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HRP20230236T1 - Postupci liječenja raka kože primjenom inhibitora pd-1 - Google Patents

Postupci liječenja raka kože primjenom inhibitora pd-1 Download PDF

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Publication number
HRP20230236T1
HRP20230236T1 HRP20230236TT HRP20230236T HRP20230236T1 HR P20230236 T1 HRP20230236 T1 HR P20230236T1 HR P20230236T T HRP20230236T T HR P20230236TT HR P20230236 T HRP20230236 T HR P20230236T HR P20230236 T1 HRP20230236 T1 HR P20230236T1
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HR
Croatia
Prior art keywords
antibody
antigen
binding fragment
amino acid
acid sequence
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Application number
HRP20230236TT
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English (en)
Inventor
Matthew G FURY
Israel Lowy
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Regeneron Pharmaceuticals, Inc.
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Application filed by Regeneron Pharmaceuticals, Inc. filed Critical Regeneron Pharmaceuticals, Inc.
Publication of HRP20230236T1 publication Critical patent/HRP20230236T1/hr

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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
    • A61K39/39541—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against normal tissues, cells
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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
    • C07K16/2803—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
    • C07K16/2818—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 against CD28 or CD152
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    • C07K16/2878—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 NGF-receptor/TNF-receptor superfamily, e.g. CD27, CD30, CD40, CD95
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Claims (18)

1. Antitijelo ili njegov fragment koji veže antigen koji se specifično veže za programiranu staničnu smrt-1 (PD-1) za upotrebu u postupku liječenja ili inhibicije rasta tumora, navedena metoda obuhvaća: (a) odabir pacijenta koji ima tumor bazalnih stanica (BCC); i (b) davanje pacijentu kojem je potrebno terapeutski efikasne količine antitijela ili njegovog fragmenta koji veže antigen; pri čemu antitijelo ili njegov fragment koji se veže za antigen sadrži tri regije koje određuju komplementarnost teškog lanca (HCDR1, HCDR2 i HCDR3) varijabilne regije teškog lanca (HCVR) i tri regije koje određuju komplementarnost lakog lanca (LCDR1, LCDR2 i LCDR3) varijabilne regije lakog lanca (LCVR); pri čemu HCDR1 sadrži aminokiselinsku sekvencu SEQ ID NO: 3; HCDR2 sadrži aminokiselinsku sekvencu SEQ ID NO: 4; HCDR3 sadrži aminokiselinsku sekvencu SEQ ID NO: 5; LCDR1 sadrži aminokiselinsku sekvencu SEQ ID NO: 6; LCDR2 sadrži aminokiselinsku sekvencu SEQ ID NO: 7; i LCDR3 sadrži aminokiselinsku sekvencu SEQ ID NO: 8.
2. Antitijelo ili njegov fragment koji veže antigen za upotrebu u postupku prema zahtjevu 1, pri čemu je BCC metastatski, neoperabilnii/ili lokalno napredni.
3. Antitijelo ili njegov fragment koji veže antigen za upotrebu u postupku prema zahtjevu 1 ili 2, u kojem: (a) navedeni pacijent je liječen barem jednom prethodnom terapijom protiv tumora (b) pacijent je rezistentan ili neadekvatno reagirana ili ima recidiv nakon prethodne terapije.
4. Antitijelo ili njegov fragment koji veže antigen za upotrebu u postupku prema zahtjevu 3, gdje je terapija protiv tumora izabrana između operacije, zračenja, kemoterapije, inhibitora “hedgehog“ puta i drugog anti-PD-1 antitijela.
5. Antitijelo ili njegov fragment koji veže antigen za upotrebu prema bilo kojem od zahtjeva 1-4, gdje BCC je napredovao poslije ranijeg tretmana s, ili je pacijent intolerantan, na inhibitor “hedgehog“ puta.
6. Antitijelo ili njegov fragment koji se veže za antigen za upotrebu u postupku prema zahtjevu 4 ili 5, gdje je inhibitor “hedgehog“ puta izabran između vismodegiba i sonedegiba.
7. Antitijelo ili njegov fragment koji se veže za antigen za upotrebu u postupku prema bilo kojem od zahtjeva 1-6, gdje se antitijelo ili njegov fragment za vezivanje antigena daje u jednoj ili više doza, gdje: (a) svaka doza je davana 0,5 do 4 tjedna neposredno nakon prethodne doze; (b) svaka doza je davana 2 tjedna neposredno nakon prethodne doze; ili (c) svaka doza je davana 3 tjedna neposredno nakon prethodne doze
8. Antitijelo ili njegov fragment koji se veže za antigen za upotrebu u postupku prema zahtjevu 7, gdje svaka doza obuhvaća anti-PD-1 antitijelo ili njegov fragment koji se veže za antigen u količini od (a) 1, 3 ili 10 mg/kg tjelesne mase pacijenta, opcionalno 3 mg/kg tjelesne mase pacijenta; ili (b) 50 - 600 mg; opcionalno 200, 250 ili 350 mg .
9. Antitijelo ili njegov fragment koji veže antigen za upotrebu u postupku prema bilo kojem od zahtjeva 1-8, pri čemu je davano kao monoterapija.
10. Antitijelo ili njegov fragment koji veže antigen za upotrebu u postupku prema bilo kojem od zahtjeva 1-9, gdje davanje dovodi do bar jednog efekta koji je izabran iz grupe koja se sastoji od inhibicije rasta tumora, regresije tumora, smanjenja veličine tumora, smanjenja broja tumorskih stanica, odlaganja rasta tumora, apskopalnom efektu, inhibiciji tumorskih metastaza, smanjenju metastatskih lezija tijekom vremena, smanjenoj upotrebi kemoterapeutika ili citotoksičnih sredstava, smanjenju u opterećenju tumora, porastu preživljavanja bez progresije, porasta u sveukupnom preživljavanju, potpunom odgovoru, parcijalnom odgovoru, i stabilnoj bolesti.
11. Antitijelo ili njegov fragment koji veže antigen za upotrebu u postupku prema bilo kojem od zahtjeva 1-8 i 10, dalje obuhvaća davanje pacijentu dodatnog terapeutskog sredstva ili terapije, pri čemu je dodatno terapeutsko sredstvo ili terapija izabrano iz grupe koja se sastoji od inhibitora “hedgehog“ puta, operacije, zračenja, kemoterapeutskog sredstva, cjepiva protiv raka, inhibitora liganda 1 programirane smrti (PD-L1), inhibitora limfocitnog aktivirajućeg gena 3 (LAG3), inhibitora citotoksičnog T-limfocit-povezanog proteina 4 (CTLA-4), inhibitora T-ćelijskog imunoglobulina i domena mucina koji sadrži-3 (TIM3), inhibitora atenuatora B- i T-limfocita (BTLA), inhibitora T stanični imunoreceptora s Ig i ITIM domenima (TIGIT), CD47 inhibitora, inhibitora indolamin-2,3-dioksigenaze (IDO), bispecifičnog anti-CD3/anti-CD20 antitijela, antagonist vaskularnog endotelnog faktora rasta (VEGF), inhibitora angiopoietina-2 (Ang2), inhibitora transformirajućeg faktora rasta beta(TGFβ), inhibitor CD38, inhibitora receptora epidermalnog faktora rasta (EGFR), faktora koji stimulira koloniju granulocita-makrofaga (GM-CSF), ciklofosfamida, antitijela specifičnog za tumor-specifični antigen, Bacillus Calmette-Guerin cjepiva, citotoksina, inhibitora receptora za interleukin 6 (IL-6R), inhibitora receptora za interleukin 4 (IL-4R), inhibitor IL-10, IL-2, IL-7, IL-21, IL-15, konjugata antitijela s lijekom, antiinflamatornog lijeka, i dodatka prehrani .
12. Antitijelo ili njegov fragment koji se veže za antigen za upotrebu u postupku prema bilo kojem od zahtjeva 1-11, pri čemu je anti-PD-1 antitijelo ili njegov fragment koji se veže na antigen primijenjen intravenozno, supkutano, ili intraperitonealno.
13. Antitijelo ili njegov fragment koji veže antigen za upotrebu u postupku prema bilo kojem od zahtjeva 1-12, pri čemu se anti-PD-1 antitijelo ili njegov fragment koji veže antigen se sastoji od HCVR koja je bar 90% identična u sekvenci sa SEQ ID NO: 1 i/ili LCVR koja je bar 90% identična u sekvenci sa SEQ ID NO: 2.
14. Antitijelo ili njegov fragment koji veže antigen za upotrebu u postupku prema bilo kojem od zahtjeva 1-13, gdje se HCVR sastoji od aminokiselinske sekvence SEQ ID NO: 1 i LCVR se sastoji od aminokiselinske sekvence SEQ ID NO: 2.
15. Antitijelo ili njegov fragment koji veže antigen za upotrebu u postupku prema bilo kojem od zahtjeva 1-14, pri čemu se antitijelo sastoji od teškog lanca koji se sastoji od aminokiselinske sekvence SEQ ID NO: 9 i lakog lanca koji se sastoji iz aminokiselinske sekvence SEQ ID NO: 10.
16. Antitijelo koje se specifično veže za programiranu staničnu smrt-1 (PD-1) za upotrebu u postupku liječenja ili inhibicije rasta tumora, pri čemu spomenuti postupak obuhvaća: (a) odabir pacijenta s metastatskim karcinomom baznih stanica (BCC) ili metastatskim BCC, pri čemu je pacijent napredovao na ili je intolerantan na inhibitor “hedgehog“ puta; i (b) intravenozno davanje pacijentu kojem je potrebno svaka tri tjedna doze 350 mg antitijela koje se specifično vezuje za PD-1; pri čemu se anti-PD-1 antitijelo sastoji iz tri regije koje određuju komplementarnost teškog lanca (HCDR1, HCDR2 i HCDR3) varijabilne regije teškog lanca (HCVR) i tri regije koje određuju komplementarnost lakog lanca (LCDR1, LCDR2 i LCDR3) varijabilne regije lakog lanca (LCVR), gdje se HCDR1 sastoji iz aminokiselinske sekvence SEQ ID NO: 3; HCDR2 se sastoji iz aminokiselinske sekvence SEQ ID NO: 4; HCDR3 se sastoji iz aminokiselinske sekvence SEQ ID NO: 5; LCDR1 se sastoji iz aminokiselinske sekvence SEQ ID NO: 6; LCDR2 se sastoji iz aminokiselinske sekvence SEQ ID NO: 7; i LCDR3 se sastoji iz aminokiselinske sekvence SEQ ID NO: 8.
17. Antitijelo za upotrebu u postupku prema zahtjevu 16, u kojem se anti-PD-1 antitijelo sastoji od HCVR koji se sastoji od aminokiselinske sekvence SEQ ID NO: 1 i LCVR koja se sastoji od aminokiselinske sekvence SEQ ID NO: 2.
18. Antitijelo za upotrebu u postupku prema bilo kojem od zahtjeva 16 ili 17, u kojem se anti-PD-1 antitijelo sastoji od teškog lanca koji se sastoji od aminokiselinske sekvence SEQ ID NO: 9 i laki lanac koji se sastoji iz aminokiselinske sekvence SEQ ID NO: 10.
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