AU2012258254B2 - Use of anti-CD19 maytansinoid immunoconjugate antibody for the treatment of B-cell malignancies symptoms - Google Patents

Use of anti-CD19 maytansinoid immunoconjugate antibody for the treatment of B-cell malignancies symptoms Download PDF

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Publication number
AU2012258254B2
AU2012258254B2 AU2012258254A AU2012258254A AU2012258254B2 AU 2012258254 B2 AU2012258254 B2 AU 2012258254B2 AU 2012258254 A AU2012258254 A AU 2012258254A AU 2012258254 A AU2012258254 A AU 2012258254A AU 2012258254 B2 AU2012258254 B2 AU 2012258254B2
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Prior art keywords
lymphoma
seq
maytansinoid immunoconjugate
patient
maytansinoid
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Ceased
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AU2012258254A
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AU2012258254A1 (en
Inventor
Rodica MORARIU
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Sanofi SA
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Sanofi SA
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Application filed by Sanofi SA filed Critical Sanofi SA
Publication of AU2012258254A1 publication Critical patent/AU2012258254A1/en
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Publication of AU2012258254B2 publication Critical patent/AU2012258254B2/en
Priority to AU2016206317A priority Critical patent/AU2016206317A1/en
Priority to AU2018201504A priority patent/AU2018201504A1/en
Ceased legal-status Critical Current
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    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
    • A61K31/537—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines spiro-condensed or forming part of bridged ring systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
    • A61K31/5365—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines ortho- or peri-condensed with heterocyclic ring systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • 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
    • A61K47/51—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
    • A61K47/6849—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 receptor, a cell surface antigen or a cell surface determinant
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A61P35/02—Antineoplastic agents specific for leukemia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [IGs], 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 [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/30—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
    • C07K16/3061—Blood cells
    • 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
    • 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
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/51—Complete heavy chain or Fd fragment, i.e. VH + CH1
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/515—Complete light chain, i.e. VL + CL
    • 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
    • C07K2317/77—Internalization into the cell
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Cell Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Hematology (AREA)
  • Dermatology (AREA)
  • Oncology (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Peptides Or Proteins (AREA)
  • Nitrogen And Oxygen Or Sulfur-Condensed Heterocyclic Ring Systems (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
AU2012258254A 2011-05-17 2012-05-16 Use of anti-CD19 maytansinoid immunoconjugate antibody for the treatment of B-cell malignancies symptoms Ceased AU2012258254B2 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
AU2016206317A AU2016206317A1 (en) 2011-05-17 2016-07-21 Use of anti-CD19 maytansinoid immunoconjugate antibody for the treatment of B-cell malignancies symptoms
AU2018201504A AU2018201504A1 (en) 2011-05-17 2018-03-01 Use of anti-CD19 maytansinoid immunoconjugate antibody for the treatment of B-cell malignancies symptoms

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP11290232.5 2011-05-17
EP11290232A EP2524929A1 (en) 2011-05-17 2011-05-17 Use of anti-CD19 maytansinoid immunoconjugate antibody for the treatment of CD19+ B-cell malignancies syptoms
PCT/EP2012/059141 WO2012156455A1 (en) 2011-05-17 2012-05-16 Use of anti-cd19 maytansinoid immunoconjugate antibody for the treatment of b-cell malignancies symptoms

Related Child Applications (1)

Application Number Title Priority Date Filing Date
AU2016206317A Division AU2016206317A1 (en) 2011-05-17 2016-07-21 Use of anti-CD19 maytansinoid immunoconjugate antibody for the treatment of B-cell malignancies symptoms

Publications (2)

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AU2012258254A1 AU2012258254A1 (en) 2013-05-02
AU2012258254B2 true AU2012258254B2 (en) 2016-04-21

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AU2012258254A Ceased AU2012258254B2 (en) 2011-05-17 2012-05-16 Use of anti-CD19 maytansinoid immunoconjugate antibody for the treatment of B-cell malignancies symptoms
AU2016206317A Abandoned AU2016206317A1 (en) 2011-05-17 2016-07-21 Use of anti-CD19 maytansinoid immunoconjugate antibody for the treatment of B-cell malignancies symptoms
AU2018201504A Abandoned AU2018201504A1 (en) 2011-05-17 2018-03-01 Use of anti-CD19 maytansinoid immunoconjugate antibody for the treatment of B-cell malignancies symptoms

Family Applications After (2)

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AU2016206317A Abandoned AU2016206317A1 (en) 2011-05-17 2016-07-21 Use of anti-CD19 maytansinoid immunoconjugate antibody for the treatment of B-cell malignancies symptoms
AU2018201504A Abandoned AU2018201504A1 (en) 2011-05-17 2018-03-01 Use of anti-CD19 maytansinoid immunoconjugate antibody for the treatment of B-cell malignancies symptoms

Country Status (30)

Country Link
US (2) US9555126B2 (OSRAM)
EP (2) EP2524929A1 (OSRAM)
JP (4) JP6050328B2 (OSRAM)
KR (1) KR20140043388A (OSRAM)
CN (2) CN103547596A (OSRAM)
AR (1) AR086412A1 (OSRAM)
AU (3) AU2012258254B2 (OSRAM)
BR (1) BR112013029330A8 (OSRAM)
CA (1) CA2835738A1 (OSRAM)
CL (1) CL2013003272A1 (OSRAM)
CO (1) CO6821893A2 (OSRAM)
CR (1) CR20130593A (OSRAM)
DO (1) DOP2013000260A (OSRAM)
EA (1) EA028574B1 (OSRAM)
EC (1) ECSP13013084A (OSRAM)
GT (1) GT201300276A (OSRAM)
IL (3) IL229380B (OSRAM)
MA (1) MA35180B1 (OSRAM)
MX (1) MX347019B (OSRAM)
MY (1) MY163736A (OSRAM)
NI (1) NI201300119A (OSRAM)
PE (1) PE20141018A1 (OSRAM)
PH (2) PH12013502305A1 (OSRAM)
SG (2) SG10201609729VA (OSRAM)
TN (1) TN2013000468A1 (OSRAM)
TW (3) TW201834687A (OSRAM)
UA (1) UA114401C2 (OSRAM)
UY (1) UY34077A (OSRAM)
WO (1) WO2012156455A1 (OSRAM)
ZA (1) ZA201309400B (OSRAM)

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WO2016180941A1 (en) * 2015-05-13 2016-11-17 Sanofi Liquid compositions for anti-cd19 antibody-drug conjugates
WO2016189014A1 (en) 2015-05-26 2016-12-01 Morphosys Ag Combination of an anti-cd19 antibody and a bruton's tyrosine kinase inhibitor and uses thereof
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JP6880006B2 (ja) 2015-09-17 2021-06-02 イミュノジェン， インコーポレイテッド 抗ｆｏｌｒ１免疫複合体を含む治療組み合わせ
JP2019501139A (ja) 2015-11-25 2019-01-17 イミュノジェン・インコーポレーテッド 医薬製剤及びその使用
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WO2018183494A1 (en) * 2017-03-31 2018-10-04 Immunogen, Inc. Cd19-targeting antibody-drug conjugates
CN110869765A (zh) * 2017-04-20 2020-03-06 Adc治疗有限公司 组合疗法
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TWI878186B (zh) * 2017-09-21 2025-03-21 中國大陸商上海藥明生物技術有限公司 新型抗cd19抗體
BR112020005675A2 (pt) 2017-09-22 2020-10-20 WuXi Biologics Ireland Limited novos complexos de polipeptideo cd3/cd19 biespecíficos
TW201934187A (zh) 2018-01-12 2019-09-01 美商免疫遺傳股份有限公司 抗體藥物結合、純化、及調配之方法
SG11202110922QA (en) 2019-04-26 2021-10-28 Immunogen Inc Camptothecin derivatives
SG11202111343TA (en) 2019-05-03 2021-11-29 Morphosys Ag Anti-cd19 therapy in patients having a limited number of nk cells
AU2020372646A1 (en) 2019-10-31 2022-05-12 Incyte Corporation Anti-tumor combination therapy comprising anti-CD19 antibody and gamma delta T-cells
CN114599392A (zh) * 2019-10-31 2022-06-07 四十七公司 基于抗cd47和抗cd20的血癌治疗
PH12022551008A1 (en) 2019-10-31 2023-03-20 Morphosys Ag Anti-cd19 therapy in combination with lenalidomide for the treatment of leukemia or lymphoma
CN111303286B (zh) * 2019-12-05 2022-05-20 常州费洛斯药业科技有限公司 一种anti-CD19的全人源抗体或抗体片段及其嵌合抗原受体和应用
WO2021259902A1 (en) 2020-06-22 2021-12-30 Morphosys Ag Anti-tumor combination therapy comprising anti-cd19 antibody and polypeptides blocking the sirpα-cd47 innate immune checkpoint
TW202229349A (zh) 2020-10-06 2022-08-01 美商山可爾股份有限公司 用於治療包括全身性紅斑性狼瘡(sle)的自體免疫疾病之生物標記、方法及組合物
CA3204063A1 (en) 2020-12-04 2022-06-09 Morphosys Ag Anti-cd19 combination therapy
WO2023073645A1 (en) 2021-10-29 2023-05-04 Takeda Pharmaceutical Company Limited Therapy comprising anti-cd19 antibody and sumo-activating enzyme inhibitor
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