RU2018114457A - Лечение syd985 пациентов с t-dm1 рефрактерным раком - Google Patents
Лечение syd985 пациентов с t-dm1 рефрактерным раком Download PDFInfo
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- RU2018114457A RU2018114457A RU2018114457A RU2018114457A RU2018114457A RU 2018114457 A RU2018114457 A RU 2018114457A RU 2018114457 A RU2018114457 A RU 2018114457A RU 2018114457 A RU2018114457 A RU 2018114457A RU 2018114457 A RU2018114457 A RU 2018114457A
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- Prior art keywords
- patient
- compound
- refractory
- trastuzumab
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- 229960001612 trastuzumab emtansine Drugs 0.000 title claims 8
- 206010070308 Refractory cancer Diseases 0.000 title 1
- 208000016691 refractory malignant neoplasm Diseases 0.000 title 1
- 150000001875 compounds Chemical class 0.000 claims 14
- 101001012157 Homo sapiens Receptor tyrosine-protein kinase erbB-2 Proteins 0.000 claims 6
- 102100030086 Receptor tyrosine-protein kinase erbB-2 Human genes 0.000 claims 6
- 238000000034 method Methods 0.000 claims 5
- 206010028980 Neoplasm Diseases 0.000 claims 4
- 230000037396 body weight Effects 0.000 claims 4
- 201000011510 cancer Diseases 0.000 claims 4
- 239000008194 pharmaceutical composition Substances 0.000 claims 4
- 229960000575 trastuzumab Drugs 0.000 claims 4
- 206010006187 Breast cancer Diseases 0.000 claims 2
- 208000026310 Breast neoplasm Diseases 0.000 claims 2
- 239000002136 L01XE07 - Lapatinib Substances 0.000 claims 2
- 238000001990 intravenous administration Methods 0.000 claims 2
- BCFGMOOMADDAQU-UHFFFAOYSA-N lapatinib Chemical compound O1C(CNCCS(=O)(=O)C)=CC=C1C1=CC=C(N=CN=C2NC=3C=C(Cl)C(OCC=4C=C(F)C=CC=4)=CC=3)C2=C1 BCFGMOOMADDAQU-UHFFFAOYSA-N 0.000 claims 2
- 229960004891 lapatinib Drugs 0.000 claims 2
- 239000000546 pharmaceutical excipient Substances 0.000 claims 1
Classifications
-
- 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
- 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
- A61K47/6855—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 breast cancer cell
-
- 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
- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
- A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
- A61K31/404—Indoles, e.g. pindolol
-
- 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
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/4353—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems
- A61K31/437—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a five-membered ring having nitrogen as a ring hetero atom, e.g. indolizine, beta-carboline
-
- 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
- A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
- A61K39/39558—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against tumor tissues, cells, antigens
-
- 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
- A61K47/6889—Conjugates wherein the antibody being the modifying agent and wherein the linker, binder or spacer confers particular properties to the conjugates, e.g. peptidic enzyme-labile linkers or acid-labile linkers, providing for an acid-labile immuno conjugate wherein the drug may be released from its antibody conjugated part in an acidic, e.g. tumoural or environment
-
- 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
- A61P35/04—Antineoplastic agents specific for metastasis
-
- 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
- C07K16/32—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against translation products of oncogenes
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Chemical & Material Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Immunology (AREA)
- Oncology (AREA)
- Organic Chemistry (AREA)
- Cell Biology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Mycology (AREA)
- Microbiology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biochemistry (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Molecular Biology (AREA)
- Biomedical Technology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Nitrogen And Oxygen Or Sulfur-Condensed Heterocyclic Ring Systems (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
Claims (18)
1. Соединение по формуле (I)
для применения в лечении пациентов с трастузумаба эмтанзин рефрактерным HER2 IHC 3+ или HER2 IHC 2+/FISH положительным раком, где 2,6-2,9 представляет собой средний DAR для соединения.
2. Соединение для применения по п. 1, где средний DAR для соединения составляет около 2,8.
3. Соединение для применения по п. 1 или 2, где пациент является рефрактерным к и трастузумабу и трастузумаба эмтанзину.
4. Соединение для применения в соответствии с одним из пп. 1-3, где пациент является рефрактерным ко всем из трастузумаба, лапатиниба и трастузумаба эмтанзина.
5. Соединение для применения по любому из пп. 1-4, где пациентом является пациент с раком молочной железы.
6. Фармацевтическая композиция, включающая соединение по формуле (I) в соответствии с любым одним из пп. 1-5 и одно или более фармацевтически приемлемых вспомогательных веществ для применения в лечении пациентов с трастузумаба эмтанзин рефрактерным HER2 IHC 3+ или HER2 IHC 2+/FISH положительным раком.
7. Соединение или фармацевтическая композиция для применения в соответствии с любым из пп. 1-6, где пациента лечат, предпочтительно раз в 3 недели, дозой в диапазоне от около 0,9 мг/кг до около 2,1 мг/кг массы тела пациента посредством внутривенного введения, предпочтительно от около 1,2 до около 1,8 мг/кг массы тела пациента посредством внутривенного введения.
8. Соединение или фармацевтическая композиция для применения в соответствии с п. 7, где доза составляет около 0,9 мг/кг, около 1,2 мг/кг, около 1,5 мг/кг, около 1,8 мг/кг, или около 2,1 мг/кг массы тела пациента, предпочтительно около 1,2 мг/кг массы тела пациента.
9. Соединение или фармацевтическая композиция для применения в соответствии с любым из пп. 1-8, где средний DAR для соединения составляет около 2,8.
10. Способ лечения пациента с трастузумаба эмтанзин рефрактерным HER2 IHC 3+ или HER2 IHC 2+/FISH положительным раком, включающий введение пациенту терапевтически эффективного количества соединения по формуле (I)
где 2,6-2,9 представляет собой средний DAR для соединения.
11. Способ по п. 10, где средний DAR для соединения составляет около 2,8.
12. Способ по п. 10 или 11, где пациент является рефрактерным и к трастузумабу и к трастузумаба эмтанзину.
13. Способ по п. 12, где пациент является рефрактерным к любому из трастузумаба, лапатиниба и трастузумаба эмтанзина.
14. Способ по п. 10 или 11, где указанным пациентом с раком является пациент с раком молочной железы.
Applications Claiming Priority (7)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP15186258.8 | 2015-09-22 | ||
| EP15186258 | 2015-09-22 | ||
| EP16158710.0 | 2016-03-04 | ||
| EP16158710 | 2016-03-04 | ||
| EP16169699.2 | 2016-05-13 | ||
| EP16169699 | 2016-05-13 | ||
| PCT/EP2016/072464 WO2017050846A1 (en) | 2015-09-22 | 2016-09-21 | Syd985 treatment of t-dm1 refractory cancer patients |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| RU2018114457A true RU2018114457A (ru) | 2019-10-24 |
| RU2018114457A3 RU2018114457A3 (ru) | 2020-01-31 |
| RU2728101C2 RU2728101C2 (ru) | 2020-07-28 |
Family
ID=57068063
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2018114457A RU2728101C2 (ru) | 2015-09-22 | 2016-09-21 | Лечение syd985 пациентов с t-dm1 рефрактерным раком |
Country Status (21)
| Country | Link |
|---|---|
| US (1) | US10821191B2 (ru) |
| EP (1) | EP3352857B1 (ru) |
| JP (1) | JP6591665B2 (ru) |
| KR (1) | KR20180052761A (ru) |
| CN (1) | CN108025190A (ru) |
| AU (1) | AU2016328461B2 (ru) |
| BR (1) | BR112018005494A2 (ru) |
| CA (1) | CA2996600A1 (ru) |
| CL (1) | CL2018000726A1 (ru) |
| CY (1) | CY1123818T1 (ru) |
| DK (1) | DK3352857T3 (ru) |
| ES (1) | ES2854298T3 (ru) |
| HR (1) | HRP20210418T1 (ru) |
| HU (1) | HUE053614T2 (ru) |
| LT (1) | LT3352857T (ru) |
| MX (1) | MX386402B (ru) |
| MY (1) | MY194488A (ru) |
| PL (1) | PL3352857T3 (ru) |
| RU (1) | RU2728101C2 (ru) |
| WO (1) | WO2017050846A1 (ru) |
| ZA (1) | ZA201801022B (ru) |
Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2020094561A1 (en) * | 2018-11-09 | 2020-05-14 | Synthon Biopharmaceuticals B.V. | Filterable duocarmycin-containing antibody-drug conjugate compositions and related methods |
| EP4076538A1 (en) * | 2019-12-20 | 2022-10-26 | Pfizer Inc. | Treatment with site specific her2 antibody-drug conjugates |
| EP4420678A4 (en) * | 2021-10-20 | 2025-12-24 | Aist | ANTICANCER AGENT, PRODRUGATION OF AN ANTICANCER AGENT, IN VITRO METHOD FOR DESTRUCTING CANCER CELLS, CANCER THERAPY METHOD AND CANCER THERAPY DEVICE |
| PL248499B1 (pl) * | 2023-07-28 | 2025-12-22 | Inst Chemii I Techniki Jadrowej | Koniugat trastuzumab-emtanzyna znakowany izotopowo o właściwościach przeciwnowotworowych, sposób jego otrzymywania i jego zastosowanie w terapii antynowotworowej |
Family Cites Families (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| AU2008312457B2 (en) * | 2007-10-19 | 2014-04-17 | Genentech, Inc. | Cysteine engineered anti-TENB2 antibodies and antibody drug conjugates |
| CN106749665B (zh) | 2010-04-21 | 2021-03-26 | 辛塔佳有限公司 | Cc-1065类似物和双功能接头的缀合物 |
| PT2948184T (pt) * | 2014-01-10 | 2016-07-08 | Synthon Biopharmaceuticals Bv | Conjugados de anticorpo-fármaco de duocarmicina apresentando uma melhor atividade antitumoral in vivo. |
-
2016
- 2016-09-21 AU AU2016328461A patent/AU2016328461B2/en not_active Ceased
- 2016-09-21 EP EP16775553.7A patent/EP3352857B1/en active Active
- 2016-09-21 US US15/762,171 patent/US10821191B2/en not_active Expired - Fee Related
- 2016-09-21 ES ES16775553T patent/ES2854298T3/es active Active
- 2016-09-21 MX MX2018003459A patent/MX386402B/es unknown
- 2016-09-21 PL PL16775553T patent/PL3352857T3/pl unknown
- 2016-09-21 CN CN201680054664.3A patent/CN108025190A/zh active Pending
- 2016-09-21 DK DK16775553.7T patent/DK3352857T3/da active
- 2016-09-21 RU RU2018114457A patent/RU2728101C2/ru active
- 2016-09-21 MY MYPI2018000414A patent/MY194488A/en unknown
- 2016-09-21 BR BR112018005494A patent/BR112018005494A2/pt not_active Application Discontinuation
- 2016-09-21 HR HRP20210418TT patent/HRP20210418T1/hr unknown
- 2016-09-21 JP JP2018515142A patent/JP6591665B2/ja not_active Expired - Fee Related
- 2016-09-21 CA CA2996600A patent/CA2996600A1/en active Pending
- 2016-09-21 KR KR1020187010953A patent/KR20180052761A/ko not_active Abandoned
- 2016-09-21 WO PCT/EP2016/072464 patent/WO2017050846A1/en not_active Ceased
- 2016-09-21 HU HUE16775553A patent/HUE053614T2/hu unknown
- 2016-09-21 LT LTEP16775553.7T patent/LT3352857T/lt unknown
-
2018
- 2018-02-14 ZA ZA2018/01022A patent/ZA201801022B/en unknown
- 2018-03-20 CL CL2018000726A patent/CL2018000726A1/es unknown
-
2021
- 2021-02-16 CY CY20211100128T patent/CY1123818T1/el unknown
Also Published As
| Publication number | Publication date |
|---|---|
| MY194488A (en) | 2022-11-30 |
| CA2996600A1 (en) | 2017-03-30 |
| EP3352857B1 (en) | 2021-01-13 |
| CY1123818T1 (el) | 2022-05-27 |
| HUE053614T2 (hu) | 2021-07-28 |
| MX386402B (es) | 2025-03-18 |
| JP6591665B2 (ja) | 2019-10-16 |
| EP3352857A1 (en) | 2018-08-01 |
| JP2018527402A (ja) | 2018-09-20 |
| CL2018000726A1 (es) | 2018-06-01 |
| AU2016328461B2 (en) | 2021-04-08 |
| BR112018005494A2 (pt) | 2018-10-09 |
| WO2017050846A1 (en) | 2017-03-30 |
| RU2018114457A3 (ru) | 2020-01-31 |
| US10821191B2 (en) | 2020-11-03 |
| MX2018003459A (es) | 2018-06-06 |
| RU2728101C2 (ru) | 2020-07-28 |
| US20180280533A1 (en) | 2018-10-04 |
| PL3352857T3 (pl) | 2021-08-02 |
| HRP20210418T1 (hr) | 2021-04-30 |
| CN108025190A (zh) | 2018-05-11 |
| DK3352857T3 (da) | 2021-03-01 |
| AU2016328461A1 (en) | 2018-02-22 |
| KR20180052761A (ko) | 2018-05-18 |
| LT3352857T (lt) | 2021-02-25 |
| ZA201801022B (en) | 2021-05-26 |
| ES2854298T3 (es) | 2021-09-21 |
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