REFERENCES CONSIDERED BY PROFESSOR LEONARD
`
`Exhibit No.
`
`Description
`
`U.S. Patent No. 6,407,213, Method for making humanized
`antibodies (filed Jul. 17, 1993) (issued June 18, 2002)
`
`Ball E.D., et al. Studies on the ability of monoclonal antibodies to
`selectively mediate complement-dependent cytotoxicity of human
`myelogenous leukemia blast cells. J. Immunol.128(3):1476-81
`(March 1982)
`
`Ball, E.D ., et al. Monoclonal antibodies reactive with small cell
`carcinoma of the lung. J. Nat’l Cancer Inst. 72(3):593-598
`(March 1984)
`
`Magnani, J.L., Ball, E.D., et al. “Monoclonal antibodies PMN 6,
`PMN 29 and PM-81 bind differently to glycolipids containing a
`sugar sequence occurring in lacto-N-fucopentaose III, “ Arch.
`Biochem. Biophys. 233(2):501-506 (September 1984)
`
`Memoli, V.A., Jordan, A.G., and Ball, E.D. A novel monoclonal
`antibody, SCCL 175, with specificity for small cell
`neuroendocrine carcinoma of the lung. Cancer Res. 48:7319-
`7322 (December 15, 1988)
`
`Ball E.D., et al. Monoclonal antibodies to myeloid differentiation
`antigens: in vivo studies of three patients with acute myelogenous
`leukemia. Blood 62(6):1203-1210 (December 1983)
`
`Ball E.D., et al. Phase I clinical trial of serotherapy in patients
`with acute myeloid leukemia with an immunoglobulin M
`monoclonal antibody to CD15. Clin Cancer Res 1:965-972
`(September1995)
`
`Bashey A., Ball E.D., et al. CTLA4 Blockade with Ipilimumab to
`Treat Relapse of Malignancy after Allogeneic Hematopoietic Cell
`Transplantation. Blood 113(7): 1581-1588 (2009)
`
`Arm and P., Ball E.D., et al. Disabling Immune Tolerance by
`Programmed Death-1 Blockade with Pidilizumab after
`
`1001
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`1012
`
`
`
`84 of 89
`
`Celltrion, Inc., Exhibit 1004B
`
`
`
`Exhibit No.
`
`Description
`
`U.S. Patent No. 6,407,213, Method for making humanized
`antibodies (filed Jul. 17, 1993) (issued June 18, 2002)
`
`Ball E.D., et al. Studies on the ability of monoclonal antibodies to
`selectively mediate complement-dependent cytotoxicity of human
`myelogenous leukemia blast cells. J. Immunol.128(3):1476-81
`(March 1982)
`
`Ball, E.D ., et al. Monoclonal antibodies reactive with small cell
`carcinoma of the lung. J. Nat’l Cancer Inst. 72(3):593-598
`(March 1984)
`
`Magnani, J.L., Ball, E.D., et al. “Monoclonal antibodies PMN 6,
`PMN 29 and PM-81 bind differently to glycolipids containing a
`sugar sequence occurring in lacto-N-fucopentaose III, “ Arch.
`Biochem. Biophys. 233(2):501-506 (September 1984)
`
`Memoli, V.A., Jordan, A.G., and Ball, E.D. A novel monoclonal
`antibody, SCCL 175, with specificity for small cell
`neuroendocrine carcinoma of the lung. Cancer Res. 48:7319-
`7322 (December 15, 1988)
`
`Ball E.D., et al. Monoclonal antibodies to myeloid differentiation
`antigens: in vivo studies of three patients with acute myelogenous
`leukemia. Blood 62(6):1203-1210 (December 1983)
`
`Ball E.D., et al. Phase I clinical trial of serotherapy in patients
`with acute myeloid leukemia with an immunoglobulin M
`monoclonal antibody to CD15. Clin Cancer Res 1:965-972
`(September1995)
`
`Bashey A., Ball E.D., et al. CTLA4 Blockade with Ipilimumab to
`Treat Relapse of Malignancy after Allogeneic Hematopoietic Cell
`Transplantation. Blood 113(7): 1581-1588 (2009)
`
`Arm and P., Ball E.D., et al. Disabling Immune Tolerance by
`Programmed Death-1 Blockade with Pidilizumab after
`
`1001
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`1012
`
`
`
`84 of 89
`
`Celltrion, Inc., Exhibit 1004B
`
`
`
`Exhibit No.
`
`1013
`
`1014
`
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`
`
`
`
`Description
`Autologous Hematopoietic Stem-Cell Transplantation for Diffuse
`Large B-Cell Lymphoma: Results of an International Phase II
`Trial. J. Clin. Oncol. 31(33):4199-4206 (November 20, 2013)
`
`Ball E.D., et al. Initial trial of bispecific antibody-mediated
`immunotherapy of CD15-bearing tumors: cytotoxicity of human
`tumor cells using a bispecific antibody comprised of anti-CD15
`(MoAb PM81) and anti-CD64/Fc gamma RI (MoAb 32). J.
`Hematotherapy 1:85-94 (1992)
`
`Chen J, Zhou J.H., Ball E.D. Monocyte-mediated lysis of acute
`myeloid leukemia cells in the presence of the bispecific antibody
`251 x 22 (anti-CD33 x anti-CD64). Clin. Can. Res. 1:1319-
`1325(November 1995)
`
`Balaian, L. and Ball, E.D. Direct effect of bispecific anti-CD33 x
`anti-CD64 antibody on proliferation and signaling in myeloid
`cells. Leukemia Res. 25:1115-1125 (2001)
`
`Chen J., Ball, E.D., et al. An immunoconjugate of Lys3-bombesin
`and monoclonal antibody 22 can specifically induce FcgammaRI
`(CD64)-dependent monocyte- and neutrophil-mediated lysis of
`small cell carcinoma of the lung cells. Clin. Can. Res. 1:425-434
`(April1995)
`
`Chen J., Ball, E.D., et al. Monocyte- and neutrophil-mediated
`lysis of SCCL by a bispecific molecule comprised of Lys3-BN and
`mAb22. Peptides 1994. 819-820(1995)
`
`Zhou J.H., Ball E.D., et al. Immunotherapy of a human small cell
`lung carcinoma (SCLC) xenograft model by the bispecific
`molecule (BsMol) mAb22xLys3-Bombesin (M22xL-BN). Peptides
`1996, 935936 (1998)
`
`Ball, E.D. and Balaian, L. Cytotoxic activity of gemtuzumab
`ozogamicin (Mylotarg) in acute myeloid leukemia correlates with
`the expression of protein kinase Syk. Leukemia, 20:2093-
`2101(2006)
`
`2
`
`85 of 89
`
`Celltrion, Inc., Exhibit 1004B
`
`
`
`Exhibit No.
`
`1020
`
`1021
`
`1022
`
`1023
`
`1024
`
`1025
`
`1026
`
`1027
`
`1028
`
`
`
`
`Description
`
`Ball E.D., et al. Update of a phase I/II trial of 5-azacytidine prior
`to gemtuzumab ozogamicin (GO) for patients with relapsed acute
`myeloid leukemia with correlative biomarker studies [abstract].
`Blood (ASH Annual Meeting Abstracts) 116: Abstract 3286
`(2010)
`
`Hudziak et al. p185HER2 Monoclonal Antibody Has
`Antiproliferative Effects In Vitro and Sensitizes Human Breast
`Tumor Cells to Tumor Necrosis Factor. Mol. Cell Biol. 9(3):
`11651172 (March 1989)
`
`Kohler and Milstein, Continuous Cultures of Fused Cells
`Secreting Antibody of Predefined Specificity. Nature
`256(5517):495-497 (August 7, 1975)
`
`Prabakaran, S. The Quest for a Magic Bullet Science,
`349(6246):389 (July 24, 2015)
`
`Marks, L. The story of Cesar Milstein and Monoclonal
`Antibodies:
`A Healthcare Revolution in the Making “ at
`http://www.whatisbiotechnology.org/exhibitions/milstein (last
`accessed September 08, 2015)
`
`Cosimi et al., Treatment of Acute Renal Allograft Rejection with
`OKT3 Monoclonal Antibody. Transplantation 32:535-539 (1981)
`
`Ortho Multicenter Transplant Study Group, A Randomized
`Clinical Trial of OKT3 Monoclonal Antibody for Acute Rejection
`of Cadveric Renal Transplants. N. Engl. J. Med. 313(6):337-342
`(August 8, 1985)
`
`Jafferset al. Monoclonal Antibody Therapy. Anti-idiotypic and
`Non-anti-idiotypic antibodies to OKT3 Arising Despite Intense
`Immunosuppression. Transplantation 41(5):572-578 (1986)
`
`Searset al. Phase-I clinical trial of monoclonal antibody in
`treatment of gastrointestinal tumours. The Lancet 762-765 (April
`3, 1982)
`
`3
`
`86 of 89
`
`Celltrion, Inc., Exhibit 1004B
`
`
`
`Exhibit No.
`
`Description
`
`1029
`
`1030
`
`1031
`
`1032
`
`1033
`
`1034
`
`1035
`
`1036
`
`1037
`
`1038
`
`
`
`
`Sikora Monoclonal antibodies in oncology. J. Clin. Pathol.
`35:369375 (1982)
`
`Ball E.D., et al. Studies on the ability of monoclonal antibodies to
`selectively mediate complement-dependent cytotoxicity of human
`myelogenous leukemia blast cells. J. Immunol. 128(3): 1476-
`1481(March 1982).
`
`Morrison et al., Chimeric Human Antibody Molecules: Mouse
`Antigen-Binding Domains with Human Constant Region
`Domains. Pro. Nat’l Acad. Sci. 81:6851-6855 (November 1984).
`
`Liu et al., Chimeric Mouse-human IgG1 Antibody that can
`Mediate Lysis of Cancer cells. Pro. Nat’l Acad. Sci. 84:3439-
`3443 (May 1987).
`
`Joneset al. Replacing the Complementarity-Determining Regions
`in a Human Antibody with those from a Mouse. Nature 321: 522-
`525 (1986)
`
`Queen et al. A Humanized Antibody that Binds to the Interleukin
`2 Receptor. Pro. Nat’l Acad. Sci. 86:10029-10033 (1989)
`
`Kirkman et al., Early Experience with anti-Tac in Clinical Renal
`Transplantation. Transplant. Proc. 21:1766-1768 (1989)
`
`Waldmann et al. The Interleukin-2 Receptor: A Target for
`Monoclonal Antibody Treatment of Human T-Cell
`Lymphotrophic Virus I-Induced Adult T-Cell Leukemias. Blood
`72:1705-1716 ( 988)
`
`Hakimi et al. Reduced Immunogenicity and Improved
`Pharmacokinetics of Humanized anti-Tac in Cynomolgus
`Monkeys. J. Immunol. 147:1352-1359 (August 15, 1991)
`
`Vincenti et al., Interleukin 2-Receptor Blockade with Daclizumab
`to Prevent Acute Rejection in Renal Transplantation. N. Engl. J.
`Med. 338(3): 161-165 (January 15, 1998)
`
`4
`
`87 of 89
`
`Celltrion, Inc., Exhibit 1004B
`
`
`
`Exhibit No.
`
`Description
`
`1039
`
`1040
`
`1041
`
`1042
`
`1043
`
`1044
`
`1045
`
`1046
`
`1047
`
`SEER Stat Fact Sheets: Breast Cancer at
`http://seer.cancer. gov/statfacts/html/breast.html (last accessed
`September 08, 2015)
`
`Harris, J.R., et al. Medical Progress: Breast Cancer. N. Engl. J.
`Med. 327(5):319-328 (1992)
`
`King C.R., Kraus M.H., and Aaronson, S.A. Amplification of a
`Novel v- erbB-Related Gene in a Human Mammary Carcinoma.
`Science 229:974-976 (1985)
`
`Semba K., et al. A v-erbB-related protooncogene, c-erbB-2, is
`distinct from the c-erbB-1/epidermal growth factor-receptor gene
`and is amplified in a human salivary gland adenocarcinoma. Pro.
`Nat’l Acad. Sci. 82:6497-6501 (1985)
`
`Coussens L., et al. Tyrosine kinase receptor with extensive
`homology to EGF receptor shares chromosomal location with
`neu oncogene. Science 230:1132-1139 (December 6, 1985)
`
`Fukushige S., et al. Localization of a Novel v-erbB-Related Gene,
`c-erbB-2, on Human Chromosome 17 and its Amplification in a
`Gastric Cancer Cell Line. Mol. Cell. Biol. 6:955-958 (1986)
`
`Slamon, D.J. et al. Human Breast Cancer Correlation of Relapse
`and Survival with Amplification of the HER-2/neu Oncogene.
`Science 235:177-182 (1987)
`
`Kraus, M.H., et al. Overexpression of the EGF receptor-related
`proto-oncogene erbB-2 in human mammary tumor cell lines by
`different molecular mechanisms. The EMBO Journal 6(3):605-
`610 (1987)
`
`Hudziak, R. M., et al. Increased expression of the putative
`growth factor receptor p185HER2 causes transformation and
`tumorigenesis ofNIH3T3 cells. Pro. Nat’l Acad. Sci. 84:7159-
`7163 (1987)
`
`1048
`
`Shepard, H. M. et al. Monoclonal Antibody Therapy of Human
`
`
`
`
`5
`
`88 of 89
`
`Celltrion, Inc., Exhibit 1004B
`
`
`
`Exhibit No.
`
`Description
`Cancer: Taking the HER2 Protooncogene to the clinic. Journal of
`Clinical Immunology, 11(3): 117-127 (1991).
`
`1068
`
`1093
`
`Verhoeyen, Milstein & Winter et al. Reshaping Human
`Antibodies: Grafting an Antilysozyme Activity. Science 239:1534-
`1536 (March 25, 1988)
`
`Morin, Michael J. From Oncogene to Drug: Development of
`Small Molecule Tyrosine Kinase Inhibitors as Anti-tumor and
`Anti-angiogenic agents. Oncogene 19:6574- 6583 (2000)
`
`6
`
`
`
`
`
`
`89 of 89
`
`Celltrion, Inc., Exhibit 1004B
`
`
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