Safety and immunotoxicity assessment of immunomodulatory monoclonal antibodies

References

• St. Clair EW. Novel targeted therapies for autoimmunity. Curr Opin Immunol 2009; 21:648 - 657
   PubMed Web of Science ®Google Scholar
• Genovese MC. Biologic therapies in clinical development for the treatment of rheumatoid arthritis. J Clin Rheumatol 2005; 11:45 - 54
   PubMed Web of Science ®Google Scholar
• Menter A. The status of biologic therapies in the treatment of moderate to severe psoriasis. Cutis 2009; 84:14 - 24
   PubMed Web of Science ®Google Scholar
• Rommer PS, Stüve O, Goertsches R, Mix E, Zettl UK. Monoclonal antibodies in the therapy of multiple sclerosis:an overview. J Neurol 2008; 255:28 - 35
   PubMed Web of Science ®Google Scholar
• Isaacs JD. Therapeutic agents for patients with rheumatoid arthritis and an inadequate response to tumor necrosis factor-alpha antagonists. Expert Opin Biol Ther 2009; 9:1463 - 1475
   PubMed Web of Science ®Google Scholar
• Melero I, Hervas-Stubbs S, Glennie M, Pardoll DM, Chen L. Immunostimulatory monoclonal antibodies for cancer therapy. Nat Rev Cancer 2007; 7:95 - 106
   PubMed Web of Science ®Google Scholar
• Deonarain MP. Recombinant antibodies for cancer therapy. Expert Opin Biol Ther 2008; 8:1123 - 1141
   PubMed Web of Science ®Google Scholar
• Griggs J, Zinkewich-Peotti K. The state of the art: immune-mediated mechanisms of monoclonal antibodies in cancer therapy. Br J Cancer 2009; 101:1807 - 1812
   PubMed Web of Science ®Google Scholar
• Suntharalingam G, Perry MR, Ward S, Brett SJ, Castello-Cortes A, Brunner MD, et al. Cytokine storm in a phase 1 trial of the anti-CD28 monoclonal antibody TGN1412. N Engl J Med 2006; 355:1018 - 1028
   PubMed Web of Science ®Google Scholar
• CDER/FDA. Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers 2005;
   Google Scholar
• EMEA/CHMP. Guideline on Strategies to Identify and Mitigate Risks for First-In-Human Clinical Trials with Investigational Medicinal Products 2007;
   Google Scholar
• Muller PY, Brennan FR. Safety assessment and dose selection for first-in-human clinical trials with immunomodulatory monoclonal antibodies. Clin Pharmacol Ther 2009; 85:247 - 258
   PubMed Web of Science ®Google Scholar
• Muller PY, Milton M, Lloyd P, Sims J, Brennan FR. The Minimum Anticipated Biological Effect Level (MABEL) for selection of first human dose in clinical trials with monoclonal antibodies. Curr Opin Biotechnol 2009; 20:1 - 8
   PubMed Web of Science ®Google Scholar
• Su X, Lacouture ME, Jia Y, Wu S. Risk of high-grade skin rash in cancer patients treated with cetuximab-an antibody against epidermal growth factor receptor:systemic review and meta-analysis. Oncology 2009; 77:124 - 133
   PubMed Web of Science ®Google Scholar
• Bria E, Cuppone F, Milella M, Verma S, Carlini P, Nistico C, et al. Trastuzumab cardiotoxicity: biological hypotheses and clinical open issues. Expert Opin Biol Ther 2008; 8:1963 - 1971
   PubMed Web of Science ®Google Scholar
• Zareba KM. Eculizumab: A novel therapy for paroxysmal nocturnal hemoglobinuria. Drugs Today 2007; 43:539 - 546
   PubMed Web of Science ®Google Scholar
• Sabashi R, Anolik JH. B-cell-targeted therapy for systemic lupus erythematosus. Drugs 2006; 66:1933 - 1948
   PubMed Web of Science ®Google Scholar
• Quintás-Cardama A, Wierda W, O’Brien S. Investigational immunotherapeutics for B cell malignancies. J Clin Oncol 2010; 28:884 - 892
   PubMed Web of Science ®Google Scholar
• Cranmer LD, Hersh E. The role of CTLA4 blockade in the treatment of malignant melanoma. Cancer Invest 2007; 25:613 - 631
   PubMed Web of Science ®Google Scholar
• Valzasina B, Guiducci C, Dislich H, Killeen N, Weinberg AD, Colombo MP. Triggering of OX40 (CD134) on CD4(+)CD25+ T cells blocks their inhibitory activity: a novel regulatory role for OX40 and its comparison with GITR. Blood 2005; 105:2845 - 2851
   PubMed Web of Science ®Google Scholar
• Khalil M, Vondeheide RH. Anti-CD40 agonist antibodies: preclinical and clinical experience. Update Cancer Ther 2007; 2:61 - 65
   PubMedGoogle Scholar
• Ponce R. Adverse consequences of immunostimulation. J Immunotoxicol 2008; 33 - 41
   PubMed Web of Science ®Google Scholar
• Descotes J. Immunotoxicity of monoclonal antibodies. mAbs 2009; 1:104 - 111
   PubMed Web of Science ®Google Scholar
• Rychly DJ, Dipiro JT. Infections associated with tumor necrosis factor-alpha antagonists. Pharmacotherapy 2005; 25:1191 - 1192
   Web of Science ®Google Scholar
• Fraser G, Smith CA, Imrie K, Meyer R. the Hematology Disease Site Group of Cancer Care Ontario’s Program in Evidence-Based Care. Alemtuzumab in chronic lymphocytic leukemia. Curr Oncol 2007; 14:96 - 109
   PubMedGoogle Scholar
• Kimby E. Tolerability and safety of rituximab (Mabthera). Cancer Treat Rev 2005; 31:456 - 473
   PubMed Web of Science ®Google Scholar
• Berger JR. Natalizumab and progressive multifocal leucoencephalopathy. Ann Rheum Dis 2006; 65:48 - 53
   Web of Science ®Google Scholar
• Lindå H, von Heijne A, Major EO, Ryschkewitsch C, Berg J, Olsson T, et al. Progressive multifocal leukoencephalopathy after natalizumab monotherapy. N Engl J Med 2009; 361:1081 - 1087
   PubMed Web of Science ®Google Scholar
• Stüve O, Marra CM, Jerome KR, Cook L, Cravens PD, Cepok S, et al. Immune surveillance in multiple sclerosis patients treated with natalizumab. Ann Neurol 2006; 59:743 - 747
   PubMed Web of Science ®Google Scholar
• Major EO. Progressive multifocal leukoencephalopathy in patients on immunomodulatory therapies. Ann Rev Med 2010; 61:35 - 47
   PubMed Web of Science ®Google Scholar
• Coles AJ, Wing M, Smith S, Coraddu F, Greer S, Taylor C, et al. Pulsed monoclonal antibody treatment and autoimmune thyroid disease in multiple sclerosis. Lancet 1999; 354:1691 - 1695
   PubMed Web of Science ®Google Scholar
• Yang JC, Hughes M, Kammula U, Royal R, Sherry RM, Topalian SL, et al. Ipilimumab (anti-CTLA4 antibody) causes regression of metastatic renal cell cancer associated with enteritis and hypophysitis. J Immunother 2007; 30:825 - 830
   PubMed Web of Science ®Google Scholar
• Wetter DA, Davis MD. Lupus-like syndrome attributable to anti-tumor necrosis factor alpha therapy in 14 patients during an 8-year period at the Mayo Clinic. Mayo Clin Proc 2009; 84:979 - 984
   PubMed Web of Science ®Google Scholar
• Kang SP, Saif MW. Infusion-related and hypersensitivity reactions of monoclonal antibodies used to treat colorectal cancer-identification prevention and management. J Support Oncol 2007; 5:451 - 457
   PubMedGoogle Scholar
• Chung CH, Mirakhur B, Chan E, Le QT, Berlin J, Morse M, et al. Cetuximab-induced anaphylaxis and IgE specific for galactose α-1,3-galactose. N Engl J Med 2008; 358:1109 - 1117
   PubMed Web of Science ®Google Scholar
• Lynch C, Hart BW, Grewal IS. Practical considerations for nonclinical safety evaluation of therapeutic monoclonal antibodies. mAbs 2009; 1:2 - 11
   PubMed Web of Science ®Google Scholar
• ICH M3 (R2): Nonclinical safety studies for the conduct of human clinical trials with pharmaceuticals (2009) available at http://www.ema.europa.eu/pdfs/human/ich/028695en.pdf.
   Google Scholar
• ICH guideline S6: Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals (1998) available at http://www.ema.europa.eu/pdfs/human/ich/030295en.pdf.
   Google Scholar
• ICH guideline S6 (R1): Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals. Step 2 Addendum (2009) available at http://www.ich.org/LOB/media/MEDIA5784.pdf.
   Google Scholar
• Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use FDA, 2000 available at http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/OtherRecommendationsforManufacturers/UCM153182.pdf.
   Google Scholar
• ICH guideline S8: Notes for Guidance on Immunotoxicity Testing of Human Pharmaceuticals (2004) available at http://www.ema.europa.eu/pdfs/human/ich/16723504en.pdf.
   Google Scholar
• FDA (CDER): Immunotoxicology Evaluation of Investigational New Drugs (2002) available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM079239.pdf.
   Google Scholar
• Japanese MHLW/JPMA Draft Guidance for Immunotoxicity Testing (draft 2001)
   Google Scholar
• Guideline on Immunogenicity Assessment of Biotechnology-Derived Therapeutic proteins (2007) available at http://www.ema.europa.eu/pdfs/human/biosimilar/1432706enfin.pdf.
   Google Scholar
• Jefferis R. Antibody therapeutics: isotype and glycoform selection. Expert Opin Biol Ther 2007; 7:1401 - 1413
   PubMed Web of Science ®Google Scholar
• Bruhns P, Iannascoli B, England P, Mancardi DA, Fernanedez N, Jorieux S, et al. Specificity and affinity of human Fcgamma receptors and their polymorphic variants for human IgG subclasses. Blood 2009; 113:3716 - 3725
   PubMed Web of Science ®Google Scholar
• Nimmerjahn F, Ravetsch JV. Fcγ receptors as regulators of immune responses. Nat Rev Immunol 2 2008; 8:34 - 47
   PubMed Web of Science ®Google Scholar
• Labrijn AF, Buijsse AO, van den Brener ETJ, Verwilligen AYW, Bleeker WK, Thorpe SJ, et al. Therapeutic IgG4 antibodies engage in Fab-arm exchange with endogenous human IgG4 in vivo. Nat Biotechnol 2009; 27:767 - 771
   PubMed Web of Science ®Google Scholar
• Oganesyan V, Gao C, Shirinian L, Wu H, Dall’Acqua WF. Structural characterization of a human Fc fragment engineered for lack of effector function. Acta Crystallogr D Biol Crystallogr 2008; 64:700 - 704
   PubMed Web of Science ®Google Scholar
• Panelli MC, White R, Foster M, Martin B, Wang E, Smith K, et al. Forecasting the cytokine storm following systemic interleukin (IL)-2 administration. J Transl Med 2004; 2:17
   PubMedGoogle Scholar
• Wing M. Monoclonal Antibody First Dose Cytokine Release Syndromes-Mechanisms and Prediction. J Immunotoxicology 2008; 5:11 - 15
   PubMed Web of Science ®Google Scholar
• Stebbings R, Findlay L, Edwards C, Eastwood D, Bird C, North D, et al. “Cytokine storm“ in the phase I trial of monoclonal antibody TGN1412: better understanding the causes to improve preclinical testing of immunotherapeutics. J Immunol 2006; 179:3325 - 3331
   Web of Science ®Google Scholar
• Hsu DH, Shi JD, Homola M, Rowell TJ, Moran J, Levitt, et al. A humanized anti-CD3 antibody, HUM291, with low mitogenic activity, mediates complete and reversible T-cell depletion in chimpanzees. Transplantation 1999; 68:545 - 554
   PubMed Web of Science ®Google Scholar
• Langezaal I, Coecke S, Hartunga T. Whole blood cytokine response as a measure of immunotoxicity. Toxicology in Vitro 2001; 15:313 - 318
   PubMed Web of Science ®Google Scholar
• Bugelski PJ. Cytokine Release Syndrome: Strategy for a Primary Screen. Slide Presentation, FDA Immunotoxicology Symposium, Cytokine Release: What Does It Mean? 2008;
   Google Scholar
• Final Report of the Expert Scientific Group on Phase I Clinical Trials and the subsequent EMEA Guideline on Strategies to Identify and Mitigate Risk for FIH Clinical Trials with Investigational Medicinal Products (EMEA/CHMP/SWP/28367/07)
   Google Scholar
• Rodriguez-Palmero M, Hara T, Thumbs A, Hünig T. Triggering of T cell proliferation through CD28 induces GATA-3 and promotes T helper type 2 differentiation in vitro and in vivo. Eur J Immunol 1999; 29:3914 - 24
   PubMed Web of Science ®Google Scholar
• Jäger M, Hara T, Thumbs A, Hünig T. The trifunctional antibody ertumaxomab destroys tumor cells that express low levels of human epidermal growth factor receptor. Cancer Res 2009; 69:4270 - 4276
   PubMed Web of Science ®Google Scholar
• Ju X, Clark G, Hart DN. Review of human DC subtypes. Methods Mol Biol 2010; 595:3 - 20
   PubMedGoogle Scholar
• Fukata M, Vamadevan AS, Abreu MR. Toll-like receptors (TLRs) and Nod-like receptors (NLRs) in inflammatory disorders. Semin Immunol 2009; 21:242 - 253
   PubMed Web of Science ®Google Scholar
• Fujii S, Liu K, Smith C, Bonito AJ, Steinman RM. The linkage of innate to adaptive immunity via maturing dendritic cells in vivo requires CD40 ligation in addition to antigen presentation and Cd80/86 costimulation. J Exp Med 2004; 199:1607 - 1618
   PubMed Web of Science ®Google Scholar
• Geissmann F, Revy P, Regnault A, Lepelletier Y, Dy M, Brousse N, et al. TGFbeta prevents the noncognate maturation of human dendritic Langerhans cells. J Immunol 1999; 162:4567 - 4575
   PubMed Web of Science ®Google Scholar
• Schuurhuis DH, Ioan-Facsinay A, Nagelkerken B, van Schip JJ, Sedlik C, Melief CJ, et al. Antigen-antibody immune complexes empower dendritic cells to efficiently prime CD8+ CTL responses in vivo. J Immunol 2002; 168:2240 - 2246
   PubMed Web of Science ®Google Scholar
• Mueller R, Karle A, Vogt A, Kropshofer H, Ross A, Maeder K, et al. Evaluation of the immuno-stimulatory potential of stopper extractable and leachables by using dendritic cells as readout. J Pharm Sci 2009; 98:3548 - 3561
   PubMed Web of Science ®Google Scholar
• Descotes J, Gouraud A. Clinical immunotoxicity of therapeutic proteins. Expert Opin Drug Metab Toxicol 2008; 4:1537 - 1549
   PubMed Web of Science ®Google Scholar
• Li J, Yang C, Xia Y, Bertino A, Glaspy J, Roberts M, et al. Thrombocytopenia caused by the development of antibodies to thrombopoietin. Blood 2007; 98:3241 - 3248
   Web of Science ®Google Scholar
• Casadevall N, Nataf J, Viron B, Kolta A, Kiladjian JJ, Martin-Dupont P, et al. Pure red-cell aplasia and anti-erythropoietin antibodies in patients treated with recombinant erythropoietin. N Engl J Med 2002; 346:469 - 475
   PubMed Web of Science ®Google Scholar
• Hermeling S, Aranha L, Damen JMA, Slijper M, Schellekens H, Crommelin DJA, et al. Structural characterization and immunogenicity in wild-type and immune tolerant mice of degraded recombinant human interferon alpha2b. Pharm Res 2005; 22:1997 - 2006
   PubMed Web of Science ®Google Scholar
• Weinblatt ME, Keystone EC, Furst DE, Moreland LW, Weisman MH, Birbara CA, et al. Adalimumab, a fully human anti-tumor necrosis factor alpha monoclonal antibody, for the treatment of rheumatoid arthritis in patients taking concomitant methotrexate: the ARMADA trial. Arthritis Rheum 2003; 48:35 - 45
   PubMed Web of Science ®Google Scholar
• Van de Putte LBA, Atkins C, Malaise M, Sany J, Russell AS, van Riel PLCM, et al. Efficacy and safety of adalimumab as monotherapy in patients with rheumatoid arthritis for whom previous disease modifying antirheumatic drug treatment has failed. Ann Rheum Dis 2004; 63:508 - 516
   PubMed Web of Science ®Google Scholar
• Rosloniec EF, Brand DD, Myers LK, Whittington KB, Gumanovskaya M, Zaller DM, et al. An HLA-DR1 transgene confers susceptibility to collagen-induced arthritis elicited with human type II collagen. J Exp Med 1997; 185:1113 - 1122
   PubMed Web of Science ®Google Scholar
• Gonzalez-Gay MA, Zanelli E, Khare SD, Krco CJ, Zhou P, Inoko H, et al. Human leukocyte antigen-DRB1*1502 (DR2Dw12) transgene reduces incidence and severity of arthritis in mice. Hum Immunol 1996; 50:54 - 60
   PubMed Web of Science ®Google Scholar
• Strauss G, Vignali DA, Schonrich G, Hammerling GJ. Negative and positive selection by HLA-DR3(DRw17) molecules in transgenic mice. Immunogenetics 1994; 40:104 - 108
   PubMed Web of Science ®Google Scholar
• Kouskoff V, Fehling HJ, Lemeur M, Benoist C, Mathis DA. A vector driving the expression of foreign cDNAs in the MHC class II-positive cells of transgenic mice. J Immunol Methods 1993; 166:287 - 291
   PubMed Web of Science ®Google Scholar
• Braud VM, McMichael AJ, Cerundolo V. Differential processing of influenza nucleoprotein in human and mouse cells. Eur J Immunol 1998; 28:625 - 635
   PubMed Web of Science ®Google Scholar
• Ito M, Hiramatsu H, Kobayashi K, Suzue K, Kawahata M, Hioki K, et al. NOD/SCID/gamma(c)(null) mouse: an excellent recipient mouse model for engraftment of human cells. Blood 2002; 100:3175 - 3182
   PubMed Web of Science ®Google Scholar
• Traggiai E, Chicca L, Mazzucchelli L, Bronz L, Piffaretti JC, Lanzavecchia A, et al. Development of a human adaptive immune system in cord blood cell-transplanted mice. Science 2004; 304:104 - 107
   PubMed Web of Science ®Google Scholar
• Sturniolo T, Bono E, Ding J, Raddrizzani L, Tuereci O, Sahin U, et al. Generation of tissue-specific and promiscuous HLA ligand databases using DNA microarrays and virtual HLA class II matrices. Nat Biotechnol 1999; 17:555 - 561
   PubMed Web of Science ®Google Scholar
• Peters B, Sette A. Generating quantitative models describing the sequence specificity of biological processes with the stabilized matrix method. BMC Bioinformatics 2005; 6:132
   PubMed Web of Science ®Google Scholar
• Nielsen M, Lundegaard C, Worning P, Hvid CS, Lamberth K, Buus S, et al. Improved prediction of MHC class I and class II epitopes using a novel Gibbs sampling approach. Bioinformatics 2004; 20:1388 - 1397
   PubMed Web of Science ®Google Scholar
• Desmet J, Meersseman G, Boutonnet N, Pletinckx J, De Clercq K, Debulpaep M, et al. Anchor profiles of HLA-specific peptides: analysis by a novel affinity scoring method and experimental validation. Proteins 2005; 58:53 - 69
   PubMed Web of Science ®Google Scholar
• Kropshofer H, Spindeldreher S. Kropshofer Harald, Vogt Anne B. Naturally processed self-peptides of MHC molecules. Antigen Presenting Cells 2005; Weinheim Wiley-VCH 159 - 198
   Google Scholar
• Perry LC, Jones TD, Baker MP. New Approaches to prediction of immune responses to therapeutic proteins during preclinical development. Drugs R D 2008; 9:385 - 396
   PubMedGoogle Scholar
• Koren E, Smith HW, Shores E, Shankar G, Finco-Kent D, Rup B, et al. Recommendations on risk-based strategies for detection and characterization of antibodies against biotechnology products. J Immunol Methods 2008; 333:1 - 9
   PubMed Web of Science ®Google Scholar
• Chapman K, Pullen N, Coney L, Dempster M, Andrew L, Bajramovic J, et al. Preclinical development of monoclonal antibodies. Considerations for the use of non-human primates. mAbs 2009; 1:505 - 516
   PubMed Web of Science ®Google Scholar
• Treacy G. Using an analogous monoclonal antibody to evaluate the reproductive and chronic toxicity potential for a humanized anti-TNF-a monoclonal antibody. Hum Exp Toxicol 2000; 19:226 - 229
   PubMed Web of Science ®Google Scholar
• Clarke J, Leach W, Pippig S, Joshi A, Wu B, House R, et al. Evaluation of a surrogate antibody for preclinical safety testing of an anti-CD11a monoclonal antibody. Regul Toxicol Pharmacol 2004; 40:219 - 226
   PubMed Web of Science ®Google Scholar
• ICHQ6B: Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products Available at http://www.ema.europa.eu/pdfs/human/ich/036596en.pdf.
   Google Scholar
• Bugelski PJ, Herzyk DJ, Rehm S, Harmsen AG, Gore EV, Williams DM, et al. Preclinical development of keliximab, a primatized anti-CD4 monoclonal antibody, in human CD4 trangenic mice: characterization of the model and safety studies. Hum Exp Toxicol 2000; 19:230 - 243
   PubMed Web of Science ®Google Scholar
• Nguyen DH, Hurtado-Ziola N, Gagneux P, Varki A. Loss of Siglec expression on T lymphocytes during human evolution. Proc Natl Acad Sci USA 2006; 103:7765 - 7770
   PubMed Web of Science ®Google Scholar
• Crocker PR. Siglecs in innate immunity. Curr Opin Pharmacol 2005; 5:431 - 437
   PubMed Web of Science ®Google Scholar
• Akari H, Terao K, Murayama Y, Nam K-H, Yoshikawa Y. Peripheral blood CD4+CD8+ lymphocytes in cynomolgus monkeys are of resting memory T lineage. Internat Immunol 1997; 9:591 - 597
   PubMed Web of Science ®Google Scholar
• Teroa K. Essentials for starting a pediatric clinical study (3): dynamic changes in early development of immune system in macaque monkeys—the significance from standpoint of preclinical toxicity test using nonhuman primates. J Toxicol Sci 2009; 34:321 - 325
   Google Scholar
• Rogers KA, Scinicariello F, Attanasio R. IgG Fc receptor III homologues in nonhuman primate species: genetic characterization and ligand interactions. J Immunol 2006; 177:3848 - 3856
   PubMed Web of Science ®Google Scholar
• Haley PJ. Species Differences in the Structure and the Function of the Immune System. Toxicology 2003; 188:49 - 71
   PubMed Web of Science ®Google Scholar
• Haley P, Perry R, Ennulat D, Frame S, Johnson C, Lapointe JM, et al. STP Immunotoxicology Working Group. STP position paper: best practice guideline for the routine pathology evaluation of the immune system. Tox Path 2005; 33:404 - 407
   PubMed Web of Science ®Google Scholar
• Kuper CF, Harleman JH, Richter-Reichelm HB, Vos JG. Histopathologic approaches to detect changes indicative of immunotoxicity. Toxicol Pathol 2000; 28:454 - 466
   PubMed Web of Science ®Google Scholar
• Germolec DR, Kashon M, Nyska A, Kuper CF, Portier C, Kommineni C, et al. The accuracy of extended histopathology to detect immunotoxic chemicals. Toxicol Sci 2004; 82:504 - 514
   PubMed Web of Science ®Google Scholar
• Luster MI, Portier C, Pait DG, Rosenthal GJ, Germolec DR, Corsini E, et al. Risk assessment in immunotoxicology II. Relationships between immune and host resistance tests. Fundam Appl Toxicol 1993; 71 - 82
   PubMedGoogle Scholar
• Orencia European Public Assessment Report; Scientific Discussion, EMEA, 2007 available at http://www.ema.europa.eu/humandocs/PDFs/EPAR/orencia/H-701-en6.pdf.
   Google Scholar
• Amevive BLA review: Pharmacology and Toxicology Assessment, FDA 2002 available at http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm086014.pdf.
   Google Scholar
• Herzyk D, Holsapple M. Immunotoxicity evaluation by immune function tests: focus on the T-dependent antibody response. J Immunotoxicol 2007; 4:143 - 147
   PubMed Web of Science ®Google Scholar
• Raptiva European Public Assessment Report; Scientific Discussion, EMEA, 2004 available at http://www.ema.europa.eu/humandocs/PDFs/EPAR/raptiva/6565604en6.pdf.
   Google Scholar
• Szekeres-Bartho J. Immunological relationship between the mother and fetus. Int Rev Immunol 2002; 21:471 - 495
   PubMedGoogle Scholar
• Laskarin G, Kammerer U, Rukavina D, Thomson AW, Fernandez N, Blois SM. Antigen-presenting cells and materno-fetal tolerance:an emerging role for dendritic cells. Am J Reprod Immunol 2007; 58:255 - 267
   PubMed Web of Science ®Google Scholar
• Riley JK, Yokoyama WM. NK cell tolerance and the materno-fetal interface. Am J Reprod Immunol 2008; 59:371 - 387
   PubMed Web of Science ®Google Scholar
• Roopenian DC, Akilesh S. FcRn: the neonatal Fc receptor comes of age. Nat Rev Immunol 2007; 7:715 - 725
   PubMed Web of Science ®Google Scholar
• Weinbauer GF, Frings W, Fuchs A, Niehaus M, Osterburg I. Cavagnaro JA. Reproductive/developmental toxicity assessment of biopharmaceuticals in nonhuman primates. Preclinical safety evaluation of biopharmaceuticals 2008; New Jersey John Wiley & Son 379 - 398
   Google Scholar
• Pentsuk N, Van der Laan JW. An interspecies comparison of placental antibody transfer-implications for developmental toxicity testing of monoclonal antibodies and for human pregnancy outcome. Birth Defects Res B 2009; 86:328 - 344
   PubMed Web of Science ®Google Scholar
• Martin PL, Oneda S, Treacy G. Effects of an anti-TNFα monoclonal antibody, administered throughout pregnancy and lactation, on the development of the macaque immune system. Am J Reprod Immunol 2007; 58:138 - 149
   PubMed Web of Science ®Google Scholar
• Stewart J. Developmental toxicity testing of monoclonal antibodies: An enhanced pre- and post-natal study design option. Reproductive Toxicol 2009; 28:220 - 225
   PubMed Web of Science ®Google Scholar
• Dietert RR. Developmental Immunotoxicology (DIT): windows of vulnerability, immune dysfunction and safety assessment. J Immunotoxicol 2008; 5:401 - 412
   PubMed Web of Science ®Google Scholar
• Burns-Naas LA, Hastings KL, Ladics GS, Makris SL, Parker GA, Holsapple MP. What’s so special about the developing immune system?. Int J Toxicol 2008; 27:223 - 254
   PubMed Web of Science ®Google Scholar
• Burleson GR, Burleson FG. Testing human biologicals in animal host resistance models. J Immunotoxicol 5:23 - 31
   PubMed Web of Science ®Google Scholar
• Burleson GR, Burleson FG. Influenza virus host resistance model. Methods 2007; 41:31 - 37
   PubMed Web of Science ®Google Scholar
• Cohen MD. Bacterial host resistance models in the evaluation of immunotoxicity. Methods 2007; 41:20 - 30
   PubMed Web of Science ®Google Scholar
• Descotes J. Cavagnaro JA. Assessment of autoimmunity and hypersensitivity. Preclinical safety evaluation of biopharmaceuticals 2008; New Jersey John Wiley & Son 487 - 497
   Google Scholar
• Agoram BM. Use of pharmacokinetic/pharmacodynamic modeling for starting dose selection in first-in-human trials of high-risk biologics. Br J Clin Pharmacol 2009; 67:153 - 160
   PubMed Web of Science ®Google Scholar
• Lowe PJ, Hijazi Y, Luttringer O, Yin H, Sarangapani R, Howard D. On the anticipation of the human dose in first-in-man trials from preclinical and prior clinical information in early drug development. Xenobiotica 2007; 37:1331 - 1354
   PubMed Web of Science ®Google Scholar