EP1056471A1 - TRAITEMENT DE LA DERMATITE ATOPIQUE A L'AIDE D'ANTAGONISTES D'IgE - Google Patents

TRAITEMENT DE LA DERMATITE ATOPIQUE A L'AIDE D'ANTAGONISTES D'IgE

Info

Publication number
EP1056471A1
EP1056471A1 EP99901309A EP99901309A EP1056471A1 EP 1056471 A1 EP1056471 A1 EP 1056471A1 EP 99901309 A EP99901309 A EP 99901309A EP 99901309 A EP99901309 A EP 99901309A EP 1056471 A1 EP1056471 A1 EP 1056471A1
Authority
EP
European Patent Office
Prior art keywords
ige
pharmaceutical composition
atopic dermatitis
antibody
human
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.)
Withdrawn
Application number
EP99901309A
Other languages
German (de)
English (en)
Other versions
EP1056471A4 (fr
Inventor
Tse Wen National Tsing Hua University CHANG
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Tanox Inc
Original Assignee
Tanox 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 Tanox Inc filed Critical Tanox Inc
Publication of EP1056471A1 publication Critical patent/EP1056471A1/fr
Publication of EP1056471A4 publication Critical patent/EP1056471A4/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/42Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against immunoglobulins
    • C07K16/4283Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against immunoglobulins against an allotypic or isotypic determinant on Ig
    • C07K16/4291Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against immunoglobulins against an allotypic or isotypic determinant on Ig against IgE
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/08Antiallergic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered

Definitions

  • the invention relates to use anti-IgE antagonists, including monoclonal
  • Immunoglobulin E is one class of immunoglobulin (or "antibody")
  • IgE is present in human serum in lower concentrations than the other
  • immunoglobulins IgG, IgM, IgA, and IgD.
  • IgE is thought to have a role in protection
  • IgE is well known as the mediator of
  • IgE In IgE-mediated allergic reactions, IgE, after it is secreted by B cells, binds
  • IgE molecules and hence the underlying receptors, and triggers the release of
  • pharmacologic mediators such as histamine, serotonin, leukotrienes and the slow-
  • dermatitis is characterized by pruritis (itching), redness, and painful skin lesions.
  • the skin can become lichenified.
  • atopic dermatitis may have a link to IgE, but that IgE alone is not the causative
  • a particular class of anti-IgE antibodies has been developed to treat allergic
  • anti-IgE antibodies also bind to IgE which is attached to the membrane of IgE-
  • B cells the "membrane form of IgE". By doing so, they may further aid
  • ADCC ADCC
  • complement mediated cytolysis the IgE-producing B cells
  • Such antagonists would include small
  • the invention includes a pharmaceutical composition for treating atopic
  • dermatitis comprising IgE antagonists which do not induce release of the
  • Such antagonists include monoclonal anti-IgE
  • the anti-IgE antibodies present on basophils, mast cells, or Langerhans cells.
  • the anti-IgE antibodies are present on basophils, mast cells, or Langerhans cells.
  • anti-IgE antibodies preferably do not bind to IgE bound to the low affinity 4 Fc ⁇ RI I receptors. If the antibodies of the invention did bind to IgE bound to the low affinity 4 Fc ⁇ RI I receptors. If the antibodies of the invention did bind to IgE bound to the low affinity 4 Fc ⁇ RI I receptors. If the antibodies of the invention did bind to IgE bound to the low affinity 4 Fc ⁇ RI I receptors. If the antibodies of the invention did bind to IgE bound to the
  • anti-IgE should prove to be a substantial
  • IgE antagonist chosen is anti-IgE antibody, it can be modified in order
  • the antibodies have a human lgG1 or lgG3 constant heavy
  • composition which is not subject to digestive degradation, or through the alveoli of the 5 lung by an inhaler. It may also be possible to administer the composition topically
  • the monoclonal anti-IgE antibodies used with are 100 in one specific embodiment, the monoclonal anti-IgE antibodies used with
  • this invention are produced by continuous (immortalized), stable, antibody-
  • the preferred antibody-producing cell lines are hybridoma and
  • transfector ⁇ a cell lines can be any cell lines which contain and are
  • Lymphoid cells which naturally produce assembled
  • immunoglobulin are preferred.
  • Hybridoma cells which produce the specific antibodies used with this
  • IgE antibodies are produced by immunizing an animal with human IgE or IgE-
  • Peptides can be synthesized or produced by recombinant DNA technology
  • lymphoid cells ⁇ e.g., splenic
  • lymphocytes are obtained from the immunized animal and fused with immortalizing
  • hybrid cells ⁇ e.g., myeloma or heteromyeloma) to produce hybrid cells.
  • the hybrid cells ⁇ e.g., myeloma or heteromyeloma
  • anti-IgE is used for treating atopic dermatitis
  • antibodies be either human or substantially human, to reduce or eliminate the
  • HAMA human anti-mouse
  • Human hybridomas which secrete human antibodies can be produced by the following
  • mice are then cross-bred to generate the human antibody
  • human antibody fragments for example, the single chain Fv region, by the phage
  • PCR PCR reaction
  • antibodies is to produce them in a rodent system, and convert them into chimeric
  • Chimeric antibodies can be produced as described, for example, in
  • One example of an anti-IgE antibody of the invention (designated TES-C21 )
  • TESC-2 chimeric mouse-human form
  • hybridoma cell lines producing TES-C21 are available from the
  • Another humanized antibody suitable for treatment of atopic dermatitis is Another humanized antibody suitable for treatment of atopic dermatitis.
  • E25 (rhuMAb-E25), produced by Genentech, Inc. This antibody is described in
  • mice were immunized several times with polyclonal human IgE from sera
  • hybridomas resulting from the fusion were then screened by enzyme-
  • TES-C21 was further screened, by ELISA, to be specific for human IgE, and
  • IgG IgM, IgA, IgD, human serum albumin, transferrin or insulin.
  • TES-C21 bound equally well to various human IgE molecules. TES-C21 bound to
  • murine cell line of SE44 or to a murine cell line secreting chimeric human IgG.
  • TES-C21 also does not bind to IgE on high affinity Fc ⁇ RI receptors or on low affinity
  • Fc ⁇ RI I receptors which are present on a wide variety of cell types. It also did not
  • TESC-2 and TES-C21 bind equally well to IgE bound to microtiter plates.
  • HRP horseradish peroxidase
  • IgG goat antimouse IgG
  • Immulon 2 plates were coated with gp120
  • TES-C21 was detected using horseradish peroxidase-conjugated streptavidin.
  • TESC-2 and TES-C21 also were shown to bind equally to IgE-producing
  • TES-C21 was detected using FITC-goat (Fab') 2 antimouse IgG; binding of TESC-2
  • IM-9 lymphoblastoid line
  • TESC-2 labeled TESC-2 or a positive control anti-IgE MAb TES-19, followed by FITC-
  • Binding of - IgE to cells was detected using biotinylated TES-19 and FITC-
  • TESC-2 was further tested to determine whether it could block the binding
  • the IgE antagonists, or antibodies, of the invention Prior to commercial availability, the IgE antagonists, or antibodies, of the invention

Landscapes

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

Abstract

Cette invention concerne une composition pharmaceutique qui permet de traiter la dermatite atopique et qui comprend un antagoniste d'IgE acceptable n'entraînant aucune émission de médiateurs d'allergie. Cette composition comprend par exemple des anticorps anti-IgE qui se lient à l'IgE sécrétée, à l'IgE de membrane à la surface de cellules B produisant de l'IgE, mais pas à l'IgE liée au FcεRI à la surface de basophiles ou de mastocytes. De préférence, ces anticorps ne se lient pas non plus à l'IgE liée aux récepteurs de FcεRII. Il est également préférable que ces anticorps possèdent des régions constantes IgG1 ou IgG3 humaines, ainsi que d'autres parties humaines le cas échéant. Cette composition pharmaceutique peut être administrée de manière systémique ou topique.
EP99901309A 1998-01-29 1999-01-06 TRAITEMENT DE LA DERMATITE ATOPIQUE A L'AIDE D'ANTAGONISTES D'IgE Withdrawn EP1056471A4 (fr)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US7303398P 1998-01-29 1998-01-29
US1526998A 1998-01-29 1998-01-29
US15269 1998-01-29
US73033P 1998-01-29
PCT/US1999/000135 WO1999038531A1 (fr) 1998-01-29 1999-01-06 TRAITEMENT DE LA DERMATITE ATOPIQUE A L'AIDE D'ANTAGONISTES D'IgE

Publications (2)

Publication Number Publication Date
EP1056471A1 true EP1056471A1 (fr) 2000-12-06
EP1056471A4 EP1056471A4 (fr) 2001-05-30

Family

ID=26687160

Family Applications (1)

Application Number Title Priority Date Filing Date
EP99901309A Withdrawn EP1056471A4 (fr) 1998-01-29 1999-01-06 TRAITEMENT DE LA DERMATITE ATOPIQUE A L'AIDE D'ANTAGONISTES D'IgE

Country Status (5)

Country Link
EP (1) EP1056471A4 (fr)
JP (1) JP2002501905A (fr)
CN (1) CN1289253A (fr)
AU (1) AU2103699A (fr)
WO (1) WO1999038531A1 (fr)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PT2000481E (pt) * 2003-02-01 2016-06-17 Tanox Inc Anticorpos anti-ige humana de alta afinidade
AU2008215926B2 (en) * 2007-02-15 2012-07-19 Astrazeneca Ab Binding members for IgE molecules
GB201610198D0 (en) * 2016-06-10 2016-07-27 Ucb Biopharma Sprl Anti-ige antibodies

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1992017207A1 (fr) * 1991-03-26 1992-10-15 Tanox Biosystems, Inc. ANTICORPS MONOCLONAUX QUI SE LIENT A L'IgE SECRETEE ET LIEE AUX MEMBRANES MAIS QUI NE SE LIENT PAS A L'IgE SE TROUVANT SUR LES LEUCOCYTES BASOPHILES
EP0589840A1 (fr) * 1992-09-24 1994-03-30 Ciba-Geigy Ag Anticorps monoclonaux transformés contre une isotype d'immunoglobuline
EP0648499A1 (fr) * 1993-10-19 1995-04-19 Chisei Ra Composition pour l'inhibition de la production d'IgE
EP0657534A1 (fr) * 1992-08-04 1995-06-14 The Green Cross Corporation Agent antiallergique
WO1998004718A1 (fr) * 1996-07-26 1998-02-05 Novartis Ag Polypeptides de fusion comprenant un domaine de liaison ige et un composant hsa, et leurs utilisations diagnostiques et therapeutiques

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5449760A (en) * 1987-12-31 1995-09-12 Tanox Biosystems, Inc. Monoclonal antibodies that bind to soluble IGE but do not bind IGE on IGE expressing B lymphocytes or basophils

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1992017207A1 (fr) * 1991-03-26 1992-10-15 Tanox Biosystems, Inc. ANTICORPS MONOCLONAUX QUI SE LIENT A L'IgE SECRETEE ET LIEE AUX MEMBRANES MAIS QUI NE SE LIENT PAS A L'IgE SE TROUVANT SUR LES LEUCOCYTES BASOPHILES
EP0657534A1 (fr) * 1992-08-04 1995-06-14 The Green Cross Corporation Agent antiallergique
EP0589840A1 (fr) * 1992-09-24 1994-03-30 Ciba-Geigy Ag Anticorps monoclonaux transformés contre une isotype d'immunoglobuline
EP0648499A1 (fr) * 1993-10-19 1995-04-19 Chisei Ra Composition pour l'inhibition de la production d'IgE
WO1998004718A1 (fr) * 1996-07-26 1998-02-05 Novartis Ag Polypeptides de fusion comprenant un domaine de liaison ige et un composant hsa, et leurs utilisations diagnostiques et therapeutiques

Non-Patent Citations (4)

* Cited by examiner, † Cited by third party
Title
CORNE JONATHAN ET AL: "The effect of intravenous administration of a chimeric anti-IgE antibody on serum IgE levels in atopic subjects: Efficacy, safety, and pharmacokinetics." 1997 , JOURNAL OF CLINICAL INVESTIGATION, VOL. 99, NR. 5, PAGE(S) 879-887 XP002164091 ISSN: 0021-9738 * the whole document * *
GRAHAM BROWN R. A. C. ET AL.: "Therapeutics in atopic dermatitis" 1997 , ADVANCES IN DERMATOLOGY, VOL. 13, PAGE(S) 3-31 XP000983988 * page 8 - page 9 * *
HAAK-FRENDSCHO M. ET AL.: "Human IgE receptor alpha-chain IgG chimera blocks passive cutaneous anaphylaxis reaction in vivo" 1993 , JOURNAL OF IMMUNOLOGY, VOL. 151, NR.1, PAGE(S) 351-358 XP000942183 * page 354, right-hand column, paragraph 2 * * page 357, left-hand column * *
See also references of WO9938531A1 *

Also Published As

Publication number Publication date
WO1999038531A1 (fr) 1999-08-05
CN1289253A (zh) 2001-03-28
JP2002501905A (ja) 2002-01-22
EP1056471A4 (fr) 2001-05-30
AU2103699A (en) 1999-08-16

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