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(12) United States Patent (10) Patent No.: US 9,573.996 B2 Ariaans Et Al

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(12) United States Patent (10) Patent No.: US 9,573.996 B2 Ariaans Et Al USOO9573996 B2 (12) United States Patent (10) Patent No.: US 9,573.996 B2 Ariaans et al. (45) Date of Patent: Feb. 21, 2017 (54) MONOCLONAL ANTIBODIES TO HUMAN (56) References Cited PROINFLAMMLATORY CYTOKNES AND METHODS FOR TREATING U.S. PATENT DOCUMENTS NFLAMMLATORY DISEASES 4,771,002 A 9, 1988 Gelvin 5,075,236 A 12/1991 Yone et al. (71) Applicant: Synthon Biopharmaceuticals B.V., 5,428, 147 A 6/1995 Barker et al. Nijmegen (NL) 5,605,690 A 2f1997 Jacobs et al. 5,656,272 A 8, 1997 Le et al. 5,919,452 A 7/1999 Le et al. (72) Inventors: Gerardus Joseph Andreas Ariaans, 6,040.498 A 3/2000 Stomp et al. Nijmegen (NL); Frans van Dalen, 6,090,382 A 7/2000 Salfeld et al. Nijmegen (NL); Declan Thomas 6,451,982 B1 9, 2002 Chou et al. 6,790.444 B2 9, 2004 Le et al. Nolan, Nijmegen (NL) 6,902,724 B1 6/2005 Parekh et al. 6,902,734 B2 6/2005 Giles-Komar et al. (73) Assignee: Synthon Biopharmaceuticals B.V., 6,914,128 B1 7/2005 Salfeld et al. Nijmegen (NL) 7,012,135 B2 3/2006 Athwal et al. 7,147,854 B2 12/2006 Ye 7,161,064 B2 1/2007 Stomp et al. (*) Notice: Subject to any disclaimer, the term of this 7,176,024 B2 2/2007 Branson et al. patent is extended or adjusted under 35 7,186,820 B2 3/2007 Athwal et al. U.S.C. 154(b) by 0 days. 7,622,573 B2 11/2009 Dickey et al. 7,632,983 B2 12/2009 Dickey et al. 7,883,704 B2 2/2011 Salfeld et al. (21) Appl. No.: 14/365.940 7,884,264 B2 2/2011 Dickey et al. 8,034,916 B2 10/2011 Dickey et al. (22) PCT Filed: Dec. 14, 2012 2009 OO60921 A1 3/2009 Dickey et al. 2009, 0214528 A1 8, 2009 Dorai et al. (86). PCT No.: PCT/EP2012/075670 2010/0209966 A1 8, 2010 Everett et al. 2012/0190.004 A1 7/2012 Parsons et al. S 371 (c)(1), 2014/0356357 A1 12/2014 Ariaans et al. 2014/03599.02 A1 12/2014 Ariaans et al. (2) Date: Jun. 16, 2014 2015.OO 10544 A1 1/2015 Ariaans et al. (87) PCT Pub. No.: WO2013/087911 FOREIGN PATENT DOCUMENTS PCT Pub. Date: Jun. 20, 2013 EP O449769 B1 12/1993 EP O932415 A1 8, 1999 (65) Prior Publication Data EP 0602126 B1 3, 2003 US 2015/O166649 A1 Jun. 18, 2015 (Continued) OTHER PUBLICATIONS Related U.S. Application Data Chan AC, et al. Nature Reviews Immunology. 10(5):301-316, May (60) Provisional application No. 61/576,727, filed on Dec. 5, 2010.* 16, 2011, provisional application No. 61/576,922, Worledge KL, et al. Digestive Diseases and Sciences. 45(12): 2298 filed on Dec. 16, 2011. 2305, Dec. 1, 2000.* Berdoz J, et al. Proc. Natl. Acad. Sci. 96(6):3029-3034, Mar. 16, (51) Int. Cl. 1999.* C07K 6/24 (2006.01) Ma J K-C et al. Science. 268:716–719, May 5, 1995.* CI2N 5/82 (2006.01) Paul, WE. Fundamental Immunology, 3rd ed. Raven Press, NY. A6 IK 9/00 (2006.01) Chap. 9, pp. 292-295, 1993.* Rudikoff S. et al. Proc. Natl. Acad. Sci. USA, 7.9:1979-1983, 1982.* A6 IK 39/00 (2006.01) Colman, PM. Research in Immunology, Elsevier, NY, 145(1):33-36, (52) U.S. Cl. 1994.* CPC ........... C07K 16/241 (2013.01); A61K 9/0053 (Continued) (2013.01); C07K 16/244 (2013.01): CI2N 15/8258 (2013.01); A61 K 39/00 (2013.01); Primary Examiner — Robert Landsman A6 IK 2039/505 (2013.01); A61 K 2039/54 (74) Attorney, Agent, or Firm — Sterne Kessler Goldstein (2013.01); C07K 2317/13 (2013.01); C07K & Fox 231 7/24 (2013.01); C07K 2317/41 (2013.01); C07K 231 7/565 (2013.01); C07K 2317/76 (57) ABSTRACT (2013.01) A monoclonal secretory IgA antibody, which binds to and (58) Field of Classification Search neutralizes a human proinflammatory cytokine or which CPC ................. A61K 9/0053: A61K 39/00; A61 K binds to and blocks a human proinflammatory cytokine 2309/505; A61K 2309/54; C07K 16/241: receptor. The secretory IgA antibody is useful in treating a C07K 2317/13; C07K 2317/24: CO7K variety of inflammatory diseases in humans. 2317/41; C07K 2317/76; C07K 2317/565 See application file for complete search history. 24 Claims, 29 Drawing Sheets US 9,573.996 B2 Page 2 (56) References Cited Journal of Immunology 152(11):5299-5304, American Association of Immunologists, United States (1994). Corthesy, B., “Recombinant Immunoglobulin A: Powerful Tools for FOREIGN PATENT DOCUMENTS Fundamental and Applied Research.” Trends in Biotechnology EP 13096.92 B1 5, 2009 20(2):65-71. Elsevier Science Publishers, England (2002). EP 1313769 B2 11/2011 Cox, K.M., et al., “Glycan Optimization of a Human Monoclonal EP O783.893 B1 4/2012 Antibody in the Aquatic Plant Lemna Minor,” Nature Biotechnol EP 1776142 B3 6, 2015 ogy 24(12): 1591-1597, Nature America Publishing, United States WO WO-8907452 A1 8, 1989 (2006). WO WO-92.16553 A1 10, 1992 Dechant, M. and Valerius, T., “IgA Antibodies for Cancer Therapy.” WO WO-9222653 A1 12, 1992 Critical Reviews in Oncology/Hematology 39(1-2):69-77. Elsevier WO WO-972.91.31 A1 8, 1997 Science Ireland, Ireland (2001). WO WO-994.9024 A2 9, 1999 Dechant, M., et al., "Chimeric IgA Antibodies Against Hla Class II WO WO-2005.007699 A2 1, 2005 Effectively Trigger Lymphoma Cell Killing.” Blood 100(13):4574 WO WO-2005035768 A1 4/2005 WO WO-2007028106 A2 3, 2007 4580, American Society of Hematology, United States (2002). WO WO-2007084672 A2 7/2007 Dechant, M., et al., “Effector Mechanisms of Recombinant IgA WO WO-2007084922 A2 7/2007 Antibodies Against Epidermal Growth Factor Receptor,” Journal of WO WO-2007084926 A2 7/2007 Immunology 179(5):2936-2943, American Association of Immu WO WO-2007 124186 A2 11/2007 nologists, United States (2007). WO WO-2009086003 A1 T 2009 Durocher, Y, et al., “High-level and High-throughput Recombinant WO WO-2011/047238 A1 4, 2011 Protein Production by Transient Transfection of Suspension-grow WO WO 2011/047328 * 4, 2011 ing Human 293-EBNA1 Cells.” Nucleic Acids Research 30(2):E9, WO WO-2012162367 A1 11 2012 Oxford University Press, England (2002). WO WO-2013O87912 A1 6, 2013 Favre, L.I., et al., “Simplified Procedure to Recover Recombinant WO WO-2013O87913 A1 6, 2013 Antigenized Secretory IgA to be Used as a Vaccine Vector,” Journal WO WO-2013O87914 A1 6, 2013 of Chromatography. B 786(1-2): 143-151, Elsevier, Netherlands (2003). OTHER PUBLICATIONS Fernandes, D., “Demonstrating Comparability of Antibody Glycosylation During Biomanufacturing.' 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