HRP20240338T1 - Imunomodulacija i liječenje solidnih tumora s protutijelima koja se specifično vežu na cd38 - Google Patents

Imunomodulacija i liječenje solidnih tumora s protutijelima koja se specifično vežu na cd38 Download PDF

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HRP20240338T1
HRP20240338T1 HRP20240338TT HRP20240338T HRP20240338T1 HR P20240338 T1 HRP20240338 T1 HR P20240338T1 HR P20240338T T HRP20240338T T HR P20240338TT HR P20240338 T HRP20240338 T HR P20240338T HR P20240338 T1 HRP20240338 T1 HR P20240338T1
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antibody
seq
specifically binds
cancer
cell
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Tahamtan Ahmadi
Tineke CASNEUF
Henk M. LOKHORST
Tuna MUTIS
Amy SASSER
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Janssen Biotech, Inc.
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    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2896Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against molecules with a "CD"-designation, not provided for elsewhere
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    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803Immunoglobulins [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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
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    • A61K39/39558Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against tumor tissues, cells, antigens
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    • A61P35/00Antineoplastic agents
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    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803Immunoglobulins [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
    • C07K16/2818Immunoglobulins [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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
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    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803Immunoglobulins [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
    • C07K16/2827Immunoglobulins [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 B7 molecules, e.g. CD80, CD86
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    • C07ORGANIC CHEMISTRY
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    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/40Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against enzymes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • A61K2039/507Comprising a combination of two or more separate antibodies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • C07K2317/565Complementarity determining region [CDR]
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    • C07K2317/73Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
    • C07K2317/732Antibody-dependent cellular cytotoxicity [ADCC]
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    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76Antagonist effect on antigen, e.g. neutralization or inhibition of binding

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Claims (15)

1. Protutijelo koje specifično veže CD38, naznačeno time, da je za uporabu u liječenju pacijenta koji ima solidni tumor, i time, da obuhvaća VH od SEQ ID NO: 4 i VL od SEQ ID NO: 5, pri čemu je protutijelo IgG1 izotipa.
2. Protutijelo koje specifično veže CD38 za uporabu prema patentnom zahtjevu 1, naznačeno time, da protutijelo sadrži aminokiselinu teškog lanca od SEQ ID NO: 12, i aminokiselinu lakog lanca od SEQ ID NO: 13.
3. Protutijelo koje specifično veže CD38 za uporabu prema patentnom zahtjevu 1, naznačeno time, da protutijelo je IgG1κ izotipa.
4. Protutijelo koje specifično veže CD38 za uporabu prema bilo kojem od patentnih zahtjeva 1 do 3, naznačeno time, da solidni tumor je melanom, rak pluća, rak skvamoznih ne-malih stanica pluća (NSCLC), ne-skvamozni NSCLC, kolorektalni rak, rak prostate, kastracijski rezistentan rak prostate, rak abdomena, rak jajnika, rak želuca, rak jetre, rak gušterače, rak štitnjače, karcinom skvamoznih stanica glave i vrata, karcinom jednjaka ili gastrointestinalnog trakta, rak dojke, rak jajovoda (falopijevih tuba), rak mozga, rak uretre, rak genitourinarnog sustava, endometrioza, rak cerviksa ili metastatske lezije raka.
5. Protutijelo koje specifično veže CD38 za uporabu prema bilo kojem od patentnih zahtjeva 1 do 4, naznačeno time, da solidni tumor nema ekspresiju CD38 koja se može prepoznati.
6. Protutijelo koje specifično veže CD38 za uporabu prema bilo kojem od patentnih zahtjeva 1 do 5, naznačeno time, da protutijelo koje specifično veže CD38 izaziva imunosni odgovor kod pacijenta, pri čemu imunosni odgovor je odgovor efektorske T stanice (Teff), gdje je Teff odgovor posredovan putem CD8+ T stanica, i pritom Teff odgovor predstavlja povećanje broja CD8+ T stanica.
7. Protutijelo koje specifično veže CD38 za uporabu prema bilo kojem od patentnih zahtjeva 1 do 5, naznačeno time, da protutijelo koje specifično veže CD38 inhibira djelovanje imunosupresorske stanice, pri čemu: a. imunosupresorska stanica je regulacijska T stanica (Treg), pri čemu Treg je CD3+CD4+CD25+CD127dim T stanica, pri čemu Treg eksprimira CD38, gdje se djelovanje Treg inhibira pomoću usmrćivanja Treg, i pri čemu je usmrćivanje Treg posredovano putem o protutijelu ovisne stanične citotoksičnosti (ADCC); ili b. imunosupresorska stanica je mijeloidno izvedena supresorska stanica (MDSC), pri čemu MDSC je CD11b+HLADR-CD14-CD33+CD15+ stanica, gdje CD11b+HLADR-CD14-CD33+CD15+ stanica eksprimira CD38, dok se djelovanje MDSC inhibira pomoću usmrćivanja MDSC, i pri čemu je usmrćivanje MDSC posredovano putem ADCC; ili c. imunosupresorska stanica je regulacijska B stanica (Breg), pri čemu Breg je CD19+CD24+CD38+ stanica, gdje se djelovanje Breg inhibira pomoću usmrćivanja Breg, i pri čemu je usmrćivanje Breg posredovano putem ADCC; ili d. imunosupresorska stanica obitava u perifernoj krvi.
8. Protutijelo koje specifično veže CD38 za uporabu prema bilo kojem od patentnih zahtjeva 1 do 7, naznačeno time, da se protutijelo koje specifično veže CD38 primjenjuje u kombinaciji s drugim terapijskim sredstvom, tako da se kod drugog terapijskog sredstva radi o kemoterapeutskom sredstvu, ciljanoj terapiji protiv raka, standardnom lijeku za liječenje solidnog tumora, ili inhibitoru imunosne kontrolne točke.
9. Protutijelo koje specifično veže CD38 za uporabu prema patentnom zahtjevu 8, naznačeno time, da se kod inhibitora imunosne kontrolne točke radi o anti-PD-1 protutijelu, anti-PD-L1 protutijelu, anti-PD-L2 protutijelu, anti-LAG3 protutijelu, anti-TIM3 protutijelu, ili anti-CTLA-4 protutijelu.
10. Protutijelo koje specifično veže CD38 za uporabu prema patentnom zahtjevu 9, naznačeno time, da: a. inhibitor imunosne kontrolne točke je anti-PD-1 protutijelo, opcionalno gdje anti-PD-1 protutijelo sadrži: i. VH od SEQ ID NO: 22 i VL od SEQ ID NO: 23; ii. VH od SEQ ID NO: 24 i VL od SEQ ID NO: 25; iii. VH od SEQ ID NO: 32 i VL od SEQ ID NO: 33; ili iv. VH od SEQ ID NO: 34 i VL od SEQ ID NO: 35; ili b. inhibitor imunosne kontrolne točke je anti-PD-L1 protutijelo, opcionalno gdje anti-PD-L1 protutijelo sadrži: i. VH od SEQ ID NO: 26 i VL od SEQ ID NO: 27; ii. VH od SEQ ID NO: 28 i VL od SEQ ID NO: 29; ili iii. VH od SEQ ID NO: 30 i VL od SEQ ID NO: 31; ili c. inhibitor imunosne kontrolne točke je anti-PD-L2 protutijelo; ili d. inhibitor imunosne kontrolne točke je anti-LAG3 protutijelo; ili e. inhibitor imunosne kontrolne točke je anti-TIM-3 protutijelo, opcionalno gdje anti-TIM-3 protutijelo sadrži: i. VH od SEQ ID NO: 36 i VL od SEQ ID NO: 37; ili ii. VH od SEQ ID NO: 38 i VL od SEQ ID NO: 39.
11. Protutijelo koje specifično veže CD38 za uporabu prema bilo kojem od patentnih zahtjeva 8 do 10, naznačeno time, da se drugo terapijsko sredstvo primjenjuje istovremeno, uzastopno ili odvojeno.
12. Protutijelo koje specifično veže CD38 za uporabu prema bilo kojem od patentnih zahtjeva 1 do 11, naznačeno time, da se protutijelo koje specifično veže CD38, primjenjuje parentalno putem intravenske infuzije ili bolusne injekcije, intramuskularno, supkutano ili intraperitonealno.
13. Protutijelo koje specifično veže CD38 za uporabu prema bilo kojem od patentnih zahtjeva 1 do 12, naznačeno time, da se protutijelo koje specifično veže CD38, primjenjuje intravenski.
14. Protutijelo koje specifično veže CD38 za uporabu prema bilo kojem od patentnih zahtjeva 1 do 12, naznačeno time, da se protutijelo koje specifično veže CD38, primjenjuje supkutano.
15. Protutijelo koje specifično veže CD38 za uporabu prema bilo kojem od patentnih zahtjeva 1 do 14, naznačeno time, da: a. pacijent se liječi ili je bio liječen radijacijskom terapijom; i/ili b. pacijent je već bio ili će biti podvrgnut kirurškom zahvatu.
HRP20240338TT 2015-06-24 2016-06-24 Imunomodulacija i liječenje solidnih tumora s protutijelima koja se specifično vežu na cd38 HRP20240338T1 (hr)

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Application Number Priority Date Filing Date Title
US201562184018P 2015-06-24 2015-06-24
US201562249546P 2015-11-02 2015-11-02
US201562250566P 2015-11-04 2015-11-04
US201562263307P 2015-12-04 2015-12-04
US201662331489P 2016-05-04 2016-05-04
EP16815351.8A EP3313441B1 (en) 2015-06-24 2016-06-24 Immune modulation and treatment of solid tumors with antibodies that specifically bind cd38
PCT/US2016/039165 WO2016210223A1 (en) 2015-06-24 2016-06-24 Immune modulation and treatment of solid tumors with antibodies that specifically bind cd38

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US (1) US20160376373A1 (hr)
EP (2) EP4385569A2 (hr)
JP (2) JP7041519B2 (hr)
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AU (1) AU2016281717B2 (hr)
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CA (1) CA2990620A1 (hr)
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DO (1) DOP2017000305A (hr)
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GT (1) GT201700286A (hr)
HK (1) HK1254942A1 (hr)
HR (1) HRP20240338T1 (hr)
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PE (1) PE20181090A1 (hr)
PH (1) PH12017502311A1 (hr)
PT (1) PT3313441T (hr)
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