CN113853217A - 包含抗cd123免疫缀合物的治疗组合 - Google Patents

包含抗cd123免疫缀合物的治疗组合 Download PDF

Info

Publication number
CN113853217A
CN113853217A CN202080037081.6A CN202080037081A CN113853217A CN 113853217 A CN113853217 A CN 113853217A CN 202080037081 A CN202080037081 A CN 202080037081A CN 113853217 A CN113853217 A CN 113853217A
Authority
CN
China
Prior art keywords
administered
immunoconjugate
day
dose
cycle
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.)
Pending
Application number
CN202080037081.6A
Other languages
English (en)
Chinese (zh)
Inventor
沙琳·亚当斯
卡勒姆·M·斯洛斯
帕特里克·茨威德勒-麦凯
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.)
Immunogen Inc
Original Assignee
Immunogen 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 Immunogen Inc filed Critical Immunogen Inc
Publication of CN113853217A publication Critical patent/CN113853217A/zh
Pending legal-status Critical Current

Links

Images

Classifications

    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2866Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for cytokines, lymphokines, interferons
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/55Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • A61K31/551Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole having two nitrogen atoms, e.g. dilazep
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/63Compounds containing para-N-benzenesulfonyl-N-groups, e.g. sulfanilamide, p-nitrobenzenesulfonyl hydrazide
    • A61K31/635Compounds containing para-N-benzenesulfonyl-N-groups, e.g. sulfanilamide, p-nitrobenzenesulfonyl hydrazide having a heterocyclic ring, e.g. sulfadiazine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7052Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
    • A61K31/706Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50Medicinal 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
    • A61K47/51Medicinal 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
    • A61K47/68Medicinal 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
    • A61K47/6801Drug-antibody or immunoglobulin conjugates defined by the pharmacologically or therapeutically active agent
    • A61K47/6803Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50Medicinal 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
    • A61K47/51Medicinal 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
    • A61K47/68Medicinal 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
    • A61K47/6801Drug-antibody or immunoglobulin conjugates defined by the pharmacologically or therapeutically active agent
    • A61K47/6803Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates
    • A61K47/68035Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates the drug being a pyrrolobenzodiazepine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50Medicinal 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
    • A61K47/51Medicinal 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
    • A61K47/68Medicinal 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
    • A61K47/6835Medicinal 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
    • A61K47/6849Medicinal 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • A61P35/02Antineoplastic agents specific for leukemia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/77Internalization into the cell

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Cell Biology (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Genetics & Genomics (AREA)
  • Hematology (AREA)
  • Oncology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)
CN202080037081.6A 2019-04-29 2020-04-29 包含抗cd123免疫缀合物的治疗组合 Pending CN113853217A (zh)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201962839974P 2019-04-29 2019-04-29
US62/839,974 2019-04-29
US201962860598P 2019-06-12 2019-06-12
US62/860,598 2019-06-12
PCT/US2020/030478 WO2020223351A1 (en) 2019-04-29 2020-04-29 Therapeutic combinations comprising anti-cd123 immunoconjugates

Publications (1)

Publication Number Publication Date
CN113853217A true CN113853217A (zh) 2021-12-28

Family

ID=73029177

Family Applications (1)

Application Number Title Priority Date Filing Date
CN202080037081.6A Pending CN113853217A (zh) 2019-04-29 2020-04-29 包含抗cd123免疫缀合物的治疗组合

Country Status (12)

Country Link
US (2) US11701428B2 (https=)
EP (1) EP3962528A4 (https=)
JP (2) JP7585231B2 (https=)
KR (1) KR20220004669A (https=)
CN (1) CN113853217A (https=)
AU (1) AU2020265225A1 (https=)
CA (1) CA3137454A1 (https=)
IL (1) IL287446A (https=)
MA (1) MA55816A (https=)
SG (1) SG11202110702WA (https=)
TW (1) TWI865521B (https=)
WO (1) WO2020223351A1 (https=)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20220004669A (ko) 2019-04-29 2022-01-11 이뮤노젠 아이엔씨 항-cd123 면역접합체를 포함하는 치료적 조합물
IL308321A (en) * 2021-05-11 2024-01-01 Abbvie Inc Venetoclax dosing regimens for use in treating myelodysplastic syndromes in combination with azacitidine
WO2024123765A1 (en) * 2022-12-08 2024-06-13 Immunogen, Inc. Therapeutic combinations comprising anti-cd123 antibody-drug conjugates and anti-cd47 antibodies
US20260083749A1 (en) * 2024-05-10 2026-03-26 Immunogen, Inc. Anti-cd123 immunoconjugates for the treatment of acute myeloid leukemia

Citations (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009080831A1 (en) * 2007-12-26 2009-07-02 Biotest Ag Method of decreasing cytotoxic side-effects and improving efficacy of immunoconjugates
US20120264710A1 (en) * 2011-04-15 2012-10-18 Marit Liland Sandvold Systems and Methods for Detecting hENT1 Expression in Hematological Disorders
US20170029514A1 (en) * 2015-06-29 2017-02-02 Immunogen, Inc. Anti-cd123 antibodies and conjugates and derivatives thereof
GB201709677D0 (en) * 2017-06-16 2017-08-02 Argenx Bvba Treatment for acute myeloid leukaemia
US20180036336A1 (en) * 2016-08-02 2018-02-08 Janssen Biotech, Inc. Combination treatment for hematological cancers
CN108601839A (zh) * 2015-11-03 2018-09-28 基因泰克公司 用于治疗癌症的Bcl-2抑制剂和MEK抑制剂组合产品
CN108601787A (zh) * 2015-10-15 2018-09-28 细胞基因公司 用于治疗恶性肿瘤的组合疗法
WO2019020606A1 (en) * 2017-07-26 2019-01-31 F. Hoffmann-La Roche Ag POLYTHERAPY WITH BET INHIBITOR, BCL-2 INHIBITOR AND ANTI-CD20 ANTIBODY
US20190062428A1 (en) * 2017-06-19 2019-02-28 Surface Oncology, Inc. Combination of anti-cd47 antibodies and cell death-inducing agents, and uses thereof
US20190076549A1 (en) * 2016-03-15 2019-03-14 Seattle Genetics, Inc. Combinations of pbd-based antibody drug conjugates with bcl-2 inhibitors
WO2019060718A1 (en) * 2017-09-22 2019-03-28 Immunogen, Inc. SEPARATION OF LIGHT TRIPLE CHAIN ANTIBODIES USING CATION EXCHANGE CHROMATOGRAPHY

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8163279B2 (en) 2007-04-13 2012-04-24 Stemline Therapeutics, Inc. IL3Rα antibody conjugates and uses thereof
TW201709932A (zh) 2015-06-12 2017-03-16 西雅圖遺傳學公司 Cd123抗體及其共軛物
SMT202000614T1 (it) 2015-06-29 2021-01-05 Immunogen Inc Coniugati di anticorpi ingegnerizzati con cisteina
US20170189548A1 (en) 2015-11-25 2017-07-06 Immunogen, Inc. Pharmaceutical formulations and methods of use thereof
WO2018098258A2 (en) 2016-11-23 2018-05-31 Immunogen, Inc. Selective sulfonation of benzodiazepine derivatives
KR20200041834A (ko) * 2017-06-01 2020-04-22 젠코어 인코포레이티드 Cd123 및 cd3에 결합하는 이중특이성 항체
CA3069558A1 (en) 2017-07-09 2019-01-17 Biosight Ltd. Combination cancer therapy
KR20200070254A (ko) * 2017-09-22 2020-06-17 이뮤노젠 아이엔씨 면역접합체에서 메티오닌 산화를 방지하는 방법
MA54088A (fr) * 2018-10-30 2022-03-16 Immunogen Inc Procédés de traitement faisant appel à des immunoconjugués anti-cd123
WO2020092344A1 (en) * 2018-10-31 2020-05-07 Health Research, Inc. Combination treatment with anti-cd123 antibody drug conjugate and parp inhibitor
KR20220004669A (ko) 2019-04-29 2022-01-11 이뮤노젠 아이엔씨 항-cd123 면역접합체를 포함하는 치료적 조합물

Patent Citations (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009080831A1 (en) * 2007-12-26 2009-07-02 Biotest Ag Method of decreasing cytotoxic side-effects and improving efficacy of immunoconjugates
US20120264710A1 (en) * 2011-04-15 2012-10-18 Marit Liland Sandvold Systems and Methods for Detecting hENT1 Expression in Hematological Disorders
US20170029514A1 (en) * 2015-06-29 2017-02-02 Immunogen, Inc. Anti-cd123 antibodies and conjugates and derivatives thereof
CN107889493A (zh) * 2015-06-29 2018-04-06 伊缪诺金公司 抗cd123抗体以及其缀合物和衍生物
CN108601787A (zh) * 2015-10-15 2018-09-28 细胞基因公司 用于治疗恶性肿瘤的组合疗法
CN108601839A (zh) * 2015-11-03 2018-09-28 基因泰克公司 用于治疗癌症的Bcl-2抑制剂和MEK抑制剂组合产品
US20190076549A1 (en) * 2016-03-15 2019-03-14 Seattle Genetics, Inc. Combinations of pbd-based antibody drug conjugates with bcl-2 inhibitors
US20180036336A1 (en) * 2016-08-02 2018-02-08 Janssen Biotech, Inc. Combination treatment for hematological cancers
GB201709677D0 (en) * 2017-06-16 2017-08-02 Argenx Bvba Treatment for acute myeloid leukaemia
US20190062428A1 (en) * 2017-06-19 2019-02-28 Surface Oncology, Inc. Combination of anti-cd47 antibodies and cell death-inducing agents, and uses thereof
WO2019020606A1 (en) * 2017-07-26 2019-01-31 F. Hoffmann-La Roche Ag POLYTHERAPY WITH BET INHIBITOR, BCL-2 INHIBITOR AND ANTI-CD20 ANTIBODY
WO2019060718A1 (en) * 2017-09-22 2019-03-28 Immunogen, Inc. SEPARATION OF LIGHT TRIPLE CHAIN ANTIBODIES USING CATION EXCHANGE CHROMATOGRAPHY

Non-Patent Citations (5)

* Cited by examiner, † Cited by third party
Title
COURTNEY D DINARDO等: "Venetoclax combined with decitabine or azacitidine in treatment-naive, elderly patients with acute myeloid leukemia", BLOOD *
EVGENIYA ANGELOVA等: "CD123 expression patterns and selective targeting with a CD123-targeted antibody-drug conjugate (IMGN632) in acute lymphoblastic leukemia", HAEMATOLOGICA *
KATIE E ARCHER等: "Synthesis of Highly Potent N-10 Amino-Linked DNA-Alkylating Indolinobenzodiazepine Antibody-Drug Conjugates (ADCs)", ACS MED CHEM LETT *
YELENA KOVTUN等: "A CD123-targeting antibody-drug conjugate, IMGN632, designed to eradicate AML while sparing normal bone marrow cells", BLOOD ADV *
YELENA KOVTUN等: "A CD123-targeting antibody-drug conjugate, IMGN632, designed to eradicate AML while sparing normal bone marrow cells", BLOOD ADV. *

Also Published As

Publication number Publication date
SG11202110702WA (en) 2021-11-29
US11701428B2 (en) 2023-07-18
EP3962528A1 (en) 2022-03-09
IL287446A (en) 2021-12-01
JP2025023995A (ja) 2025-02-19
JP7585231B2 (ja) 2024-11-18
MA55816A (fr) 2022-03-16
WO2020223351A1 (en) 2020-11-05
US20210023237A1 (en) 2021-01-28
TW202106716A (zh) 2021-02-16
US20240033371A1 (en) 2024-02-01
CA3137454A1 (en) 2020-11-05
JP2022533009A (ja) 2022-07-21
AU2020265225A1 (en) 2021-10-28
KR20220004669A (ko) 2022-01-11
EP3962528A4 (en) 2023-01-11
TWI865521B (zh) 2024-12-11

Similar Documents

Publication Publication Date Title
US20240033371A1 (en) Therapeutic combinations comprising anti-cd123 immunoconjugates
US12144818B2 (en) Method for treating cancer in a human patient by administering an anti-CD37 immunoconjugate using various dosing regimens
EP3624839A1 (en) Anti-cd33 immunoconjugate dosing regimens
JP2025072466A (ja) 抗cd123免疫複合体を用いた治療法
RU2832141C2 (ru) Терапевтические комбинации, содержащие иммуноконъюгаты анти-cd123
US20260083749A1 (en) Anti-cd123 immunoconjugates for the treatment of acute myeloid leukemia
RU2816847C2 (ru) Способы лечения с использованием анти-cd123 иммуноконъюгатов
TW202423485A (zh) 包含抗cd123抗體-藥物結合物及抗cd47抗體之治療組合
HK40010658A (en) Dosing for treatment with anti-cd20/anti-cd3 bispecific antibodies

Legal Events

Date Code Title Description
PB01 Publication
PB01 Publication
SE01 Entry into force of request for substantive examination
SE01 Entry into force of request for substantive examination