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(12) United States Patent (10) Patent No.: US 7,393,534 B2 Aylsworth Et Al

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(12) United States Patent (10) Patent No.: US 7,393,534 B2 Aylsworth Et Al USOO7393534B2 (12) United States Patent (10) Patent No.: US 7,393,534 B2 Aylsworth et al. (45) Date of Patent: Jul. 1, 2008 (54) COMPOSITIONS AND METHODS FOR 5,821,047 A 10, 1998 Garrard et al. MMUNOTHERAPY OF CANCER AND 5,969,108 A 10/1999 McCafferty et al. NFECTIOUS DISEASES 6,001,363 A 12/1999 Tomley et al. (75) Inventors: Charles Aylsworth, Holt, MI (US); 6,008,342 A 12/1999 Binger et al. Siu-Cheong Ho, East Lansing, MI (US); 6,100,241 A 8, 2000 Kok et al. David Juckett, East Lansing, MI (US); 6,331415 B1 1 1/2001 Lind John W. Judge, Holt, MI (US); Igor V. 6,407,213 B1 6/2002 Carter et al. Zlatkin, Lansing, MI (US); Tatiana 6,451,984 B1 9/2002 Lillehoi et al. Zlatkin, Lansing, MI (US) 6,528,485 B1 3/2003 Veronese et al. (73) Assignee: Barros Research Institute, Holt, MI (US) (*) Notice: Subject to any disclaimer, the term of this FOREIGN PATENT DOCUMENTS patent is extended or adjusted under 35 EP 239.400 A2 9, 1987 U.S.C. 154(b) by 0 days. EP 519596 A1 12, 1992 (21) Appl. No.: 10/892,659 EP 592106 A1 4f1994 WO WO 86,05807 A1 6, 1987 (22) Filed: Jul. 15, 2004 WO WO 89.01.036 A1 2, 1989 WO WO90,02809 A1 3, 1990 (65) Prior Publication Data WO WO91f10737 A1 7, 1991 US 2005/O169935A1 Aug. 4, 2005 WO WO91f10741 A1 7, 1991 WO WO92/04461 3, 1992 Related U.S. Application Data WO WO92,06180 A1 4f1992 (60) Provisional application No. 60/487.336, filed on Jul. WO WO 91.01134 A1 10, 1992 15, 2003. (51) Int. Cl. A6 IK 38/00 (2006.01) (Continued) A6 IK 39/00 (2006.01) (52) U.S. Cl. ......................................... 424/185.1: 514/2 OTHER PUBLICATIONS (58) Field of Classification Search ................ 435/69.7; Aliberti et al. (2003), "Molecular mimicry of a CCR5 binding 424/185.1: 514/2 clomain in the microbial activation of dendritic cells”. Nature Immu See application file for complete search history. nology 4(5): 485-490. (56) References Cited (Continued) U.S. PATENT DOCUMENTS Primary Examiner Karen Cochrane Carlson 4,444,887 A 4, 1984 Hoffmann Assistant Examiner—Marsha Tsay 4,716,111 A 12/1987 Osband et al. (74) Attorney, Agent, or Firm Wolf, Greenfield & Sacks, 4,816,397 A 3, 1989 BOSS et al. P.C. 4,816,567 A 3/1989 Cabilly et al. 4,980,286 A 12/1990 Morgan et al. (57) ABSTRACT 5,122,464 A 6, 1992 Wilson et al. 5,223,409 A 6, 1993 Ladner et al. 5,225,539 A 7, 1993 Winter 5,403.484 A 4/1995 Ladner et al. The present invention provides compositions and methods for 5,427,908 A 6, 1995 Dower et al. the prevention and treatment of primary and metastatic neo 5,436,146 A 7, 1995 Shenk et al. plastic diseases and infectious diseases, for stimulating an 5,516,637 A 5/1996 Huang et al. immune response in a Subject, and for use as an alternative to 5,530,101 A 6/1996 Queen et al. interleukin-12 (IL-12) treatment. In particular, the present 5,565,332 A 10/1996 Hoogenboom et al. invention provides Apicomplexa-related proteins (ARPs) that 5,571,698 A 11/1996 Ladner et al. have immune stimulatory activity and thus have uses in the 5,580,717 A 12/1996 Dower et al. treatment and prevention of cancer and infectious diseases 5,585,089 A 12/1996 Queen et al. and in immune modulation. Compositions comprising an 5,658,727 A 8, 1997 Barbas et al. ARP are provided. Methods of use of an ARP for the preven 5,698,426 A 12, 1997 Huse tion and/or treatment of cancer and/or infectious diseases, for 5,733,743 A 3, 1998 Johnson et al. use as an alternative to interleukin-12 (IL-12) treatment, and 5,750,753 A 5, 1998 Kimae et al. for eliciting an immune response in a subject, are also pro 5,766,886 A 6, 1998 Studnicka et al. vided. 5,780,225 A 7/1998 Wigler et al. 5,792,644 A 8, 1998 Vermeulen et al. 5,807,715 A 9, 1998 Morrison et al. 13 Claims, 38 Drawing Sheets US 7,393,534 B2 Page 2 FOREIGN PATENT DOCUMENTS nucleoside Reverse Transcriptase Inhibitor of HIV Type I” AIDS Res. Hum. Retroviruses 1997, 13.9 pp. 789-796. WO WO92, 18619 A1 10, 1992 Burton et al., “Human Antibodies from Combinatorial Libraries” WO WO92/2O316 A2 11/1992 1994, Advances in Immunology 57:191-280. 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