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NZ778160B2 - Compound targeting il-23a and b-cell activating factor (baff) and uses thereof - Google Patents
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NZ778160B2 - Compound targeting il-23a and b-cell activating factor (baff) and uses thereof - Google Patents

Compound targeting il-23a and b-cell activating factor (baff) and uses thereof

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Publication number
NZ778160B2
NZ778160B2 NZ778160A NZ77816016A NZ778160B2 NZ 778160 B2 NZ778160 B2 NZ 778160B2 NZ 778160 A NZ778160 A NZ 778160A NZ 77816016 A NZ77816016 A NZ 77816016A NZ 778160 B2 NZ778160 B2 NZ 778160B2
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NZ
New Zealand
Prior art keywords
seq
polypeptide
amino acid
acid sequence
compound
Prior art date
Application number
NZ778160A
Other versions
NZ778160A (en
Inventor
Rachel Rebecca Barrett
Pankaj Gupta
Leslie S Johnson
Sarah Low
Qi Pan
Sanjaya Singh
Haixia Wu
Original Assignee
Boehringer Ingelheim International Gmbh
Macrogenics Inc
Filing date
Publication date
Application filed by Boehringer Ingelheim International Gmbh, Macrogenics Inc filed Critical Boehringer Ingelheim International Gmbh
Publication of NZ778160A publication Critical patent/NZ778160A/en
Publication of NZ778160B2 publication Critical patent/NZ778160B2/en

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    • 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
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • 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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/12—Drugs for disorders of the urinary system of the kidneys
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/06—Antipsoriatics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • 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
    • C07K16/24—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/241—Tumor Necrosis Factors
    • 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
    • C07K16/24—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/244—Interleukins [IL]
    • 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
    • C07K16/2875—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 NGF/TNF superfamily, e.g. CD70, CD95L, CD153, CD154
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/46—Hybrid immunoglobulins
    • C07K16/468—Immunoglobulins having two or more different antigen binding sites, e.g. multifunctional antibodies
    • 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
    • C07K2317/50—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
    • C07K2317/53—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
    • 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
    • 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
    • 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
    • C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
    • 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
    • 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
    • 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
    • C12N15/63—Introduction of foreign genetic material using vectors; Vectors; Use of hosts therefor; Regulation of expression
    • 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
    • C12N5/00—Undifferentiated human, animal or plant cells, e.g. cell lines; Tissues; Cultivation or maintenance thereof; Culture media therefor
    • C12N5/10—Cells modified by introduction of foreign genetic material
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12P—FERMENTATION OR ENZYME-USING PROCESSES TO SYNTHESISE A DESIRED CHEMICAL COMPOUND OR COMPOSITION OR TO SEPARATE OPTICAL ISOMERS FROM A RACEMIC MIXTURE
    • C12P21/00—Preparation of peptides or proteins

Abstract

The disclosure relates to compounds specific for IL23A and BAFF, compositions comprising the compounds, and methods of use thereof. Nucleic acids, cells, and methods of production related to the compounds and compositions are also disclosed.

Claims (24)

Claims
1. A compound comprising a first polypeptide and a second polypeptide, wherein: (A) said first polypeptide comprises: (i) a light chain variable domain of a first immunoglobulin (VL1) specific for a first target protein; (ii) a heavy chain variable domain of a second immunoglobulin (VH2) specific for a second target protein; and (iii) a hinge region, a heavy chain constant region 2 (CH2) and a heavy chain constant region 3 (CH3); and (B) said second polypeptide comprises: (i) a light chain le domain of the second immunoglobulin (VL2) specific for said second target protein; (ii) a heavy chain variable domain of the first globulin (VH1) specific for said first target protein; wherein: a) said VL1 and VH1 associate to form a binding site that binds said first target protein; b) said VL2 and VH2 associate to form a binding site that binds said second target protein; c) said heavy chain constant region 2 (CH2) ses a ne at position 252, a ine at position 254 and a glutamic acid a position 256, ed according to the EU index as in Kabat; and d) said first target protein is BAFF and said second target protein is IL-23A or said first target protein is IL-23A and said second target protein is BAFF; and wherein: (i) said VL1 comprises SEQ ID NO:4, said VH1 comprises SEQ ID NO:3, said VL2 comprises SEQ ID NO:91 and said VH2 comprises SEQ ID NO:90 and further wherein said first polypeptide comprises a first linker between said VL1 and said VH2 and said second polypeptide ses a second linker between said VL2 and said VH1 and said first polypeptide further comprises a heavy chain constant region 1 domain (CH1) and said second polypeptide further comprises a light chain constant region domain (CL), wherein said CL and said CH1 are associated together via a disulfide bond to form a C1 domain and said first ptide further comprises a third linker between said VH2 and said CH1 and said second polypeptide further comprises a fourth linker between said VH1 and said C, and the amino acid sequence of said hinge region, said heavy chain constant region 2 (CH2) and said heavy chain constant region 3 (CH3) is derived from a IgG1 or from a IgG4, wherein said first linker and said second linker cannot both comprise the amino acid sequence GGGSGGGG (SEQ ID NO:69).
2. A compound ing to claim 1, wherein said first linker or said second linker comprise the amino acid sequence GGGSGGGG (SEQ ID NO:69).
3. A compound according to claim 1 or 2, wherein said third linker or said fourth linker or both comprise the amino acid ce LGGGSG (SEQ ID NO:70).
4. A compound according to claim 1, wherein said heavy chain constant region 2 (CH2) comprises an alanine at positions 234 and an alanine at position 235, numbered according to the EU index as in Kabat or said hinge region comprises the amino acid sequence EPKSCDKTHTCPPCP (SEQ ID NO:76), the amino acid sequence LEPKSSDKTHTCPPCP (SEQ ID NO: 130) or the amino acid sequence ESKYGPPCPPCP (SEQ ID NO: 134).
5. A compound ing to claim 1, wherein: (i) said first polypeptide comprises the amino acid sequence of SEQ ID NO:45 and said second polypeptide comprises the amino acid sequence of SEQ ID NO:46; or (ii) said first polypeptide comprises the amino acid sequence of SEQ ID NO:47 and said second polypeptide ses the amino acid sequence of SEQ ID NO:48; or (iii) said first polypeptide ses the amino acid sequence of SEQ ID NO:49 and said second ptide comprises the amino acid sequence of SEQ ID NO:50; or (iv) said first polypeptide comprises the amino acid sequence of SEQ ID NO:51 and said second polypeptide comprises the amino acid sequence of SEQ ID NO:52.
6. A compound according to claim 1, wherein said first polypeptide comprises the amino acid sequence of SEQ ID NO:49 and said second polypeptide comprises the amino acid sequence of SEQ ID NO:50.
7. A compound according to claim 1, wherein said compound comprises two of said first polypeptides and two of said second ptides, wherein each of said first polypeptides comprises a CH1, hinge, a CH2 and a CH3 and each of said second polypeptides comprises a CL and further wherein the hinge, CH2 and CH3 of one of the first polypeptides ates with the hinge, CH2 and CH3 of the other of the first polypeptides and the CH1 of each said first polypeptides associates with the CL of one said second polypeptides to form a tetravalent molecule (xi) one according to claim 1 or claim 2(i) to (x), wherein said compound comprises two said first polypeptides and two said second polypeptides, wherein said two first polypeptides are associated together via at least one disulfide bond.
8. A ceutical composition comprising a compound according to any one of claims 1 to
9. Use of a compound according to any one of claims 1 to 7, or a pharmaceutical composition comprising said compound in the preparation of a medicament for treatment of an autoimmune disease in a subject in need thereof.
10. Use of a nd according to any one of claims 1 to 7, or a pharmaceutical ition comprising said nd in the in the preparation of a medicament for treatment of an inflammatory disease in a subject in need thereof.
11. Use of a compound according to any one of claims 1 to 7, in the preparation of a medicament.
12. A nucleic acid comprising a nucleotide sequence ng a polypeptide according to any one of claims 1 to 7
13. A vector comprising the nucleic acid according to claim 12.
14. A vector comprising the nucleic acid according to claim 12, further comprising a promoter operably linked to said nucleic acid.
15. An isolated cell comprising the nucleic acid or vector according to any one of claims 12-
16. An in vitro method of producing a polypeptide according to any one of claims 1 to 7, comprising obtaining a cell according to claim 15, expressing said nucleic acid in a cell e comprising said cell and isolating the expressed polypeptide from the cell or cell culture.
17. Use according to claim 9 or 10, wherein the autoimmune or an inflammatory disease ses systemic lupus erythematosus (SLE), ic lupus erythematosus with kidney involvement, Lupus Nephritis (LN), ANCA-associated vasculitis (AAV), primary n’s syndrome (pSS), c graft versus host disease (cGVHD), systemic sclerosis (SSc), Rheumatoid Arthritis (RA), Psoriasis (Ps), Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PA).
18. The compound of any one of claims 1-7, substantially as herein described and with reference to any example thereof and with or without reference to the figures.
19. The composition of claim 8, substantially as herein described and with nce to any example thereof and with or t reference to the figures.
20. The use according to any one of claims 9, 10, 11 and 17, substantially as herein described and with reference to any example thereof and with or without reference to the figures.
21. The nucleic acid or isolated cell according to claim 12, substantially as herein bed and with reference to any example thereof and with or without reference to the figures.
22. The vector as claimed in claim 13 or 14, substantially as herein bed and with reference to any example thereof and with or without reference to the figures.
23. An isolated cell as claimed in claim 15, substantially as herein described and with reference to any example thereof and with or without reference to the figures.
24. The method of claim 16, substantially as herein described and with nce to any example thereof and with or without reference to the figures. l / 5 First Fm?'ypamitia Chain 2 / 5 Finn Paigmp??e Emma Linkerwith optional Cysteine residue 53.411111111ng- 3 / 5 5 100 5 1o E 1 0 168 336 Time (h) Compound Serum Predicted 0 4 8 12 16 20 24 Weeks .............................................................................................................................. Lo 5° U1 Percentage U3 U3 “my\:«0,0001x\+\99‘511“ R2 = 3873 £0 00 U1 Monomer £0 00 0 50 100 150 ,"“,"“,"“,"“,"“,"“,"“,"“,"“,"“,"“,"“,"“,"“,"“,"“,"“,"“,"“,““,““,““,““,¢ 8220+ B ce? Numbers C9515 cmswzzm “dive Citrate EV huBAFF 8.13 0.1; 1.3 0.10 0.3 1.0 We“ “‘9 huBAFF+ huBAFF+ Compound 8 Control Antibody 1 {mgikg} (mgfka = [K 0.05 y ANN/A iOHOWBCI DY Bll?ll?ll’s mulliple comparisons IESI VS. llllBAFF?lC CO?ll‘Ol -§ 3“ 7;“ m * * '5 .52 > *1 > a E m a 5 g. 509 . :1' .2 J . a . A ~5 2 "if . < w 7 > r (UM: rim-23 0.13 (1k 3.3 9.10 8.3 3.9 9.1% (hit-23 0.13 OJ; 1.3 8.10 03 1 0 85A EVA. rim-23 4 Compound 8 mil-23 + Contra! Antibody!». rhIL-ZES + Compound B {ML-ZS 4- l dy h (mgfkg‘) (mgfkg (mg/Sq) (mgikg) *3 p< 0.05 One~way ANOVAfo?owed by Dunne?’s muitipie comparisons test vs, rhEL~23 contra?
NZ778160A 2016-07-21 Compound targeting il-23a and b-cell activating factor (baff) and uses thereof NZ778160B2 (en)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US201562196170P 2015-07-23 2015-07-23
US201562201067P 2015-08-04 2015-08-04
US201662355302P 2016-06-27 2016-06-27
NZ738942A NZ738942B2 (en) 2016-07-21 Compound targeting il-23a and b-cell activating factor (baff) and uses thereof

Publications (2)

Publication Number Publication Date
NZ778160A NZ778160A (en) 2025-05-02
NZ778160B2 true NZ778160B2 (en) 2025-08-05

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