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(12) United States Patent (10) Patent No.: US 8,119,101 B2 Byrd Et Al

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(12) United States Patent (10) Patent No.: US 8,119,101 B2 Byrd Et Al USOO8119101B2 (12) United States Patent (10) Patent No.: US 8,119,101 B2 Byrd et al. (45) Date of Patent: *Feb. 21, 2012 (54) ANTI-CD74 IMMUNOCONJUGATES AND is: A 9. 3. Shih,etaCe al. METHODS OF USE 4,816,567 A 3/1989 Cabilly et al. 4,824,659 A 4, 1989 Hawth (75) Inventors: John C. Byrd, Columbus, OH (US); 4,916,213. A 4/1990 Nial. David M. Goldenberg, Mendham, NJ 4,918,163 A 4/1990 Young et al. SS Hans J. Hansen, Picayune, MS 4,932,4124,925,922 A 6/19905/1990 GoldenbergByers et al. (US) 4.946,778 A 8, 1990 Ladner et al. 5,057,313 A 10, 1991 Shih et al. (73) Assignees: The Ohio State University, Columbus, 5,106,955 A 4, 1992 Endo et al. OH (US); Immunomedics, Inc., Morris 5,134,075 A 7, 1992 Hellstrom et al. Plains, NJ (US) 5,171,665 A 12/1992 Hellstrom et al. s 5,196,337 A 3, 1993 Ochi et al. (*) Notice: Subject to any disclaimer, the term of this 3.299 A 232 slet al. patent is extended or adjusted under 35 5.443,953 A 8, 1995 Hansen et al. U.S.C. 154(b) by 0 days. 5,484,892 A 1/1996 Tedder et al. 5,525,338 A 6/1996 Goldenber This patent is Subject to a terminal dis- 5,565,215. A 10/1996 Grefet g claimer. 5,567,610 A 10, 1996 Borrebaecket al. 5,593,676 A 1/1997 Bhat et al. (21) Appl. No.: 12/789,575 5,618,920 A 4/1997 Robinson et al. 5,620,708 A 4/1997 Amkraut et al. (22) Filed: May 28, 2010 5,633,425 A 5/1997 Lonberg et al. (Continued) (65) Prior Publication Data US 2010/0272636A1 Oct. 28, 2010 FOREIGN PATENT DOCUMENTS EP O332865 9, 1989 Related U.S. Application Data (Continued) (63) Continuation-in-part of application No. 10/706,852, filed on Nov. 12, 2003, now Pat. No. 7,829,064, which OTHER PUBLICATIONS is a continuation-in-part of application No. 10/314,330, filed on Dec. 9, 2002, now Pat No. Hertlein et al. (Blood, 2010, 116 2554-2558)." 7,837,995, which is a continuation of application No. (Continued) 09/965,796, filed on Oct. 1, 2001, now Pat. No. 7.910,103, which is a continuation of application No. 09/307,816, filed on May 10, 1999, now Pat. No. Primary Examiner — Peter J Reddig 6,306,393, said application No. 10/706,852 is a Assistant E iner — Yan Xiao continuation-in-part of application No. 10/350,096, SSIS OF EXCFlife filed on Jan. 24, 2003, which is a continuation of (74) Attorney, Agent, or Firm — Richard A. Nakashima application No. 09/590,284, filed on Jun. 9, 2000, now Pat. No. 7,074,403, said application No. 10/706,852 is a continuation-in-part of application No. 10/377,122, (57) ABSTRACT filed on Mar. 3, 2003, now Pat. No. 7,312,318. Disclosed are compositions that include anti-CD74 immuno (60) Provisional application No. 61/265,999, filed on Dec. conjugates and optionally a therapeutic and/or diagnostic 2, 2009, provisional application No. 607478,830, filed agent. In preferred embodiments, the immunoconjugates on Jun. 17, 2003, provisional application No. comprise one or more anti-CD74 antibodies or antigen-bind 60/360,259, filed on Mar. 1, 2002. ing fragments thereof, conjugated to a liposome or micelle. 51) Int. C Also disclosed are methods for preparing the immunoconju (51) 39/44 (2006.01) gates and using the immunoconjugates in diagnostic and A6 IK5I/2 (2006.015 therapeutic procedures. In certain preferred embodiments, A 6LX 9/27 (200 6,015 the therapeutic methods comprise administering to a subject A6 IK39/00 (2006.015 with a CD74-expressing disease an anti-CD74 immunocon (52) U.S. Cl 424/1 21. 424f1 78.1: 424/179.1: jugate and thereby inducing apoptosis of CD74-expressing Oa - - - - - - - - - - - - - - - - - - - - - 434,450. 424/180 i. 424/182 cells. In more preferred embodiments, the CD74 immuno (58) Field of Classification search • us None conjugate is capable of inducing cell death in the absence of See application file for complete search history. any other therapeutic agent, although Such agents may be optionally administered prior to, together with or Subsequent (56) References Cited to administration of the anti-CD74 immunoconjugate. The compositions may be part of a kit for administering the anti U.S. PATENT DOCUMENTS CD74 immunoconjugates or compositions. 4,036,945 A T. 1977 Haber 4,046,722 A 9, 1977 Rowland 4.331,647 A 5/1982 Goldenberg 34 Claims, 11 Drawing Sheets US 8,119,101 B2 Page 2 U.S. PATENT DOCUMENTS Riechmann et al., “Reshaping human antibodies for therapy'. Nature 5,686,072 A 11, 1997 Uhr et al. 332(6162):323-7 (1988). 5,693,762 A 12/1997 Queen et al. 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Saltzman et al., “Transport rates of proteins in porous materials with 6,051,228 A 4/2000 Aruffo et al. 6,051,230 A 4/2000 Thorpe et al. known microgeometry”. Biophys. J. 55 (1):163–71 (1989). 6,077.499 A 6, 2000 Griffiths et al. Sandhu, J. S., “Protein engineering of antibodies'. Crit. Rev. 6,096,289 A 8/2000 Goldenberg Biotechnol. 12(5-6):437-62 (1992). 6,165,440 A 12/2000 Esenaliev Schlom, J. "Monoclonal Antibodies: They're More and Less Than 6,183,744 B1 2/2001 Goldenberg You Think”. Molecular Foundations of Oncology, Broader, S. (Ed.), 6,187,287 B1 2/2001 Leung et al. pp. 95-134 (1991). 6,254,868 B1 7/2001 Leung et al. Sherwood et al., “Controlled antibody delivery systems', 6,306,393 B1 10/2001 Goldenberg 6,331,175 B1 12/2001 Goldenberg Biotechnology 10(11): 1446-9 (1992). 6,379,698 B1 4/2002 Leamon Shih et al., “Site-specific linkage of methotrexate to monoclonal 6,387,350 B2 5/2002 Goldenberg antibodies using an intermediate carrier'. Int J Cancer 41(6):832-9 6,395,276 B1 5/2002 Rybak et al. (1988). 6,530,944 B2 3/2003 West et al. Shih et al., "A fluorouridine-anti-CEA immunoconjugate is therapeu 6,562,318 B1 5, 2003 Filler tically effective in a human colonic cancer xenograft model”, Int. J. 6,653,104 B2 11/2003 Goldenberg 7,074,403 B1 7/2006 Goldenberg et al. Cancer 46(6): 1101-6 (1990). 7,387,779 B2 6, 2008 Kalluri Shih et al., “Internalization and intracellular processing of an anti-B- 7,829,064 B2 * 1 1/2010 Griffiths et al. .............. 424f1.21 cell lymphoma monoclonal antibody, LL2, IntJ Cancer 56(4):538 2002fOO18749 A1 2/2002 Hudson et al. 45 (1994). 2004/0076683 A1 4/2004 Hoarau et al. Shih et al., “Localization of an antibody to CD74 (MHC class II 2004/0197328 A1* 10/2004 Young et al. ............... 424,141.1 invariant chain) to human B cell lymphoma xenografts in nude mice'. 2010/0266496 A1* 10, 2010 Hansen et al. ... 424/1.49 Cancer Immunol. Immunother. 49(4-5):208-16 (2000). 2011/007O155 A1 3f2011 Griffiths et al. .............. 424f1.21 Singer et al., "Optimal humanization of 1B4, an anti-CD18 murine FOREIGN PATENT DOCUMENTS monoclonal antibody, is achieved by correct choice of human V-re EP O510949 10, 1992 gion framework sequences”. J. Immunol. 150(7):2844-57 (1993). WO 91.13974 9, 1991 Stein et al., “Epitope specificity of the anti-(B cell lymphoma) WO 94.27638 12/1994 monoclonal antibody, LL2, Cancer Immunol. Immunother. WO 95099.17 4f1995 37(5):293-8 (1993). WO 96,04925 2, 1996 Straubinger et al., “Endocytosis and intracellular fate of liposomes WO 98/.42378 10, 1998 using pyranine as a probe'. Biochemistry 29 (20):4929-39 (1990). WO 98.50435 11, 1998 Tatsuta et al., “Diagnosis of gastric cancers with fluorescein-labeled WO 99/O2567 1, 1999 monoclonal antibodies to carcinoembryonic antigen'. Lasers Surg. WO 99.54440 10, 1999 Med. 9(4):422-6 (1989). WO OO/29584 5, 2000 Taylor et al., “A transgenic mouse that expresses a diversity of human WO OOf 67795 11, 2000 sequence heavy and light chain immunoglobulins'. Nucleic Acids WO OOf 74.718 12/2000 Res. 20023):6287-95 (1992). OTHER PUBLICATIONS Tempest et al., “Reshaping a human monoclonal antibody to inhibit human respiratory syncytial virus infection in vivo”. Biotechnology Dillman (Annals of Internal Medicine, 1989 1 11:592-603).* 9(3):266-71 (1991).
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