(12) United States Patent (10) Patent No.: US 8,592,165 B2 Goletz Et Al

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(12) United States Patent (10) Patent No.: US 8,592,165 B2 Goletz Et Al US0085921 65B2 (12) United States Patent (10) Patent No.: US 8,592,165 B2 Goletz et al. (45) Date of Patent: Nov. 26, 2013 (54) CARBOHYDRATE SPECIFIC CELLULAR 2007, OO16704 A1 1/2007 Harariet al. MMUNITY INDUCING MICROORGANISMS 2008, 0226681 A1 9, 2008 Goletz et al. 2010, 0028947 A1 2/2010 Goletz et al. AND FRACTIONS THEREOF 2010. O158952 A1 6, 2010 Goletz (75) Inventors: Steffen Goletz, Glienicke-Nordbahn FOREIGN PATENT DOCUMENTS (DE); Philippe Ulsemer, Berlin (DE); Anja Löffler, Schorfheide (DE) DE 4329 004 A1 3, 1995 EP O 117060 A2 8, 1984 (73) Assignee: Glycotope GmbH, Berlin (DE) EP 1167 537 A1 1, 2002 WO WO92, 15682 9, 1992 WO WO93f2O841 A1 10, 1993 (*) Notice: Subject to any disclaimer, the term of this WO WO94,29469 A2 12, 1994 patent is extended or adjusted under 35 WO WO97/OO957 A1 1, 1997 U.S.C. 154(b) by 742 days. WO WO 97.30O87 A1 8, 1997 WO WO 97/40182 A1 10, 1997 WO WO99.29834 A1 6, 1999 (21) Appl. No.: 12/514,200 WO WOOO,52135 9, 2000 WO WOO1? 12217 A1 2, 2001 (22) PCT Filed: Nov. 12, 2007 WO WO O2/44217 A2 6, 2002 WO WOO3,O16329 2, 2003 (86). PCT No.: PCT/EP2007/0097.65 WO WOO3,O23O23 A1 3, 2003 WO WOO3,035636 5, 2003 S371 (c)(1), WO WO 03/044051 A1 5, 2003 (2), (4) Date: Nov. 11, 2009 WO WO 2004/009632 A2 1, 2004 WO WO 2004/O18659 A1 3, 2004 WO WO 2004/050707 A2 6, 2004 (87) PCT Pub. No.: WO2008/055702 WO WO 2005/O16962 A2 2, 2005 PCT Pub. Date: May 15, 2008 WO WO 2005/017130 A2 2, 2005 WO WO 2005/040221 A1 5, 2005 (65) Prior Publication Data WO WO 2005/080585 A1 9, 2005 WO WO 2005,1084.23 A1 11/2005 US 2010/O3O3837 A1 Dec. 2, 2010 WO WO 2006/O12616 A2 2, 2006 WO WO 2008028686 A2 3, 2008 (30) Foreign Application Priority Data WO WO 2008/O55703 A2 5, 2008 OTHER PUBLICATIONS Nov. 10, 2006 (EP) ..................................... O6090208 Nov. 10, 2006 (EP) ..................................... O6090209 Bagshawe, K. et al., “Antibody-Directed Enzyme Prodrug Therapy (ADEPT) for Cancer.” Expert Opinion on Biological Therapy, vol. 4. (51) Int. Cl. No. 11, pp. 1777-1789 (2004). GOIN33/50 (2006.01) Benoist, H. et al., “Studies on the Susceptibility to NK-Mediated (52) U.S. Cl. Lysis and the Simultaneous Expression of Various Surface Molecules USPC ........................................................... 435/7.1 in Anthracyclin-Treated K562 Cells and in Four K562 Cell Clones.” (58) Field of Classification Search Immunology Letters, vol. 34, pp. 45-55 (1992). None Cao, Y. et al., “Expression of CD175 (Tn), CD175s (Sialosyl-Tn) and See application file for complete search history. CD 176 (Thomsen-Friedenreich Antigen) on Malignant Human Hematopoietic Cells.” International Journal of Cancer, vol. 123, pp. (56) References Cited 89-99 (2008). Carbone, M. et al., “Multistep and Multifactorial Carcinogenesis: U.S. PATENT DOCUMENTS When Does a Contributing Factor Become a Carcinogen?” Seminars in Cancer Biology, vol. 14, pp. 399-405 (2004). 4,931,275 A 6/1990 Shinitzky et al. 5,506,343 A 4, 1996 Kufe (Continued) 5,547.933 A 8, 1996 Lin 5,683,674. A 11/1997 Taylor-Papadimitriou et al. Primary Examiner — Brian J Gangle 5,739,277 A 4, 1998 Presta et al. 5,804,187 A 9, 1998 do Couto et al. (74) Attorney, Agent, or Firm — Nelson Mullins Riley & 5,961.979 A 10, 1999 Srivastava Scarborough LLP; Jane E. Remillard, Esq.; Jill Gorny Sloper, 6,168,793 B1 1/2001 Srivastava Esq. 6,315,997 B1 1 1/2001 do Couto et al. 6,984,384 B1 1/2006 Subjecket al. 7,268,120 B1 9, 2007 Horton et al. (57) ABSTRACT 7,595,192 B2 9, 2009 Goletz et al. 8,017,388 B2 9, 2011 Goletz et al. The present invention relates to the field of prevention and 8,088,357 B2 1/2012 Goletz et al. treatment of disorders associated with the occurrence of cer 2002/0132771 A1 9/2002 Madiyalakan tain carbohydrate epitopes. The present invention relates to 2004/0265998 A1 12/2004 Goletz et al. the prevention and treatment of carbohydrate epitope positive 2005/0187378 A1 8, 2005 Kim tumors. The invention relates to formulations and methods for 2005/020301.0 A1 9, 2005 Kim 2006, O127419 A1 6, 2006 Goletz et al. the induction of an effective carbohydrate specific cellular 2006, O251668 A1 11/2006 Goletz et al. immune response. 2006,029.2129 A1 12/2006 Goletz et al. 2007, OO15239 A1 1/2007 Bihoreau et al. 19 Claims, 20 Drawing Sheets US 8,592,165 B2 Page 2 (56) References Cited of TAG Specific Immune Response in Infected Individuals.” Immu nological Investigations, vol. 31, No. 3/4, pp. 191-204 (2002). 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Carcinomas: Role of Tumour-Associated Carbohydrate Antigens.” Melcher, A. et al., “Tumor Immunogenicity is Determined by the Scandinavian Journal of Immunology, vol. 61, No. 5, pp. 391-397 Mechanism of Cell Death Via Induction of Heat Shock Protein (2005). Expression.” Nature Medicine, vol. 4, No. 5, pp. 581-587 (1998). Croce, M.V., et al., “The Use of Carbohydrate Antigens for the Melcher, A. et al., “Apoptosis or Necrosis for Tumor Immunotherapy: Preparation of Vaccines for Therapy in Breast Cancer.” Drugs of What's in a Name?,” Journal of Molecular Medicine, vol. 77, pp. Today, vol. 38, No. 11, pp. 759-768 (2002). 824-833 (1999). Maclean, G.D., et al., “Active Immunization of Human Ovarian Mondovi, B. et al., “Increased Immunogenicity of Ehrlich Ascites Cancer Patients Against a Common Carcinoma (Thomsen Cells. 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