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(12) United States Patent (10) Patent No.: US 8,501,198 B2 Gunn (45) Date of Patent: Aug

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(12) United States Patent (10) Patent No.: US 8,501,198 B2 Gunn (45) Date of Patent: Aug US008501 198B2 (12) United States Patent (10) Patent No.: US 8,501,198 B2 Gunn (45) Date of Patent: Aug. 6, 2013 (54) TISSUE TARGETED ANTIGENIC W SS 12: ACTIVATION OF THE IMMUNE RESPONSE TO TREAT CANCERS WO 201OO68413 6, 2010 OTHER PUBLICATIONS (75) Inventor: Harold David Gunn, Vancouver (CA) Erb et al., JNucl MedTechnol, 2000, 28(1): 12-18.* (73) Assignee: Qu Biologics Inc., British Columbia Brunda et al., Cancer Research, 1980, 40:3211-3213. Fenton et al., JNatl Cancer Inst, 1995, 87(24): 1853-1861.* (CA) Cosenza et al., Am. Surg., 1999, 65(3): 218-21.* Radford et al., Gene Therapy, 2002, 9:1455-1463.* (*) Notice: Subject to any disclaimer, the term of this Beuth J. Braun JM. Modulation of murine tumor growth and coloni patent is extended or adjusted under 35 Zation by bromelaine, an extract of the pineapple plant (Ananas U.S.C. 154(b) by 241 days. comosum) In Vivo Mar.-Apr. 2005; 19(2):483-5. Cole WH. Spontaneous regression of cancer and the importance of (21) Appl. No.: 12/843,296 finding its cause. NCI Monogr. 1976; 44.5-9. Comeri GC, Belvisi P. Conti G. Cretarola E. Duvia R. Furgoni R. (22) Filed: Jul. 26, 2010 Gianneo E. Radice GP. Role of BCG in T 1G3 bladder transitional cell carcinoma (TCC): our experience. Arch Urol Ital Androl Feb. 1996; (65) Prior Publication Data 68(1):55-9. US 2011 FOO2O4O1 A1 Jan. 27, 2011 Daum SM, Seidman H. et al. Mortality experience of a cohort of cotton textile workers. Final progress report on Contract No. HSM 99-72-71 (NIOSH), Mar. 1, 1975. Davidson SS. Carcinoma and malaria. Br. Med J 1902; 1:77. Related U.S. Application Data Eichenwald HF, McCracken Jr GH. Acute diarrheal disease. Med (63) Continuation-in-part of application No. 12/234,569, ClinNAm 1970:54:443-54. filed on Sep.19, 2008, now Pat. No. 8,034,359, which Enterline PE, Sykora JL, et al. Endotoxins, cotton dust and cancer. is a continuation-in-part of application No. Lancet 1985:2:934-5. 1 1/553,972, filed on Oct. 27, 2006, now abandoned, Friedman Hetal (1987): Distinctive immunomodulatory effects of which is a continuation-in-part of application No. endotoxin and nontoxic lipopolysaccharide derivatives in lymphoid PCT/CA2005/000812, filed on May 30, 2005, said cell cultures J Biol Response Mod 6(6):664-77. application No. 12/234,569 is a continuation-in-part of Haldane DR. The co-existence of tubercle and cancer. Edinburgh application No. PCT/CA2007/001915, filed on Oct. Med J 1862;8:343-9. 25, 2007. (Continued) (60) Provisional application No. 60/577,206, filed on Jun. 7, 2004. Primary Examiner — Hong Sang (74) Attorney, Agent, or Firm — Bozicevic, Field & Francis (51) Int. Cl. LLP: Bret E. Field; Shweta Chandra A6 IK39/08 (2006.01) (52) U.S. Cl. (57) ABSTRACT USPC ....................................................... 424/257.1 The invention provides in part methods of treating cancers of (58) Field of Classification Search a specific organ or tissue by administering a composition that None is antigenically specific for one or more microbes that are See application file for complete search history. pathogenic in the specific organ or tissue in which the cancer is situated. The formulations of the invention thereby facili (56) References Cited tate activation of an immune response to a cancer in a par ticular tissue or organ. The compositions may for example U.S. PATENT DOCUMENTS include killed or attenuated microbial pathogens, such as 3,928,565 A 12/1975 Homma et al. whole killed bacterial cells, and may be administered at sites 4.329,452 A 5/1982 Maruyama distant from the cancer, for example the skin. In some 4,880,626 A 11, 1989 McMichael 5,652,332 A 7/1997 Little, II embodiments, microbial species of endogenous flora that are 5,869,057 A * 2/1999 Rock .......................... 424,192.1 known to cause infection in the relevant organ or tissue may 6,348,586 B1 2/2002 Chang et al. be used in the formulation of the antigenic compositions. In 6,902,743 B1 6, 2005 Setterstrom et al. alternative embodiments, exogenous microbial pathogens 2002/0044948 A1* 4/2002 Khleifet al. ............... 424,234.1 2003/0073628 A1* 4/2003 Shailubhai et al. ............. 514/12 that are known to cause infection in the relevant organ or 2006, O147477 A1* 7, 2006 Cabezon Silva et al. 424,277.1 tissue may be used in the formulation of the antigenic com 2007/0134264 A1 6, 2007 Marshall positions. The administration of the immunogenic composi tions may be repeated relatively frequently over a relatively FOREIGN PATENT DOCUMENTS long period of time. In embodiments for intradermal or sub EP 1415655 5, 2004 cutaneous injection, dosages may be adjusted so that injec WO 9526742 10, 1995 tions reproduce a consistent, visible, delayed inflammatory WO O223994 3, 2002 immune reaction at the Successive site or sites of administra WO WOO3,OO9859 2, 2003 WO O3O49751 6, 2003 tion. WO O3063593 8, 2003 WO WO 2005/099.750 10/2005 20 Claims, 21 Drawing Sheets US 8,501,198 B2 Page 2 (56) References Cited Barreda DR. Hanington PC, Belosevic M. Regulation of myeloid development and function by colony stimulating factors. Dev Comp OTHER PUBLICATIONS Immunol 2004:28:509. Beaman BL, Moring SE, Ioneda T. Effect of growth stage on mycolic Hewitt JA, Mokbel K et al. Exercise for breast cancer Survival: the acid structure in cell walls of Nocardia asteroides GUH-2. Journal of effect on cancer risk and cancer-related fatique. IntJ Fertill Womens Bacteriology 1988: 170(3): 1137-1142. Med Sep.-Oct. 2005:50(5 Pt 1):231-9. Behr MA, WilsonMA. Gill WPetal. 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