 10, October 1991 (1991-10-01), pages 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, vol. 62, no. 9, 1 May 2002 (2002-05-01), pages 2546 - 2553, XP001191282, ISSN: 0008-5472 *
SMITH S: "TECHNOLOGY EVALUATION: C242-DM1, IMMUNOGEN INC", CURRENT OPINION IN MOLECULAR THERAPEUTICS, CURRENT DRUGS, LONDON,, GB, vol. 3, no. 2, April 2001 (2001-04-01), pages 198 - 203, XP008011026, ISSN: 1464-8431 *

Cited By (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

Also Published As

Publication number Publication date
DE10361599A1 (en) 2005-07-28
WO2005065717A2 (en) 2005-07-21
TW200529871A (en) 2005-09-16

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