WO2005065709A3 - Formulation lyophilisee de conjugues d'anticorps - Google Patents

Formulation lyophilisee de conjugues d'anticorps Download PDF

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Publication number
WO2005065709A3
WO2005065709A3 PCT/EP2004/014585 EP2004014585W WO2005065709A3 WO 2005065709 A3 WO2005065709 A3 WO 2005065709A3 EP 2004014585 W EP2004014585 W EP 2004014585W WO 2005065709 A3 WO2005065709 A3 WO 2005065709A3
Authority
WO
WIPO (PCT)
Prior art keywords
antibody conjugate
lyophilized antibody
conjugate formulation
antibody
relates
Prior art date
Application number
PCT/EP2004/014585
Other languages
German (de)
English (en)
Other versions
WO2005065709A2 (fr
Inventor
Patrick Garidel
Stefan Bassarab
Nicole Denkinger
Christian Berger
Original Assignee
Boehringer Ingelheim Int
Boehringer Ingelheim Pharma
Patrick Garidel
Stefan Bassarab
Nicole Denkinger
Christian Berger
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
Priority claimed from DE2003161598 external-priority patent/DE10361598A1/de
Priority claimed from DE102004014783A external-priority patent/DE102004014783A1/de
Application filed by Boehringer Ingelheim Int, Boehringer Ingelheim Pharma, Patrick Garidel, Stefan Bassarab, Nicole Denkinger, Christian Berger filed Critical Boehringer Ingelheim Int
Publication of WO2005065709A2 publication Critical patent/WO2005065709A2/fr
Publication of WO2005065709A3 publication Critical patent/WO2005065709A3/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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides 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
    • A61K47/06—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
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents

Landscapes

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

Abstract

L'invention concerne des compositions pharmaceutiques lyophilisées d'anticorps, de préférence, d'anticorps conjugués à un maytansinoïde. La présente invention concerne notamment des formulations lyophilisées stables de complexes d'anticorps-DM1. L'invention concerne également un procédé de lyophilisation de complexes d'anticorps-DM.
PCT/EP2004/014585 2003-12-24 2004-12-22 Formulation lyophilisee de conjugues d'anticorps WO2005065709A2 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
DE2003161598 DE10361598A1 (de) 2003-12-24 2003-12-24 Gefriergetrocknete Formulierung von Antikörperkonjugaten
DE10361598.9 2003-12-24
DE102004014783A DE102004014783A1 (de) 2004-03-24 2004-03-24 Gefriergetrocknete Formulierung von Antikörperkonjugaten
DE102004014783.3 2004-03-24

Publications (2)

Publication Number Publication Date
WO2005065709A2 WO2005065709A2 (fr) 2005-07-21
WO2005065709A3 true WO2005065709A3 (fr) 2006-08-24

Family

ID=34751258

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2004/014585 WO2005065709A2 (fr) 2003-12-24 2004-12-22 Formulation lyophilisee de conjugues d'anticorps

Country Status (3)

Country Link
AR (1) AR046774A1 (fr)
TW (1) TW200533375A (fr)
WO (1) WO2005065709A2 (fr)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE10361599A1 (de) * 2003-12-24 2005-07-28 Boehringer Ingelheim Pharma Gmbh & Co. Kg Flüssigformulierung von Antikörperkonjugaten
EA014513B1 (ru) 2005-08-03 2010-12-30 Иммьюноджен, Инк. Композиция иммуноконъюгата
GB201220901D0 (en) 2012-11-21 2013-01-02 Kit Karlsrusher Inst Fuer Technologie Und Inst Fuer Toxikologie Und Genetik And Amcure Gmbh CD44v6-derived peptides for treating pancreatic cancer
GB201220889D0 (en) * 2012-11-21 2013-01-02 Kit Karlsrusher Inst Fuer Technologie Und Inst Fuer Toxikologie Und Genetik And Amcure Gmbh CD44v6-derived peptides for treating metastasizing cancers
GB201220891D0 (en) * 2012-11-21 2013-01-02 Kit Karlsrusher Inst Fuer Technologie Und Inst Fuer Toxikologie Und Genetik And Amcure Gmbh CD44v6-derived peptides for treating breast cancers
EA201591710A1 (ru) 2013-03-13 2016-03-31 Сиэтл Дженетикс, Инк. Композиции, содержащие циклодекстрин и конъюгат антитело-лекарственное средство
GB201421647D0 (en) 2014-12-05 2015-01-21 Amcure Gmbh And Ruprecht-Karls-Universitat And Karlsruher Institut F�R Technologie CD44v6-derived cyclic peptides for treating cancers and angiogenesis related diseases
CN113474360A (zh) 2019-02-18 2021-10-01 伊莱利利公司 治疗性抗体制剂
CN116479088A (zh) * 2022-11-15 2023-07-25 江苏默乐生物科技股份有限公司 一种生物试剂冻干保存的试剂组合、试剂盒、方法及应用

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
WO2005065717A2 (fr) * 2003-12-24 2005-07-21 Boehringer Ingelheim International Gmbh Formulations liquides 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
WO2005065717A2 (fr) * 2003-12-24 2005-07-21 Boehringer Ingelheim International Gmbh Formulations liquides de conjugues d'anticorps

Non-Patent Citations (7)

* Cited by examiner, † Cited by third party
Title
ANDYA J ET AL: "The Effect of Sugars and Buffer Excipients on the Stabilization of a Lyophilized Formulation for an Anti-IgE Humanized Monoclonal Antibody", PHARMACEUTICAL RESEARCH, NEW YORK, NY, US, vol. 13, no. 9, 1996, pages S78, BIOTECH 2008, XP002987379, ISSN: 0724-8741 *
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 *
WILLIAMS N A ET AL: "THE LYOPHILIZATION OF PHARMACEUTICALS: A LITERATURE REVIEW", JOURNAL OF PARENTERAL SCIENCE AND TECHNOLOGY, vol. 38, no. 2, 1 March 1984 (1984-03-01), pages 48 - 59, XP000670830, ISSN: 0279-7976 *

Also Published As

Publication number Publication date
WO2005065709A2 (fr) 2005-07-21
TW200533375A (en) 2005-10-16
AR046774A1 (es) 2005-12-21

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