DK3075745T3 - Muterede interleukin-2-polypeptider - Google Patents

Muterede interleukin-2-polypeptider Download PDF

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Publication number
DK3075745T3
DK3075745T3 DK16164244.2T DK16164244T DK3075745T3 DK 3075745 T3 DK3075745 T3 DK 3075745T3 DK 16164244 T DK16164244 T DK 16164244T DK 3075745 T3 DK3075745 T3 DK 3075745T3
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Denmark
Prior art keywords
seq
polypeptide
sequence
mutant
immunoconjugate
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DK16164244.2T
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English (en)
Inventor
Oliver Ast
Peter Bruenker
Anne Freimoser-Grundschober
Sylvia Herter
Thomas U Hofer
Ralf Hosse
Christian Klein
Ekkehard Moessner
Valeria G Nicolini
Pablo Umana
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Roche Glycart Ag
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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/40—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against enzymes
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/52—Cytokines; Lymphokines; Interferons
    • C07K14/54—Interleukins [IL]
    • C07K14/55—IL-2
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/19—Cytokines; Lymphokines; Interferons
    • A61K38/20—Interleukins [IL]
    • A61K38/2013—IL-2
    • 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
    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/39558—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against tumor tissues, cells, antigens
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    • 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
    • A61K47/6811—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates the drug being a protein or peptide, e.g. transferrin or bleomycin
    • A61K47/6813—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates the drug being a protein or peptide, e.g. transferrin or bleomycin the drug being a peptidic cytokine, e.g. an interleukin or interferon
    • A—HUMAN NECESSITIES
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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
    • A61K47/6835—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
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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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
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    • A—HUMAN NECESSITIES
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    • 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
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    • C07K—PEPTIDES
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Claims (17)

1. Immunkonjugat, der omfatter et muteret IL-2-polypeptid og en antigenbindende del, hvor det muterede IL-2-polypeptid omfatter sekvensen ifølge SEQ ID NO: 19 og hvor den antigenbindende del er et IgGi-underklasse-immunglobulinmolekyle, der er specifikt for Fibroblast Activation Protein (FAP), omfattende (i) sekvensen af den variable tungkæderegion ifølge SEQ ID NO: 41 og sekvensen af den variable letkæderegion ifølge SEQ ID NO: 39, (ii) sekvensen af den variable tungkæderegion ifølge SEQ ID NO: 51 og sekvensen af den variable letkæderegion ifølge SEQ ID NO: 49, (iii) sekvensen af den variable tungkæderegion ifølge SEQ ID NO: 111 og sekvensen af den variable letkæderegion ifølge SEQ ID NO: 109, (iv) sekvensen af den variable tungkæderegion ifølge SEQ ID NO: 143 og sekvensen af den variable letkæderegion ifølge SEQ ID NO: 141 eller (v) sekvensen af den variable tungkæderegion ifølge SEQ ID NO: 151 og sekvensen af den variable letkæderegion ifølge SEQ ID NO: 149.
2. Immunkonjugat ifølge krav 1, hvor det muterede IL-2-polypeptid er forbundet ved sin aminoterminale aminosyre til den carboxyterminale aminosyre af en af immunglobulintungkædeme.
3. Immunkonjugat ifølge krav 1 eller 2, hvor immunkonjugatet omfatter ikke mere end ét muteret IL-2-polypeptid.
4. Immunkonjugat ifølge et hvilket som helst af kravene 1 til 3, hvor IgGi-underklasse-immunglobulinmolekylet i Fc-domænet omfatter en ”knob-into-hole”-modifikation, der omfatter en ”knob”-modifikation i den ene af immunglobulintungkædeme og en ”hole”-modifikation i den anden af immunglobulintungkædeme, hvor ”knob”-modifikationen omfatter aminosyresubstitutionen T366W i den ene af de to immunglobulintungkæder, og ”hole”-modifikationen omfatter aminosyresubstitutionerne T366S, L368A og Y407V i den anden af de to immunglobulintungkæder.
5. Immunkonjugat ifølge krav 4, hvor immunglobulintungkæden, der omfatter ”knob”-modifikationen, yderligere omfatter aminosyresubstitutionen S354C, og immunglobulintungkæden, der omfatter ”hole”-modifikationen, yderligere omfatter aminosyresubstitutionen Y349C.
6. Immunkonjugat ifølge et hvilket som helst af kravene 1 til 5, hvor IgG i-molekylet omfatter aminosyremutationerne L234A, L235A og P329G i sit Fc-domæne.
7. Immunkonjugat ifølge et hvilket som helst af kravene 1 til 6, der omfatter (i) en polypeptidsekvens, der er mindst 80 %, 85 %, 90 %, 95 %, 96 %, 97 %, 98 %, 99 % eller 100 % identisk med SEQ ID NO: 297, en polypeptidsekvens, der er mindst 80 %, 85 %, 90 %, 95 %, 96 %, 97 %, 98 %, 99 % eller 100 % identisk med SEQ ID NO: 299 og en polypeptidsekvens, der er mindst 80 %, 85 %, 90 %, 95 %, 96 %, 97 %, 98 %, 99 % eller 100 % identisk med SEQ ID NO: 233, (ii) en polypeptidsekvens, der er mindst 80 %, 85 %, 90 %, 95 %, 96 %, 97 %, 98 %, 99 % eller 100 % identisk med SEQ ID NO: 301, en polypeptidsekvens, der er mindst 80 %, 85 %, 90 %, 95 %, 96 %, 97 %, 98 %, 99 % eller 100 % identisk med SEQ ID NO: 303 og en polypeptidsekvens, der er mindst 80 %, 85 %, 90 %, 95 %, 96 %, 97 %, 98 %, 99 % eller 100 % identisk med SEQ ID NO: 231 eller (iii) en polypeptidsekvens, der er mindst 80 %, 85 %, 90 %, 95 %, 96 %, 97 %, 98 %, 99 % eller 100 % identisk med SEQ ID NO: 315, en polypeptidsekvens, der er mindst 80 %, 85 %, 90 %, 95 %, 96 %, 97 %, 98 %, 99 % eller 100 % identisk med SEQ ID NO: 317 og en polypeptidsekvens, der er mindst 80 %, 85 %, 90 %, 95 %, 96 %, 97 %, 98 %, 99 % eller 100 % identisk med SEQ ID NO: 233.
8. Immunkonjugat ifølge et hvilket som helst af kravene 1 til 7, hvor IgGi-mo lekylet, der er specifikt for FAP, omfatter sekvensen af den variable tungkæderegion ifølge SEQ ID NO: 111 og sekvensen af den variable letkæderegion ifølge SEQ ID NO: 109.
9. Immunkonjugat ifølge et hvilket som helst af kravene 1 til 8, der omfatter en polypeptidsekvens ifølge SEQ ID NO: 301, en polypeptidsekvens ifølge SEQ ID NO: 303 og en polypeptidsekvens ifølge SEQ ID NO: 231.
10. Immunkonjugat ifølge et hvilket som helst af kravene 1 til 9, der består af et muteret IL-2-polypeptid og et IgGi-molekyle forbundet med en linkersekvens.
11. Isoleret polynukleotid, der koder for immunkonjugatet ifølge et hvilket som helst af kravene 1 til 10.
12. Værtscelle, der omfatter polynukleotidet ifølge krav 11.
13. Fremgangsmåde til fremstilling af et immunkonjugat, der omfatter et muteret IL-2-polypeptid og en antigenbindende del, hvilken fremgangsmåde omfatter dyrkning af værtscellen ifølge krav 12 under betingelser, der er egnede til ekspression af immunkonjugatet.
14. Immunkonjugat, der omfatter et muteret IL-2-polypeptid og en antigenbindende del, der er fremstillet ved hjælp af fremgangsmåden ifølge krav 13, hvor det muterede IL-2-polypeptid omfatter sekvensen ifølge SEQ ID NO: 19, og hvor den antigenbindende del er et IgGi-underklasse-immunglobulinmolekyle, der er specifikt for FAP.
15. Farmaceutisk sammensætning, der omfatter immunkonjugatet ifølge et hvilket som helst af kravene 1 til 10 eller 14 og en farmaceutisk acceptabel bærer.
16. Immunkonjugat ifølge et hvilket som helst af kravene 1 til 10 eller 14 til anvendelse i behandlingen af en sygdom hos en person med behov derfor.
17. Immunkonjugat til anvendelse i behandlingen af en sygdom ifølge krav 16, hvor sygdommen er cancer.
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