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(12) United States Patent (10) Patent No.: US 9,494,587 B2 Goletz Et Al

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(12) United States Patent (10) Patent No.: US 9,494,587 B2 Goletz Et Al USOO9494.587B2 (12) United States Patent (10) Patent No.: US 9,494,587 B2 Goletz et al. (45) Date of Patent: Nov. 15, 2016 (54) MICROORGANISMS OR FRACTIONS (56) References Cited THEREOF CAPABLE OF ACTIVATING CELLULAR IMMUNITY AGAINST U.S. PATENT DOCUMENTS CARBOHYDRATES 4,931.275 A 6/1990 Shinitzky et al. 5,506,343 A 4/1996 Kufe (75) Inventors: Steffen Goletz, Glienicke-Nordbahn 5,547.933 A 8, 1996 Lin (DE); Philippe Ulsemer, Berlin (DE): 5,683,674. A 11/1997 Taylor-Papadimitriou et al. Anja Löffler, Schorfheide (DE) 5,739,277 A 4/1998 Presta et al. 5,804,187 A 9, 1998 do Couto et al. 5.948,646 A 9, 1999 Srivastava (73) Assignee: Glycotope GmbH, Berlin (DE) 5,961,979 A 10/1999 Srivastava 6,168,793 B1 1/2001 Srivastava (*) Notice: Subject to any disclaimer, the term of this 6,315,997 B1 1 1/2001 do Couto et al. patent is extended or adjusted under 35 6,984,384 B1 1/2006 Subjeck et al. U.S.C. 154(b) by 1438 days. 7,268,120 B1 9/2007 Horton et al. 7,595,192 B2 * 9/2009 Goletz et al. ................. 435/325 (21) Appl No.: 12A514,248 8,017,388 B2 * 9/2011 Goletz et al. ...... 435/325 9 8,088,357 B2 * 1/2012 Goletz et al. ................ 424,149 8,592,165 B2 11/2013 Goletz et al. (22) PCT Filed: Nov. 12, 2007 8,609,370 B2 * 12/2013 Goletz et al. ................ 435/69.1 8,642,276 B2 * 2/2014 Goletz et al. .................. 435/71 (86). PCT No.: PCT/EP2007/009766 8,741,365 B2 6/2014 Goletz et al. 371 1 2002/0132771 A1 9/2002 Madiyalakan S (c)(1). 2004/0265998 A1 12/2004 Goletz et al. (2), (4) Date: Nov. 25, 2009 2005, 0187378 A1 8, 2005 Kim 2005/020301.0 A1 9, 2005 Kim (87) PCT Pub. No.: WO2008/055703 2006/O127419 A1 6/2006 Goletz et al. 2006/025 1668 A1 11/2006 Goletz et al. PCT Pub. Date: May 15, 2008 2006/0292129 A1 12/2006 Goletz et al. O O 2007, OO15239 A1 1/2007 Bihoreau et al. (65) Prior Publication Data 2007/0016704 A1 1/2007 Harari et al. US 201O/O158952 A1 Jun. 24, 2010 (Continued) (30) Foreign Application Priority Data FOREIGN PATENT DOCUMENTS Nov. 10, 2006 (EP) ..................................... O6090208 DE 4329004 3, 1995 Nov. 10, 2006 (EP) ..................................... O6090209 EP O 117 060 A2 8, 1984 (Continued) (51) Int. Cl. A2.3L I/30 (2006.01) GOIN 33/569 (2006.01) OTHER PUBLICATIONS A6 IK 39/00 (2006.01) Goletz, Glycobiology, Nov. 2011, 21/11:1524 abstract only.* A6 IK 39/02 (2006.01) (Continued) C07K 6/30 (2006.01) CI2N L/20 (2006.01) CI2R I/OI (2006.01) CI2R L/19 (2006.01) Primary Examiner — Nita M Minnifield GOIN 33/50 (2006.01) (74) Attorney, Agent, or Firm — Nelson Mullins Riley & (52) U.S. Cl. Scarborough LLP; Jane E. Remillard, Esq.; Jill Gorny CPC ....... G0IN 33/56972 (2013.01); A23L I/3014 Sloper, Esq. (2013.01); A61K 39/00II (2013.01); A61 K 39/02 (2013.01); C07K 16/3092 (2013.01); CI2N 1/20 (2013.01); CI2R I/01 (2013.01); (57) ABSTRACT CI2R 1/19 (2013.01); G0IN 33/5058 (2013.01); G0IN 33/569 II (2013.01); A61 K The present invention relates to the field of prevention and 2039/5152 (2013.01); A61 K 2039/5154 treatment of tumors and gastrointestinal disorders. The pres (2013.01); A61 K 2039/5158 (2013.01); A61 K ent invention relates to the prevention and treatment of 2039/52 (2013.01); A61 K 2039/521 (2013.01); Core-1-positive carcinomas. The invention relates to coreot A6 IK 2039/522 (2013.01); A61 K 2039/54 ics and a method of producing the same and to a method of (2013.01); A6 IK 2039/542 (2013.01); A61 K prevention and treatment of core-1 positive disorders using 2039/57 (2013.01); C07K 2317/73 (2013.01); the same. The invention relates to microorganisms or frac G0IN 2400/00 (2013.01); G0IN 24.69/20 tions thereof capable of activating cellular immunity against (2013.01) carbohydrates. (58) Field of Classification Search None See application file for complete search history. 15 Claims, 20 Drawing Sheets US 9,494,587 B2 Page 2 (56) References Cited Bagshawe et al., “Antibody-Directed Enzyme Prodrug Terapy (ADEPT) for Cancer.” Expert Opin Biol Ther. vol. 4, No. 11, U.S. PATENT DOCUMENTS 1777-1789 (2004). Baumeister, “A novel expression system for production of higher 2008, 0226681 A1 9, 2008 Goletz et al. active biotherapeutics with optimised glycosylation.” PharmaChem, 2010, 0028947 A1 2/2010 Goletz et al. 5(4): 21-24 (2006). 2010/0158952 A1* 6, 2010 Goletz ....................... 424,243.1 Baumeister et al. "GlycoExpress: a novel expression system for the 2010/0303837 A1* 12/2010 Goletz et al. .............. 424,184.1 2011/0129570 A1* 6, 2011 Goletz ............................ 426,61 optimal glycosylation of biotherapeutics.” Specialty Chemicals 2012/O128676 A1* 5, 2012 Goletz et al. 424,137.1 Magazine, (25): 46-48 (2005). 2012/0149877 A1* 6, 2012 Goletz et al. .. 530,387.3 Benoist, H. et al., “Studies on the susceptibility to NK-meidated 2014/0302093 A1* 10, 2014 Goletz et al. .............. 424,234.1 lysis and the simultaneous expression of various Surface molecules in anthracyclin-treated K562 cell clones.” Immunology Letters, vol. FOREIGN PATENT DOCUMENTS 34, Issue 1, 45-55 (1992). Berd, “Autologous hapten-modified melanoma vaccine as postSur EP 1 167 537 A1 1, 2002 gical adjuvant treatment after resection of nodal metastases,” J. EP 1920.781 * 5/2008 Clin. Oncol., 15:2359-2370 (1997). EP 1920.781 A1 * 5, 2008 Berthier-Vergnes, “Induction of IgG Antibodies Directed to a M. WO WO92, 15682 9, 1992 31,000 Melanoma Antigenin Patients Immunized with Vaccinia WO WO 93,20841 10, 1993 Virus Melanoma Oncolysates,” Cancer Res. 54:2433-2439 (1994). WO WO 94,29469 12/1994 Binder, "Cutting Edge: Heat Shock Protein gp96 Induces Matura WO WO 97/OO957 1, 1997 tion and Migration of CD11c Cells In Vivo, J. Immunol. WO WO 97,30087 A1 8, 1997 WO WO 97/40182 10, 1997 165:6029-6035 (2000). WO WO 99.29834 6, 1999 Boel et al., “Functional Human Monoclonal Antibodies of All WO WOOO,52135 9, 2000 Isotypes Constructed from Phage Display Library-Derived Single WO WO O1? 12217 2, 2001 Chain Fv Antibody Fragments,” J. Immunological Methods, 239, WO WO O2/44217 6, 2002 153-166 (2000). WO WO O3,O16329 2, 2003 Böhm et al., “Carbohydrate Recognition on MUC1-Expressing WO WO O3,O23023 3, 2003 Targets Enhances Cytoxicity of a T cell Subpopulation'. Scandina WO WO O3,035636 5, 2003 vian Journal of Immunology, vol. 46, No. 1 pp. 27-34. WO WO 03/044051 A1 5, 2003 XP-002323.076 (1997). WO WO 04/OO9632 1, 2004 Bomford et al., “The control of the antibody isotype responses to WO WO 04/O18659 3, 2004 recombinant human immunodeficiency virus gp 120 antigen by WO WO 04/050707 6, 2004 adjuvants.” AIDS Res. Hum. Retroviruses, 8:1765 et seq. (1992). WO 2005/OO3773 A1 1, 2005 Bonig et al. "Glycosylated vs non-glycosylated granulocyte colony WO WO 2005/O16962 A2 2, 2005 WO WO 2005/017130 A2 2, 2005 stimulating factor (G-CSF)—results of a prospective randomized WO WO 2005/040221 A1 5, 2005 monocentre study.” Bone Marrow Trans. 25: 259-264 (2001). WO WO 2005/080585 A1 9, 2005 Bourdon, “Inhibition of Tumoral Graft Growth by Pretreatment WO WO 2005,1084.23 A1 11, 2005 with Normal or Heat-modified Tumoral Cells.” Ann. Immunology WO WO 2006/O12616 A2 2, 2006 1, 43-63 (1981). WO WO 2008/028686 A2 3, 2008 Brechbiel et al., “Synthesis of 1-(p-isothiocyanatobenzyl) Deriva WO WO 08/O55702 5, 2008 tives of DTPA and EDTA. Antibody Labeling and Tumor-Imaging WO WO 2008/O55703 A2 5, 2008 Studies.” Inorg. Chem., 25, 2772-2781 (1986). WO WO 2208/O55703 A2 * 5, 2008 Brummelkamp, et al. “A System for Stable Expression of Short WO WO 2013/026887 A1 * 2/2013 Interfering RNAs in Mammalian Cells”. Science, vol. 296, pp. 550-553, (2002). OTHER PUBLICATIONS Burgess et al., “Possible Dissociation of the Heparin-Binding and Mitogenic Activities of the Heparin-Binding (Acidic Fibroblast) Goletz et al. Glycobiology, Nov. 2011, 21/11:1525 abstract only.* Growth Factor-1 from its Receptor Binding Activities by Site Matsumoto-Takasaki et al. BioScience Trends. 2009; 3(3):87-95.* Directed Mutagenesis of a Sinale lvsine Residue.” Journal of Cell Ravn et al. Cancer Immunol Immunother (2007) 56:1345-1357.* Biology, vol. 111, pp. 2129-2138, 1990. Bain et al. PLoS One, Sep. 2011, 6/9: e25007, 10 pages.* Cao, “Immunodetection of epithelial mucin (MUC1, MUC3) and Goletz et al. 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