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United States Patent (19) 11 Patent Number: 6,090,365 Kaminski Et Al

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United States Patent (19) 11 Patent Number: 6,090,365 Kaminski Et Al US006090365A United States Patent (19) 11 Patent Number: 6,090,365 Kaminski et al. (45) Date of Patent: *Jul.18, 2000 54 RADIOIMMUNOTHERAPY OF LYMPHOMA DeNardo et al., Pilot Studies of Radioimmunotherapy of B USING ANT-CD20 ANTIBODIES Cell Lymphoma and Leukemia Using I-131 Lym-1 Mono clonal Antibody, Antibody, Innunoconjugates, and Radiop 75 Inventors: Mark S. Kaminski, Ann Arbor, Mich.; harmaceuticals, 1 (1):17–33 (1988). Gregory M. Butchko, Miami Lakes; Grossbard, M.L., et al., Monoclonal Antibody-Based Thera Stephan D. Glenn, Davie, both of Fla.; pies of Leukemia and Lymphoma, Blood, 80 (4) :863–878 Richard L. Wahl, Ann Arbor, Mich. (Aug. 15, 1992). Anderson et al., U.S. Serial No. 07/978,891, Filed Nov. 13, 73 Assignees: Coulter Pharmaceutical, Inc., So. San 1992. Francisco, Calif.; Regents of the Anderson et al., U.S. Serial No. 08/149,099, Filed Nov. 3, University of Michigan, Ann Arbor, 1993. Mich. Badger, C.C., et al., Experimental Radioimmunotherapy with I-131-Antibody Against a Differentiation Antigen, J. * Notice: This patent issued on a continued pros Nuclear Med., 26(5):P67 (1985). ecution application filed under 37 CFR Badger, C.C., et al., Experimental Radioimmunotherapy of 1.53(d), and is subject to the twenty year Murine Lymphoma with I-Labeled Anti-T-Cell Anti patent term provisions of 35 U.S.C. bodies, Can. Res., 46:6223–6228 (1986). 154(a)(2). Buchsbaum et al., “Therapy with Unlabeled and 'I-La beled Pan-B-cell Monoclonal Antibodies in Nude Mice 21 Appl. No.: 08/972,900 Bearing Raji Burkitt's Lymphoma Xenografts”, Cancer 22 Filed: Nov. 18, 1997 Research, 52:6476–6481 (1992). Buchsbaum et al., “Improved Delivery of Radiolabeled Related U.S. Application Data Anti-B1 Monoclonal Antibody to Raji Lymphoma Xenografts by Predosing with Unlabeled Anti-B1 Mono 60 Continuation of application No. 08/639,988, Apr. 26, 1996, clonal Antibody”, Cancer Reesarch, 52:637–642 (1992). abandoned, which is a division of application No. 08/121, Czuczman et al., “A Phase 1 Dose Escalation Trial of 582, Sep. 16, 1993, Pat. No. 5,595,721. '''Labeled Monoclonal antibody OKB7 in Patients with B Cell Lymphoma', Fourth Conference on Radioimmunode tection and Radioimmunotherapy of Cancer, Abstract #55 51) Int. Cl." .......................... A61K 51/10; A61K 45/05; (Sep.1992). CO7K 16/00 DeNardo et al., “Fractionated Radioimmunotherapy of B-Cell Malignancies with ''I-Lym-1”, Cancer Research 52 U.S. Cl. .................... 424/1.49; 424/1.53; 424/144.1; (Suppl.), 50:1014s-1016s (Feb. 1990). 424/143.1; 424/154.1; 530/391.3 Eary et al., “Imaging and Treatment of B-Cell Lymphoma' Journal of Nuclear Medicine, 31(8) : 1257–1268 (Aug. 58 Field of Search .................................. 424/1.53, 1.49, 1990). 424/1441, 130.1, 131.1, 143.1, 154.1, 156.1, Eary et al., “Treatment of B-Cell Lymphoma with I-131 1741, 1.69; 530/387.2, 388.22, 391.3 Labelled Murine Monoclonal Antibodies”, Proceedings of the 35th Annual Meeting, Scientific Papers, 29(5) Abstract 56) References Cited 70 (1988). U.S. PATENT DOCUMENTS Ettinger et al., “Phase I-II Study of Isotopic Immunoglo 4.331,647 5/1982 Goldenberg .............................. 424/1.1 bulin Therapy for Primary Liver Cancer Cancer Treatment 4,361,544 11/1982 Goldenberg .............................. 424/1.1 Reports, 66(2):289-297 (Feb. 1982). 4,444,744 4/1984 Goldenberg .............................. 424/1.1 Goldenberg et al., “Targeting, Dosimetry, and Radioimmu 4,472,371 9/1984 Burchiel et al. ... 424/1.49 notherapy of B-Cell Lymphomas With Iodine-131-Labeled 4,724.213 2/1988 Epstein ......... ... 435/240.27 LL2 Monoclonal Antibody”, Journal of Clinical Oncology, 4,735,210 4/1988 Goldenberg. ... 128/654 9(4):548–564 (Apr. 1991). 4,921,690 5/1990 Beatty et al. ... ... 424/1.1 5,034.223 7/1991 Abrams et al. .. ... 424/85.8 (List continued on next page.) 5,120,525 6/1992 Goldenberg.......... ... 424/1.49 5,273.738 12/1993 Matthews et al. ... ... 424/1.49 Primary Examiner Jose G. Dees 5,595,721 1/1997 Kaminski et al. ... ... 424/1.49 Assistant Examiner Michael G. Hartley 5,736,137 4/1998 Anderson et al. ... ... 424/133.1 Attorney, Agent, or Firm-Cooley Godward LLP 5,776,456 7/1998 Anderson et al. ................... 424/133.1 57 ABSTRACT FOREIGN PATENT DOCUMENTS O 669 836 B1 9/1995 European Pat. Off.. Methods for the treatment of lymphoma by administration of WO 92/07466 5/1992 WIPO ............................ AO1N 33/20 a B cell-specific antibody are described. The invention WO 94/11026 5/1994 WIPO. encompasses providing to a patient both unlabeled antibod ies and antibodies labeled with a radioisotope. A principal OTHER PUBLICATIONS advantage of the method is that tumor responses can be Appelbaum, F.R., Radiolabeled Monoclonal Antibodies in obtained in a radiometric dose range that does not require the Treatment of Non-Hodgkin's Lymphoma, Hematology/ hematopoietic Stem cell replacement as an adjunct therapy. Oncology Clinics of North America, 5 (5):1013–1025 (Oct. 1991). 18 Claims, 7 Drawing Sheets 6,090,365 Page 2 OTHER PUBLICATIONS Order et al., “Phase I-II Study of Radiolabeled Antibody Kaminski et al., “Radioimmunotherapy of B-Cell Lym Integrated in the Treatment of Primary Hepatic Malignan phoma with ''I)Anti-B1 (Anti-CD20) Antibody”, New cies”, Int. J. Radiation Oncology Biol. Phys., 6:703–710 England Journal of Medicine, 329:459–465 (Aug. 1993). (1980). Kaminski et al., “Initial Clinical Radioimmunotherapy Parker et al., “Radioimmunotherapy of Human B-Cell Lym Results with 131-I-Anti-B1 (Anti CD20) Refractory phoma with 'Y-Conjugated Antiidiotype Monoclonal Anti B-Cell Lymphoma', Fourth Conference on Radioimmuno body”, Cancer Research, (Suppl.) 50:1022s-1028s (Feb. detection and Radioimmunotherapy of Cancer, Abstract #57 (Sep.1992). 1990). Kaminski et al., “131-I Anti-B1: Initial Clinical Evaluation Press et al., “Treatment of Refractory Non-Hodgkin's Lym in B-Cell Lymphoma', Third Conference On Radioimmu phoma With Radiolabeled MB-1 (Anti-CD37) Antibody", nodetection and Radioimmunotherapy of Cancer, Abstract Journal of Clinical Oncology, 7(8): 1027-1038 (Aug. 1989). No. 144 (Nov. 1990). Letvin et al., “Use of Radiolabeled Monoclonal Anti-B1 Press et sl., “Monoclonal Antibody IF5 (Anti-CD20) Sero Antibody for B Lymphocyte Imaging in Rhesus Monkeys”, therapy of Human B Cell Lymphomas’, Blood, 69:584-591 Nucl. Med. Biol., 14(2):99-105 (1987). (1987). Macklis et al., “Induction of Programmed Cell Death in Press et al., “Radiolabeled Antibody (RAb) Therapy of Malignant Lymphomas After Radioimmunotherapy”, Relapsed B Cell Lymphomas', Lymphom, Abstract #1077 Fourth Conference on Radioimmunodetection and Radio (Apr. 1992). immunotherapy of Cancer, Abstract #39 (Sep. 1992). Macklis et al., “Cell Cycle Alterations, Apoptosis, and Stashenko et al., “Characterization of a Human B Lympho Response to Low-Dose-Rate Radioimmunotherapy in Lym cyte-Specific Antigen”, Journal of Immunology, 125(4) phoma Cells' Int. J. Radiation Oncology Biol. PhyS., :1678–1685 (Oct. 1980). 27:643-650 (1993). Macklis et al., “Radiobiologic Basis of Lymphoma Weinstein et al., “Monoclonal Antibodies in the Lymphatics: Radio-Immunotherapy”, Radiation Oncology Biol. Phys., Toward the Diagnosis and Therapy of Tumor Metastases”, vol. 24, Supplement 1, p. 184, Abstract #101 (1992). Science, 218:1334–1337 (Dec. 1982). Order, "Monoclonal Antibodies: Potential Role in Radiation “Immunomedics Reports on Lymphoma Imaging and Therapy and Oncology”, Int. J. Radiation Oncology Biol. Therapy Progress at Cancer Conference”, New Jersey, Can Phys., 8(7): 1193–1201 (1982). cer Research Weekly (1993). U.S. Patent Jul.18, 2000 Sheet 1 of 7 6,090,365 A U.S. Patent Jul.18, 2000 Sheet 2 of 7 6,090,365 U.S. Patent Jul.18, 2000 Sheet 3 of 7 6,090,365 FG.2A U.S. Patent Jul.18, 2000 Sheet 4 of 7 6,090,365 FG.2C U.S. Patent Jul.18, 2000 Sheet 5 of 7 6,090,365 FG. 3A COOH O2N NH2 p-NO2-Phe STEP HC MeOH O 2 OCH3C NH2HCI me-p-NO2-Phe STEP 2 TEACH3 H2N NH2 O H(CH3) H3(H) - O2N NH NH2 NH2 p-NO2-Bz-2-oxo-methyl-diethylenetriomine STEP3 BHTHF HC H(CH3) CH3(H) /-Q O2 N NH NH 2 -3HC NH2 p-NO2-BZ-methyl-diethylenetriomine STEP4 Br KOH ( COOH U.S. Patent Jul.18, 2000 Sheet 6 of 7 6,090,365 FG. 3B H(CH3) CH3(H) on-Y)- NCOOH COOH} COOH COOH COOH p-NO2-Bz- methyl-DTPA H2 STEP 5 PC/C pHIO H(CH3) CH3(H) N go Y N 1 o COOH COOH COOH p-NH2-Bz-methyl-DTPA S STEP 6 /V C Cl pH 8.5 H(CH3) CH3(H) so-YY(c. COOH COOH> COOH OOH OOH p-SCN-BZ- methyl-DTPA U.S. Patent Jul.18, 2000 Sheet 7 of 7 6,090,365 (6IQO)Þ8 (OZOO)|8 (2200)28§§ qÔI 28(IZOO) 6,090,365 1 2 RADIOMMUNOTHERAPY OF LYMPHOMA In light of these findings, it is worth considering whether USING ANT-CD20 ANTIBODIES leSS restricted antigens on lymphoid tumor cells might be appropriate targets for therapy. In general, anti-tumor effects CROSS REFERENCE TO RELATED of antibodies against Such antigens have only been modest. APPLICATIONS Patients with chronic lymphocytic leukemia (CLL) and cutaneous T-cell lymphomas, for instance, have been treated This application is a Continuation of U.S. application Ser. with the T101 antibody which binds a 65 Kd glycoprotein No. 08/639,988, filed Apr. 26, 1996, now abandoned, which present on malignant and Some normal T-cells (7). Transient is a Divisional of application Ser. No. 08/121,582, filed Sep.
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