Practical considerations for nonclinical safety evaluation of therapeutic monoclonal antibodies.

PubWeight™: 0.81‹?›

🔗 View Article (PMC 2715182)

Published in MAbs on January 04, 2010

Authors

Carmel M Lynch1, Bruce W Hart, Iqbal S Grewal

Author Affiliations

1: Departments of Preclinical Therapeutics, Regulatory Affairs and Nonclinical Development, Bothell, Washington, USA.

Articles cited by this

Cytokine storm in a phase 1 trial of the anti-CD28 monoclonal antibody TGN1412. N Engl J Med (2006) 15.04

Cancer regression and autoimmunity induced by cytotoxic T lymphocyte-associated antigen 4 blockade in patients with metastatic melanoma. Proc Natl Acad Sci U S A (2003) 10.71

Monoclonal antibody therapy of cancer. Nat Biotechnol (2005) 5.79

Potent antibody therapeutics by design. Nat Rev Immunol (2006) 4.87

Selecting and screening recombinant antibody libraries. Nat Biotechnol (2005) 4.51

Monoclonal antibody successes in the clinic. Nat Biotechnol (2005) 4.43

Antibody targeted drugs as cancer therapeutics. Nat Rev Drug Discov (2006) 3.08

Tolerability and safety of rituximab (MabThera). Cancer Treat Rev (2005) 2.15

Therapeutic antibodies for human diseases at the dawn of the twenty-first century. Nat Rev Drug Discov (2003) 2.13

Human antibodies from transgenic animals. Nat Biotechnol (2005) 2.04

Phase I study of anti--epidermal growth factor receptor antibody cetuximab in combination with radiation therapy in patients with advanced head and neck cancer. J Clin Oncol (2001) 1.87

Progressive multifocal leukoencephalopathy and natalizumab--unforeseen consequences. N Engl J Med (2005) 1.85

International Conference on Harmonisation; guidance on S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals; availability. Notice. Fed Regist (2005) 1.85

Clinical trials of antibody therapy. Immunol Today (2000) 1.77

Antibody production. Adv Drug Deliv Rev (2006) 1.62

The molecular basis of class side effects due to treatment with inhibitors of the VEGF/VEGFR pathway. Curr Clin Pharmacol (2008) 1.60

Points to consider in the manufacture and testing of monoclonal antibody products for human use (1997). U.S. Food and Drug Administration Center for Biologics Evaluation and Research. J Immunother (1997) 1.50

Rituximab therapy in hematologic malignancy patients with circulating blood tumor cells: association with increased infusion-related side effects and rapid blood tumor clearance. J Clin Oncol (1999) 1.36

Preclinical safety testing of monoclonal antibodies: the significance of species relevance. Nat Rev Drug Discov (2007) 1.27

An acid dissociation bridging ELISA for detection of antibodies directed against therapeutic proteins in the presence of antigen. J Immunol Methods (2005) 1.23

Lessons learned from anti-CD40L treatment in systemic lupus erythematosus patients. Lupus (2004) 1.22

Epidermal growth factor receptors as a target for cancer treatment: the emerging role of IMC-C225 in the treatment of lung and head and neck cancers. Semin Oncol (2002) 1.20

Engineering therapeutic monoclonal antibodies. Immunol Rev (2008) 1.06

Cardiac toxicity of trastuzumab-related regimens in HER2-overexpressing breast cancer. Clin Breast Cancer (2007) 1.03

Natalizumab and progressive multifocal leucoencephalopathy. Ann Rheum Dis (2006) 1.01

Immunogenicity testing by electrochemiluminescent detection for antibodies directed against therapeutic human monoclonal antibodies. Clin Chem (2005) 0.99

Antibody engineering for the development of therapeutic antibodies. Mol Cells (2005) 0.98

The problem with potency. Nat Biotechnol (2005) 0.97

Duration of chronic toxicity studies for biotechnology-derived pharmaceuticals: is 6 months still appropriate? Regul Toxicol Pharmacol (2007) 0.96

Evaluation of a surrogate antibody for preclinical safety testing of an anti-CD11a monoclonal antibody. Regul Toxicol Pharmacol (2004) 0.92

International Conference on Harmonisation; Guidance on S8 Immunotoxicity Studies for Human Pharmaceuticals; availability. Notice. Fed Regist (2006) 0.84

International Conference on Harmonisation; guidance on the duration of chronic toxicity testing in animals (rodent and nonrodent toxicity testing); availability. Notice. Food and Drug Administration, HHS. Fed Regist (1999) 0.84

Flexibility--the guiding principle for antibody manufacturing. Nat Biotechnol (2005) 0.84

Preclinical safety testing of biotechnology-derived pharmaceuticals: understanding the issues and addressing the challenges. Mol Biotechnol (2004) 0.83

Comparative pharmacodynamics of keliximab and clenoliximab in transgenic mice bearing human CD4. J Pharmacol Exp Ther (2000) 0.82

Inhibition of contact sensitivity in human CD4+ transgenic mice by human CD4-specific monoclonal antibodies: CD4+ T-cell depletion is not required. Immunology (2000) 0.81

Clinical and immunologic effects of a PRIMATIZED anti-CD4 monoclonal antibody in active rheumatoid arthritis: results of a phase I, single dose, dose escalating trial. J Rheumatol (1998) 0.81

Immunotoxicity assessment of biotechnology products: a regulatory point of view. Toxicology (1995) 0.77

Articles by these authors

BAFF/BLyS receptor 3 binds the B cell survival factor BAFF ligand through a discrete surface loop and promotes processing of NF-kappaB2. Immunity (2002) 2.75

Loss of TACI causes fatal lymphoproliferation and autoimmunity, establishing TACI as an inhibitory BLyS receptor. Immunity (2003) 2.51

Immunomodulatory drug lenalidomide (CC-5013, IMiD3) augments anti-CD40 SGN-40-induced cytotoxicity in human multiple myeloma: clinical implications. Cancer Res (2005) 1.84

Combination of the anti-CD30-auristatin-E antibody-drug conjugate (SGN-35) with chemotherapy improves antitumour activity in Hodgkin lymphoma. Br J Haematol (2008) 1.40

APRIL-deficient mice have normal immune system development. Mol Cell Biol (2004) 1.29

A phase 1 multidose study of SGN-30 immunotherapy in patients with refractory or recurrent CD30+ hematologic malignancies. Blood (2007) 1.29

Preclinical antilymphoma activity of a humanized anti-CD40 monoclonal antibody, SGN-40. Cancer Res (2005) 1.28

Therapeutic interventions targeting CD40L (CD154) and CD40: the opportunities and challenges. Adv Exp Med Biol (2009) 1.26

Engineered anti-CD70 antibody with multiple effector functions exhibits in vitro and in vivo antitumor activities. Blood (2006) 1.21

Potent anticarcinoma activity of the humanized anti-CD70 antibody h1F6 conjugated to the tubulin inhibitor auristatin via an uncleavable linker. Clin Cancer Res (2008) 1.11

Macrophages contribute to the antitumor activity of the anti-CD30 antibody SGN-30. Blood (2007) 1.09

Potent antitumor activity of the anti-CD19 auristatin antibody drug conjugate hBU12-vcMMAE against rituximab-sensitive and -resistant lymphomas. Blood (2009) 1.03

TNF-related apoptosis-inducing ligand (TRAIL)/Apo2L suppresses experimental autoimmune encephalomyelitis in mice. Immunol Cell Biol (2005) 1.00

Preclinical characterization of SGN-70, a humanized antibody directed against CD70. Clin Cancer Res (2008) 0.98

Antibody targeting of B-cell maturation antigen on malignant plasma cells. Mol Cancer Ther (2007) 0.98

Anti-leukemic activity of lintuzumab (SGN-33) in preclinical models of acute myeloid leukemia. MAbs (2009) 0.97

Preclinical pharmacokinetics, pharmacodynamics, and activity of a humanized anti-CD40 antibody (SGN-40) in rodents and non-human primates. Br J Pharmacol (2006) 0.96

Targeting CD30/CD30L in oncology and autoimmune and inflammatory diseases. Adv Exp Med Biol (2009) 0.96

NTB-A, a new activating receptor in T cells that regulates autoimmune disease. J Biol Chem (2004) 0.95

Targeting CD70 for human therapeutic use. Adv Exp Med Biol (2009) 0.94

A novel in vivo role for osteoprotegerin ligand in activation of monocyte effector function and inflammatory response. J Biol Chem (2004) 0.93

CD27-CD70 interactions in the pathogenesis of Waldenstrom macroglobulinemia. Blood (2008) 0.89

Blocking of CD27-CD70 pathway by anti-CD70 antibody ameliorates joint disease in murine collagen-induced arthritis. J Immunol (2009) 0.89

Antibody drug-conjugates targeting the tumor vasculature: Current and future developments. MAbs (2010) 0.88

Distinct apoptotic signaling characteristics of the anti-CD40 monoclonal antibody dacetuzumab and rituximab produce enhanced antitumor activity in non-Hodgkin lymphoma. Clin Cancer Res (2011) 0.88

Targeting inflammatory cells to improve anti-VEGF therapies in oncology. Recent Results Cancer Res (2010) 0.87

Recombinant humanized anti-CD40 monoclonal antibody triggers autologous antibody-dependent cell-mediated cytotoxicity against multiple myeloma cells. Br J Haematol (2003) 0.86

CD40 expression on antigen presenting cells and correlation with disease severity in atopic dermatitis. Eur J Dermatol (2008) 0.85

Role of L-selectin in the development of autoimmune diabetes in non-obese diabetic mice. Int Immunol (2004) 0.82

CD30 expression on CD1a+ and CD8+ cells in atopic dermatitis and correlation with disease severity. Eur J Dermatol (2007) 0.82

A crucial role of CD4 T cells as a functional source of CD154 in the initiation of insulin-dependent diabetes mellitus in the non-obese diabetic mouse. Int Immunol (2003) 0.80

Targeting of BAFF and APRIL for autoimmunity and oncology. Adv Exp Med Biol (2009) 0.80

Novel antibody-based therapeutic agents targeting CD70: a potential approach for treating Waldenström's macroglobulinemia. Clin Lymphoma Myeloma (2009) 0.79