HRP20210274T1 - Supkutane formulacije protutijela anti-cd38 i njihove uporabe - Google Patents
Supkutane formulacije protutijela anti-cd38 i njihove uporabe Download PDFInfo
- Publication number
- HRP20210274T1 HRP20210274T1 HRP20210274TT HRP20210274T HRP20210274T1 HR P20210274 T1 HRP20210274 T1 HR P20210274T1 HR P20210274T T HRP20210274T T HR P20210274TT HR P20210274 T HRP20210274 T HR P20210274T HR P20210274 T1 HRP20210274 T1 HR P20210274T1
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- Croatia
- Prior art keywords
- seq
- antibody
- hyaluronidase
- pharmaceutical preparation
- concentration
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- 238000009472 formulation Methods 0.000 title 1
- 239000000203 mixture Substances 0.000 title 1
- 238000007920 subcutaneous administration Methods 0.000 title 1
- 108010003272 Hyaluronate lyase Proteins 0.000 claims 26
- 102000001974 Hyaluronidases Human genes 0.000 claims 26
- 229960002773 hyaluronidase Drugs 0.000 claims 26
- 239000000825 pharmaceutical preparation Substances 0.000 claims 25
- 229920001213 Polysorbate 20 Polymers 0.000 claims 14
- 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 claims 14
- 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 claims 14
- 229940068977 polysorbate 20 Drugs 0.000 claims 14
- HNDVDQJCIGZPNO-YFKPBYRVSA-N L-histidine Chemical compound OC(=O)[C@@H](N)CC1=CN=CN1 HNDVDQJCIGZPNO-YFKPBYRVSA-N 0.000 claims 13
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 claims 12
- FFEARJCKVFRZRR-BYPYZUCNSA-N L-methionine Chemical compound CSCC[C@H](N)C(O)=O FFEARJCKVFRZRR-BYPYZUCNSA-N 0.000 claims 11
- 229960002885 histidine Drugs 0.000 claims 11
- 229960004452 methionine Drugs 0.000 claims 11
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims 10
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 claims 9
- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 claims 9
- 229930182817 methionine Natural products 0.000 claims 9
- 239000000600 sorbitol Substances 0.000 claims 9
- 239000011780 sodium chloride Substances 0.000 claims 5
- 102100031585 ADP-ribosyl cyclase/cyclic ADP-ribose hydrolase 1 Human genes 0.000 claims 4
- 101000777636 Homo sapiens ADP-ribosyl cyclase/cyclic ADP-ribose hydrolase 1 Proteins 0.000 claims 4
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims 3
- 208000002250 Hematologic Neoplasms Diseases 0.000 claims 3
- 229930195725 Mannitol Natural products 0.000 claims 3
- 206010028980 Neoplasm Diseases 0.000 claims 3
- 239000003246 corticosteroid Substances 0.000 claims 3
- 239000000594 mannitol Substances 0.000 claims 3
- 235000010355 mannitol Nutrition 0.000 claims 3
- FFEARJCKVFRZRR-UHFFFAOYSA-N L-Methionine Natural products CSCCC(N)C(O)=O FFEARJCKVFRZRR-UHFFFAOYSA-N 0.000 claims 2
- 229930195722 L-methionine Natural products 0.000 claims 2
- 208000034578 Multiple myelomas Diseases 0.000 claims 2
- 206010035226 Plasma cell myeloma Diseases 0.000 claims 2
- 229940079156 Proteasome inhibitor Drugs 0.000 claims 2
- 229940100198 alkylating agent Drugs 0.000 claims 2
- 239000002168 alkylating agent Substances 0.000 claims 2
- 230000010056 antibody-dependent cellular cytotoxicity Effects 0.000 claims 2
- 230000005888 antibody-dependent cellular phagocytosis Effects 0.000 claims 2
- 201000011510 cancer Diseases 0.000 claims 2
- 230000004540 complement-dependent cytotoxicity Effects 0.000 claims 2
- 229960003957 dexamethasone Drugs 0.000 claims 2
- 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 2
- 239000002552 dosage form Substances 0.000 claims 2
- 201000005787 hematologic cancer Diseases 0.000 claims 2
- 208000024200 hematopoietic and lymphoid system neoplasm Diseases 0.000 claims 2
- 238000000034 method Methods 0.000 claims 2
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 claims 2
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims 2
- 229920000053 polysorbate 80 Polymers 0.000 claims 2
- 229940068968 polysorbate 80 Drugs 0.000 claims 2
- 239000003207 proteasome inhibitor Substances 0.000 claims 2
- 239000000126 substance Substances 0.000 claims 2
- 230000001225 therapeutic effect Effects 0.000 claims 2
- FDKXTQMXEQVLRF-ZHACJKMWSA-N (E)-dacarbazine Chemical compound CN(C)\N=N\c1[nH]cnc1C(N)=O FDKXTQMXEQVLRF-ZHACJKMWSA-N 0.000 claims 1
- UEJJHQNACJXSKW-UHFFFAOYSA-N 2-(2,6-dioxopiperidin-3-yl)-1H-isoindole-1,3(2H)-dione Chemical compound O=C1C2=CC=CC=C2C(=O)N1C1CCC(=O)NC1=O UEJJHQNACJXSKW-UHFFFAOYSA-N 0.000 claims 1
- 208000023761 AL amyloidosis Diseases 0.000 claims 1
- 208000024893 Acute lymphoblastic leukemia Diseases 0.000 claims 1
- 208000014697 Acute lymphocytic leukaemia Diseases 0.000 claims 1
- 208000031261 Acute myeloid leukaemia Diseases 0.000 claims 1
- 208000032791 BCR-ABL1 positive chronic myelogenous leukemia Diseases 0.000 claims 1
- COVZYZSDYWQREU-UHFFFAOYSA-N Busulfan Chemical group CS(=O)(=O)OCCCCOS(C)(=O)=O COVZYZSDYWQREU-UHFFFAOYSA-N 0.000 claims 1
- DLGOEMSEDOSKAD-UHFFFAOYSA-N Carmustine Chemical compound ClCCNC(=O)N(N=O)CCCl DLGOEMSEDOSKAD-UHFFFAOYSA-N 0.000 claims 1
- 208000010833 Chronic myeloid leukaemia Diseases 0.000 claims 1
- CMSMOCZEIVJLDB-UHFFFAOYSA-N Cyclophosphamide Chemical compound ClCCN(CCCl)P1(=O)NCCCO1 CMSMOCZEIVJLDB-UHFFFAOYSA-N 0.000 claims 1
- XXPXYPLPSDPERN-UHFFFAOYSA-N Ecteinascidin 743 Natural products COc1cc2C(NCCc2cc1O)C(=O)OCC3N4C(O)C5Cc6cc(C)c(OC)c(O)c6C(C4C(S)c7c(OC(=O)C)c(C)c8OCOc8c37)N5C XXPXYPLPSDPERN-UHFFFAOYSA-N 0.000 claims 1
- 206010066476 Haematological malignancy Diseases 0.000 claims 1
- 208000031671 Large B-Cell Diffuse Lymphoma Diseases 0.000 claims 1
- GQYIWUVLTXOXAJ-UHFFFAOYSA-N Lomustine Chemical compound ClCCN(N=O)C(=O)NC1CCCCC1 GQYIWUVLTXOXAJ-UHFFFAOYSA-N 0.000 claims 1
- 208000025205 Mantle-Cell Lymphoma Diseases 0.000 claims 1
- 208000033761 Myelogenous Chronic BCR-ABL Positive Leukemia Diseases 0.000 claims 1
- 208000033776 Myeloid Acute Leukemia Diseases 0.000 claims 1
- 208000015914 Non-Hodgkin lymphomas Diseases 0.000 claims 1
- 208000006664 Precursor Cell Lymphoblastic Leukemia-Lymphoma Diseases 0.000 claims 1
- 229930006000 Sucrose Natural products 0.000 claims 1
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims 1
- BPEGJWRSRHCHSN-UHFFFAOYSA-N Temozolomide Chemical compound O=C1N(C)N=NC2=C(C(N)=O)N=CN21 BPEGJWRSRHCHSN-UHFFFAOYSA-N 0.000 claims 1
- FOCVUCIESVLUNU-UHFFFAOYSA-N Thiotepa Chemical compound C1CN1P(N1CC1)(=S)N1CC1 FOCVUCIESVLUNU-UHFFFAOYSA-N 0.000 claims 1
- 230000006907 apoptotic process Effects 0.000 claims 1
- 229960002707 bendamustine Drugs 0.000 claims 1
- YTKUWDBFDASYHO-UHFFFAOYSA-N bendamustine Chemical compound ClCCN(CCCl)C1=CC=C2N(C)C(CCCC(O)=O)=NC2=C1 YTKUWDBFDASYHO-UHFFFAOYSA-N 0.000 claims 1
- 229960001467 bortezomib Drugs 0.000 claims 1
- GXJABQQUPOEUTA-RDJZCZTQSA-N bortezomib Chemical compound C([C@@H](C(=O)N[C@@H](CC(C)C)B(O)O)NC(=O)C=1N=CC=NC=1)C1=CC=CC=C1 GXJABQQUPOEUTA-RDJZCZTQSA-N 0.000 claims 1
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- 229960004562 carboplatin Drugs 0.000 claims 1
- 190000008236 carboplatin Chemical compound 0.000 claims 1
- 229960002438 carfilzomib Drugs 0.000 claims 1
- BLMPQMFVWMYDKT-NZTKNTHTSA-N carfilzomib Chemical compound C([C@@H](C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC=1C=CC=CC=1)C(=O)N[C@@H](CC(C)C)C(=O)[C@]1(C)OC1)NC(=O)CN1CCOCC1)CC1=CC=CC=C1 BLMPQMFVWMYDKT-NZTKNTHTSA-N 0.000 claims 1
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- 229960005243 carmustine Drugs 0.000 claims 1
- 229960004630 chlorambucil Drugs 0.000 claims 1
- JCKYGMPEJWAADB-UHFFFAOYSA-N chlorambucil Chemical compound OC(=O)CCCC1=CC=C(N(CCCl)CCCl)C=C1 JCKYGMPEJWAADB-UHFFFAOYSA-N 0.000 claims 1
- 229960004316 cisplatin Drugs 0.000 claims 1
- DQLATGHUWYMOKM-UHFFFAOYSA-L cisplatin Chemical compound N[Pt](N)(Cl)Cl DQLATGHUWYMOKM-UHFFFAOYSA-L 0.000 claims 1
- 229960004397 cyclophosphamide Drugs 0.000 claims 1
- 229960003901 dacarbazine Drugs 0.000 claims 1
- 229960002204 daratumumab Drugs 0.000 claims 1
- 206010012818 diffuse large B-cell lymphoma Diseases 0.000 claims 1
- 239000003937 drug carrier Substances 0.000 claims 1
- 230000000694 effects Effects 0.000 claims 1
- 201000003444 follicular lymphoma Diseases 0.000 claims 1
- 229960001101 ifosfamide Drugs 0.000 claims 1
- HOMGKSMUEGBAAB-UHFFFAOYSA-N ifosfamide Chemical compound ClCCNP1(=O)OCCCN1CCCl HOMGKSMUEGBAAB-UHFFFAOYSA-N 0.000 claims 1
- 229960003648 ixazomib Drugs 0.000 claims 1
- MXAYKZJJDUDWDS-LBPRGKRZSA-N ixazomib Chemical compound CC(C)C[C@@H](B(O)O)NC(=O)CNC(=O)C1=CC(Cl)=CC=C1Cl MXAYKZJJDUDWDS-LBPRGKRZSA-N 0.000 claims 1
- 229960004942 lenalidomide Drugs 0.000 claims 1
- GOTYRUGSSMKFNF-UHFFFAOYSA-N lenalidomide Chemical compound C1C=2C(N)=CC=CC=2C(=O)N1C1CCC(=O)NC1=O GOTYRUGSSMKFNF-UHFFFAOYSA-N 0.000 claims 1
- 229960002247 lomustine Drugs 0.000 claims 1
- 229960004961 mechlorethamine Drugs 0.000 claims 1
- HAWPXGHAZFHHAD-UHFFFAOYSA-N mechlorethamine Chemical compound ClCCN(C)CCCl HAWPXGHAZFHHAD-UHFFFAOYSA-N 0.000 claims 1
- 229960001924 melphalan Drugs 0.000 claims 1
- SGDBTWWWUNNDEQ-LBPRGKRZSA-N melphalan Chemical compound OC(=O)[C@@H](N)CC1=CC=C(N(CCCl)CCCl)C=C1 SGDBTWWWUNNDEQ-LBPRGKRZSA-N 0.000 claims 1
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- DWAFYCQODLXJNR-BNTLRKBRSA-L oxaliplatin Chemical compound O1C(=O)C(=O)O[Pt]11N[C@@H]2CCCC[C@H]2N1 DWAFYCQODLXJNR-BNTLRKBRSA-L 0.000 claims 1
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- UVSMNLNDYGZFPF-UHFFFAOYSA-N pomalidomide Chemical compound O=C1C=2C(N)=CC=CC=2C(=O)N1C1CCC(=O)NC1=O UVSMNLNDYGZFPF-UHFFFAOYSA-N 0.000 claims 1
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Classifications
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Claims (20)
1. Farmaceutski pripravak, naznačen time, da sadrži protutijelo anti-CD38 i hijaluronidazu, pri čemu:
a) protutijelo sadrži varijabilnu regiju teškog lanca (VH) od SEQ ID NO: 4 i varijabilnu regiju lakog lanca (VL) od SEQ ID NO: 5; i
b) pripravak sadrži oko 1800 mg protutijela anti-CD38 i oko 30 000 U hijaluronidaze.
2. Farmaceutski pripravak prema patentnom zahtjevu 1, naznačen time, da:
a) nadalje sadrži farmaceutski prihvatljiv nosač; i/ili
b) se radi o fiksnoj kombinaciji ili ne-fiksnoj kombinaciji.
3. Farmaceutski pripravak prema patentnom zahtjevu 1 ili zahtjevu 2, naznačen time, da sadrži:
a) od oko 20 mg/mL do oko 160 mg/mL protutijela anti-CD38;
b) od oko 20 mg/mL do oko 140 mg/mL protutijela anti-CD38;
c) od oko 20 mg/mL do oko 120 mg/mL protutijela anti-CD38;
d) od oko 40 mg/mL do oko 120 mg/mL protutijela anti-CD38;
e) od oko 60 mg/mL do oko 120 mg/mL protutijela anti-CD38;
f) od oko 80 mg/mL do oko 120 mg/mL protutijela anti-CD38;
g) od oko 100 mg/mL do oko 120 mg/mL protutijela anti-CD38.
4. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 3, naznačen time, da sadrži:
a) oko 20 mg/mL protutijela anti-CD38;
b) oko 100 mg/mL protutijela anti-CD38; ili
c) oko 120 mg/mL protutijela anti-CD38.
5. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 4, naznačen time, da sadrži:
a) od oko 500 U/ml do oko 5000 U/mL hijaluronidaze;
b) od oko 1000 U/ml do oko 5000 U/mL hijaluronidaze;
c) od oko 2000 U/ml do oko 5000 U/mL hijaluronidaze;
d) od oko 500 U/ml do oko 2000 U/mL hijaluronidaze; ili
e) od oko 1000 U/ml do oko 2000 U/mL hijaluronidaze.
6. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 5, naznačen time, da sadrži:
a) oko 500 U/mL hijaluronidaze;
b) oko 2000 U/mL hijaluronidaze; ili
c) oko 5000 U/mL hijaluronidaze.
7. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 6, naznačen time, da protutijelo anti-CD38 sadrži teški lanac od SEQ ID NO: 12 i laki lanac od SEQ ID NO: 13.
8. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 7, naznačen time, da sadrži:
a) od oko 20 mg/mL do oko 120 mg/mL protutijela anti-CD38 koje sadrži VH od SEQ ID NO: 4 i VL od SEQ ID NO: 5, u oko 25 mM octene kiseline, oko 60 mM natrijevog klorida, oko 140 manitola i oko 0,04 % m/v polisorbata-20 (PS-20); uz pH vrijednost od 5,5; i hijaluronidazu u 10 mM L-histidina, 130 mM NaCl, 10 mM L-metionina, 0,02% polisorbata-80, uz pH od 6,5; ili
b) oko 20 mg/mL protutijela anti-CD38 koje sadrži VH od SEQ ID NO: 4 i VL od SEQ ID NO: 5, u oko 25 mM octene kiseline, oko 60 mM natrijevog klorida, oko 140 manitola i oko 0,04 % m/v polisorbata-20 (PS-20); uz pH vrijednost od 5,5; i hijaluronidazu u 10 mM L-histidina, 130 mM NaCl, 10 mM L-metionina, 0,02% polisorbata-80, uz pH od 6,5;
opcionalno gdje se radi o hijaluronidazi rHuPH20 (SEQ ID NO: 22), opcionalno se radi o ne-fiksnoj kombinaciji.
9. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 7, naznačen time, da sadrži:
a) od oko 1 mg/mL do oko 180 mg/mL protutijela anti-CD38 koje sadrži VH od SEQ ID NO: 4 i VL od SEQ ID NO: 5;
b) od oko 50 U/mL do oko 5000 U/mL hijaluronidaze;
c) od oko 5 mM do oko 50 mM histidina; i
d) od oko 50 mM do oko 400 mM sorbitola;
opcionalno:
i) nadalje sadrži od oko 0,01% m/v do oko 0,1% m/v PS-20; i/ili od oko 0,1 mg/mL do oko 2,5 mg/mL metionina; ili
ii) sadrži od oko 100 mg/mL do oko 120 mg/mL protutijela anti-CD38 koje sadrži VH od SEQ ID NO: 4 i VL od SEQ ID NO: 5; od oko 50 U/mL do oko 5000 U/mL hijaluronidaze; oko 10 mM histidina; i od oko 100 mM do oko 300 mM sorbitola; opcionalno dalje sadrži od oko 0,01% m/v do oko 0,04% m/v PS-20; i od oko 1 mg/mL do oko 2 mg/mL metionina.
10. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 7 ili 9, naznačen time, da sadrži oko 120 mg/mL protutijela anti-CD38 koje sadrži VH od SEQ ID NO: 4 i VL od SEQ ID NO: 5; oko 2000 U/mL rHuPH20; oko 10 mM histidina; oko 300 mM sorbitola; oko 0,04% m/v PS-20; i oko 1 mg/mL metionina; uz pH od oko 5,5.
11. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 10, naznačen time, da:
a) se pritom radi o hijaluronidazi rHuPH20 (SEQ ID NO: 22); i/ili
b) se nalazi u obliku dozne jedinice.
12. Farmaceutski pripravak, naznačen time, da je za uporabu u postupku liječenja raka kod pojedinca, pri čemu postupak obuhvaća davanje farmaceutskog pripravka pojedincu supkutano i pri čemu farmaceutski pripravak sadrži protutijelo anti-CD38 i hijaluronidazu, pri čemu:
a) protutijelo sadrži varijabilnu regiju teškog lanca (VH) od SEQ ID NO: 4 i varijabilnu regiju lakog lanca (VL) od SEQ ID NO: 5; i
b) pripravak sadrži oko 1800 mg protutijela anti-CD38 i oko 30 000 U hijaluronidaze.
13. Farmaceutski pripravak za uporabu prema patentnom zahtjevu 12, naznačen time, da:
a) se radi o farmaceutskom pripravku koji je fiksna kombinacija ili ne-fiksna kombinacija;
b) pritom farmaceutski pripravak sadrži od oko 20 mg/mL do oko 160 mg/mL, od oko 20 mg/mL do oko 140 mg/mL, od oko 20 mg/mL do oko 120 mg/mL, od oko 40 mg/mL do oko 120 mg/mL, od oko 60 mg/mL do oko 120 mg/mL, od oko 80 mg/mL do oko 120 mg/mL, od oko 100 mg/mL do oko 120 mg/mL, oko 20 mg/mL, oko 100 mg/mL, ili oko 120 mg/mL protutijela anti-CD38; i/ili
c) pritom farmaceutski pripravak sadrži od oko 500 U/mL do oko 5000 U/mL, od oko 1000 U/mL do oko 5000 U/mL, od oko 2000 U/mL do oko 5000 U/mL, od oko 50 U/mL do oko 2000 U/mL, od oko 500 U/mL do oko 2000 U/mL, od oko 1000 U/mL do oko 2000 U/mL, oko 500 U/mL, oko 2000 U/mL ili oko 5000 U/mL hijaluronidaze.
14. Farmaceutski pripravak za uporabu prema patentnom zahtjevu 12 ili zahtjevu 13, naznačen time, da farmaceutski pripravak sadrži:
a) oko 20 mg/mL protutijela anti-CD38 koje sadrži VH od SEQ ID NO: 4 i VL od SEQ ID NO: 5, oko 25 mM octene kiseline, oko 60 mM natrijevog klorida, oko 140 manitola i oko 0,04 % m/v polisorbata-20 (PS-20), uz pH vrijednost od oko 5,5;
b) od oko 1 mg/mL do oko 180 mg/mL protutijela anti-CD38 koje sadrži VH od SEQ ID NO: 4 i VL od SEQ ID NO: 5, od oko 50 U/mL do oko 5000 U/mL hijaluronidaze, 25 mM octene kiseline, od oko 5 mM do oko 50 mM histidina i od oko 50 mM do oko 400 mM sorbitola, opcionalno dalje sadrži od oko 0,01% m/v do oko 0,1% m/v PS-20 i/ili od oko 0,1 mg/mL do oko 2,5 mg/mL metionina;
c) od oko 100 mg/mL do oko 120 mg/mL protutijela anti-CD38 koje sadrži VH od SEQ ID NO: 4 i VL od SEQ ID NO: 5, od oko 50 U/mL do oko 5000 U/mL hijaluronidaze, oko 10 mM histidina i od oko 100 mM do oko 300 mM sorbitola, opcionalno dalje sadrži od oko 0,01% m/v do oko 0,04% m/v PS-20 i/ili od oko 1 mg/mL do oko 2 mg/mL metionina; ili
d) oko 120 mg/mL protutijela anti-CD38 koje sadrži VH od SEQ ID NO: 4 i VL od SEQ ID NO: 5, oko 2000 U/mL hijaluronidaze, oko 10 mM histidina, oko 300 mM sorbitola, oko 0,04% m/v PS-20 i oko 1 mg/mL metionina; uz pH od oko 5,5.
15. Farmaceutski pripravak za uporabu prema bilo kojem od patentnih zahtjeva 12 do 14, naznačen time, da:
a) se radi o hijaluronidazi rHuPH20 (SEQ ID NO: 22);
b) pri čemu je rak:
i) čvrsti tumor; ili
ii) CD38-pozitivna hematološka malignost, opcionalno gdje je CD38-pozitivna hematološka malignost multipli mijelom, folikularni limfom, veliki difuzni limfom B-stanice, amiloidoza lakog lanca, ne-Hodgkinov limfom, akutna limfoblastna leukemija, limfom plaštenih stanica, akutna mijeloidna leukemija ili kronična mijeloidna leukemija, dok je CD38-pozitivna hematološka malignost primjerice multipli mijelom;
c) dodatno se daje druga terapijska tvar, primjerice gdje je druga terapijska tvar inhibitor proteazoma, alkilacijsko sredstvo ili derivat glutaminske kiseline, ili njihove kombinacije, kao kada:
i) inhibitor proteazoma je bortezomib, karfilzomib ili iksazomib;
ii) alkilacijsko sredstvo je busulfan, ciklofosfamid, bendamustin, klorambucil, karboplatin, cisplatin, temozolomid, melfalan, karmustin, lomustin, dakarbazin, oksaliplatin, ifosfamid, mekloretamin, tiotepa, trabektedin ili streptozocin; i
iii) derivat glutaminske kiseline je lenalidomid, talidomid ili pomalidomid; i/ili
d) nadalje se daje kortikosteroid, opcionalno pritom kortikosteroid je deksametazon ili prednizon, gdje kortikosteroid jest deksametazon.
16. Oblik za jedinično doziranje, naznačen time, da sadrži:
a) protutijelo anti-CD38 koje sadrži VH od SEQ ID NO: 4 i VL od SEQ ID NO: 5, u količini od oko 1800 mg;
b) hijaluronidazu u količini od oko 30 000 U;
c) histidin u koncentraciji od oko 5 mM do oko 15 mM;
d) sorbitol u koncentraciji od oko 100 mM do oko 300 mM;
e) PS-20 u koncentraciji od oko 0,01% m/v do oko 0,04% m/v; i
f) metionin u koncentraciji od oko 1 mg/mL do oko 2 mg/mL, uz pH od oko 5,5;
opcionalno pritom:
i) histidin se nalazi u koncentraciji od oko 10 mM;
ii) sorbitol se nalazi u koncentraciji od oko 300 mM;
iii) polisorbat se nalazi u koncentraciji od oko 0,04% m/v;
iv) metionin se nalazi u koncentraciji od oko 1 mg/mL;
v) sadrži saharozu u koncentraciji od oko 100 mM do oko 200 mM; i/ili
vi) hijaluronidaza jest rHuPH20 (SEQ ID NO: 22).
17. Oblik za jedinično doziranje prema patentnom zahtjevu 16, naznačen time, da sadrži:
a) protutijelo anti-CD38 koje sadrži VH od SEQ ID NO: 4 i VL od SEQ ID NO: 5, u količini od oko 1800 mg;
b) hijaluronidazu u količini od oko 30 000 U;
c) histidin u koncentraciji od oko 10 mM;
d) sorbitol u koncentraciji od oko 300 mM;
e) PS-20 u koncentraciji od oko 0,04% m/v; i
f) metionin u koncentraciji od oko 1 mg/mL, uz pH od oko 5,5.
18. Spremnik, naznačen time, da sadrži oblik za jedinično doziranje prema patentnom zahtjevu 16 ili zahtjevu 17.
19. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 11, farmaceutski pripravak za uporabu prema bilo kojem od patentnih zahtjeva 12 do 15, oblik za jedinično doziranje prema patentnom zahtjevu 16 ili zahtjevu 17, ili spremnik prema patentnom zahtjevu 18, naznačen time, da protutijelo anti-CD38:
a) pripada podtipu IgG1/κ; i/ili
b) inducira usmrćivanje tumorskih stanica koje eksprimiraju CD38 pomoću stanično posredovane citotoksičnosti koja ovisi o protutijelu (ADCC), stanične fagocitoze koja ovisi o protutijelu (ADCP), komplementarno ovisne citotoksičnosti (CDC), apoptoze, ili modulacije CD38-enzimskih aktivnosti.
20. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 11, farmaceutski pripravak za uporabu prema bilo kojem od patentnih zahtjeva 12 do 15, oblik za jedinično doziranje prema patentnom zahtjevu 16 ili zahtjevu 17, ili spremnik prema patentnom zahtjevu 18, naznačen time, da protutijelo anti-CD38 jest daratumumab.
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