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United States Patent (19) 11 Patent Number: 5,919,452 Le Et Al

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United States Patent (19) 11 Patent Number: 5,919,452 Le Et Al USOO59 19452A United States Patent (19) 11 Patent Number: 5,919,452 Le et al. (45) Date of Patent: *Jul. 6, 1999 54 METHODS OF TREATING TNFo-MEDIATED 92.16553 10/1992 WIPO. DISEASE USING CHMERIC ANT-TNF WO 93/02108 2/1993 WIPO. ANTIBODIES OTHER PUBLICATIONS 75 Inventors: Junming Le, Jackson Heights; Jan Shalaby, M.R. et al. Transplantation. 47:1057-1061, Jun. Vilcek, New York, both of N.Y.; Peter 1989. Dadonna, Palo Alto, Calif.; John Natanson, C. et al. Annals of Internal Medicine. Ghrayeb, Thorndale; David Knight, 120(9):771–783, May 1994. Berwyn, both of Pa.; Scott Seigal, Sun et al., Journal of Clinical Investigation, Vol. Westborough, Mass. 81:1328–1331, “Bowel Necrosis Induced by Tumor Necro sis Factor in Rats Is Mediated by Platelet-activating Factor”, 73 Assignees: New York University, New York, N.Y.; May 1988. Centocor, Inc., Malvern, Pa. Murch et al., Gut, vol. 32:913–917, "Serum concentrations of Tumour Necrosis Factor alpha in Childhood Chronic * Notice: This patent is Subject to a terminal dis Inflammatory Bowel Disease”, 1991. claimer. DerkX et al., The Lancet, vol. 342:173-174, Tumour-necro Sis-factor antibody treatement In Crogn's disease, Jul. 17, 1993. 21 Appl. No.: 08/192,861 Rademacher et al., Seminars in Immunopathology, Vol. 10:231-249, “Role of IgG Glycoforms in the Pathogenesis 22 Filed: Feb. 4, 1994 of Rheumatoid Arthritis', 1988. Lichtenstein et al., Current Opinions in Gastroenterology, Related U.S. Application Data vol. 8(4):655-662, “Clinical Advances in Inflammatory 63 Continuation-in-part of application No. 08/010,406, Jan. 29, Bowel Disease', 1992. 1993, abandoned, and application No. 08/013,413, Feb. 2, Beutler, B. et al., “Identity of tumour necrosis factor and the 1993, abandoned, which is a continuation-in-part of appli macrophage-Secreted factor cachectin, Nature, cation No. 07/943,852, Sep. 11, 1992, abandoned, which is a continuation-in-part of application No. 07/853,606, Mar. 316:552–554 (1985). 18, 1992, abandoned, which is a continuation-in-part of Beutler, B. et al., “Passive Immunization Against Cachectin/ application No. 07/670,827, Mar. 18, 1991, abandoned. Tumor Necrosis Factor Protects Mice from Lethal Effect of Endotoxin,” Science, 229:869–871 (1985). 51) Int. Cl. ......................... A61K.39/395; CO7K 16/24 Morrison, Sherie L., “Transfectomas Provide Novel Chi 52 U.S. Cl. ..................................... 424/133.1; 424/145.1; meric Antibodies." Science, 229:1202–1207 (1985). 424/158.1; 530/387.3; 530/38823: 530/389.2 Brennan, F.M. et al. The Lancet. 2(8657):244-247, Jul. 58 Field of Search ................................. 424/158.1, 810, 1989. 424/133.1, 145.1; 435/69.6, 70.21, 240.27, Moller, A. et al. Cytokine. 2(3):162–169, May 1990. 1722; 935/15; 530/388.23,389.2, 809, Echtenacher, Bernd et al., “Requirement of Endogenous 387.3 Tumor Necrosis Factor/Cachectin for Recovery from Experimental Peritonitis,” J. of Immunology, 56) References Cited 145(11):3762–3766 (1990). Smith, Craig R., “Human and Chimeric Antibodies to LPS U.S. PATENT DOCUMENTS and TNF,” Abstract, Endotoxemia & Sepsis Conference 4,603,106 7/1986 Cerami et al. .............................. 435/7 1991). 4,822,776 4/1989 Cerami et al. ............................ 514/21 ER, Mark, “Humanized Antibodies for Anti-TNF 5,183,657 2/1993 Buurman et al. ...................... 424/85.8 Therapy,” Abstract, Endotoxemia & Sepsis Conference 5,231,024 7/1993 Moeller et al. ... ... 435/240.27 (1991). 5,658,570 8/1997 Newman et al. ... 424/184.1 5,672,347 9/1997 Aggarwal et al. ... 424/139.1 (List continued on next page.) 5,750,105 5/1998 Newman et al. .................... 424/133.1 Primary Examiner Toni R. Scheiner FOREIGN PATENT DOCUMENTS Assistant Examiner Nancy A. Johnson Attorney, Agent, or Firm-Hamilton, Brook, Smith & 0212489A2 3/1987 European Pat. Off.. Reynolds, P.C. 0218868A2 4/1987 European Pat. Off.. 0260610A2 3/1988 European Pat. Off.. 57 ABSTRACT 0288088A2 10/1988 European Pat. Off.. 0308378A2 3/1989 European Pat. Off.. Treatment of tumor necrosis factor, TNF, mediated patholo O350690A2 1/1990 European Pat. Off.. gies is provided by administering anti-TNF compounds, 0351789A2 1/1990 European Pat. Off.. such as anti-TNF antibodies and anti-TNF peptides, which 038.0068A1 8/1990 European Pat. Off.. compounds are specific for tumor necrosis factor-O. (TNFC) O393438A3 10/1990 European Pat. Off.. or tumor necrosis factor-B (TNFB) and which are useful for O398327A1 11/1990 European Pat. Off.. in Vivo therapy or diagnosis of TNFC.-mediated pathologies 0412486A1 2/1991 European Pat. Off.. 0433900A1 6/1991 European Pat. Off.. and conditions, wherein the anti-TNF compound is selected 0526905A2 2/1993 European Pat. Off.. from the group consisting of at least one of an immunoglo 90/00902 2/1990 WIPO. bulin variable region, a fragment of a TNF receptor and an WO91/02078 2/1991 WIPO. anti-TNF peptide, such as a structural analog of a anti-TNF 91/O9967 7/1991 WIPO. antibody fragment or a TNF receptor fragment. WO92/07076 4/1992 WIPO. WO92/11383 7/1992 WIPO. 13 Claims, 36 Drawing Sheets 5,919,452 Page 2 OTHER PUBLICATIONS Harris, William J. and Emery, Steven, “Therapeutic anti bodies-the coming of age.” TIBTECH, 11:42-44 (1993). Grau GE et al Science 237: 1210-1212, 1987. Morrison SL Hospital Practice pp. 65-80, Oct. 15, 1987. Parrillo, Joseph E., “Pathogenetic Mechanisms of Septic Piguet PF et al J Exp Med 166:1280–1289, 1987. Shock.” N.E. Journal of Medicine, 328(20): 1471–1477 Piguet DF et al J Exp Med 170:655–663, 1989. (1993). Herve, P. et al., “Monoclonal Anti TNF C. Antibody for the Aggarwal, Bharat B. et al., “Human Tumor Necrosis Factor Treatment of Severe Acute GvHD in Humans,' Abstract Production, Purification and Characterization,” J. of Biol. 3.25, Lymphoma Res. 9:591 (1990). Chem., 260(4):2345–2354 (1985). Silva, Ayona T. et al., “Prophylactic and Therapeutic Effects Liang, Chi-Ming et al., “Production and Characterization of of a Monoclonal Antibody to Tumor Necrosis Factor-C. in Monoclonal Antibodies Against Recombinant Human Experimental Gram-Negative Shock,” J. Of Infectious Dis Tumor Necrosis Factor/Cachectin,” Biochem. & Biophy. eases, 162:421–427 (1990). Res. Comm., 137(2):847-854 (1986). Opal, Steven M. et al., “Efficacy of a Monoclonal Antibody Hirai, Makoto et al., “Production and characterization of Directed Against Tumor Necrosis Factor in Protecting Neu monoclonal antibodies to human tumor necrosis factor, J. tropenic Rats from Lethal Infection with Pseudomonas of Immun. Methods, 96:57-62 (1987). aeruginosa,” J. Of Infectious diseases, 161:1148–1152 Piguet, Pierre-Francois et al., “Tumor Necrosis Factor/ (1990). Cachectin is an Effector of Skin and Gut Lesions of the Tavernier, Jan et al., “Analysis of the Structure-Function Acute Phase of Graft-vs.-Host Disease,” J. Exp. Med., Relationship of Tumour Necrosis Factor. Human/Mouse 166:1280–1289 (1987). Chimeric TNF Proteins: General Properties and Epitope Meager, Anthony et al., “Preparation and Characterization of Analysis,” J. Mol. Biol., 211:493-501 (1990). Monoclonal Antibodies Directed Against Antigenic Deter Lucas, R. et al., “Generation and characterization of a minants of Recombinant Human Tumour Necrosis Factor neutralizing rat anti-rm TNF-C. monoclonal antibody.” (rTNF).” Hybridoma, 6(3):305-311 (1987). Immunology, 71:218–223 (1990). Fendly, Brian M. et al., “Murine Monoclonal Antibodies Hinshaw, L.B. et al., “Survival of Primates in LDoo Septic Defining Neutralizing Epitopes on Tumor Necrosis Factor,” Shock Following Therapy with Antibody to Tumor Necrosis Hybridoma, 6(4):359-370 (1987). Factor (TNFo),” Circulatory Shock, 30:279-292 (1990). Bringman, Timothy S. and Aggarwal, Bharat B., “Mono Nophar, Yaron et al., “Soluble forms of tumor necrosis factor clonal Antibodies to Human Tumor Necrosis Factors Alpha receptors (TNF-Rs). The cDNA for the type 1 TNF-R, and Beta: Applications for Affinity Purification, Immunoas cloned using amino acid Sequence data of its Soluble form, says, and as Structural Probes.” Hybridoma, 6(5):489-507 encodes both the cell Surface and a soluble form of the (1987). receptor.” The EMBO Journal, 9(10):3269-3278 (1990). Tracey, Kevin J. et al., “Anti-cachectin/TNF monoclonal Engelmann, Hartmut et al., “Two Tumor Necrosis Factor-b- antibodies prevent Septic Shock during lethal bacteraemia,” inding Proteins Purified from Human Urine,” J. of Bio. Chem., 265(3):1531–1536 (1990). Nature, 330:662-664 (1987). Verhoef, J. and Torensma, R., “Prospects for Monoclonal Nagai, M. et al., “Antibody to tumor necrosis factor (TNF) Antibodies in the Diagnosis and Treatment of Bacterial reduces endotoxin fever,” Experientia, 44:606–607 (1988). Infections,” Eur: J. Clin. Microbiol. Dis., 9(4):247-250 Shimamoto, Yoshinori et al., “Monoclonal antibodies (1990). against human recombinant tumor necrosis factor: preven Loetscher, Hansruedi et al., “Molecular Cloning and Expres tion of endotoxic shock.” Immunology Letters, 17:311-318 sion of the Human 55 kd Tumor Necrosis Factor Receptor,” (1988). Cell, 61:351–359 (1990). Collins, M.S. et al., “Immunoprophylaxis of Polymicrobic Schall, Thomas J. et al., “Molecular Cloning and Expression Cellulitis with a Human Monoclonal Antibody Against of a Receptor for Human Tumor Necrosis Factor,” Cell, Lipopolysaccharide Antigen of Pseudomonas aeruginosa, 61:361-370 (1990). Abstract E-63, Abstracts of Annual Meeting 1989. Akama, Hideto et al., “Mononuclear Cells Enhance Pros Exley, A.R. et al., “Monoclonal Antibody (Mab) to Recom taglandin E Production of Polymorphonuclear Leukocytes binant Human Tumour Necrosis Factor (rhTNF) in the via Tumor Necrosis Factor C.” Biochemical and Biophysical Prophylaxis and Treatment of Endotoxic Shock in Cyno Research Comm., 168(2):857–862 (1990). molgus Monkeys,” Medical Research Society, Abstract 184, Exley, A.R. et al., “Monoclonal antibody to TNF in severe p.
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