HRP20220399T1 - Režim doziranja imunokonjugata protutijela i sn-38 za poboljšanu učinkovitost i smanjenu toksičnost - Google Patents

Režim doziranja imunokonjugata protutijela i sn-38 za poboljšanu učinkovitost i smanjenu toksičnost Download PDF

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Publication number
HRP20220399T1
HRP20220399T1 HRP20220399TT HRP20220399T HRP20220399T1 HR P20220399 T1 HRP20220399 T1 HR P20220399T1 HR P20220399T T HRP20220399T T HR P20220399TT HR P20220399 T HRP20220399 T HR P20220399T HR P20220399 T1 HRP20220399 T1 HR P20220399T1
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Croatia
Prior art keywords
cancer
immunoconjugate
use according
preparation
antibody
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HRP20220399TT
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English (en)
Inventor
Serengulam V. Govindan
David M. Goldenberg
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Immunomedics, Inc.
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Application filed by Immunomedics, Inc. filed Critical Immunomedics, Inc.
Publication of HRP20220399T1 publication Critical patent/HRP20220399T1/hr

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    • C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance

Claims (17)

1. Imunokonjugat, naznačen time, da sadrži SN-38 konjugiran na humanizirano protutijelo, gdje postoji poveznik CL2A između SN-38 i protutijela, humanizirano protutijelo je hRS7 (anti-TROP-2), 5 do 7 molekula SN-38 vezano na svaku molekulu protutijela i pri čemu je struktura imunokonjugata MAb-CL2A-SN-38 [image] za uporabu u postupku liječenja raka koji obuhvaća davanje imunokonjugata ljudskom pojedincu koji ima rak; pri čemu se protutijelo veže na EGP-1 (TROP-2); i pri čemu se imunokonjugat daje u dozi od između 8 mg/kg i 10 mg/kg.
2. Pripravak imunokonjugata, naznačen time, da sadrži SN-38 konjugiran na humanizirano protutijelo, gdje postoji poveznik CL2A između SN-38 i protutijela, humanizirano protutijelo je hRS7 (anti-TROP-2), molekule protutijela su vezane s 5 do 7 molekula SN-38 i gdje je struktura imunokonjugata MAb-CL2A-SN-38 [image] za uporabu u postupku liječenja raka koji obuhvaća davanje pripravka ljudskom pojedincu koji ima rak; pri čemu se protutijelo veže na EGP-1 (TROP-2); i pri čemu se pripravak daje u dozi imunokonjugata od između 8 mg/kg i 10 mg/kg.
3. Imunokonjugat za uporabu prema patentnom zahtjevu 1 ili pripravak za uporabu prema patentnom zahtjevu 2, naznačen time, da se doza bira iz skupine koja se sastoji od 8 mg/kg, 9 mg/kg i 10 mg/kg.
4. Imunokonjugat za uporabu prema patentnom zahtjevu 1 ili pripravak za uporabu prema patentnom zahtjevu 2, naznačen time, da anti-EGP-1 protutijelo sadrži sljedove regije koja određuje komplementarnost (CDR) lakog lanca CDR1 (KASQDVSIAVA, SEQ ID NO: 90); CDR2 (SASYRYT, SEQ ID NO: 91); i CDR3 (QQHYITPLT, SEQ ID NO: 92) i sljedove CDR teškog lanca CDR1 (NYGMN, SEQ ID NO: 93); CDR2 (WINTYTGEPTYTDDFKG, SEQ ID NO: 94); i CDR3 (GGFGSSYWYFDV, SEQ ID NO: 95).
5. Imunokonjugat za uporabu prema patentnom zahtjevu 1 ili pripravak za uporabu prema patentnom zahtjevu 2, naznačen time, da rak je čvrsti tumor i liječenje rezultira u smanjenju veličine tumora od najmanje 15%, najmanje 20%, najmanje 30%, ili najmanje 40%.
6. Imunokonjugat za uporabu prema patentnom zahtjevu 1 ili pripravak za uporabu prema patentnom zahtjevu 2, naznačen time, da se rak bira iz skupine koju čine limfom B stanica, leukemija B stanica, rak debelog crijeva, rak želuca, rak jednjaka, medularni rak štitne žlijezde, rak bubrega, rak dojke, rak pluća, rak gušterače, rak mokraćnog mjehura, rak jajnika, rak maternice, rak cerviksa, rak testisa, rak prostate, rak jetre, rak kože, rak kosti, rak mozga, rak rektuma i melanom.
7. Imunokonjugat ili pripravak za uporabu prema patentnom zahtjevu 6, naznačen time, da se leukemija B stanica ili limfom B stanica bira iz skupine koju čine indolentni oblici limfoma B stanica, agresivni oblici limfoma B stanica, kronična limfocitna leukemija, akutna limfocitna leukemija, leukemija kosmatih stanica, ne-Hodgkinov limfom, Hodgkinov limfom, Burkittov limfom, folikularni limfom, difuzni limfom B stanica, limfom plaštenih stanica i multipli mijelom.
8. Imunokonjugat ili pripravak za uporabu prema patentnom zahtjevu 6, naznačen time, da rak je metastatski.
9. Imunokonjugat ili pripravak za uporabu prema patentnom zahtjevu 8, naznačen time, da postupak nadalje obuhvaća smanjivanje veličine ili eliminaciju metastaza.
10. Imunokonjugat za uporabu prema patentnom zahtjevu 1 ili pripravak za uporabu prema patentnom zahtjevu 2, naznačen time, da je za pacijenta najmanje jedna drugačija terapija imala neuspješan rezultat , prije liječenja s imunokonjugatom ili pripravkom.
11. Imunokonjugat ili pripravak za uporabu prema patentnom zahtjevu 10, naznačen time, da je za pacijenta terapija s irinotekanom imala neuspješan rezultat, prije liječenja s imunokonjugatom ili pripravkom.
12. Imunokonjugat ili pripravak za uporabu prema patentnom zahtjevu 10, naznačen time, da rak je čvrsti tumor i liječenje rezultira u smanjenju veličine tumora od najmanje 15%, najmanje 20%, najmanje 30%, ili najmanje 40%.
13. Imunokonjugat za uporabu prema patentnom zahtjevu 1 ili pripravak za uporabu prema patentnom zahtjevu 2, naznačen time, da postoji šest molekula SN-38 koje su vezane na svaku molekulu protutijela.
14. Imunokonjugat za uporabu prema patentnom zahtjevu 1 ili pripravak za uporabu prema patentnom zahtjevu 2, naznačen time, da postoji sedam molekula SN-38 koje su vezane na svaku molekulu protutijela.
15. Imunokonjugat za uporabu prema patentnom zahtjevu 1 ili pripravak za uporabu prema patentnom zahtjevu 2, naznačen time, da se imunokonjugat ili pripravak daje u kombinaciji s jednim ili više terapijskih modaliteta odabranih iz skupine koju čine nekonjugirana protutijela, radiološki označena protutijela, protutijela konjugirana s lijekom, protutijela konjugirana s toksinom, genska terapija, kemoterapija, terapijski peptidi, citokinska terapija, oligonukleotidi, lokalizirana radioterapija, operativni zahvat i interferentna RNA terapija.
16. Imunokonjugat za uporabu prema patentnom zahtjevu 1 ili pripravak za uporabu prema patentnom zahtjevu 2, naznačen time, da rak je rak gušterače, kolorektalni rak, rak pluća, želuca, mokraćnog mjehura, renalni rak, rak dojke, jajnika, maternice ili prostate.
17. Imunokonjugat ili pripravak za uporabu prema patentnom zahtjevu 16, naznačen time, da rak je metastatski rak debelog crijeva i za pacijenta je bila neuspješna kemoterapija FOLFIRI ili FOLFOX, prije davanja imunokonjugata ili pripravka; ili je rak trostruko negativni metastatski rak dojke i za pacijenta je bila neuspješna terapija s CMF, karboplatinom ili paklitakselom, prije davanja imunokonjugata ili pripravka; ili je rak metastatski rak pluća i pacijentu je bila neuspješna terapija s karboplatinom, bevacizumabom, etopozidom, topotekanom, docetakselom ili gemcitabinom, prije davanja imunokonjugata ili pripravka.
HRP20220399TT 2012-12-13 2013-07-23 Režim doziranja imunokonjugata protutijela i sn-38 za poboljšanu učinkovitost i smanjenu toksičnost HRP20220399T1 (hr)

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