EP3337508A4 - Subkutaner monoklonaler anti-hla-dr-antikörper zur behandlung hämatologischer malignitäten - Google Patents

Subkutaner monoklonaler anti-hla-dr-antikörper zur behandlung hämatologischer malignitäten Download PDF

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Publication number
EP3337508A4
EP3337508A4 EP16839842.8A EP16839842A EP3337508A4 EP 3337508 A4 EP3337508 A4 EP 3337508A4 EP 16839842 A EP16839842 A EP 16839842A EP 3337508 A4 EP3337508 A4 EP 3337508A4
Authority
EP
European Patent Office
Prior art keywords
hla
antibody
treatment
subcutaneous administration
monoclonal anti
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Withdrawn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
EP16839842.8A
Other languages
English (en)
French (fr)
Other versions
EP3337508A1 (de
Inventor
David M. Goldenberg
William A. Wegener
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.)
Immunomedics Inc
Original Assignee
Immunomedics 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
Priority claimed from US14/876,200 external-priority patent/US9683050B2/en
Application filed by Immunomedics Inc filed Critical Immunomedics Inc
Publication of EP3337508A1 publication Critical patent/EP3337508A1/de
Publication of EP3337508A4 publication Critical patent/EP3337508A4/de
Withdrawn legal-status Critical Current

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Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2887—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against CD20
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
    • 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
    • A61K47/6835—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 the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site
    • A61K47/6851—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 the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site the antibody targeting a determinant of a tumour cell
    • A61K47/6867—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 the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site the antibody targeting a determinant of a tumour cell the tumour determinant being from a cell of a blood cancer
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • C07K16/2833—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily against MHC-molecules, e.g. HLA-molecules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • A61K2039/507—Comprising a combination of two or more separate antibodies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/54—Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/55—Medicinal preparations containing antigens or antibodies characterised by the host/recipient, e.g. newborn with maternal antibodies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/55—Medicinal preparations containing antigens or antibodies characterised by the host/recipient, e.g. newborn with maternal antibodies
    • A61K2039/552—Veterinary vaccine
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/42—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against immunoglobulins
    • C07K16/4283—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against immunoglobulins against an allotypic or isotypic determinant on Ig
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/33—Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant or Fc region; Isotype
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant or Fc region; Isotype
    • C07K2317/53—Hinge
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/73—Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/75—Agonist effect on antigen

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Cell Biology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Oncology (AREA)
  • Hematology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
EP16839842.8A 2015-08-21 2016-08-18 Subkutaner monoklonaler anti-hla-dr-antikörper zur behandlung hämatologischer malignitäten Withdrawn EP3337508A4 (de)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US201562208128P 2015-08-21 2015-08-21
US14/876,200 US9683050B2 (en) 2011-05-02 2015-10-06 Stable compositions of high-concentration allotype-selected antibodies for small-volume administration
US201562262692P 2015-12-03 2015-12-03
PCT/US2016/047483 WO2017034906A1 (en) 2015-08-21 2016-08-18 Subcutaneous anti-hla-dr monoclonal antibody for treatment of hematologic malignancies

Publications (2)

Publication Number Publication Date
EP3337508A1 EP3337508A1 (de) 2018-06-27
EP3337508A4 true EP3337508A4 (de) 2019-04-03

Family

ID=58100864

Family Applications (1)

Application Number Title Priority Date Filing Date
EP16839842.8A Withdrawn EP3337508A4 (de) 2015-08-21 2016-08-18 Subkutaner monoklonaler anti-hla-dr-antikörper zur behandlung hämatologischer malignitäten

Country Status (3)

Country Link
EP (1) EP3337508A4 (de)
CA (1) CA2987644A1 (de)
WO (1) WO2017034906A1 (de)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11780924B2 (en) 2016-06-21 2023-10-10 University Of Oslo HLA binding vaccine moieties and uses thereof

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012151199A1 (en) * 2011-05-02 2012-11-08 Immunomedics, Inc. Ultrafiltration concentration of allotype selected antibodies for small-volume administration

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP3957765B2 (ja) * 1997-04-07 2007-08-15 ジェネンテク・インコーポレイテッド 抗ｖｅｇｆ抗体
ES2665422T3 (es) * 2005-03-03 2018-04-25 Immunomedics Inc. Anticuerpos L243 humanizados

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012151199A1 (en) * 2011-05-02 2012-11-08 Immunomedics, Inc. Ultrafiltration concentration of allotype selected antibodies for small-volume administration

Non-Patent Citations (9)

* Cited by examiner, † Cited by third party
Title
ANONYMOUS: "Archive History for NCT01728207: Phase I Dose Escalation Study of IMMU-114 in Relapsed or Refractory NHL and CLL.", 11 March 2015 (2015-03-11), XP055560263, Retrieved from the Internet <URL:https://clinicaltrials.gov/ct2/history/NCT01728207?V_4=View#StudyPageTop> [retrieved on 20190221] *
C. JACKISCH ET AL: "Subcutaneous Administration of Monoclonal Antibodies in Oncology", GEBURTSHILFE UND FRAUENHEILKUNDE, vol. 74, no. 04, 28 April 2014 (2014-04-28), DE, pages 343 - 349, XP055573377, ISSN: 0016-5751, DOI: 10.1055/s-0034-1368173 *
DEBORAH M STEPHENS ET AL: "Subcutaneous Injections of IMMU-114 (Anti-HLA-DR IgG4 Monoclonal Antibody): Initial Results of a Phase I First-in-Man Study in Hematologic Malignancies | Blood Journal", BLOOD, 3 December 2015 (2015-12-03), XP055559444, Retrieved from the Internet <URL:http://www.bloodjournal.org/content/126/23/2740?sso-checked=true> [retrieved on 20190220] *
HOYER B F ET AL: "Biologics therapy for systemic lupus erythematosus", ZEITSCHRIFT FÜR RHEUMATOLOGIE, SPRINGER, DE, vol. 74, no. 3, 9 April 2015 (2015-04-09), pages 206 - 214, XP035478732, ISSN: 0340-1855, [retrieved on 20150409], DOI: 10.1007/S00393-014-1458-0 *
SCHWEIGHOFER CARMEN D. ET AL: "Clinical safety and pharmacological profile of the HLA-DR antibody 1D09C3 in patients with B cell chronic lymphocytic leukemia and lymphoma: results from a phase I study", CANCER IMMUNOLOGY IMMUNOTHERAPY, vol. 61, no. 12, 23 October 2012 (2012-10-23), Berlin/Heidelberg, pages 2367 - 2373, XP093104290, ISSN: 0340-7004, Retrieved from the Internet <URL:http://link.springer.com/article/10.1007/s00262-012-1362-x/fulltext.html> DOI: 10.1007/s00262-012-1362-x *
See also references of WO2017034906A1 *
THOMAS M CARDILLO ET AL: "Abstract 587: Superior anti-tumor effects of an anti-HLA-DR IgG4 antibody, IMMU-114, in chronic and acute lymphocytic leukemia (CLL and ALL): Comparison to anti-CD20 therapy, chemotherapy, or combined with kinase inhibitors", CANCER RESEARCH, 1 July 2016 (2016-07-01), XP055560255, Retrieved from the Internet <URL:http://cancerres.aacrjournals.org/content/76/14_Supplement/587> [retrieved on 20190221] *
THOMAS S. LIN ET AL: "A phase I/II dose escalation study of apolizumab (Hu1D10) using a stepped-up dosing schedule in patients with chronic lymphocytic leukemia and acute leukemia", LEUKEMIA AND LYMPHOMA., vol. 50, no. 12, 19 December 2009 (2009-12-19), US, pages 1958 - 1963, XP055415743, ISSN: 1042-8194, DOI: 10.3109/10428190903186486 *
ZIV ROSMAN ET AL: "Biologic therapy for autoimmune diseases: an update", BMC MEDICINE, vol. 11, no. 1, 1 December 2013 (2013-12-01), XP055560340, DOI: 10.1186/1741-7015-11-88 *

Also Published As

Publication number Publication date
WO2017034906A8 (en) 2017-10-12
CA2987644A1 (en) 2017-03-02
WO2017034906A1 (en) 2017-03-02
EP3337508A1 (de) 2018-06-27

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