Drug – bio-affecting and body treating compositions – Lymphokine – Interleukin
Reexamination Certificate
2008-05-13
2008-05-13
Mertz, Prema M. (Department: 1646)
Drug, bio-affecting and body treating compositions
Lymphokine
Interleukin
C530S351000
Reexamination Certificate
active
07371371
ABSTRACT:
Interleukin-2 (IL-2) mutants having reduced toxicity, which include full-length IL-2, truncated forms of IL-2 and forms of IL-2 that are linked to another molecule are disclosed herein. Particular substitutions within IL-2, particularly within the permeability enhancing peptide region of IL-2 achieve substantial reduction of vasopermeability activity as compared to a wildtype form of the mutant IL-2 while retaining many of the immune activating properties of IL-2. Invention IL-2 mutants can be used to stimulate the immune system of an animal and may be used in the treatment of various disorders and conditions.
REFERENCES:
patent: 4604377 (1986-08-01), Fernandes et al.
patent: 4766106 (1988-08-01), Katre et al.
patent: 4959314 (1990-09-01), Mark et al.
patent: RE33653 (1991-07-01), Mark et al.
patent: 5116943 (1992-05-01), Koths et al.
patent: 5116964 (1992-05-01), Capon et al.
patent: 5206344 (1993-04-01), Katre et al.
patent: 5498530 (1996-03-01), Schatz et al.
patent: 5565332 (1996-10-01), Hoogenboom et al.
patent: 5837500 (1998-11-01), Ladner et al.
patent: 5969108 (1999-10-01), McCafferty et al.
patent: 6008319 (1999-12-01), Epstein et al.
patent: 6348192 (2002-02-01), Chan et al.
patent: 60126088 (1985-07-01), None
patent: WO 87/00056 (1987-01-01), None
patent: WO 93/20849 (1993-10-01), None
Callard and Gearing (1994), The Cytokine Factsbook, Academic Press Ltd., pp. 39-40.
Ruoff et al.. Development of low-toxicity IL-2 analogs for the immunotherapy of solid tumors. Proceedings for the American Association for Cancer Researcb Annual Meeting. 40: p. 76, Mar. 1999.
Allegretta et al., “The Development of anti-interlerkin-2 antibodies in patients treated with recombinant human interleukin-2 (IL-2),” Journal of Clinical Immunology, 6(6): 481-490, 1986.
Bergmann et al., “Phase separation analysis of recombinant interleukin 2,” Molecular Immunology, 28(1): 99-105, 1991.
Buttke et al., “Use of an aqueous solube tetrazolium/formazan assay to measure viability and proliferation of lymphokine-dependent cell lines,” Journal of Immunological Methods, 157: 233-240, 1993.
Cotran et al., “Endothelial activation during interleukin 2 immunotherapy,” The Journal of Immunology, 139: 1883-1888, 1987.
Eckenberg et al., “Analysis of human IL-2/IL-2 receptor βchain interactions: Monoclonal antibody h2-8 and new IL-2 mutants define the critical role of α helix-A and IL-2,” Cytokine, 9(7): 488-498, 1997.
Farner et al., “Distinction between γcdetection and function in YT lymphoid cells and in the granulocyte-macrophage colony-stimulating factor-responsive human myeloid cell line, Tf-1,” Blood, 86(12): 4568-4578, 1995.
Frankel et al., “The Rapid determination of binding constants for antiviral antibodies by a radioimmunoassay. An analysis of the interaction between hybridoma proteins and influenza virus,” Mol. Immun., 16:101-106, 1979.
Gieni et al., “Comparison of [3H]thymidine incorporation with MTT- and MTS-based bioassayss for human and murine IL-2 and IL-4 analysis Tetrazolium assays provide markedly enhanced sensitivity,” Journal of Immunological Methods, 187:85-93, 1995.
Hornick et al., “A New Chemically Modified Chimeric TNT-3 Monoclonal Antibody Directed Against DNA for the Radioimmunotherapy of solid tumors,” Cancer Biotherapy & Radiopharmaceuticals, 13(14): 255-268, 1998.
Hornick et al., “Single amino acid substitution in the Fc region chimeric TNT-3 antibody accelerates clearance and improves immunoscintigraphy of solid tumors,” J.Nucl.Med., 41:355-362, 2000.
Huse et al., “Generation of a large combinatorial library of the immunoglobulin repertoire in phage lambda,” Science, 246:1275-1281, 1989.
Lam et al., “A new type of synthetic peptide library for identifying ligand-binding activity,” Nature, 354: 82-84, 1991.
LeBerthon et al., “Enhanced tumor uptake of marcomolecules induced by a novel vasoactive interleukin 2 immunoconjugate,” Cancer Research, 51:2694-2698, 1991.
Marks et al., “Characterization and responsiveness of the Madison 109 lung carcinoma to various antitumor agents,” Cancer Treatment Reports, 61(8): 1459-1470, 1977.
Oda et al., “Induction of IL-1β-converting enzyme-independent apoptosis by IL-2 in human T cell lines,” International Immunology, 9(9): 1303-1310, 1997.
Ohsugi et al., “Tumorigenicity of human malignant lymphoblasts: Comparative study with unmanipulated nude mice, antilymphocyte serum-treated nude mice, and X-irradiated nude mice,” JNCL, 63(4): 715-718, 1980.
Rong et al., “Analysis of IL-2 functional structure by multiple cysteine substitutions,” Biochemical and Biophysical Research Communications, 188(2): 949-955, 1992.
Shanafelt et al., “A T-cell-selective interleukin 2 mutein exhibits potent antitumor activity and is well tolerated in vivo,” Nature Biotechnology, 18:1197-1202, 2000.
Shipley et al., “Regulation of growth of an interleukin 2(IL-2)-dependent murine T-cell clone (HT-2) in a defined serum-free medium,” Cellular Immunology, 93:459-466, 1985.
Taniguchi et al., “Structure and expression of a cloned cDNA for human interleukin-2,” Nature, 302:305-310, 1983.
Theze et al., “Interleukin 2 and its receptors: recent advances and new immunological functions,” Immunology Today, 17:481-486, 1996.
Tom et al., “Human colonic adenocarcinoma cells,” In Vitro, 12(3): 180-191, 1976.
Tsudo et al., “Reconstitution of a functinal IL-2 receptor by the β-chain cDNA,” Journal of Immunology, 143:4039-4043, 1989.
Weigel et al., “Mutant proteins of human interleukin 2: Renaturation yield, proliferative and receptor binding,” Eur. J. Biochem., 180:295-300, 1989.
Yodoi et al., “TCGF (IL 2)-receptor inducing factors(s): Regulation of IL 2 receptor on a natural killer-like cell in (YT cells),” The Journal of Immunology, 134: 1623-1630, 1985.
Supplementary Partial European Search Report for EP Application No. 02 75 2821.
Cassell et al. Therapeutic Enhancement of IL-2 through Molecular Design. Current Pharmaceutical Design, 8:2171-2183, 2002.
Epstein et al., Identification of a Protein Fragment of Interlerkin 2 Responsible for Vasopermeability. Journal of the National Cancer Institute, 95(10): 741-749, 2003.
Heaton et al., Human Interleukin 2 Analogues that Preferentially Bind the Intermediate-Affinity Interleukin 2 Receptor Lead to Reduced Secondary Cytokine Secretion: Implications for the Use of These Interleukin 2 Analogues in Cancer Immunotherapy. Cancer Research, 53: 2597-2602, 1993.
Heaton et al., Induction of Lymphokine-Activated Killing with Reduced Secretion of Interleuking-1β, Tumor Necrosis Factor-α, and Interferon-γ by Interluekin-2 Analogs. Annals of Surgical Oncology. 1(3): 198-203, 1994.
Hu et al., Generation of low-toxicity interleukin-2 fusion proteins devoid of vasopermeability activity. Blood, 101(12): 4853-4861, 2003.
Ju et al, Structure-Function Analysis of Human Interleukin-2. The Journal of Biological Chemistry. 262:5723-5731, 1967.
Ruoff et al., Developement of low-toxicity IL-2 analogs for the immunotherapy of solid tumors. Proceedings for the American Association for Cancer Research Annual Meeting, 40: p. 76, Mar. 1999.
Sauve et al., Localization in human interleukin 2 of the binding site to the α chain (p55) of the interleukin 2 receptor. Proc. Nat. Acad. Sci. USA, 88: 436-4640, Jun. 1991.
A Poster Presentation on Interleukin-2 (IL-2) from the 1999 AACR meeting, p. 1-7, Ruoff et al.
Epstein Alan L.
Hu Peisheng
Foley & Lardner LLP
Mertz Prema M.
University of Southern California
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