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HRP20210410T1 - Konjugirana antitijela prema ly75 za liječenje raka - Google Patents

Konjugirana antitijela prema ly75 za liječenje raka Download PDF

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Publication number
HRP20210410T1
HRP20210410T1 HRP20210410TT HRP20210410T HRP20210410T1 HR P20210410 T1 HRP20210410 T1 HR P20210410T1 HR P20210410T T HRP20210410T T HR P20210410TT HR P20210410 T HRP20210410 T HR P20210410T HR P20210410 T1 HRP20210410 T1 HR P20210410T1
Authority
HR
Croatia
Prior art keywords
antibody
antigen
cancer
lymphoma
seq
Prior art date
Application number
HRP20210410TT
Other languages
English (en)
Inventor
Jonathan Alexander Terrett
James Edward ACKROYD
Original Assignee
Oxford Bio Therapeutics Limited
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Oxford Bio Therapeutics Limited filed Critical Oxford Bio Therapeutics Limited
Publication of HRP20210410T1 publication Critical patent/HRP20210410T1/hr

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Classifications

    • 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
    • C07K16/2851—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 lectin superfamily, e.g. CD23, CD72
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
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    • A61K47/68—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A61K47/6801—Drug-antibody or immunoglobulin conjugates defined by the pharmacologically or therapeutically active agent
    • A61K47/6803—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates
    • A61K47/68033—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates the drug being a maytansine
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    • A61K47/6835—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site
    • A61K47/6851—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site the antibody targeting a determinant of a tumour cell
    • A61K47/6855—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site the antibody targeting a determinant of a tumour cell the tumour determinant being from breast cancer cell
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    • A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
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    • A61K47/6851—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site the antibody targeting a determinant of a tumour cell
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    • A61K47/6851—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site the antibody targeting a determinant of a tumour cell
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Claims (15)

1. Izolirano antitijelo, ili njegov antigen-vezujući dio, koje se veže za LY75, pri čemu navedeno antitijelo sadrži: a) varijabilnu regiju teškog lanca koja sadrži: i) prvi vhCDR koji sadrži SEQ ID NO: 5; ii) drugi vhCDR koji sadrži SEQ ID NO: 6; i iii) treći vhCDR koji sadrži SEQ ID NO: 7; i b) varijabilnu regiju lakog lanca koja sadrži: i) prvi vlCDR koji sadrži SEQ ID NO: 8; ii) drugi vlCDR koji sadrži SEQ ID NO: 9; i iii) treći vlCDR koji sadrži SEQ ID NO: 10, pri čemu bilo koja od jedne ili više od gore navedenih SEQ ID NO neovisno sadrže jednu ili dvije amino-kiselinske supstitucije i pri čemu je antitijelo internalizirano.
2. Izolirano antitijelo, ili njegov antigen-vezujući dio, koje se veže za LY75, pri čemu navedeno antitijelo sadrži: a) varijabilnu regiju teškog lanca koja sadrži: i) prvi vhCDR koji sadrži SEQ ID NO: 5; ii) drugi vhCDR koji sadrži SEQ ID NO: 6; i iii) treći vhCDR koji sadrži SEQ ID NO: 7; i b) varijabilnu regiju lakog lanca koja sadrži: i) prvi vlCDR koji sadrži SEQ ID NO: 8; ii) drugi vlCDR koji sadrži SEQ ID NO: 9; i iii) treći vlCDR koji sadrži SEQ ID NO: 10.
3. Izolirano antitijelo ili njegov antigen-vezujući dio u skladu sa patentnim zahtjevom 1 ili patentnim zahtjevom 2, koje sadrži teški lanac koji ima najmanje 80%, 85%, 90%, 95% ili 99% identiteta amino-kiselinske sekvence sa SEQ ID NO: 1 i laki lanac koji ima najmanje 80%, 85%, 90%, 95% ili 99% identiteta amino-kiselinske sekvence sa SEQ ID NO: 2.
4. Izolirano antitijelo ili njegov antigen-vezujući dio u skladu sa bilo kojim od patentnih zahtjeva 1 do 3 koje dodatno sadrži kovalentno vezani ostatak, izborno pri čemu je navedeni ostatak lijek.
5. Izolirano antitijelo ili njegov antigen-vezujući dio u skladu sa patentnim zahtjevom 4, naznačeno time što je navedeni lijek odabran iz grupe koja se sastoji od majtansinoida, dolastatina, hemiasterlina, auristatina, trihotecena, kaliheamicina, CC1065 i njihovih derivata, poželjno pri čemu je navedeni lijek majtansinoid odabran iz grupe koja se sastoji od DM4 i DM1.
6. Farmaceutski pripravak koji sadrži antitijelo ili njegov antigen-vezujući dio u skladu sa bilo kojim od prethodnih patentnih zahtjeva, zajedno sa jednim ili više farmaceutski prihvatljivih razrjeđivača, ekscipijenata ili nosača.
7. Nukleinska kiselina koja kodira: i) teški lanac antitijela ili njegov antigen-vezujući dio prema bilo kojem od patentnih zahtjeva 1 do 5; i ii) laki lanac antitijela ili njegov antigen-vezujući dio prema bilo kojem od patentnih zahtjeva 1 do 5.
8. Vektor ekspresije koji sadrži jednu ili obje od nukleinskih kiselina prema patentnom zahtjevu 7 operativno povezane sa jednim ili više regulatornih elemenata.
9. Stanica domaćina koja sadrži: (i) vektor ekspresije koji sadrži nukleinske kiseline prema patentnom zahtjevu 7 operativno povezane sa jednim ili više regulatornih elemenata; ili (ii) prvi vektor ekspresije koji sadrži nukleinsku kiselinu koja kodira teški lanac antitijela ili njegov antigen-vezujući dio prema patentnom zahtjevu 7 operativno povezanu sa jednim ili više regulatornih elemenata i drugi vektor ekspresije koji sadrži nukleinsku kiselinu koja kodira laki lanac antitijela ili njegov antigen-vezujući dio prema patentnom zahtjevu 7 operativno povezanu sa jednim ili više regulatornih elemenata.
10. Postupak za izradu antitijela ili njegovog antigen-vezujućeg dijela, koji sadrži uzgajanje stanice domaćina u skladu sa patentnim zahtjevom 9 pod uvjetima gdje se antitijelo ili njegov antigen-vezujući dio izražava i izborno izoliranje antitijela ili njegovog antigen-vezujućeg dijela.
11. Antitijelo ili njegov antigen-vezujući dio u skladu sa bilo kojim od patentnih zahtjeva 1 do 5 za uporabu u liječenju raka.
12. Antitijelo ili njegov antigen-vezujući dio za uporabu u skladu sa patentnim zahtjevom 11, naznačeno time što je antitijelo ili njegov antigen-vezujući dio internaliziran stanicom koja izražava LY75.
13. Antitijelo ili njegov antigen-vezujući dio za uporabu u skladu sa patentnim zahtjevom 11 ili 12, naznačeno time što antitijelo ili antigen-vezujući dio sadrži kovalentno vezan lijek konjugat, poželjno, pri čemu je kovalentno vezan lijek konjugat majtansinoid, poželjnije DM4.
14. Antitijelo ili njegov antigen-vezujući dio za uporabu u skladu sa bilo kojim od patentnih zahtjeva 11 do 13 naznačeno time što je navedeni rak odabran iz grupe koja se sastoji od raka gušterače, raka jajnika, raka dojke poželjno trostruko negativnog raka dojke, kolorektalnog raka, raka jednjaka, raka kože, raka štitne žlijezde, raka pluća, raka bubrega, raka jetre, raka glave i vrata, raka mjehura, raka želuca, leukemije, poželjno akutne mijeloidne leukemije ili kronične limfocitne leukemije, mijeloma, poželjno multiplog mijeloma i limfoma, poželjno difuznog krupnog B-staničnog limfoma (DLBCL), B-staničnog limfoma, folikularnog limfoma, limfoma plaštnih stanica, limfoma limfoidnog tkiva povezanog sa mukozom (MALT), T-stanicama/histiocitima bogatog B-staničnog limfoma, Burkittovog limfoma, limfoplazmocitnog limfoma, limfoma malih limfocita, limfoma marginalne zone, T-staničnog limfoma, perifernog T- staničnog limfoma, anaplastičnog krupnostaničnog limfoma i angioimunoblastnog T- staničnog limfoma.
15. Antitijelo, ili njegov antigen-vezujući dio, u skladu sa bilo kojim od patentnih zahtjeva 1 do 5 za uporabu u terapiji ili za uporabu kao medikament.
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