HRP20191034T1 - Pripravci koji sadrže anti-cd38 protutijela i lenalidomid - Google Patents
Pripravci koji sadrže anti-cd38 protutijela i lenalidomid Download PDFInfo
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- HRP20191034T1 HRP20191034T1 HRP20191034TT HRP20191034T HRP20191034T1 HR P20191034 T1 HRP20191034 T1 HR P20191034T1 HR P20191034T T HRP20191034T T HR P20191034TT HR P20191034 T HRP20191034 T HR P20191034T HR P20191034 T1 HRP20191034 T1 HR P20191034T1
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- 229960004942 lenalidomide Drugs 0.000 title claims 18
- 239000000203 mixture Substances 0.000 title claims 9
- GOTYRUGSSMKFNF-UHFFFAOYSA-N lenalidomide Chemical compound C1C=2C(N)=CC=CC=2C(=O)N1C1CCC(=O)NC1=O GOTYRUGSSMKFNF-UHFFFAOYSA-N 0.000 title claims 8
- -1 lenalidomide compound Chemical class 0.000 claims 17
- 125000003275 alpha amino acid group Chemical group 0.000 claims 16
- 230000010056 antibody-dependent cellular cytotoxicity Effects 0.000 claims 12
- 230000004540 complement-dependent cytotoxicity Effects 0.000 claims 12
- 229960003957 dexamethasone Drugs 0.000 claims 12
- 238000002560 therapeutic procedure Methods 0.000 claims 12
- 208000034578 Multiple myelomas Diseases 0.000 claims 10
- 206010035226 Plasma cell myeloma Diseases 0.000 claims 10
- 102100031585 ADP-ribosyl cyclase/cyclic ADP-ribose hydrolase 1 Human genes 0.000 claims 6
- 101000777636 Homo sapiens ADP-ribosyl cyclase/cyclic ADP-ribose hydrolase 1 Proteins 0.000 claims 6
- 239000003146 anticoagulant agent Substances 0.000 claims 6
- 230000006907 apoptotic process Effects 0.000 claims 6
- UREBDLICKHMUKA-CXSFZGCWSA-N dexamethasone Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@]2(F)[C@@H]1[C@@H]1C[C@@H](C)[C@@](C(=O)CO)(O)[C@@]1(C)C[C@@H]2O UREBDLICKHMUKA-CXSFZGCWSA-N 0.000 claims 5
- BSYNRYMUTXBXSQ-UHFFFAOYSA-N Aspirin Chemical compound CC(=O)OC1=CC=CC=C1C(O)=O BSYNRYMUTXBXSQ-UHFFFAOYSA-N 0.000 claims 2
- 229960001138 acetylsalicylic acid Drugs 0.000 claims 2
- PJVWKTKQMONHTI-UHFFFAOYSA-N warfarin Chemical compound OC=1C2=CC=CC=C2OC(=O)C=1C(CC(=O)C)C1=CC=CC=C1 PJVWKTKQMONHTI-UHFFFAOYSA-N 0.000 claims 2
- 229960005080 warfarin Drugs 0.000 claims 2
- 206010028980 Neoplasm Diseases 0.000 claims 1
- 201000011510 cancer Diseases 0.000 claims 1
- 150000001875 compounds Chemical class 0.000 claims 1
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- 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
- C07K16/2896—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against molecules with a "CD"-designation, not provided for elsewhere
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- A61K31/365—Lactones
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- A61K31/37—Coumarins, e.g. psoralen
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- 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
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
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- A61K31/00—Medicinal preparations containing organic active ingredients
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- 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
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/445—Non condensed piperidines, e.g. piperocaine
- A61K31/4523—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems
- A61K31/454—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. pimozide, domperidone
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- 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
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
- A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
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- 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
- A61K31/60—Salicylic acid; Derivatives thereof
- A61K31/612—Salicylic acid; Derivatives thereof having the hydroxy group in position 2 esterified, e.g. salicylsulfuric acid
- A61K31/616—Salicylic acid; Derivatives thereof having the hydroxy group in position 2 esterified, e.g. salicylsulfuric acid by carboxylic acids, e.g. acetylsalicylic acid
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
- A61K31/726—Glycosaminoglycans, i.e. mucopolysaccharides
- A61K31/727—Heparin; Heparan
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- 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
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- 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
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- C07K2317/32—Immunoglobulins specific features characterized by aspects of specificity or valency specific for a neo-epitope on a complex, e.g. antibody-antigen or ligand-receptor
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- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
- C07K2317/34—Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
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Claims (21)
1. Pripravak koji sadrži anti-CD38 protutijelo za uporabu za liječenje multiplog mijeloma kod ljudskog subjekta, pri čemu liječenje obuhvaća davanje terapeutski učinkovite količine pripravka u kombinaciji s terapeutski djelotvornom količinom spoja lenalidomida, proizvoljno lenalidomida,
pri čemu je subjekt primio najmanje jednu prethodnu terapiju ili dvije prethodne terapije za multipli mijelom, te pri čemu anti-CD38 protutijelo sadrži:
teški lanac koji sadrži tri uzastopne CDR koje imaju sekvence aminokiselina koje obuhvaćaju SEQ ID NOs: 13, 81, i 15, i laki lanac koji sadrži tri uzastopne CDR koje imaju sekvence aminokiselina koje obuhvaćaju SEQ ID NOs: 16, 17, i 18,
proizvoljno pri čemu je anti-CD38 protutijelo sposobno ubijati CD38+ stanice apoptozom, staničnom citotoksičnošću ovisnom o protutijelima (ADCC), i citotoksičnošću ovisnom o komplementu (CDC).
2. Pripravak koji sadrži spoj lenalidomida, proizvoljno lenalidomid, za uporabu za liječenje multiplog mijeloma kod ljudskog subjekta, pri čemu liječenje obuhvaća davanje terapeutski učinkovite količine pripravka u kombinaciji s terapeutski djelotvornom količinom anti-CD38 protutijela,
pri čemu je subjekt primio najmanje jednu prethodnu terapiju ili dvije prethodne terapije za multipli mijelom, i
pri čemu anti-CD38 protutijelo sadrži teški lanac koji sadrži tri uzastopne CDR koje imaju sekvence aminokiselina koje obuhvaćaju SEQ ID NOs: 13, 81, i 15, i laki lanac koji sadrži tri uzastopne CDR koje imaju sekvence aminokiselina koje obuhvaćaju SEQ ID NOs: 16, 17, i 18,
proizvoljno pri čemu je anti-CD38 protutijelo sposobno ubijati CD38+ stanice apoptozom, staničnom citotoksičnošću ovisnom o protutijelima (ADCC), i citotoksičnošću ovisnom o komplementu (CDC).
3. Pripravak za uporabu prema zahtjevu 1 ili 2, naznačen time što se anti-CD38 protutijelo primjenjuje intravenski, pri čemu se spoj lenalidomida primjenjuje oralno, ili pri čemu se anti-CD38 protutijelo i spoj lenalidomida primjenjuju uzastopno.
4. Pripravak za uporabu prema bilo kojem od zahtjeva 1-3, naznačen time što navedeno liječenje nadalje obuhvaća davanje subjektu spoja deksametazona, proizvoljno deksametazona.
5. Pripravak za uporabu prema zahtjevu 4, naznačen time što se spoj deksametazona daje oralno.
6. Pripravak za uporabu prema zahtjevu 4 ili 5, naznačen time što se anti-CD38 protutijelo, spoj lenalidomida, i spoj deksametazona primjenjuju uzastopno.
7. Pripravak za uporabu prema bilo kojem od zahtjeva 1-6, naznačen time što navedeno liječenje nadalje obuhvaća davanje subjektu anti-koagulacijskog sredstva, proizvoljno pri čemu je anti-koagulacijsko sredstvo odabrano iz skupine koju čine aspirin i varfarin.
8. Pripravak za uporabu prema zahtjevu 7, naznačen time što se anti-CD38 protutijelo, spoj lenalidomida, i anti-koagulacijsko sredstvo primjenjuju uzastopno.
9. Pripravak za liječenje multiplog mijeloma kod ljudskog subjekta koji je primio najmanje jednu prethodnu terapiju ili dvije prethodne terapije za multipli mijelom, te pripravak sadrži;
a) anti-CD38 protutijelo koje sadrži teški lanac koji sadrži tri uzastopne CDR koje imaju sekvence aminokiselina koje obuhvaćaju SEQ ID NOs: 13, 81, i 15, i laki lanac koji sadrži tri uzastopne CDR koje imaju sekvence aminokiselina koje obuhvaćaju SEQ ID NOs: 16, 17, i 18,
proizvoljno pri čemu je anti-CD38 protutijelo sposobno ubijati CD38+ stanice apoptozom, staničnom citotoksičnošću ovisnom o protutijelima (ADCC), i citotoksičnošću ovisnom o komplementu (CDC); i
b) spoj lenalidomida, proizvoljno lenalidomid.
10. Pripravak prema zahtjevu 9, naznačen time što nadalje sadrži spoj deksametazona, proizvoljno deksametazon.
11. Komplet naznačen time što sadrži:
a) anti-CD38 protutijelo koje sadrži teški lanac koji sadrži tri uzastopne CDR koje imaju sekvence aminokiselina koje obuhvaćaju SEQ ID NOs: 13, 81, i 15, i laki lanac koji sadrži tri uzastopne CDR koje imaju sekvence aminokiselina koje obuhvaćaju SEQ ID NOs: 16, 17, i 18,
proizvoljno pri čemu je anti-CD38 protutijelo sposobno ubijati CD38+ stanice apoptozom, staničnom citotoksičnošću ovisnom o protutijelima (ADCC), i citotoksičnošću ovisnom o komplementu (CDC); i
b) spoj lenalidomida, proizvoljno lenalidomid.
12. Komplet prema zahtjevu 11, naznačen time što su anti-CD38 protutijelo i spoj lenalidomida pakirani za uzastopnu primjenu subjektu.
13. Komplet prema zahtjevu 11 ili 12, naznačen time što nadalje sadrži spoj deksametazona, proizvoljno deksametazon, i/ili anti-koagulacijsko sredstvo.
14. Kombinacija za liječenje multiplog mijeloma kod ljudskog subjekta koji je primio najmanje jednu prethodnu terapiju ili dvije prethodne terapije za multipli mijelom, te kombinacija sadrži:
(i) anti-CD38 protutijelo koje sadrži teški lanac koji sadrži tri uzastopne CDR koje imaju sekvence aminokiselina koje obuhvaćaju SEQ ID NOs: 13, 81, i 15, i laki lanac koji sadrži tri uzastopne CDR koje imaju sekvence aminokiselina koje obuhvaćaju SEQ ID NOs: 16, 17, i 18,
proizvoljno pri čemu je anti-CD38 protutijelo sposobno ubijati CD38+ stanice apoptozom, staničnom citotoksičnošću ovisnom o protutijelima (ADCC), i citotoksičnošću ovisnom o komplementu (CDC); i
(ii) spoj lenalidomida, proizvoljno lenalidomid; te proizvoljno
(iii) spoj deksametazona, proizvoljno deksametazon; te proizvoljno
(iv) anti-koagulacijsko sredstvo, proizvoljno pri čemu je anti-koagulacijsko sredstvo odabrano iz skupine koja sadrži aspirin i varfarin.
15. Kombinacija prema zahtjevu 14, naznačena time što je kombinacija prema za uzastopnu uporabu.
16. Pripravak za uporabu prema bilo kojem od zahtjeva 1-8, pripravak prema bilo kojem od zahtjeva 9-10, ili kombinacija prema bilo kojem od zahtjeva 14-15, naznačeni time što anti-CD38 protutijelo sadrži varijabilnu regiju teškog lanca (VH) koja obuhvaća sekvencu aminokiseline prikazanu u SEQ ID NO: 66, i varijabilnu regiju lakog lanca (VL) koja obuhvaća sekvencu aminokiseline prikazanu u SEQ ID NO: 62.
17. Pripravak za uporabu prema bilo kojem od zahtjeva 1-8, pripravak prema bilo kojem od zahtjeva 9-10, ili kombinacija prema bilo kojem od zahtjeva 14-15, naznačeni time što subjekt pokazuje dokaz da je rak napredovao dok je subjekt bio podvrgnut prethodnoj terapiji.
18. Pripravak za uporabu prema bilo kojem od zahtjeva 1-8, pripravak prema bilo kojem od zahtjeva 9-10, ili kombinacija prema bilo kojem od zahtjeva 14-15, naznačeni time što je subjekt bio refraktoran na prethodnu terapiju.
19. Anti-CD38 protutijelo za uporabu u liječenju multiplog mijeloma kod čovjeka, u kombinaciji sa spojem lenalidomida, proizvoljno s lenalidomidom, pri čemu je subjekt primio najmanje jednu prethodnu terapiju ili dvije prethodne terapije za multipli mijelom,
pri čemu navedeno protutijelo sadrži:
teški lanac koji sadrži tri uzastopne CDR koje imaju sekvence aminokiselina koje obuhvaćaju SEQ ID NOs: 13, 81, i 15, te laki lanac koji sadrži tri uzastopne CDR koje imaju sekvence aminokiselina koje obuhvaćaju SEQ ID NOs: 16, 17, i 18,
proizvoljno pri čemu je anti-CD38 protutijelo sposobno ubijati CD38+ stanice apoptozom, staničnom citotoksičnošću ovisnom o protutijelima (ADCC), i citotoksičnošću ovisnom o komplementu (CDC).
20. Anti-CD38 protutijelo za uporabu prema zahtjevu 19 naznačeno time što navedeno protutijelo sadrži varijabilnu regiju teškog lanca (VH) koja obuhvaća sekvencu aminokiseline prikazanu u SEQ ID NO: 66, i varijabilnu regiju lakog lanca (VL) koja obuhvaća sekvencu aminokiseline prikazanu u SEQ ID NO: 62.
21. Anti-CD38 protutijelo za uporabu prema bilo kojem od zahtjeva 19-20, naznačeno time što je anti-CD38 protutijelo nadalje u kombinaciji sa spojem deksametazona, proizvoljno s deksametazonom.
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201261734524P | 2012-12-07 | 2012-12-07 | |
| US201361769247P | 2013-02-26 | 2013-02-26 | |
| US201361808372P | 2013-04-04 | 2013-04-04 | |
| EP13861470.6A EP2928495B1 (en) | 2012-12-07 | 2013-12-06 | Compositions comprising anti-cd38 antibodies and lenalidomide |
| PCT/US2013/073540 WO2014089416A1 (en) | 2012-12-07 | 2013-12-06 | Compositions comprising anti-cd38 antibodies and lenalidomide |
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| Publication Number | Publication Date |
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| HRP20191034T1 true HRP20191034T1 (hr) | 2019-08-23 |
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| Application Number | Title | Priority Date | Filing Date |
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| HRP20191034TT HRP20191034T1 (hr) | 2012-12-07 | 2019-06-07 | Pripravci koji sadrže anti-cd38 protutijela i lenalidomid |
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| EP (2) | EP3597191A1 (hr) |
| JP (2) | JP6499971B2 (hr) |
| KR (2) | KR102193045B1 (hr) |
| CN (1) | CN105263520B (hr) |
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| AU (2) | AU2013355064B2 (hr) |
| BR (1) | BR112015012987A2 (hr) |
| CA (1) | CA2893946A1 (hr) |
| CL (2) | CL2015001558A1 (hr) |
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| DK (1) | DK2928495T3 (hr) |
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| HK (1) | HK1215536A1 (hr) |
| HR (1) | HRP20191034T1 (hr) |
| HU (3) | HUE044142T2 (hr) |
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| UA (1) | UA118255C2 (hr) |
| WO (1) | WO2014089416A1 (hr) |
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| UA112170C2 (uk) | 2010-12-10 | 2016-08-10 | Санофі | Протипухлинна комбінація, що містить антитіло, яке специфічно розпізнає cd38, і бортезоміб |
| US10342869B2 (en) | 2012-12-07 | 2019-07-09 | The Regents Of The University Of California | Compositions comprising anti-CD38 antibodies and lenalidomide |
| US9732154B2 (en) | 2014-02-28 | 2017-08-15 | Janssen Biotech, Inc. | Anti-CD38 antibodies for treatment of acute lymphoblastic leukemia |
| US9603927B2 (en) | 2014-02-28 | 2017-03-28 | Janssen Biotech, Inc. | Combination therapies with anti-CD38 antibodies |
| WO2015195555A1 (en) * | 2014-06-16 | 2015-12-23 | The United States Of America, As Represented By The Secretary, Department Of Health & Human Services | Blocking cd38 using anti-cd38 antibody conjugated to protein g to protect nk cells |
| WO2016022589A2 (en) | 2014-08-08 | 2016-02-11 | The Regents Of The University Of California | Methods for treating multiple myeloma |
| PE20171094A1 (es) | 2014-12-04 | 2017-08-07 | Janssen Biotech Inc | Anticuerpos anti-cd38 para el tratamiento de la leucemia linfoblastica aguda |
| WO2016187546A1 (en) | 2015-05-20 | 2016-11-24 | Janssen Biotech, Inc. | Anti-cd38 antibodies for treatment of light chain amyloidosis and other cd38-positive hematological malignancies |
| JP6816038B2 (ja) | 2015-06-22 | 2021-01-20 | ヤンセン バイオテツク，インコーポレーテツド | 抗ｃｄ３８抗体及びサバイビン阻害剤による血液悪性疾患の併用療法 |
| US20170044265A1 (en) | 2015-06-24 | 2017-02-16 | Janssen Biotech, Inc. | Immune Modulation and Treatment of Solid Tumors with Antibodies that Specifically Bind CD38 |
| MY202415A (en) | 2015-11-03 | 2024-04-27 | Janssen Biotech Inc | Subcutaneous formulations of anti-cd38 antibodies and their uses |
| US10781261B2 (en) | 2015-11-03 | 2020-09-22 | Janssen Biotech, Inc. | Subcutaneous formulations of anti-CD38 antibodies and their uses |
| MA50514A (fr) | 2017-10-31 | 2020-09-09 | Janssen Biotech Inc | Méthodes de traitement du myélome multiple à haut risque |
| KR102286500B1 (ko) * | 2018-04-13 | 2021-08-05 | 주식회사 삼양홀딩스 | 레날리도마이드를 포함하는 경구용 고형제제의 제조방법 |
| KR102286499B1 (ko) * | 2018-04-13 | 2021-08-05 | 주식회사 삼양홀딩스 | 레날리도마이드를 포함하는 약제학적 조성물 |
| KR102286498B1 (ko) * | 2018-04-13 | 2021-08-05 | 주식회사 삼양홀딩스 | 레날리도마이드의 경구용 코팅 정제 조성물 |
| KR102286497B1 (ko) * | 2018-04-13 | 2021-08-05 | 주식회사 삼양홀딩스 | 다양한 용량의 레날리도마이드의 경구용 정제 조성물 |
| WO2019199135A1 (ko) * | 2018-04-13 | 2019-10-17 | 주식회사 삼양바이오팜 | 레날리도마이드를 포함하는 경구용 고형제제의 제조방법 |
| US20220144965A1 (en) * | 2019-03-15 | 2022-05-12 | Morphosys Ag | Anti-cd38 antibodies and pharmaceutical compositions thereof for the treatment of autoantibody-mediated autoimmune disease |
| US11655302B2 (en) | 2019-06-10 | 2023-05-23 | Sanofi | Anti-CD38 antibodies and formulations |
| US20210188996A1 (en) | 2019-12-05 | 2021-06-24 | Sanofi-Aventis U.S. Llc | Formulations of anti-cd38 antibodies for subcutaneous administration |
| CA3226428A1 (en) * | 2021-08-02 | 2023-02-09 | Hangzhou Unogen Biotech, Ltd | Anti-cd38 antibodies, anti-cd3 antibodies, and bispecific antibodies, and uses thereof |
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| IL296666A (en) * | 2005-03-23 | 2022-11-01 | Genmab As | Antibodies against 38cd for the treatment of multiple myeloma |
| DK2081595T3 (da) * | 2006-09-26 | 2019-07-15 | Genmab As | Anti-cd38 plus corticosteroid plus et ikke-corticosteroid kemoterapeutikum til behandling af tumorer |
| EP1914242A1 (en) * | 2006-10-19 | 2008-04-23 | Sanofi-Aventis | Novel anti-CD38 antibodies for the treatment of cancer |
| EP2191843A1 (en) * | 2008-11-28 | 2010-06-02 | Sanofi-Aventis | Antitumor combinations containing antibodies recognizing specifically CD38 and cyclophosphamide |
| EP2191840A1 (en) * | 2008-11-28 | 2010-06-02 | Sanofi-Aventis | Antitumor combinations containing antibodies recognizing specifically CD38 and melphalan |
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