WO2000064487A2 - Apport de toxines antimicrobiennes - Google Patents

Apport de toxines antimicrobiennes Download PDF

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Publication number
WO2000064487A2
WO2000064487A2 PCT/US2000/008389 US0008389W WO0064487A2 WO 2000064487 A2 WO2000064487 A2 WO 2000064487A2 US 0008389 W US0008389 W US 0008389W WO 0064487 A2 WO0064487 A2 WO 0064487A2
Authority
WO
WIPO (PCT)
Prior art keywords
antimicrobial
ligand
antibody
toxin
conjugate
Prior art date
Application number
PCT/US2000/008389
Other languages
English (en)
Other versions
WO2000064487A8 (fr
Inventor
Wenda C. Carlyle
Original Assignee
St. Jude Medical, Inc.
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 St. Jude Medical, Inc. filed Critical St. Jude Medical, Inc.
Priority to BR0009947-3A priority Critical patent/BR0009947A/pt
Priority to JP2000613477A priority patent/JP2003523315A/ja
Priority to EP00921508A priority patent/EP1212094A2/fr
Publication of WO2000064487A2 publication Critical patent/WO2000064487A2/fr
Publication of WO2000064487A8 publication Critical patent/WO2000064487A8/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/14—Materials characterised by their function or physical properties, e.g. lubricating compositions
    • A61L29/16—Biologically active materials, e.g. therapeutic substances
    • 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
    • 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
    • A61K47/6811—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates the drug being a protein or peptide, e.g. transferrin or bleomycin
    • A61K47/6817—Toxins
    • A61K47/6819—Plant toxins
    • A61K47/6825—Ribosomal inhibitory proteins, i.e. RIP-I or RIP-II, e.g. Pap, gelonin or dianthin
    • 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
    • A61K47/6957—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 the form being a device or a kit, e.g. stents or microdevices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/54—Biologically active materials, e.g. therapeutic substances
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
    • A61L2300/252—Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines
    • A61L2300/254—Enzymes, proenzymes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
    • A61L2300/252—Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines
    • A61L2300/256—Antibodies, e.g. immunoglobulins, vaccines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/404—Biocides, antimicrobial agents, antiseptic agents

Definitions

  • the invention relates to the delivery of antimicrobial toxins using antimicrobial antibodies/ ligands conjugated with the toxins.
  • antibodies/ligands having affinities for microorganisms are conjugated with toxins that kill or inhibit at least some forms of microorganisms.
  • the invention further relates to medical devices associated with toxin- conjugated antimicrobial antibodies/ligands.
  • microorganisms can be associated with disease in animals.
  • the diseases can be due to a systemic infection with microorganisms or due to proliferation of microorganisms in a localized area of the body, such as sinuses or gastrointestinal track.
  • a systemic infection with microorganisms or due to proliferation of microorganisms in a localized area of the body, such as sinuses or gastrointestinal track.
  • many microbial infections can be difficult to treat and remain potentially fatal.
  • serious microbial infections can be associated with the invasive use of
  • Medical articles are being developed that incorporate standard antibiotics on the surface of the device.
  • the in vitro efficacy of these modified articles has yet to be determined.
  • their use on a permanently indwelling device such as a heart valve prosthesis may be contraindicated in certain embodiments due to the increased risk of developing an antibiotic resistant infection.
  • the invention pertains to an antimicrobial conjugate comprising an antibody or ligand associated with an antimicrobial agent.
  • the antibody or ligand has an affinity for microbial antigens or receptors.
  • the invention pertains to a medical article comprising a biocompatible material associated with an antimicrobial conjugate.
  • the antimicrobial conjugate comprises an antibody or ligand bonded to an antimicrobial agent.
  • the antibody or ligand has an affinity for microbial antigens or receptors .
  • the invention pertains to a method of eliminating viable microorganisms comprising placing an antimicrobial conjugate in contact with a solution from which viable microorganisms are to be eliminated.
  • the antimicrobial conjugate preferably comprises an antibody or ligand associated with an antimicrobial agent.
  • the antibody or ligand has an affinity for microbial antigens or receptors.
  • the toxin is brought into physical proximity with a microorganism.
  • the microbial cell that attaches to the antibody/ligand becomes the target of the toxin associated with the antibody/ligand. Since the antibodies/ligands direct the toxin to a microorganism, any potential toxicity to the patient's cells is reduced or eliminated. Furthermore, due to synergism resulting from targeting with the antibody/ ligand, the effectiveness of the toxin against the microorganisms should increase significantly for a particular amount of toxin.
  • the toxins are conjugated to an antibody or ligand, either natural or synthetic, to direct the toxin to target microorganisms .
  • the term antibody is intended for broad interpretation as any type of immunoglobulin, modified immunoglobulins and/or fragments thereof.
  • the specific binding portion of an appropriate antibody recognizes a cell surface feature, generally a cell surface antigen, of target microorganisms.
  • the term ligand is intended for broad interpretation ' as any specific binding agent, other than an antibody, that has specificity for a cell receptor, generally a cell surface receptor.
  • Bacterial adhesins can be divided into two major groups: pili or fimbriae adhesins and non-pilus or afimbrial adhesins.
  • pili or fimbriae adhesins and non-pilus or afimbrial adhesins.
  • a single pathogen may express many different adhesins, and some of these organisms have a highly evolved capacity for genetic rearrangement that allows for antigenic variation.
  • RIP immunotoxin as an antimicrobial toxin.
  • these are very potent toxins with an enzymatic nechanism and IC 50 (concentration to achieve 50 percent protein synthesis inhibition) values in the nanomolar range .
  • IC 50 values for ricin A-chain activity is described by Press et a1. , Immunol. Letters, 14:37-41 (1986), incorporated herein by reference. Only low levels of antibody/ligand binding are needed to produce toxicity. The implication is that antibodies/ligands binding even minor components of the bacterial cell surface can be used as targets. This increases the likelihood of finding appropriate cross- strain antigens for broad spectrum toxicity.
  • the medical article can be constructed such that the additional antimicrobial agents are associated with only a particular region of the medical article, such as at different portions of a biocompatible material or in different biocompatible materials of the medical device.
  • a region of the medical article is not associated with toxin-conjugated antibodies/ligands, that region can be associated with an alternative antimicrobial agent to reduce the risk of infection.
  • the toxin conjugated antibodies/ligands preferably are formulated into a pharmaceutical composition for packaging and distribution.
  • the packages generally include instructions for administration of the composition and other labels including labels required by the Food and Drug Administration.
  • the toxin-conjugated antibodies/ligands can be formulated into injectable preparations, preparations for oral administration and/or topical preparations.
  • Preferred injectable formulations include therapeutically effective amounts of toxin-conjugated antibodies/ligands in a sterile liquid solution or a sterile liquid suspension, particularly a glycerol suspension. Lyophilized versions of the formulations can be prepared, which are reconstituted later with injectable liquid carriers, such as sterile water, saline, or 0.3% glycine.
  • a solution of the toxin- conjugated antibody/ligand is packaged separately from the medical article along with instructions for performing modification of a medical article and, optionally, distributed together as a kit.
  • a kit can be distributed comprising a container of the toxin-conjugated antibody/ligand and a separate container of a chemical binding agent or an adhesive, optionally along with instructions for modification of a biocompatible material.
  • a selected medical device can be modified using the compositions from the kit prior to medical use. Once the medical device is modified with the toxin-conjugated antibody/ligand, it can be implanted/applied or stored for a reasonable period of time .
  • incorpora toxin-conjugated antibody/ ligand into a medical device can reduce the risk of infection associated with the contact of the medical article with the patient's bodily fluids or tissue. Reduction in the risk of infection thereby reduces associated health risks to the patient from microbial infections associated with implantation of the medical article. By reducing the risk of infection, there is a corresponding reduction in the need for replacement of the medical article.
  • the toxin-conjugated antibodies/ligands are particularly effective for the treatment of microorganisms that are resistant and infections, such as biofilms, which are difficult to treat. Furthermore, the toxin-conjugated antibodies/ligands are more easily able to target specific microorganisms.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Molecular Biology (AREA)
  • Biomedical Technology (AREA)
  • Immunology (AREA)
  • Toxicology (AREA)
  • Organic Chemistry (AREA)
  • Oncology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Dermatology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Botany (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Communicable Diseases (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Peptides Or Proteins (AREA)
  • Materials For Medical Uses (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)

Abstract

La présente invention concerne un conjugué antimicrobien (100, 120, 154) comprenant un anticorps (100, 122) ou un ligand lié à un agent antimicrobien (106, 124). L'anticorps (102, 122, 154) ou le ligand présente une affinité pour des antigènes ou des récepteurs microbiens. Le conjugué antimicrobien (100, 120, 154) peut être utilisé seul ou en association avec un matériau biocompatible (152) incorporé dans un dispositif médical (150). Ce conjugué (100, 120, 154) peut être placé en contact avec une solution afin d'éliminer de la solution des micro-organismes viables. En particulier, il (100, 120, 154) peut être utilisé afin de réduire le risque d'infection associé au contact d'un dispositif médical avec des tissus ou des fluides corporels de patients.
PCT/US2000/008389 1999-04-23 2000-03-30 Apport de toxines antimicrobiennes WO2000064487A2 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
BR0009947-3A BR0009947A (pt) 1999-04-23 2000-03-30 Conjugado antimicrobiano, método de eliminar microorganismos viáveis, dispositivo médico, e, método de formar um conjugado antimicrobiano
JP2000613477A JP2003523315A (ja) 1999-04-23 2000-03-30 抗菌剤と接合した抗体またはリガンドを含む抗菌性接合体
EP00921508A EP1212094A2 (fr) 1999-04-23 2000-03-30 Apport de toxines antimicrobiennes

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US29863899A 1999-04-23 1999-04-23
US09/298,638 1999-04-23

Publications (2)

Publication Number Publication Date
WO2000064487A2 true WO2000064487A2 (fr) 2000-11-02
WO2000064487A8 WO2000064487A8 (fr) 2002-01-31

Family

ID=23151378

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2000/008389 WO2000064487A2 (fr) 1999-04-23 2000-03-30 Apport de toxines antimicrobiennes

Country Status (5)

Country Link
EP (1) EP1212094A2 (fr)
JP (1) JP2003523315A (fr)
BR (1) BR0009947A (fr)
WO (1) WO2000064487A2 (fr)
ZA (1) ZA200108639B (fr)

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2002036612A1 (fr) * 2000-11-03 2002-05-10 Cambridge University Technical Services Limited Agents antibacteriens comprenant des conjugues de glycopeptides et des elements peptidiques d'association membranaire
WO2004030823A1 (fr) * 2002-09-27 2004-04-15 Micronas Holding Gmbh Procede et dispositif pour determiner la concentration de ligands contenus dans un echantillon liquide
WO2013130538A3 (fr) * 2012-02-27 2015-03-12 Beech Tree Labs, Inc. Méthode de traitement de la broncho-pneumopathie chronique obstructive
WO2017083515A3 (fr) * 2015-11-10 2017-07-13 Visterra, Inc. Conjugués molécules anticorps-médicaments et leurs utilisations
US11890319B2 (en) 2017-01-18 2024-02-06 Visterra, Inc. Antibody molecule-drug conjugates and uses thereof
US11969476B2 (en) 2020-04-03 2024-04-30 Visterra, Inc. Antibody molecule-drug conjugates and uses thereof

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ATE292475T1 (de) * 1999-09-16 2005-04-15 Unilever Nv Abgabesystem für ein mittel gegen schuppen

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
No Search *

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2002036612A1 (fr) * 2000-11-03 2002-05-10 Cambridge University Technical Services Limited Agents antibacteriens comprenant des conjugues de glycopeptides et des elements peptidiques d'association membranaire
US7078380B2 (en) 2000-11-03 2006-07-18 Cambridge University Technical Services Limited Antibacterial agents comprising conjugates of glycopeptides and peptidic membrane associating elements
WO2004030823A1 (fr) * 2002-09-27 2004-04-15 Micronas Holding Gmbh Procede et dispositif pour determiner la concentration de ligands contenus dans un echantillon liquide
WO2013130538A3 (fr) * 2012-02-27 2015-03-12 Beech Tree Labs, Inc. Méthode de traitement de la broncho-pneumopathie chronique obstructive
US8980826B2 (en) 2012-02-27 2015-03-17 Beech Tree Labs, Inc. Method of treating chronic obstructive pulmonary disease
WO2017083515A3 (fr) * 2015-11-10 2017-07-13 Visterra, Inc. Conjugués molécules anticorps-médicaments et leurs utilisations
US11168131B2 (en) 2015-11-10 2021-11-09 Visterra, Inc. Antibody molecule-drug conjugates and uses thereof
US11890319B2 (en) 2017-01-18 2024-02-06 Visterra, Inc. Antibody molecule-drug conjugates and uses thereof
US11969476B2 (en) 2020-04-03 2024-04-30 Visterra, Inc. Antibody molecule-drug conjugates and uses thereof

Also Published As

Publication number Publication date
EP1212094A2 (fr) 2002-06-12
BR0009947A (pt) 2002-12-31
ZA200108639B (en) 2003-07-30
WO2000064487A8 (fr) 2002-01-31
JP2003523315A (ja) 2003-08-05

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