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NZ751479B2 - Cd123 binding proteins and related compositions and methods - Google Patents
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NZ751479B2 - Cd123 binding proteins and related compositions and methods - Google Patents

Cd123 binding proteins and related compositions and methods

Info

Publication number
NZ751479B2
NZ751479B2 NZ751479A NZ75147917A NZ751479B2 NZ 751479 B2 NZ751479 B2 NZ 751479B2 NZ 751479 A NZ751479 A NZ 751479A NZ 75147917 A NZ75147917 A NZ 75147917A NZ 751479 B2 NZ751479 B2 NZ 751479B2
Authority
NZ
New Zealand
Prior art keywords
polypeptide
seq
chain variable
variable region
amino acid
Prior art date
Application number
NZ751479A
Other versions
NZ751479A (en
Inventor
David Bienvenue
John W Blankenship
Hoyos Gabriela Hernandez
Catherine J Mcmahan
Danielle Mitchell
Peter Pavlik
Elaine T Sewell
Original Assignee
Aptevo Research And Development Llc
David Bienvenue
John W Blankenship
Hoyos Gabriela Hernandez
Catherine J Mcmahan
Danielle Mitchell
Peter Pavlik
Elaine T Sewell
Filing date
Publication date
Application filed by Aptevo Research And Development Llc, David Bienvenue, John W Blankenship, Hoyos Gabriela Hernandez, Catherine J Mcmahan, Danielle Mitchell, Peter Pavlik, Elaine T Sewell filed Critical Aptevo Research And Development Llc
Priority claimed from PCT/US2017/052808 external-priority patent/WO2018057802A1/en
Publication of NZ751479A publication Critical patent/NZ751479A/en
Publication of NZ751479B2 publication Critical patent/NZ751479B2/en

Links

Classifications

    • 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
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • 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
    • A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • 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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A61P35/02—Antineoplastic agents specific for leukemia
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/005—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies constructed by phage libraries
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [IG], 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 [IG], 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2866—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for cytokines, lymphokines, interferons
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2896—Immunoglobulins [IG], 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/30—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
    • C07K16/3061—Blood cells
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/31—Immunoglobulins specific features characterized by aspects of specificity or valency multispecific
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/33—Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant or Fc region; Isotype
    • C07K2317/524—CH2 domain
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant or Fc region; Isotype
    • C07K2317/526—CH3 domain
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant or Fc region; Isotype
    • C07K2317/53—Hinge
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565—Complementarity determining region [CDR]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/60—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments
    • C07K2317/62—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments comprising only variable region components
    • C07K2317/622—Single chain antibody (scFv)
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/73—Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/73—Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
    • C07K2317/732—Antibody-dependent cellular cytotoxicity [ADCC]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/73—Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
    • C07K2317/734—Complement-dependent cytotoxicity [CDC]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/75—Agonist effect on antigen
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N15/00—Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09—Recombinant DNA-technology
    • C12N15/11—DNA or RNA fragments; Modified forms thereof; Non-coding nucleic acids having a biological activity
    • C12N15/62—DNA sequences coding for fusion proteins

Abstract

The present disclosure relates to protein molecules that specifically bind to CD123, which may have at least one humanized or human CD123-binding domain. Such molecules are useful for the treatment of cancer. The protein molecule binding to CD123 may have a second binding domain that binds to another target. In one embodiment, multi-specific polypeptide molecules bind both CD123-expressing cells and the T-cell receptor complex on T-cells to induce target-dependent T-cell cytotoxicity, activation, and proliferation. The disclosure also provides pharmaceutical compositions comprising the CD123-binding polypeptide molecules, nucleic acid molecules encoding these polypeptides and methods of making these molecules.

Claims (33)

CLAIMS :
1. A recombinant polypeptide comprising a CD123-binding domain, n the CD123-binding domain comprises (i) an immunoglobulin light chain variable region comprising LCDR1, LCDR2, and LCDR3, and (ii) an immunoglobulin heavy chain variable region sing HCDR1, HCDR2, and HCDR3, wherein the LCDR1 comprises the amino acid sequence set forth in SEQ ID NO:6; the LCDR2 comprises the amino acid sequence set forth in SEQ ID NO:8; the LCDR3 comprises the amino acid sequence set forth in SEQ ID NO:10, the HCDR1 comprises the amino acid sequence set forth in SEQ ID NO:12; the HCDR2 comprises the amino acid sequence set forth in SEQ ID NO:14; and the HCDR3 comprises the amino acid sequence set forth in SEQ ID NO:16.
2. The ptide of claim 1, wherein the CD123-binding domain ses: (i) the immunoglobulin light chain variable region comprising the amino acid sequence of SEQ ID NO:2; and (ii) the globulin heavy chain variable region comprising the amino acid sequence of SEQ ID NO:4.
3. The polypeptide of claim 1, wherein the polypeptides bind to human CD123 with specificity.
4. The polypeptide claim 1, wherein the CD123-binding domain comprises a human immunoglobulin light chain variable region and a human immunoglobulin heavy chain region.
5. The polypeptide of claim 1, wherein the CD123-binding domain is a single chain variable fragment (scFv).
6. The polypeptide of claim 5, wherein the heavy chain variable region of said scFv is amino-terminal to the light chain variable region of said scFv.
7. The polypeptide of claim 5, wherein the light chain le region of said scFv is amino-terminal to the heavy chain variable region of said scFv.
8. The ptide of claim 1, wherein said binding domain is conjugated to a drug or a toxin.
9. The polypeptide of claim 1, r comprising an immunoglobulin constant region.
10. The polypeptide of claim 1, further comprising a second binding .
11. A recombinant polypeptide comprising, in order from amino terminus to yl terminus, (i) a CD123-binding , (ii) a hinge region, (iii) an immunoglobulin constant region, (iv) a carboxyl-terminus linker, and (v) a CD3- binding domain, wherein The CD123-binding domain comprises an immunoglobulin light chain variable region comprising the amino acid sequence of SEQ ID NO: 2; and an immunoglobulin heavy chain variable region comprising the amino acid sequence of SEQ ID NO: 4; and wherein the nding domain comprises an immunoglobulin light chain variable region sing the amino acid sequence of SEQ ID NO: 158; and an immunoglobulin heavy chain variable region comprising the amino acid of SEQ ID NO: 159.
12. The polypeptide of claim 11, wherein the CD123-binding domain is an scFv and the CD3-binding domain is an scFv.
13. The polypeptide of claim 11, wherein the carboxyl-terminus linker comprises or consists of SEQ ID NO:288.
14. The polypeptide of claim 11, n the immunoglobulin constant region comprises immunoglobulin CH2 and CH3 domains of IgG1, IgG2, IgG3, IgG4, IgA1, IgA2 or IgD.
15. The polypeptide of claim 11, wherein the immunoglobulin constant region comprises a human IgG1 CH2 domain comprising the substitutions L234A, L235A, G237A, and K322A, according to the EU numbering system.
16. The polypeptide of claim 11, wherein (i) the polypeptide comprises the amino acid sequence of SEQ ID NO:130; or (ii) the polypeptide comprises the amino acid sequence of SEQ ID
17. The polypeptide of claim 12, wherein the CD123-binding domain is an scFv comprising an immunoglobulin light chain variable region and an immunoglobulin heavy chain variable region; and wherein said light chain variable region and said heavy chain variable region are joined by an amino acid sequence comprising (Gly4Ser)n, n n=1-5 as defined in SEQ ID NO:214.
18. The polypeptide of claim 12, wherein the CD3-domain is an scFv comprising an immunoglobulin light chain variable region and an immunoglobulin heavy chain variable region; and wherein said light chain variable region and said heavy chain variable region are joined by an amino acid sequence comprising (Gly4Ser)n, wherein n=1-5 as defined in SEQ ID NO:214.
19. The polypeptide of claim 11, wherein the carboxyl-terminus linker comprises an amino acid sequence sing (Gly4Ser)n, wherein n=1-7 as defined in SEQ ID
20. The polypeptide of claim 19, wherein n=3-5.
21. A dimer sing two identical polypeptides of claim 11.
22. A pharmaceutical composition comprising the polypeptide of any one of claims 1-20 or the dimer of claim 21 and a pharmaceutically acceptable carrier, diluent, or excipient.
23. An isolated nucleic acid molecule encoding the recombinant polypeptide of any one of claims 1-20.
24. The ed nucleic acid molecule of claim 23, n the nucleic acid molecule comprises a nucleotide sequence set forth in SEQ ID NO:1, SEQ ID NO:3, SEQ ID NO:129, or SEQ ID NO:131.
25. An expression vector comprising a nucleic acid segment encoding the polypeptide of any one of claims 1-20, wherein the nucleic acid segment is operatively linked to regulatory sequences le for expression of the nucleic acid segment in a host cell.
26. The expression vector of claim 25, wherein the c acid segment comprises a nucleotide sequence set forth in SEQ ID NO:1, SEQ ID NO:3, SEQ ID NO:129, or SEQ ID NO:131.
27. An isolated recombinant host cell comprising the expression vector of claim 25 or 26.
28. A method of ing a CD123-binding polypeptide, the method comprising culturing a recombinant host cell comprising the expression vector of claim 26 or 27 under conditions whereby the c acid segment is expressed, thereby producing the CD123-binding polypeptide.
29. Use of the polypeptide according to any one of claims 1-20 in the preparation of a medicament for the treatment of , wherein the polypeptide is formulated to induce redirected T-cell cytotoxicity (RTCC) t a cancerous cell pressing CD123, wherein the RTCC against the overexpressing cell is induced.
30. Use of the ptide according to any one of claims 1-20 in the preparation of a medicament for the treatment of cancer, wherein the polypeptide is ated to induce T-cell dependent lysis of a cancerous cell overexpressing CD123, wherein T- cell dependent lysis of the CD123-overexpressing cell is induced.
31. Use of the dimer of claim 21 in the ation of a medicament for the treatment of cancer in a subject in need thereof, wherein the cancer is characterized by overexpression of CD123, and wherein the cancer is acute myeloid leukemia (AML), B-lymphoid leukemia, blastic plasmacytoid dendritic neoplasm (BPDCN), hairy cell leukemia, acute lymphoblastic leukemia, refractory anemia with excess blasts, myelodysplastic syndrome, chronic myeloid leukemia, or Hodgkin’s lymphoma.
32. The polypeptide of claim 1, wherein said polypeptide binds to non-human primate CD123 with specificity.
33. The polypeptide of claim 12, wherein the nding domain comprises the amino acid sequence of SEQ ID NO: 312.
NZ751479A 2017-09-21 Cd123 binding proteins and related compositions and methods NZ751479B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201662397736P 2016-09-21 2016-09-21
US201762466192P 2017-03-02 2017-03-02
PCT/US2017/052808 WO2018057802A1 (en) 2016-09-21 2017-09-21 Cd123 binding proteins and related compositions and methods

Publications (2)

Publication Number Publication Date
NZ751479A NZ751479A (en) 2025-09-26
NZ751479B2 true NZ751479B2 (en) 2026-01-06

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