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(12) United States Patent (10) Patent No.: US 7,605,138 B2 Krieg (45) Date of Patent: Oct

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(12) United States Patent (10) Patent No.: US 7,605,138 B2 Krieg (45) Date of Patent: Oct USOO7605138B2 (12) United States Patent (10) Patent No.: US 7,605,138 B2 Krieg (45) Date of Patent: Oct. 20, 2009 (54) NUCLEICACID COMPOSITIONS FOR 6,589,940 B1 7/2003 Raz et al. STMULATING IMMUNE RESPONSES 6,610,308 B1 8, 2003 Haensler 6,610,661 B1 8, 2003 Carson et al. (75) Inventor: Arthur M. Krieg, Wellesley, MA (US) 6,653,292 B1 1 1/2003 Krieg et al. 6,727,230 B1 4/2004 Hutcherson et al. (73) Assignee: Coley Pharmaceutical Group, Inc., 6,749,856 B1 6/2004 Berzofsky et al. New York, NY (US) 6.821,957 B2 11/2004 Krieg et al. 6,835,395 B1 12/2004 Semple et al. (*) Notice: Subject to any disclaimer, the term of this 6,852,705 B2 2/2005 Audonnet et al. patent is extended or adjusted under 35 6,943,240 B2 9, 2005 Bauer et al. U.S.C. 154(b) by 732 days. 6,949,520 B1 9, 2005 Hartmann et al. 7,001,890 B1 2/2006 Wagner et al. (21) Appl. No.: 10/613,524 7,223,741 B2 5/2007 Krieg 7,271,156 B2 9/2007 Krieg et al. (22) Filed: Jul. 3, 2003 7.303,881 B2 12/2007 Huang et al. 7,354,711 B2 4/2008 Macfarlane (65) Prior Publication Data 7,354,909 B2 4/2008 Klinman et al. 7,402,572 B2 7/2008 Krieg et al. US 2004/O19868O A1 Oct. 7, 2004 7,410,975 B2 8/2008 Lipford et al. 2001/0044416 A1 11/2001 McCluskie et al. Related U.S. Application Data 2002fOO64515 A1 5/2002 Krieg et al. (60) Provisional application No. 60/394,091, filed on Jul. 3, 2002/0065236 A1 5, 2002 Yew et al. 2002. 2002/009 1097 A1 7/2002 Bratzler et al. 2002fO142977 A1 10/2002 Raz et al. (51) Int. Cl. 2002fO151518 A1 10/2002 Agrawal et al. AOIN 43/04 (2006.01) 2002fO156033 A1 10/2002 Bratzler et al. AOIN 25/08 (2006.01) 2002fO164341 A1 11/2002 Davis et al. A 6LX 9/52 (2006.01) 2002fO165178 A1 11/2002 Schetter et al. A6 9/22 (2006.01) C7H 2L/04 (2006.01) C7H 2L/02 (2006.01) (Continued) C7H 2L/00 (2006.01) FOREIGN PATENT DOCUMENTS A6 IK3I/70 (2006.01) (52) U.S. Cl. ....................... 514/44; 536/23.1536/25.3: EP 1 187629 A2 10, 2000 536/25.6; 424/408; 424/409: 424/422; 424/430; 424/450; 424/457; 424/468; 424/490 (Continued) (58) Field of Classification Search ....................... None See application file for complete search history. OTHER PUBLICATIONS (56) References Cited Agrawal et al. Trends in Molecular Medicine, 2002, 8/3:114-121.* Gura Scddience vol. 270 p. 575-577, 1995.* U.S. PATENT DOCUMENTS Chatterjee et al. Cancer Immunol. Immunother, 1994, 38:75-82.* 4,806.463. A 2f1989 Goodchild et al. Gramzinski et al. Infection and Immunity, Mar. 2001, p. 1643-1649.* 5,004,810 A 4/1991 Draper Mechanisms of Microbial Diseases 3rd edition, edited by Moselio et 5,166,195 A 11/1992 Ecker al. 1999, p. XV-XVI.* 5, 194428 A 3/1993 Agrawal et al. Agrawal et al., Medicinal chemistry and therapeutic potential of CpG 5,264,423 A 11/1993 Cohen et al. DNA. Trends Mol Med. Mar. 2002:8(3): 114-21. 5,276,019 A 1/1994 Cohen et al. Askew et al., CpG DNA induces maturation of dendritic cells with 5,416.203 A 5/1995 Letsinger distinct effects on nascent and recycling MHC-II antigen-processing 5,663,153 A 9, 1997 Hutcherson et al. mechanisms. J Immunol. Dec. 15, 2000; 165(12):6889-95. 5,723,335 A 3, 1998 Hutcherson et al. 5,780,448 A 7, 1998 Davis (Continued) 6,030,955 A 2/2000 Stein et al. 6,194,388 B1 2/2001 Krieg et al. Primary Examiner Robert B Mondesi 6,207,646 B1 3/2001 Krieg et al. Assistant Examiner Oluwatosin Ogunbiyi 6,214,806 B1 4/2001 Krieg et al. (74) Attorney, Agent, or Firm Wolf, Greenfield & Sacks, 6,218,371 B1 4/2001 Krieg et al. P.C.; Gregg C. Benson 6,221,882 B1 4/2001 Macfarlane 6,239,116 B1 5/2001 Krieg et al. (57) ABSTRACT 6,339,068 B1 1/2002 Krieg et al. 6,399,630 B1 6, 2002 Macfarlane 6,406,705 B1 6, 2002 Davis et al. The invention provides an immunostimulatory nucleic acid 6,429,199 B1 8/2002 Krieg et al. comprising CpG motifs, and methods of use thereof in stimu 6.479,504 B1 1 1/2002 Macfarlane et al. lating immunity. 6,521,637 B2 2/2003 Macfarlane 6,558,670 B1 5, 2003 Friede et al. 50 Claims, 9 Drawing Sheets US 7,605,138 B2 Page 2 U.S. PATENT DOCUMENTS 2005, 0004061 A1 1/2005 Krieg et al. 2005/0004062 A1 1/2005 Krieg et al. 2002/0168340 Al 1 1/2002 Agrawal 2005, 0004144 A1 1/2005 Carson et al. 2002/0192184 A1 12/2002 Carpentier et al. 2005/OOO9774 A1 1/2005 Krieg et al. 2002fO1981.65 A1 12/2002 Bratzler et al. 2005, OO13812 A1 1/2005 Dow et al. 2003/0026782 A1 2/2003 Krieg et al. 2005/001934.0 A1 1/2005 Garcon et al. 2003/0026801 A1 2/2003 Weiner et al. 2005/0031638 A1 2/2005 Dalemans et al. 2003, OO32443 A1 2/2003 Johnson et al. 2005/OO32734 A1 2/2005 Krieg et al. 2003/0050261 A1 3/2003 Krieg et al. 2005/0032736 A1 2/2005 Krieg et al. 2003/0050263 A1 3/2003 Krieg et al. 2005/0037403 A1 2/2005 Krieg et al. 2003/0050268 A1 3/2003 Krieg et al. 2005/0037985 A1 2/2005 Krieg et al. 2003/0055014 A1 3/2003 Bratzler 2005/OO38239 A1 2/2005 Catchpole 2003/0087848 A1 5, 2003 Bratzler et al. 2005.0043529 A1 2/2005 Davis et al. 2003/009 1599 A1 5, 2003 Davis et al. 2005.00492.15 A1 3/2005 Krieg et al. 2003/0100527 A1 5/2003 Krieg et al. 2005/0049216 A1 3/2005 Krieg et al. 2003/0104523 A1 6/2003 Bauer et al. 2005/0054601 A1 3/2005 Wagner et al. 2003/01 19773 A1 6, 2003 Raz et al. 2005/0054602 A1 3/2005 Krieg et al. 2003/O125279 A1 7/2003 Junghans et al. 2005/00596.19 A1 3/2005 Krieg et al. 2003/0129605 A1 7, 2003 Yu et al. 2005/0059625 A1 3/2005 Krieg et al. 2003/0139364 A1 7/2003 Krieg et al. 2005, OO64401 A1 3, 2005 Olek et al. 2003. O14831.6 A1 8/2003 Lipford et al. 2005/0070491 A1 3/2005 Krieg et al. 2003/0148976 A1 8/2003 Krieg et al. 2005.0075302 A1 4/2005 Hutcherson et al. 2003/0166001 A1 9/2003 Lipford 2005, 00791.52 A1 4, 2005 Bot et al. 2003/0176389 A1 9, 2003 Raz et al. 2005, 0100983 A1 5.2005 Bauer et al. 2003. O181406 A1 9, 2003 Schetter et al. 2005/0101554 A1 5/2005 Krieg et al. 2003/019 1079 A1 10/2003 Krieg et al. 2005/0101557 A1 5/2005 Krieg et al. 2003/0212026 A1 1 1/2003 Krieg et al. 2005/01 19273 A1 6/2005 Lipford et al. 2003/0212029 A1 1 1/2003 Agrawal et al. 2005/O123523 A1 6/2005 Krieg et al. 2003/022401.0 A1 12/2003 Davis et al. 2005/0130911 A1 6/2005 Uhlmann et al. 2003/022501.6 A1 12/2003 Fearon et al. 2005/O148537 A1 7/2005 Krieg et al. 2003/0232074 Al 12/2003 Lipford et al. 2005/O159351 A1 7/2005 Grate et al. 2003/0232443 A1 12/2003 Bennett et al. 2005, 0169888 A1 8/2005 Hartmann et al. 2003/0232856 All 12/2003 MacFarlane 2005/0171047 A1 8/2005 Krieg et al. 2004/0006010 A1 1/2004 Carson et al. 2005/0181422 A1 8/2005 Bauer et al. 2004/OOO6034 A1 1/2004 Raz et al. 2005/O182017 A1 8/2005 Krieg 2004/0009949 A1 1/2004 Krieg 2005/01973 14 A1 9/2005 Krieg et al. 2004/00301 18 A1 2/2004 Wagner et al. 2005/0209.184 A1 9, 2005 Klinman et al. 2004/0038922 A1 2, 2004 Haensler et al. 2005/0215500 A1 9/2005 Krieg et al. 2004/0047869 A1 3f2004 Garcon et al. 2005/0215501 A1 9/2005 Lipford et al. 2004/0053880 A1 3/2004 Krieg 2005/0233.995 A1 10/2005 Krieg et al. 2004, OO67902 A9 4/2004 Bratzler et al. 2005/0233999 A1 10/2005 Krieg et al. 2004/0067905 A1 4/2004 Krieg 2005/0239732 A1 10/2005 Krieg et al. 2004/0076905 A1 4/2004 Yagihashi et al. 2005/0239.733 A1 10, 2005 Jurk et al. 2004/0087534 A1 5/2004 Krieg et al. 2005/0239734 A1 10, 2005 Uhlmann et al. 2004/0087538 A1 5/2004 Krieg et al. 2005/023973.6 A1 10/2005 Krieg et al. 2004/0092468 A1 5, 2004 Schwartz 2005/0244379 A1 1 1/2005 Krieg et al. 2004/0092472 A1 5/2004 Krieg 2005/0244380 A1 1 1/2005 Krieg et al. 2004/0106568 A1 6/2004 Krieg et al. 2005/0245477 A1 1 1/2005 Krieg et al. 2004/O131628 A1 7/2004 Bratzler et al. 2005/0250726 A1 1 1/2005 Krieg et al. 2004/0132685 A1 7/2004 Krieg et al. 2005/0256073 A1 1 1/2005 Lipford et al.
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