WO2006093923A2 - Treatment of bone disorders - Google Patents

Treatment of bone disorders Download PDF

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Publication number
WO2006093923A2
WO2006093923A2 PCT/US2006/006998 US2006006998W WO2006093923A2 WO 2006093923 A2 WO2006093923 A2 WO 2006093923A2 US 2006006998 W US2006006998 W US 2006006998W WO 2006093923 A2 WO2006093923 A2 WO 2006093923A2
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Prior art keywords
antibody
bone
mammal
cell
administered
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French (fr)
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WO2006093923A8 (en
WO2006093923B1 (en
WO2006093923A3 (en
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K. Lea Sewell
Joanne Quan
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Genentech Inc
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Genentech Inc
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Priority to CA002597097A priority Critical patent/CA2597097A1/en
Priority to AU2006218733A priority patent/AU2006218733A1/en
Priority to BRPI0608109-6A priority patent/BRPI0608109A2/pt
Priority to EP06736340A priority patent/EP1856157A2/en
Priority to MX2007010307A priority patent/MX2007010307A/es
Priority to JP2007558120A priority patent/JP2008531699A/ja
Application filed by Genentech Inc filed Critical Genentech Inc
Publication of WO2006093923A2 publication Critical patent/WO2006093923A2/en
Publication of WO2006093923A3 publication Critical patent/WO2006093923A3/en
Publication of WO2006093923B1 publication Critical patent/WO2006093923B1/en
Priority to IL185052A priority patent/IL185052A0/en
Anticipated expiration legal-status Critical
Publication of WO2006093923A8 publication Critical patent/WO2006093923A8/en
Priority to NO20074911A priority patent/NO20074911L/no
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    • C07K16/2887—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against CD20
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    • A61K38/19—Cytokines; Lymphokines; Interferons
    • A61K38/20—Interleukins [IL]
    • A61K38/2026—IL-4
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    • A—HUMAN NECESSITIES
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    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
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    • A61P19/00—Drugs for skeletal disorders
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A61P19/10—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
    • A—HUMAN NECESSITIES
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    • A61P35/00—Antineoplastic agents
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    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered

Definitions

  • the promonocytes may proliferate and differentiate along the macrophage pathway, eventually forming a tissue macrophage, or may differentiate along the osteoclast pathway, depending on the cytokines to which they become exposed.
  • the receptor activator NF- ⁇ B ligand (RANKL) (Simonet et al. Cell 89:309-319 (1997)), a cytokine expressed on the membrane surface of osteoblasts, influences promonocytes to differentiate into osteoclasts rather than macrophages, while treatment with M-CSF drives the promonocyte to develop into macrophages.
  • Lymphocytes are one of many types of white blood cells produced in the bone marrow during the process of hematopoiesis. There are two major populations of lymphocytes: B lymphocytes (B cells) and T lymphocytes (T cells). The lymphocytes of particular interest herein are B cells.
  • CD20 regulates an early step(s) in the activation process for cell- cycle initiation and differentiation (Tedder et al., supra), and possibly functions as a calcium- ion channel. Tedder et al., J. Cell. Biochem. 14D:195 (1990).
  • the rituximab antibody (the active agent in the products marketed in the U.S. as RlTUXAN ® and elsewhere as MABTHERA ® ) is a genetically engineered chimeric murine/human monoclonal antibody directed against the CD20 antigen.
  • Rituximab is the antibody called "C2B8" in US Patent No. 5,736,137 issued April 7, 1998 (Anderson et al).
  • Rituximab is indicated for the treatment of patients with relapsed or refractory low-grade or follicular, CD20-positive, B-cell non-Hodgkin's lymphoma.
  • TGF- ⁇ transforming growth factor-beta
  • B-lymphocyte progenitors may give rise to functional osteoclasts (Grcevic et al, Wegn Medical Journal, 42 (4): 384- 392 (2001)).
  • the bone disorder is osteoporosis, or a focal bone erosion including marginal joint erosions and subchondral bone erosions (bone marrow), a bone defect, childhood idiopathic bone loss, alveolar bone loss, bone fracture, or osteopenia such as juxta-articular osteopenia, or is bone loss associated with an autoimmune disease such as rheumatoid arthritis.
  • the invention provides a method for preventing erosive bone disease in inflammatory arthritides, such as rheumatoid arthritis, comprising administering to a mammal suffering from such disease an effective amount of a CD20 antibody.
  • such second medicament is an agent that treats osteoclast-associated disorders (such as osteoprotegerin, a MMP inhibitor, a cytokine such as IL-4, a beta glucan, an integrin antagonist, calcitonin, a proton pump inhibitor, a protease inhibitor, or a bisphosphonate such as risedronate, etidronate, clodronate, NE-58095, zoledronate, pamidronate, or alendronate), an immunosuppressive agent, a disease-modifying anti-rheumatic drug (DMARD), a cytotoxic agent, a non-steroidal anti-inflammatory drug (NSAID), a hormone, or a combination thereof.
  • osteoclast-associated disorders such as osteoprotegerin, a MMP inhibitor, a cytokine such as IL-4, a beta glucan, an integrin antagonist, calcitonin, a proton pump inhibitor, a protease inhibitor, or a bisphosphonate such
  • FIG. 3 is a sequence alignment comparing the heavy-chain amino acid sequences of the humanized 2H7.vl6 variant (SEQ ED NO:8) and humanized 2H7.vl38 variant (SEQ ID NO:29).
  • B-cell surface markers include RPl 05, FcRH2, B-cell CR2, CCR6, P2X5, HLA-DOB, CXCR5, FCER2, BR3, Btig, NAG14, SLGC16270, FcRHl, IRTA2, ATWD578, FcRH3, IRTAl, FcRH6, BCMA, and 239287.
  • the B-cell surface marker of particular interest is preferentially expressed on B cells compared to other non-B-cell tissues of a mammal and may be expressed on both precursor B cells and mature B cells.
  • the preferred B-cell surface markers herein are CD20 and CD22.
  • an “intact antibody” is one comprising heavy and light variable domains as well as an Fc region.
  • the antibody comprises the substitution SlOOaR in VH-CDR3, preferably further comprising at least one amino acid substitution in the Fc region that improves ADCC but decreases CDC activity, such as one that comprises at least the amino acid substitution K322A, as well as one that further comprises the amino acid substitutions S298A, E333A, K334A.
  • the cells express at least Fc ⁇ RIII and carry out ADCC effector function.
  • human leukocytes that mediate ADCC include peripheral blood mononuclear cells (PBMC), natural killer (NK) cells, monocytes, cytotoxic T cells and neutrophils; with PBMCs and NK cells being preferred.
  • Chimeric antibodies of interest herein include "primatized" antibodies comprising variable domain antigen-binding sequences derived from a non-human primate (e.g. Old World Monkey, such as baboon, rhesus or cynomolgus monkey) and human constant region sequences (US Pat No. 5,693,780).
  • a non-human primate e.g. Old World Monkey, such as baboon, rhesus or cynomolgus monkey
  • human constant region sequences US Pat No. 5,693,780
  • beta glucans for treatment of osteoporosis and other diseases of bone resorption as described in US20040058889, one or more compounds known in the art to be beneficial to bone formation, such as calcium, fluoride, magnesium, boron, or a combination thereof; thienyl-substituted acylguanidines as inhibitors of bone resorption and vitronectin receptor antagonists as described in US Pat. No. 6,660,728; acylquanidine derivatives as described in US Pat. No. 6,602,878; a matrix selected from the group consisting of glycolic acid, lactic acid, collagen, demineralized bone, or a combination thereof.
  • osteoprotegerin an interleukin, a MMP inhibitor, a beta glucan, an integrin antagonist, calcitonin, a proton pump inhibitor, a protease inhibitor, a bisphosphonate, insulin-like growth factor- 1, platelet- derived growth factor, epidermal growth factor, an inhibitor of transforming growth factor- alpha, transforming growth factor-beta, a bone morphogenetic protein, parathyroid hormone, osteoprotegerin, a fibroblast growth factor, Vitamin D, calcium, fluoride, magnesium, or boron, vitro
  • non-steroidal anti-inflammatory drugs NSAIDs
  • ganciclovir tacrolimus, glucocorticoids such as Cortisol or aldosterone
  • anti-inflammatory agents such as a cyclooxygenase inhibitor, a 5 -lipoxygenase inhibitor, or a leukotriene receptor antagonist
  • purine antagonists such as azathioprine or mycophenolate mofetil (MMF)
  • alkylating agents such as cyclophosphamide; bromocryptine; danazol; dapsone; glutaraldehyde (which masks the MHC antigens, as described in U.S. Pat. No.
  • cytotoxic agent refers to a substance that inhibits or prevents the function of cells and/or causes destruction of cells.
  • the term is intended to include radioactive isotopes (e.g.
  • calicheamicin especially calicheamicin gammall and calicheamicin omegall (see, e.g., Angew, Chem lntl. Ed. Engl, 33: 183-186 (1994)); dynemicin, including dynemicin A; an esperamicin; as well as neocarzinostatin chromophore and related chromoprotein enediyne antibiotic chromophores), aclacinomysins, actinomycin, authramycin, azaserine, bleomycins, cactinomycin, carabicin, carminomycin, carzinophilin, chromomycins, dactinomycin, daunorubicin, detorubicin, 6-diazo-5-oxo-L-norleucine, doxorubicin (including ADRIAMYCIN ® , morpholino-doxorubicin, cyan
  • hormone refers to polypeptide hormones, which are generally secreted by glandular organs with ducts. Included among the hormones are, for example, growth hormone such as human growth hormone, N-methionyl human growth hormone, and bovine growth hormone; parathyroid hormone; thyroxine; insulin; proinsulin; relaxin; estradiol; hormone-replacement therapy; androgens such as calusterone, dromostanolone propionate, epitiostanol, mepitiostane, or testolactone; prorelaxin; glycoprotein hormones such as follicle stimulating hormone (FSH), thyroid stimulating hormone (TSH), and luteinizing hormone (LH); prolactin, placental lactogen, mouse gonadotropin-associated peptide, gonadotropin-releasing hormone; inhibin; activin; mullerian-inhibiting substance; and thrombopoietin. As used herein, the term hormone includes proteins from
  • Examples of "disease-modifying anti-rheumatic drugs” or “DMARDs” include hydroxycloroquine, sulfasalazine, methotrexate, leflunomide, etanercept, infliximab (plus oral and subcutaneous methotrexate), azathioprine, D-penicillamine, gold salts (oral), gold salts (intramuscular), minocycline, cyclosporine including cyclosporine A and topical cyclosporine, staphylococcal protein A (Goodyear and Silverman, J. Exp. Med., 197, (9), pi 125-39 (2003)), including salts and derivatives thereof, etc.
  • a direct binder is a polypeptide comprising any portion of a BAFF receptor that binds BAFF such as an extracellular domain of a BAFF receptor, or fragments and variants thereof that bind native BAFF.
  • BAFF antagonists include the polypeptides having a sequence of a polypeptide comprising the sequence of Formula I:
  • Forma I (SEQ ID NO: 18) wherein Xl, X3, X5, X7, X8, X9, XlO, Xl 1, X12, X14, X15 and X17 are any amino acid except cysteine; and wherein Xl 6 is an amino acid selected from the group consisting of L, F, I and V; and wherein the polypeptide does not comprise a cysteine within seven amino acid residues N- terminal to the most N-terminal cysteine C and C-terminal to the most C-terminal cysteine C of Formula I.
  • a polypeptide comprising the sequence of Formula II has a disulfide bond between the two Cs and has the conformation OfXsLX 7 Xg forming a type I beta turn structure with the center of the turn between L and X 7 ; and has a positive value for the dihedral angle phi of Xs.
  • X 3 is an amino acid selected from the group consisting of M, A, V, L, I, Y, F, W and a non-polar amino acid.
  • X 5 is selected from the group consisting of V, L, P, S, I, A and R.
  • Xs is selected from the group consisting of R, K, G, N, H and D-amino acid.
  • X 9 is selected from the group consisting of H, K, A, R and Q.
  • the term "bone disorder” refers to a disease characterized by bone loss, i.e., a disease, condition, disorder or syndrome that has as a symptom or pathology a decrease in bone mass or density.
  • diseases characterized by bone loss include, but are not limited to, osteolysis, including osseous metastasis, aseptic prosthetic loosening, periodontitis, osteoporosis, Paget's disease, metastatic bone disease, and rheumatoid arthritis.
  • Such bone disorders include those associated with autoimmune diseases such as lupus and rheumatoid arthritis.
  • Ostoprogenitor refers to a differentiated bone precursor cell derived from a bone stromal cell.
  • Examples of such additional medicaments include an agent that treats osteoclast-associated disorders, a chemotherapeutic agent, an interferon class drug such as interferon-alpha (e.g., from Amarillo Biosciences, Inc.), IFN- ⁇ -la (REB IF ® and AVONEX ® ) or IFN- ⁇ -lb (BETASERON ® ), an oligopeptide such as glatiramer acetate (COPAXONE ® ), an agent blocking CD40-CD40 ligand, a cytotoxic or immunosuppressive agent (such as mitoxantrone (NOVANTRONE ® ), methotrexate, cyclophosphamide, chlorambucil, leflunomide, and azathioprine), intravenous immunoglobulin (gamma globulin), lymphocyte-depleting therapy (e.g., mitoxantrone, cyclophosphamide, CAMPATHTM antibodies, anti-
  • TNF inhibitor such as an antibody to TNF- ⁇ , DMARD, NSAID, plasmapheresis or plasma exchange, trimethoprim- sulfamethoxazole (BACTRIMTM, SEPTRATM), mycophenolate mofetil, H2-blockers or proton- pump inhibitors (during the use of potentially ulcerogenic immunosuppressive therapy), levothyroxine, cyclosporin A (e.g.
  • polylactide polyglycolide, polylactide/polyglycolide copolymers, polydioxanone, polyglycolide/trimethylene carbonate copolymers, polyacrylic acid, polymethacrylic acid, polyvinyl pyrrolidone, and polyvinyl alcohol.
  • Such materials can be prepared in a variety shapes, including films, plates, pins, rods, screws, blocks, lattices, and the like for attachment to or insertion into bone. See, for example, U.S. Pat. No. 5,863,297; and WO 93/20859.
  • These materials may further include a carrier such as albumin, a polyoxyethylenesorbitan detergent or glutamic acid.
  • Degradation of the matrix and consequent release of growth factors therefrom can be modulated by adjusting such parameters as molecular weight, copolymer structure, copolymer ratio, matrix thickness, and porosity, and by including a carrier as disclosed above.
  • PLA/PGA films for example, are generally formulated to provide a ratio of PLA:PGA between 75:25 and 25:75, more commonly between 65:35 and 35:65.
  • an implant will be prepared using a copolymer having a molecular weight between 10,000 and 200,000 Daltons.
  • US 2004/0126364 discloses delivery of polypeptides to mammals to promote bone tissue growth using living odontoprogenitor cells or osteoprogenitor cells (OPCs), a method applicable herein.
  • the cells can be used for autologous or allogeneic cell transplants to serve as a cell-based platform to deliver the antibody herein in a site-specific, regulated manner.
  • the dose of cells to be administered ranges from 1 x 10 cells to 1 x 10 10 cells in volume suitable for the location of transplantation (e.g., a smaller volume is used for implantation into mandibular tissue or into the periodontal ligament compared to implantation into the bone marrow of the femur).
  • Clinical protocols for such implantation procedures are known in the art.
  • a dose of 1 xlO 8 cells per kg of body weight may be administered to femoral bone marrow.
  • Repeated implants may be required for long-term diseases such as rheumatoid arthritis.
  • P-INP is procollagen type 1 N-terminal propeptide
  • Rituximab positive control compound, PBS, or vehicle alone is administered subcutaneously once per day for 35 days.
  • rituximab is formulated in implantable pellets that are implanted for 35 days. All animals, including sham OVX/vehicle and OVX/vehicle groups, are injected intraperitoneal Iy with calcein nine days and two days before sacrifice (two injections of calcein administered each designated day, to ensure proper labeling of newly formed bone). Weekly body weights are determined. At the end of the 35- day cycle, the animals' blood and tissues are processed as described above. It is expected that rituximab, or humanized 2H7, will be effective versus the control groups in preventing bone loss in this model.
  • Example 8 Bone Effects in Chronic OVX Animals

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BRPI0608109-6A BRPI0608109A2 (pt) 2005-02-28 2006-02-28 tratamento de distúrbios ósseos
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CA2597097A1 (en) 2006-09-08
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NO20074911L (no) 2007-11-27
AR054427A1 (es) 2007-06-27
RU2007135878A (ru) 2009-04-10
KR20070114196A (ko) 2007-11-29
ZA200707280B (en) 2008-12-31
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