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FI4234581T3 - Terapeuttisia vasta-aineita ja niiden käyttöjä - Google Patents

Terapeuttisia vasta-aineita ja niiden käyttöjä

Info

Publication number
FI4234581T3
FI4234581T3 FIEP23171630.9T FI23171630T FI4234581T3 FI 4234581 T3 FI4234581 T3 FI 4234581T3 FI 23171630 T FI23171630 T FI 23171630T FI 4234581 T3 FI4234581 T3 FI 4234581T3
Authority
FI
Finland
Prior art keywords
seq
set forth
sequence set
lymphoma
cell
Prior art date
Application number
FIEP23171630.9T
Other languages
English (en)
Inventor
Tracy Chia-Chien Kuo
Riggers Javier Fernando Chaparro
Wei Chen
Amy Shaw-Ru Chen
Edward Derrick Pascua
Blarcom Thomas John Van
Leila Marie Boustany
Weihsien Ho
Yik Andy Yeung
Pavel Strop
Arvind Rajpal
Original Assignee
Pfizer
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=55661497&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=FI4234581(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Pfizer filed Critical Pfizer
Application granted granted Critical
Publication of FI4234581T3 publication Critical patent/FI4234581T3/fi

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    • C07—ORGANIC CHEMISTRY
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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
    • C07K16/2878—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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    • 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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    • A61K31/7034—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin
    • A61K31/704—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin attached to a condensed carbocyclic ring system, e.g. sennosides, thiocolchicosides, escin, daunorubicin
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    • A61K47/6849—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 receptor, a cell surface antigen or a cell surface determinant
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    • A61K47/6879—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 being a hybrid immunoglobulin the immunoglobulin having two or more different antigen-binding sites, e.g. bispecific or multispecific immunoglobulin
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    • 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
    • C07K16/2809—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 the T-cell receptor (TcR)-CD3 complex
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    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
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Claims (15)

PATENTTIVAATIMUKSET
1. Bispesifinen vasta-aine, jossa bispesifinen vasta-aine on täyspitkä vasta-aine, joka käsittää en- simmäisen vasta-aineen muuttuvan domeenin, joka sitou- tuu spesifisesti CD3:een, ja toisen vasta-aineen muut- tuvan domeenin, joka sitoutuu spesifisesti BCMA:han, jossa ensimmäinen vasta-aineen muuttuva domeeni käsit- tää: raskasketjun muuttuvan (VH) alueen, joka käsittää (i) VH CDR1:n, joka käsittää SEQ ID NO: 332:ssa, 331:ssä tai 333:ssa esitetyn sekvenssin; (ii) VH CDR2:n, joka käsittää SEQ ID NO: 417:ssä tai 336:ssa esitetyn sek- venssin; ja (iii) VH CDR3:n, joka käsittää SEO ID NO: 335:ssä esitetyn sekvenssin; ja kevytketjun muuttuvan (VL) alueen, joka käsittää (i) VL CDR1l:n, joka käsittää SEQ ID NO: 343:ssa esitetyn sekvenssin; (ii) VL CDR2:n, joka käsittää SEO ID NO: 341:ssä esitetyn sekvenssin; ja (iii) VL CDR3:n, joka käsittää SEQ ID NO: 342:ssa esitetyn sekvenssin; ja toinen vasta-aineen muuttuva domeeni käsittää: raskasketjun muuttuvan (VH) alueen, joka käsittää (i) VH CDR1l:n, joka käsittää SEQ ID NO: 151:ssä, 156:ssa tai 157:ssä esitetyn sekvenssin; (ii) VH CDR2:n, joka käsittää SEQ ID NO: 159:ssä tai 158:ssa esitetyn sekvenssin; ja (iii) VH CDR3:n, joka käsittää SEQ ID NO: 155:ssä esitetyn sekvenssin; ja kevytketjun muuttuvan (VL) alueen, joka käsittää (i) VL CDRI:n, joka käsittää SEO ID NO: 209:ssä esitetyn sekvenssin; (ii) VL CDR2:n, joka käsittää SEO ID NO: 221:ssä esitetyn sekvenssin; ja (iii) VL CDR3:n, joka käsittää SEO ID NO: 225:ssä esitetyn sekvenssin.
2. Patenttivaatimuksen 1 mukainen bispesifinen vasta-aine, jossa ensimmäinen vasta-aineen muuttuva do- meeni käsittää: raskasketjun muuttuvan (VH) alueen, joka käsittää (i) VH CDR1:n, joka käsittää SEQ ID NO: 332:ssa esitetyn sekvenssin; (ii) VH CDR2:n, joka käsittää SEO ID NO: 417:ssä esitetyn sekvenssin; ja (iii) VH CDR3:n, joka käsittää SEO ID NO: 335:ssä esitetyn sekvenssin; ja kevytketjun muuttuvan (VL) alueen, joka käsittää (i)
VL CDR1:n, joka käsittää SEO ID NO: 343:ssa esitetyn sekvenssin; (ii) VL CDR2:n, joka käsittää SEO ID NO: 341:ssä esitetyn sekvenssin; ja (iii) VL CDR3:n, joka käsittää SEO ID NO: 342:ssa esitetyn sekvenssin; ja toi- nen vasta-aineen muuttuva domeeni käsittää: raskasket- jun muuttuvan (VH) alueen, joka käsittää (i) VH CDR1:n, joka käsittää SEO ID NO: 151:ssä esitetyn sekvenssin; (ii) VH CDR2:n, joka käsittää SEO ID NO: 159:ssä esite- tyn sekvenssin; ja (iii) VH CDR3:n, joka käsittää SEQ ID NO: 155:ssä esitetyn sekvenssin; ja kevytketjun muut- tuvan (VL) alueen, joka käsittää (i) VL CDRI:n, joka käsittää SEO ID NO: 209:ssä esitetyn sekvenssin; (ii) VL CDR2:n, joka käsittää SEO ID NO: 221:ssä esitetyn sekvenssin; ja (iii) VL CDR3:n, joka käsittää SEO ID NO: 225:ssä esitetyn sekvenssin.
3. Nukleiinihappo, joka koodittaa patentti- vaatimuksen 1 tai 2 mukaista vasta-ainetta.
4. Vektori, joka käsittää patenttivaatimuksen 3 mukaisen nukleiinihapon.
5. Isäntäsolu, joka käsittää patenttivaati- muksen 3 mukaisen nukleiinihapon tai patenttivaatimuk- sen 4 mukaisen vektorin.
6. Farmaseuttinen koostumus, joka käsittää pa- tenttivaatimuksen 1 tai 2 mukaisen bispesifisen vasta- aineen.
7. Patenttivaatimuksen 6 mukainen farmaseut- tinen koostumus, jossa koostumus lisäksi käsittää far- maseuttisesti hyväksyttävän apuaineen.
8. Patenttivaatimuksen 1 tai 2 mukainen bispesifinen vasta-aine, tai patenttivaatimuksen 6 tai 7 mukainen farmaseuttinen koostumus, käytettäväksi lääkkeenä.
9. Patenttivaatimuksen 1 tai 2 mukainen bispesifinen vasta-aine, tai patenttivaatimuksen 6 tai 7 mukainen farmaseuttinen koostumus, käytettäväksi syö- vän hoidossa kohteessa.
10. Bispesifinen vasta-aine tai farmaseutti- nen koostumus käytettäväksi patenttivaatimuksen 9 mu- kaisesti, jossa syöpä on B-soluihin liittyvä syöpä, joka valitaan ryhmästä, joka koostuu seuraavista: mul- tippeli myelooma, pahanlaatuinen plasmasolukasvain, Hodgkinin lymfooma, nodulaarinen lymfosyyttipainottei- nen Hodgkinin lymfooma, Kahlerin tauti ja myelomatoosi, plasmasoluleukemia, plasmasytooma, B-solujen prolymfo- syyttinen leukemia, karvasoluleukemia, B-solujen non- Hodgkinin lymfooma (NHL), akuutti myelooinen leukemia (AML), krooninen lymfaattinen leukemia (CLL), akuutti lymfaattinen leukemia (ALL), krooninen myelooinen leu- kemia (CML), follikulaarinen lymfooma, Burkittin lym- fooma, marginaalivyöhykkeen lymfooma, manttelisolulym- fooma, suurisoluinen lymfooma, B-lymfaattisen lymfooman esiaste, myelooinen leukemia, Waldenströmin makroglo- bulienemia, diffuusi suurisoluinen B-solulymfooma, li- makalvoon liittyvä imukudoslymfooma, pienisoluinen lym- faattinen lymfooma, primaarinen välikarsinan (kateen- korvan) suurisoluinen B-solulymfooma, lymfoplasmatyyp- pinen lymfooma, nodaalinen marginaalivyöhykkeen B-so- lulymfooma, pernan marginaalivyöhykkeen lymfooma, in- travaskulaarinen suurisoluinen B-solulymfooma, primaa- rinen effuusio-lymfooma, lymfomatoidinen granuloma- toosi, T-solu/histosyytti-rikas suurisoluinen B-solu- lymfooma, primaarinen keskushermoston lymfooma, primaa- rinen ihon diffuusi suurten B-solujen lymfooma (jalka- tyyppi (leg type)), EBV-positiivinen iäkkäiden diffuusi suurisoluinen B-solulymfooma, tulehdukseen liittyvä diffuusi suurisoluinen B-solulymfooma, ALK-positiivi- nen suurisoluinen B-solulymfooma, plasmablastinen lym- fooma, HHV8:aan liittyvässä monikeskuksisessa Castle- manin taudissa (HHV8-associated multicentric Castleman disease) syntyvä suurisoluinen B-solulymfooma, luokit- telematon B-solulymfooma, jonka piirteet ovat diffuusin suurisoluisen B-solulymfooman ja Burkittin lymfooman väliltä, luokittelematon B-solulymfooma, jonka piirteet ovat diffuusin suurisoluisen B-solulymfooman ja klas- sisen Hodgkinin lymfooman väliltä, ja muut B-soluihin liittyvät lymfoomat.
11. Bispesifinen vasta-aine tai farmaseutti- nen koostumus käytettäväksi patenttivaatimuksen 9 tai mukaisesti, jossa estetään kasvaimen kasvua tai ete- nemistä kohteessa, jolla on pahanlaatuisia soluja, jotka ilmentävät BCMA:ta.
12. Bispesifinen vasta-aine tai farmaseutti- 10 nen koostumus käytettäväksi patenttivaatimuksen 9 tai 10 mukaisesti, jossa estetään BCMA:ta ilmentävien pa- hanlaatuisten solujen metastaasia kohteessa.
13. Bispesifinen vasta-aine tai farmaseutti- nen koostumus käytettäväksi patenttivaatimuksen 9 tai 10 mukaisesti, jossa indusoidaan kasvaimen regressio kohteessa, jolla on pahanlaatuisia soluja, jotka ilmen- tävät BCMA:ta.
14. Patenttivaatimuksen 1 tai 2 mukainen bispesifinen vasta-aine, tai patenttivaatimuksen 6 tai 7 mukainen farmaseuttinen koostumus, käytettäväksi mul- tippelin myelooman hoitomenetelmässä sen tarpeessa ole- vassa kohteessa, jossa bispesifistä vasta-ainetta tai farmaseuttista koostumusta annetaan yhdessä yhden tai useamman muun terapeuttisen aineen kanssa.
15. Bispesifinen vasta-aine tai farmaseutti- nen koostumus käytettäväksi patenttivaatimuksen 14 mu- kaisesti, jossa muu terapeuttinen aine on valittu ryh- mästä, joka koostuu bortetsomibista, lenalidomidista, karfiltsomibista ja doksorubisiinista.
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