Drug – bio-affecting and body treating compositions – Immunoglobulin – antiserum – antibody – or antibody fragment,... – Structurally-modified antibody – immunoglobulin – or fragment...
Reexamination Certificate
2011-03-15
2011-03-15
Huynh, Phuong (Department: 1644)
Drug, bio-affecting and body treating compositions
Immunoglobulin, antiserum, antibody, or antibody fragment,...
Structurally-modified antibody, immunoglobulin, or fragment...
C424S174100, C424S178100, C424S185100, C424S192100, C424S193100, C424S195110, C514S007700, C530S351000, C530S387300, C530S388220, C530S388800, C530S391500
Reexamination Certificate
active
07906118
ABSTRACT:
The present invention concerns methods and compositions for forming cytokine-antibody complexes using dock-and-lock technology. In preferred embodiments, the cytokine-MAb DNL complex comprises an IgG antibody attached to two AD (anchor domain) moieties and four cytokines, each attached to a DDD (docking and dimerization domain) moiety. The DDD moieties form dimers that bind to the AD moieties, resulting in a 2:1 ratio of DDD to AD. The cytokine-MAb complex exhibits improved pharmacokinetics, with a significantly longer serum half-life than either naked cytokine or PEGylated cytokine. The cytokine-MAb complex also exhibits significantly improved in vitro and in vivo efficacy compared to cytokine alone, antibody alone, unconjugated cytokine plus antibody or cytokine-MAb DNL complexes incorporating an irrelevant antibody. In a most preferred embodiment the complex comprises an anti-CD20 IgG antibody conjugated to four IFN-α2b moieties, although other antibodies and cytokines have been used to form effect DNL complexes.
REFERENCES:
patent: 4046722 (1977-09-01), Rowland
patent: 4699784 (1987-10-01), Shih et al.
patent: 4868109 (1989-09-01), Lansdorp et al.
patent: 5770198 (1998-06-01), Coller et al.
patent: 6261537 (2001-07-01), Klaveness et al.
patent: 6306393 (2001-10-01), Goldenberg
patent: 6524854 (2003-02-01), Monia et al.
patent: 6617135 (2003-09-01), Gillies et al.
patent: 7060506 (2006-06-01), Craig
patent: 7151164 (2006-12-01), Hansen et al.
patent: 7432342 (2008-10-01), Braun et al.
patent: 7521056 (2009-04-01), Chang et al.
patent: 7527787 (2009-05-01), Chang et al.
patent: 7534866 (2009-05-01), Chang et al.
patent: 7541440 (2009-06-01), Goldenberg et al.
patent: 7550143 (2009-06-01), Chang et al.
patent: 7591994 (2009-09-01), Govindan et al.
patent: 7666400 (2010-02-01), Chang et al.
patent: 2003/0198956 (2003-10-01), Makowski et al.
patent: 2003/0219433 (2003-11-01), Hansen et al.
patent: 2003/0232420 (2003-12-01), Braun et al.
patent: 2004/0018587 (2004-01-01), Makowski et al.
patent: 2005/0003403 (2005-01-01), Rossi et al.
patent: 2006/0210475 (2006-09-01), Goldenberg et al.
patent: 2007/0020259 (2007-01-01), Hansen et al.
patent: 2007/0264265 (2007-11-01), Goldenberg et al.
patent: 2009/0060862 (2009-03-01), Chang et al.
patent: 2009/0111143 (2009-04-01), Goldenberg et al.
patent: 00/68248 (2000-11-01), None
patent: 2006/107617 (2006-10-01), None
patent: 2006/107786 (2006-10-01), None
patent: 2007/075270 (2007-07-01), None
patent: 2008/033413 (2008-03-01), None
Mecchia et al. “Type I consensus interferon (CIFN) gene transfer into human melanoma cells up-regulates p53 and enhances cisplatin-induced apoptosis: implications for new therapeutic strategies with IFN-alpha” Gene Ther. (2000) 7, 167-179.
Newlon et al. “A Novel Mechanism of PKA Anchoring Revealed by Solution Structures of Anchoring Complexes”, EMBO J. 2001; 20:1651-1662.
Newlon et al. “The molecular basis for protein kinase A anchoring revealed by solution NMR”, Nature Struct. Biol. 1999; 3:222-227.
Ngo et al. “Computational Complexity, Protein Structure Prediction, and the Levinthal Paradox”, The Protein Folding Problem and Tertiary Structure Prediction, Ch. 14, pp. 492-495, (Mertz & Le Grand, Eds.), Birkhauser Boston, 1994.
Osborn et al. “Pharmacokinetic and Pharmacodynamic Studies of a Human Serum Albumin-Interferon-α Fusion Protein in Cynomolgus Monkeys” J. Pharmacol. Exp. Ther. 303(2):540-548 (2002).
Oyen et al. “Human testis cDNA for the regulatory subunit Rllα of cAMP-dependent protein kinase encodes an alternate amino-terminal region”, FEBS Letters 246:57-64, 1989.
Ozzello et al. “Conjugation of interferon alpha to a humanized monoclonal antibody (HuBrE-3vl) enhances the selective localization and antitumor effects of interferon in breast cancer xenografts” Breast Cancer Res. Treat. 48: 135-147 (1998).
Paquette et al. “Interferon-α and granulocyte-macrophage colony-stimulating factor differentiate peripheral blood monocytes into potent antigen-presenting cells” J. Leukoc. Biol. 64:358-367; 1998.
Pelham et al. “Interferon-α conjugation to human osteogenic sarcoma monoclonal antibody 791T/36” Cancer Immunol. Immuother. 1983;15(3):210-216.
Pepinsky et al. “Improved Pharmacokinetic Properties of a Polyethylene Glycol-Modified Form of Interferon-β-1a with Preserved in Vitro Bioactivity” Pharmacol. Exp. Ther. 2001; 297(3):1059-1066.
Pilling et al. “Interferon-β mediates stromal cell rescue of T cells from apoptosis” Eur. J. Immunol. 29:1041-1050 (1999).
Rabjohn et al. “Molecular Cloning and Epitope Analysis of the Peanut Allergen Ara h 3” J. Clinical Investigation 103 (4):535-542 (1999).
Raefsky et al. “Studies of Interferon as a regulator of hematopoietic cells proliferation” J. Immunol. 135(4):2507-2512 (1985).
Rose et al. “Structural basis of dimerization, coactivator recognition and MODY3 mutations in HNF-1α”, Nature Struct. Biol. 2000; 7:744-748.
Rosendahl et al. “A Long-Acting, Highly Potent Interferon α-2 Conjugate Created Using Site-Specific PEGylation” Bioconjugate Chem. 2005;16:200-207.
Rossi et al. “Novel Designs of Multivalent Anti-CD20 Humanized Antibodies as Improved Lymphoma Therapeutics”, Cancer Res. 68:8384-92, 2008.
Rossi et al. “Stably tethered multifunctional structures of defined composition made by the dock and lock method for use in cancer targeting” Proc. Natl. Acad. Sci. Epub Apr. 24, 2006, vol. 103, No. 18, pp. 6841-6846.
Rustandi et al. “The Ca2+-Dependent Interaction of S100B(ββ) with a Peptide Derived from p53”, Biochemistry 1998; 37: 1951-1960.
Sabaawy et al. “Enhancement of 5-fluorouracil cytotoxicity on human colon cancer cells by retrovirus-mediated interferon-α gene transfer” Int. J. Oncol. Jun. 1999; 14(6):1143-51.
Salles et al. “Rituximab combined with chemotherapy and interferon in follicular lymphoma patients: results of the GELA-GOELAMS FL2000 study” Blood 2008; 112:4824-4831.
Santini et al. “Type I Interferon as a Powerful Adjuvant for Monocyte-derived Dendritic Cell Development and Activity In Vivo and in Hu-PBL-SCID Mice” J. Exp. Med. 191(10):1777-1788 (2000).
Scott et al. “Type II Regulatory Subunit Dimerization Determines the Subcellular Localization of the cAMP-dependent Protein Kinase”, J. Biol. Chem. 265:21561-66 (1990).
Scott et al. “Cyclic nucleotide-dependent protein kinases” Pharmacol. Ther. 1991;50(1):123-45.
Seffernick et al. “Melamine Deaminase and Atrazine Chlorohydrolase: 98 Percent Identical but Functionally Different” J. Bacteriol. 183(8):2405-2410 (2001).
Sharkey et al. “Improved Therapeutic Results by Pretargeted Radioimmunotherapy of Non-Hodgkin's Lymphoma with a New Recombinant, Trivalent, Anti-CD20, Bispecific Antibody”, Cancer Res. 68:5282-90, 2008.
Sharkey et al. “Metastatic Human Colonic Carcinoma: Molecular Imaging with Pretargeted SPECT and PET in a Mouse Model”, Radiology 246:497-507, 2008.
Sidky and Borden “Inhibition of Angiogenesis by Interferons: Effects on Tumor- and Lymphocyte-induced Vascular Responses” Cancer Res. 47:5155-5161, Oct. 1, 1987.
Stein et al. “Characterization of a New Humanized Anti-CD20 Monoclonal Antibody, IMMU-106, and Its Use in Combination with the Humanized Anti-CD22 Antibody, Epratuzumab, for the Therapy of Non-Hodgkin's Lymphoma” Clin. Cancer Res. vol. 10, 2868-2878, Apr. 15, 2004.
Stein et al. “Characterization of a humanized IgG4 anti-HLA-DR monoclonal antibody that lacks effector cell functions but retains direct antilymphoma activity and increases the potency of rituximab” Blood 2006;108:2736-2744.
Stokka et al. “Characterization of A-kinase-anchoring disruption using a solution-based assay” Biochem. J. (2006) 400, 4
Chang Chien-Hsing
Goldenberg David M.
Rossi Edmund A.
Huynh Phuong
IBC Pharmaceuticals, Inc.
Nakashima Richard A.
LandOfFree
Modular method to prepare tetrameric cytokines with improved... does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Modular method to prepare tetrameric cytokines with improved..., we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Modular method to prepare tetrameric cytokines with improved... will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-2672053