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9504742.Pdf (2.885Mb) US009504742B2 a2) United States Patent (10) Patent No.: US 9,504,742 B2 Dickeyetal. (45) Date of Patent: Nov. 29, 2016 (54) COMPOSITIONS FOR STIMULATION OF 5,238,944 A 8/1993 Wick et al. veces 514/293 MAMMALIAN INNATE IMMUNE 5,266,575 A 11/1993 Gerster et al. .. .. 514/293 5,268,376 A 12/1993. Gester ......... .. 514/293 RESISTANCE TO PATHOGENS 5,346,905 A 9/1994. Gerster vce .. 514/293 (71) Applicant: The Board of Regents, The University 5,352,784 A 10/1994 Nikolaides etal. .. 544/126 of Texas System.ystem, Austin, , TX (US)(US 5,389,640 A 2/1995 Gerster et al. we 514/293 TX 5,395,937 A 3/1995 Nikolaides et al. ........... 546/82 (72) Inventors: Burton Dickey, Houston, TX (US); oaee13s A wyee Metzgeretal. eee eno ta Michael‘.Tuvim, Houston, TX (US);. 5,494,916’ 5 A 2/1996 Lindstromatton et al.et al........sss.... 514/303. Scott Evans, Houston, TX (US) 5,525,612 A 6/1996 Gerster veeeecceccee 514/293 (73) Assignee: THE BOARD OF REGENTS, THE Cees wt y7000 Meet GE AL nnoaeoe UNIVERSITY OF TEXAS SYSTEM, 6.039.969 A 3/2000 Tomai et al. 2... 424/434 Austin, TX (US) 6,066,447 A 5/2000 De Mesmaekeretal. ....... 435/5 6,110,929 A 8/2000 Gerster et al. oo... 514/293 (*) Notice: Subject to any disclaimer, the term of this 6,214,806 BL 4/2001: Krieg et al. ose 514/44 patent is extended or adjusted under 35 eat BI tt Rae ‘ at ve ve aaad e 239, ieg etal. .... bee U.S.C. 154(b) by 0 days. 6,288,042 Bl 9/2001 Rando et al. we... 514/44 A 6,294,177 Bl 9/2001 Fattom ............ 424/243.1 (21) Appl. No.: 14/862,884 6,331,539 Bl 12/2001 Crooks et al. .. .. 514/228.5 6,339,068 Bl 1/2002 Krieg et al. .... _.. 514/44 R (22) Filed: Sep. 23, 2015 6,406,705 Bl 6/2002 Davis etal. .... » 424/278.1 6,429,199 BL 8/2002. Krieg et al. sevens 514/44 . att 6,451,810 Bl 9/2002 Coleman etal. 1. 514/293 (65) Prior Publication Data 6,488,953 B2 12/2002 Halliday et al. oo... 424/434 US 2016/0074508 Al Mar. 17, 2016 6,517,839 Bl 2/2003 Modlin et al. .. .. 424/190.1 6,534,062 B2 3/2003 Razetal. ....... 424/193.1 wg 6,552,006 B2 4/2003 Razetal. ........... we 514/44 R Related U.S. Application Data 6.727.230 BL 4/2004 Hutchersonet al. ....... 514/44 R riot ‘cati 6,737,045 B2 5/2004 Patton et al. we 424/46 (62) acoionNOobontheaun 6,794,357 Bl 9/2004. Edman et al. .. ve S14ITA 2 A011, DOW Fal. INO. 751 OO, WAC 18 & OIVISION 6,797,258 B2 9/2004 Platz et al. occ: 424/45 of application No. 13/259,761, filed as application No. PCT/US2010/028658 on Mar. 25, 2010, now Pat. FOREIGN PATENT DOCUMENTS No. 8,883,174. oe fo. EP 1 550 458 7/2005 (60) Provisional application No. 61/179,246, filed on May EP 1 707 232 8/2010 18, 2009, provisional application No. 61/163,137, (Continued) filed on Mar. 25, 2009. (51) Int. Cl. OTHER PUBLICATIONS AGIK 39/39 (2006.01) Abuchowskiet al., “Effect of covalent attachment of polyethylene AGIK 9/00 (2006.01) glycol on immunogenicity and circulating life of bovine liver A61K 45/06 (2006.01) catalase,” J. Biol. Chem., 252:3582-6, 1977. AGIK 38/08 (2006.01) Adachiet al., “Targeted disruption ofthe MyD88generesults in loss AGIK 31/7125 (2006.01) aa and IL-18- mediated function ,” Immunity, 9:143-150, A6ILK 39/00 (2006.01) Akinbi et al., “Bacterial killing is enhanced by expression of (52) U.S. Cl. lysozyme in the lungs of transgenic mice,” J. Immunol., CPC we A6LK 39/39 (2013.01); A6LK 9/0078 165(10):5760-6, 2000. (2013.01); AIK 31/7125 (2013.01); A6IK Sitaot Boe.Tens.31,3837-42.3003 receptor signaling,” 38/08 (2013.01); A6LK 45/06 (2013.01); AOIK Aliprantis et al., “Cell activation and apoptosis by bacterial lipo- 2039/54 (2013.01); AOIK 2039/55516 proteins through toll-like receptor-2,” Science, 285:736-739, 1999. (2013.01); AGLK 2039/55561 (2013.01) Apidianakis et al., “Profiling early infection responses: . .. Pseudomonasaeruginosa eludes host defenses by suppressing anti- (58) Field of Classification Search microbial peptide gene expression,” Proc. Natl. Acad. Sci. U.S.A., None 102:2573-2578, 2005. See application file for complete search history. (Continued) (56) References Cited Primary Examiner — Oluwatosin Ogunbiyi (74) Attorney, Agent, or Firm — Norton Rose Fulbright U.S. PATENT DOCUMENTS US LLP 57 ABSTRACT 3,608,066 A 9/1971. Mlartein ccccccccccccecees aoaigg 7) : .: . 4,406,889 A 9/1983 Hartmann etal. 514/23 Embodiments of the invention are directed to methods of 4,406,890 A 9/1983 Taresay et al. ...... 514/20.9 treating, inhibiting or attenuating a microbial infection in an t4g04s A along eo sre teesneeees aus individual who has or is at risk for developing such an 4,666,886 A 5/1987 Baschanget al. ... 514/17 infection, comprising the step of administering an effective 1 eee3x ‘ 5 tony cittanen we ae3S amount of a StIR composition to the individual. ;; erster ..... 4,929,624 A 5/1990 Gerster et al. 0. 514/293 12 Claims, 20 Drawing Sheets US 9,504,742 B2 Page 3 (56) References Cited 2009/0163532 Al 6/2009 Perman et al... 514/293 2009/0163533 Al 6/2009 Hayset al. ...... .. 514/293 U.S. PATENT DOCUMENTS 2009/0169529 Al 7/2009 Hartmann et al. 424/93.21 2009/0176696 Al 7/2009 Mills et al. oo... 514/1.1 2006/01889 13 Al 8/2006 Krieg et al. oe. 435/6.16 2009/0176821 Al 7/2009 Kshirsagar et al. .......... 514/293 2006/0211644 Al 9/2006 Krieg et al. .... 514/44 A 2009/0191188 Al 7/2009 Krieg et al. ..... 424/130.1 2006/0217328 Al 9/2006 Kandimalla et al. ....... 514/44 A 2009/0208468 Al 8/2009 Klinman et al. .. 424/93.7 2006/0229271 Al 10/2006 Krieg et alo 514/44 R 2009/0214578 Al 8/2009 Bauer etal. ..... 424/184.1 2006/024 1076 Al 10/2006 Uhlmann etal. 514/44 R 2009/0220528 Al 9/2009 Turka et al. ..... vw 424/173.1 2006/0246035 Al 11/2006 Ahluwalia et al. ws. 424/85.7 2009/0253695 Al 10/2009 Kshirsagar et al. » 514/232.8 2009/0263405 Al 10/2009 Verthelyi etal. ... 424/184.1 2006/0286070 Al 12/2006 Hartmann etal. .. 424/85.7 2006/0287263 Al 12/2006 Davis et al. .... 514/44 A 2009/0306017 Al 12/2009 Kuritz et al. .... .. 514/106 2009/0306177 Al 12/2009 Uhlmannetal. ........... 514/44 A = 2006/0292179 Al 12/2006 Ducatelle et al. 424/234.1 2007/0004654 Al 1/2007 Raz et alo ee 514/43 2009/0311277 Al 12/2009 Krieg et al. ww... 424/184.1 2007/0009482 A9 1/2007 Krieg et al. 424/93.2 2009/0318337 Al 12/2009 Lowell et al. ... we SL4/1.1 2007/00 10470 A9 1/2007 Krieg et alo 514/44 R 2009/0324639 Al 12/2009 Lowell et al. 424/206.1 2007/0026018 Al 2/2007 Ellis et al. ww. 424/234.1 2007/0037767 Al 2/2007 Bratzler et al . 514/44 A FOREIGN PATENT DOCUMENTS 2007/0049550 Al 3/2007 Fearon et al. .. 514/44 R 2007/0066553 Al 3/2007 Krieg et al. 514/44 R WO WO 94/06498 3/1994 2007/0066554 Al 3/2007 Krieg et al. 514/44 R WO WO 94/08552 4/1994 2007/0078104 Al 4/2007 Krieg et al. 514/44 A WO WO 94/16970 8/1994 2007/0129320 A9 6/2007 Davis et al. .... 514/44 R WO WO 97/25086 TN997 2007/01423 15 Al 6/2007 Forsbachet al. 514/44 A WO WO 98/16427 4/1998 2007/0167409 Al 7/2007 Chow et al. .... .. 514/80 WO WO 98/35888 8/1998 2007/0179103 Al 8/2007 Agrawal et al. 514/44 A WO WO 98/55495 12/1998 2007/0184465 Al 8/2007 Wagneret al. 435/6.16 WO WO 02/46189 6/2002 2007/0202128 Al 8/2007 Krieg et al. .... 424/234.1 WO WO 02/46192 6/2002 2007/0219153 Al 9/2007 Kandimalla et al. ....... 514/44 R WO WO 03/035695 5/2003 2007/02242 10 Al 9/2007 Krieg et al. wc. 424/185.1 WO WO 2003/06799 1 8/2003 2007/0232622 Al 10/2007 Lipford et al. .. 514/258.1 WO WO 2008/085549 7/2008 2008/0009455 A9 1/2008 Krieg et al. .... 514/44 R 2008/003 1936 Al 2/2008 Krieg et al. .... we 424/450 2008/0045473 Al 2/2008 Uhlmann et al... 514/44 R OTHER PUBLICATIONS 2008/0070907 Al 3/2008 Griesgraber et al. ...... $14/230.2 Bafika et al., “Cutting edge: TLR9 and TLR2 signaling together 2008/0089883 Al 4/2008 Kandimalla et al. ...... 424/130.1 account for MyD88-dependent control of parasitemia in 2008/0113929 Al 5/2008 Lipford et al. ........ 514/44 A Trypanosoma cruzi infection,” J Immunol, 177:3515-3519, 2006. 2008/0114019 Al 5/2008 Kshirsagar et al... 514/293 Bals and Hiemstra, “Antimicrobial peptides in COPD—hasicbiol- 2008/0124366 Al 5/2008 Ohlfest et al.
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