HRP20231229T1 - Paradigma liječenja za protutijelo anti-cd19 i venetoklaks kombinacijsko liječenje - Google Patents
Paradigma liječenja za protutijelo anti-cd19 i venetoklaks kombinacijsko liječenje Download PDFInfo
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- HRP20231229T1 HRP20231229T1 HRP20231229TT HRP20231229T HRP20231229T1 HR P20231229 T1 HRP20231229 T1 HR P20231229T1 HR P20231229T T HRP20231229T T HR P20231229TT HR P20231229 T HRP20231229 T HR P20231229T HR P20231229 T1 HRP20231229 T1 HR P20231229T1
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- Prior art keywords
- combination
- use according
- lymphoma
- antibody
- seq
- Prior art date
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- 238000011282 treatment Methods 0.000 title claims 5
- LQBVNQSMGBZMKD-UHFFFAOYSA-N venetoclax Chemical compound C=1C=C(Cl)C=CC=1C=1CC(C)(C)CCC=1CN(CC1)CCN1C(C=C1OC=2C=C3C=CNC3=NC=2)=CC=C1C(=O)NS(=O)(=O)C(C=C1[N+]([O-])=O)=CC=C1NCC1CCOCC1 LQBVNQSMGBZMKD-UHFFFAOYSA-N 0.000 title claims 2
- 229960001183 venetoclax Drugs 0.000 title claims 2
- 238000011284 combination treatment Methods 0.000 title 1
- 239000012664 BCL-2-inhibitor Substances 0.000 claims 8
- 229940123711 Bcl2 inhibitor Drugs 0.000 claims 8
- 208000015914 Non-Hodgkin lymphomas Diseases 0.000 claims 8
- 230000003442 weekly effect Effects 0.000 claims 5
- 208000010839 B-cell chronic lymphocytic leukemia Diseases 0.000 claims 2
- 208000031422 Lymphocytic Chronic B-Cell Leukemia Diseases 0.000 claims 2
- 206010025323 Lymphomas Diseases 0.000 claims 2
- 208000032852 chronic lymphocytic leukemia Diseases 0.000 claims 2
- 210000004698 lymphocyte Anatomy 0.000 claims 2
- 208000036170 B-Cell Marginal Zone Lymphoma Diseases 0.000 claims 1
- 208000011691 Burkitt lymphomas Diseases 0.000 claims 1
- 208000031671 Large B-Cell Diffuse Lymphoma Diseases 0.000 claims 1
- 201000003791 MALT lymphoma Diseases 0.000 claims 1
- 208000025205 Mantle-Cell Lymphoma Diseases 0.000 claims 1
- 206010012818 diffuse large B-cell lymphoma Diseases 0.000 claims 1
- 201000003444 follicular lymphoma Diseases 0.000 claims 1
- 201000007924 marginal zone B-cell lymphoma Diseases 0.000 claims 1
- 208000021937 marginal zone lymphoma Diseases 0.000 claims 1
- 239000000825 pharmaceutical preparation Substances 0.000 claims 1
Classifications
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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
- A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
- A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
-
- 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
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/496—Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene
-
- 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
- A61K31/63—Compounds containing para-N-benzenesulfonyl-N-groups, e.g. sulfanilamide, p-nitrobenzenesulfonyl hydrazide
- A61K31/635—Compounds containing para-N-benzenesulfonyl-N-groups, e.g. sulfanilamide, p-nitrobenzenesulfonyl hydrazide having a heterocyclic ring, e.g. sulfadiazine
-
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- 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
-
- 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
- A61K2039/545—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
- A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Immunology (AREA)
- Epidemiology (AREA)
- Organic Chemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biochemistry (AREA)
- Mycology (AREA)
- Molecular Biology (AREA)
- Engineering & Computer Science (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Microbiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Endocrinology (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Peptides Or Proteins (AREA)
Claims (23)
1. Kombinacija, naznačena time, da sadrži protutijelo anti-CD19 i BCL-2 inhibitor, za uporabu u liječenju pacijenta koji boluje od ne-Hodgkinovog limfoma, kronične limfocitne leukemije i/ili limfoma malih limfocita, pri čemu se navedeno protutijelo anti-CD19 daje najmanje sedam dana prije prve primjene navedenog BCL-2 inhibitora, gdje navedeni BCL-2 inhibitor jest venetoklaks i gdje protutijelo anti-CD19 sadrži HCDR1 regiju sa slijedom SYVMH (SEQ ID NO: 1), HCDR2 regiju sa slijedom NPYNDG (SEQ ID NO: 2), HCDR3 regiju sa slijedom GTYYYGTRVFDY (SEQ ID NO: 3), LCDR1 regiju sa slijedom RSSKSLQNVNGNTYLY (SEQ ID NO: 4), LCDR2 regiju sa slijedom RMSNLNS (SEQ ID NO: 5), i LCDR3 regiju sa slijedom MQHLEYPIT (SEQ ID NO: 6).
2. Kombinacija za uporabu prema patentnom zahtjevu 1, naznačena time, da se protutijelo anti-CD19 daje tjedno, dvotjedno ili mjesečno nakon prve primjene na Dan 1 i pritom se BCL-2 inhibitor daje prvi puta na Dan 8.
3. Kombinacija za uporabu prema bilo kojem od prethodnih patentnih zahtjeva, naznačena time, da se protutijelo anti-CD19 nakon prve primjene na Dan 1, daje tjedno u prva tri mjeseca.
4. Kombinacija za uporabu prema patentnom zahtjevu 3, naznačena time, da se protutijelo anti-CD19 nakon prve primjene na Dan 1, daje tjedno prva tri mjeseca i dvotjedno najmanje sljedeća tri mjeseca.
5. Kombinacija za uporabu prema patentnom zahtjevu 4, naznačena time, da se protutijelo anti-CD19 nakon prve primjene na Dan 1, daje tjedno prva tri mjeseca, dvotjedno sljedeća tri mjeseca i nakon toga mjesečno.
6. Kombinacija za uporabu prema bilo kojem od prethodnih patentnih zahtjeva, naznačena time, da postoji dodatno doziranje protutijela anti-CD19 na Dan 4.
7. Kombinacija za uporabu prema bilo kojem od prethodnih patentnih zahtjeva, naznačena time, da se BCL-2 inhibitor daje prvi puta na Dan 8 s početnom dozom od 20 mg, nakon čega slijedi tjedno podizanje doziranja od 50 mg, 100 mg, 200 mg i 400 mg, opcionalno nadalje slijedi dnevno doziranje od 400 mg.
8. Kombinacija za uporabu prema bilo kojem od prethodnih patentnih zahtjeva, naznačena time, da se spomenuto protutijelo anti-CD19 i spomenuti BCL-2 inhibitor formuliraju u različitim farmaceutskim pripravcima.
9. Kombinacija za uporabu prema bilo kojem od prethodnih patentnih zahtjeva, naznačena time, da se spomenuto protutijelo anti-CD19 i spomenuti BCL-2 inhibitor primjenjuju odvojeno.
10. Kombinacija za uporabu prema bilo kojem od prethodnih patentnih zahtjeva, naznačena time, da se spomenuto protutijelo anti-CD19 i spomenuti BCL-2 inhibitor primjenjuju u vremenu kada su kod pacijenta istovremeno aktivna oba sastojka iz kombinacije.
11. Kombinacija za uporabu prema bilo kojem od prethodnih patentnih zahtjeva, naznačena time, da protutijelo anti-CD19 sadrži varijabilni teški lanac sa slijedom
EVQLVESGGGLVKPGGSLKLSCAASGYTFTSYVMHWVRQAPGKGLEWIGYINPYNDGTKYNEKFQGRVTISSDKSISTAYMELSSLRSEDTAMYYCARGTYYYGTRVFDYWGQGTLVTVSS (SEQ ID NO: 10)
i varijabilni laki lanac sa slijedom
DIVMTQSPATLSLSPGERATLSCRSSKSLQNVNGNTYLYWFQQKPGQSPQLLIYRMSNLNSGVPDRFSGSGSGTEFTLTISSLEPEDFAVYYCMQHLEYPITFGAGTKLEIK (SEQ ID NO: 11).
12. Kombinacija za uporabu prema bilo kojem od prethodnih patentnih zahtjeva, naznačena time, da protutijelo anti-CD19 sadrži konstantnu domenu teškog lanca sa slijedom
ASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGGPDVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVQFNWYVDGVEVHNAKTKPREEQFNSTFRVVSVLTVVHQDWLNGKEYKCKVSNKALPAPEEKTISKTKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPMLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK (SEQ ID NO: 12).
13. Kombinacija za uporabu prema bilo kojem od prethodnih patentnih zahtjeva, naznačena time, da protutijelo anti-CD19 sadrži konstantnu domenu lakog lanca sa slijedom
RTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC (SEQ ID NO: 13).
14. Kombinacija za uporabu prema bilo kojem od prethodnih patentnih zahtjeva, naznačena time, da se protutijelo anti-CD19 primjenjuje u koncentraciji od 12 mg/kg.
15. Kombinacija za uporabu prema bilo kojem od prethodnih patentnih zahtjeva, naznačena time, da je za uporabu u liječenju ne-Hodgkinovog limfoma.
16. Kombinacija za uporabu prema patentnom zahtjevu 15, naznačena time, da ne-Hodgkinov limfom je folikularni limfom.
17. Kombinacija za uporabu prema patentnom zahtjevu 15, naznačena time, da ne-Hodgkinov limfom je limfom limfoidnog tkiva povezanog sa sluznicom.
18. Kombinacija za uporabu prema patentnom zahtjevu 15, naznačena time, da ne-Hodgkinov limfom je limfom marginalne zone.
19. Kombinacija za uporabu prema patentnom zahtjevu 15, naznačena time, da ne-Hodgkinov limfom je difuzni veliki limfom B stanica.
20. Kombinacija za uporabu prema patentnom zahtjevu 15, naznačena time, da ne-Hodgkinov limfom je Burkittov limfom.
21. Kombinacija za uporabu prema patentnom zahtjevu 15, naznačena time, da ne-Hodgkinov limfom je limfom plaštenih stanica.
22. Kombinacija za uporabu prema bilo kojem od patentnih zahtjeva 1 do 14, naznačena time, da je za uporabu u liječenju kronične limfocitne leukemije.
23. Kombinacija za uporabu prema bilo kojem od patentnih zahtjeva 1 do 14, naznačena time, da je za uporabu u liječenju limfoma malih limfocita.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP17173712 | 2017-05-31 | ||
| EP18728153.0A EP3630177B1 (en) | 2017-05-31 | 2018-05-30 | Treatment paradigm for an anti-cd19 antibody and venetoclax combination treatment |
| PCT/EP2018/064229 WO2018220040A1 (en) | 2017-05-31 | 2018-05-30 | Treatment paradigm for an anti-cd19 antibody and venetoclax combination treatment |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20231229T1 true HRP20231229T1 (hr) | 2024-02-02 |
Family
ID=59070416
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20231229TT HRP20231229T1 (hr) | 2017-05-31 | 2018-05-30 | Paradigma liječenja za protutijelo anti-cd19 i venetoklaks kombinacijsko liječenje |
Country Status (24)
| Country | Link |
|---|---|
| EP (2) | EP3630177B1 (hr) |
| JP (2) | JP7399713B2 (hr) |
| KR (1) | KR20200010472A (hr) |
| CN (1) | CN110678201A (hr) |
| AU (1) | AU2018276384A1 (hr) |
| BR (1) | BR112019025034A2 (hr) |
| CA (1) | CA3062400A1 (hr) |
| DK (1) | DK3630177T3 (hr) |
| ES (1) | ES2961940T3 (hr) |
| FI (1) | FI3630177T3 (hr) |
| HR (1) | HRP20231229T1 (hr) |
| HU (1) | HUE063119T2 (hr) |
| IL (2) | IL270855B2 (hr) |
| LT (1) | LT3630177T (hr) |
| MA (1) | MA48751B1 (hr) |
| MD (1) | MD3630177T2 (hr) |
| MX (1) | MX2019014330A (hr) |
| PL (1) | PL3630177T3 (hr) |
| PT (1) | PT3630177T (hr) |
| RS (1) | RS64746B1 (hr) |
| SG (1) | SG11201909715VA (hr) |
| SI (1) | SI3630177T1 (hr) |
| WO (1) | WO2018220040A1 (hr) |
| ZA (1) | ZA201907369B (hr) |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2022115120A1 (en) * | 2020-11-30 | 2022-06-02 | Incyte Corporation | Combination therapy with an anti-cd19 antibody and parsaclisib |
| TW202241436A (zh) * | 2020-11-30 | 2022-11-01 | 美商英塞特公司 | 抗ｃｄ１９抗體及帕薩昔布（ｐａｒｓａｃｌｉｓｉｂ）之組合療法 |
Family Cites Families (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US7902338B2 (en) | 2003-07-31 | 2011-03-08 | Immunomedics, Inc. | Anti-CD19 antibodies |
| EP1648512A4 (en) | 2003-07-31 | 2009-01-21 | Immunomedics Inc | ANTI-CD19 ANTIBODIES |
| AU2006262232A1 (en) | 2005-06-20 | 2007-01-04 | Medarex, Inc. | CD19 antibodies and their uses |
| EA016429B1 (ru) | 2005-12-30 | 2012-04-30 | Мерк Патент Гмбх | Антитела против cd19 с пониженной иммуногенностью |
| SI2059536T1 (sl) | 2006-08-14 | 2014-06-30 | Xencor, Inc. | Optimirana protitelesa, ki ciljajo CD19 |
| KR101456728B1 (ko) | 2006-09-08 | 2014-10-31 | 메디뮨 엘엘씨 | 인간화 항-ｃｄ19 항체, 및 이것의 종양학, 이식 및 자가면역 질환의 치료에서의 용도 |
| EP2211904B1 (en) | 2007-10-19 | 2016-08-17 | Seattle Genetics, Inc. | Cd19 binding agents and uses thereof |
| CN102421800A (zh) | 2009-02-23 | 2012-04-18 | 格兰马克药品股份有限公司 | 结合cd19的人源化抗体及其用途 |
| US8546399B2 (en) | 2009-05-26 | 2013-10-01 | Abbvie Inc. | Apoptosis inducing agents for the treatment of cancer and immune and autoimmune diseases |
| EP4083071A3 (en) * | 2011-08-16 | 2023-02-22 | MorphoSys AG | Combination therapy with an anti-cd19 antibody and a purine analog |
| KR20200058583A (ko) * | 2011-08-16 | 2020-05-27 | 모르포시스 아게 | 항-cd19 항체 및 질소 머스타드를 사용한 조합 요법 |
| WO2017032679A1 (en) | 2015-08-21 | 2017-03-02 | Morphosys Ag | Combinations and uses thereof |
| RS62036B1 (sr) | 2016-10-28 | 2021-07-30 | Morphosys Ag | Kombinacija anti cd19 antitela sa bcl-2 inhibitorom i njihova upotreba |
-
2018
- 2018-05-30 HU HUE18728153A patent/HUE063119T2/hu unknown
- 2018-05-30 PT PT187281530T patent/PT3630177T/pt unknown
- 2018-05-30 HR HRP20231229TT patent/HRP20231229T1/hr unknown
- 2018-05-30 WO PCT/EP2018/064229 patent/WO2018220040A1/en active Application Filing
- 2018-05-30 EP EP18728153.0A patent/EP3630177B1/en active Active
- 2018-05-30 MD MDE20200316T patent/MD3630177T2/ro unknown
- 2018-05-30 SI SI201831004T patent/SI3630177T1/sl unknown
- 2018-05-30 IL IL270855A patent/IL270855B2/en unknown
- 2018-05-30 SG SG11201909715V patent/SG11201909715VA/en unknown
- 2018-05-30 BR BR112019025034-4A patent/BR112019025034A2/pt unknown
- 2018-05-30 LT LTEPPCT/EP2018/064229T patent/LT3630177T/lt unknown
- 2018-05-30 FI FIEP18728153.0T patent/FI3630177T3/fi active
- 2018-05-30 MX MX2019014330A patent/MX2019014330A/es unknown
- 2018-05-30 PL PL18728153.0T patent/PL3630177T3/pl unknown
- 2018-05-30 IL IL297461A patent/IL297461A/en unknown
- 2018-05-30 MA MA48751A patent/MA48751B1/fr unknown
- 2018-05-30 AU AU2018276384A patent/AU2018276384A1/en active Pending
- 2018-05-30 KR KR1020197037961A patent/KR20200010472A/ko not_active IP Right Cessation
- 2018-05-30 RS RS20230937A patent/RS64746B1/sr unknown
- 2018-05-30 CA CA3062400A patent/CA3062400A1/en active Pending
- 2018-05-30 JP JP2019565795A patent/JP7399713B2/ja active Active
- 2018-05-30 CN CN201880035726.5A patent/CN110678201A/zh active Pending
- 2018-05-30 DK DK18728153.0T patent/DK3630177T3/da active
- 2018-05-30 ES ES18728153T patent/ES2961940T3/es active Active
- 2018-05-30 EP EP23190328.7A patent/EP4268900A3/en active Pending
-
2019
- 2019-11-06 ZA ZA2019/07369A patent/ZA201907369B/en unknown
-
2023
- 2023-12-06 JP JP2023205931A patent/JP2024028865A/ja active Pending
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