Herbst R et al. B-cell depletion in vitro and in vivo with an afucosylated anti-CD19 antibody. J Pharmacol Exp Ther. 2010 Oct;335(1):213-22.
Ward E et al. A glycoengineered anti-CD19 antibody with potent antibody-dependent cellular cytotoxicity activity in vitro and lymphoma growth inhibition in vivo. Br J Haematol. 2011 Nov; 155(4):426-37.
Matlawska-Wasowska K et al. Macrophage and NK-mediated killing of precursor-B acute lymphoblastic leukemia cells targeted with a-fucosylated anti-CD19 humanized antibodies. Leukemia. 2013 Jun;27(6):1263-74.
Chen D et al. Single dose of glycoengineered anti-CD19 antibody (MEDI551) disrupts experimental autoimmune encephalomyelitis by inhibiting pathogenic adaptive immune responses in the bone marrow and spinal cord while preserving peripheral regulatory mechanisms. J Immunol. 2014 Nov 15;193(10):4823-32.
Yusuf I et al. Germinal center B cell depletion diminishes CD4+ follicular T helper cells in autoimmune mice. PLoS One. 2014 Aug 7;9(8):e102791.
Chen D et al. Autoreactive CD19+CD20- Plasma Cells Contribute to Disease Severity of Experimental Autoimmune Encephalomyelitis.J Immunol. 2016 Feb 15;196(4):1541-9.
Gallagher S et al. MEDI-551 Treatment Effectively Depletes B Cells and Reduces Serum Titers of Autoantibodies in Mice Transgenic for Sle1 and Human CD19. Arthritis Rheumatol. 2016 Apr;68(4):965-76.
Gallagher S et al. Pharmacological profile of MEDI-551, a novel anti-CD19 antibody, in human CD19 transgenic mice. Int Immunopharmacol. 2016 Jul;36:205-212.
Wang, S. et al. 2018. Role and Regulation of CD11chi T-bet+ B cells in SLE. Nature Communications, 9:1758 DOI 10.1038s41467-018-03750-7
Schiopu E, et al. Safety and tolerability of an anti-CD19 monoclonal antibody, MEDI-551, in subjects with systemic sclerosis: a phase I, randomized, placebo-controlled, escalating single-dose study. Arthritis Research & Therapy (2016) 18:131 DOI 10.1186/s13075-016-1021-2
Guo et al. Suppression of T Cell Activation and Collagen Accumulation by an Anti-IFNAR1 mAb, Anifrolumab, in Adult Patients with Systemic Sclerosis Journal of Investigative Dermatology (2015) 135, 2402–2409; doi:10.1038/jid.2015.188 (includes Inebilizumab data)
Agius MA et al. Safety and tolerability of inebilizumab (MEDI-551), an anti-CD19 monoclonal antibody, in patients with relapsing forms of multiple sclerosis: Results from a phase 1 randomised, placebo-controlled, escalating intravenous and subcutaneous dose study. Mult Scler. 2019 Feb;25(2):235-245.
Streicher K et al. Baseline Plasma Cell Gene Signature Predicts Improvement in Systemic Sclerosis Skin Scores Following Treatment With Inebilizumab (MEDI-551) and Correlates With Disease Activity in Systemic Lupus Erythematosus and Chronic Obstructive Pulmonary Disease. Arthritis Rheumatol. 2018 Dec;70(12):2087-2095.
Cree B, et al. A randomised, placebo-controlled, double-blind trial of inebilizumab for the treatment of neuromyelitis optica spectrum disorder: results of the N-MOmentum study. 2019, Lancet in press
Blüml, S. et al. 2013. B Cells: Physiology, Implications in Autoimmune Disease, and Targets for Antibody-based Therapeutics. Arthritis Research & Therapy 15(Suppl 1):S4 (4 April 2013)
Chen D et al. Inebilizumab, a B Cell-Depleting Anti-CD19 Antibody for the Treatment of Autoimmune Neurological Diseases: Insights from Preclinical Studies. J Clin Med. 2016 Nov 24;5(12).
Forsthuber TG et al. B cell-based therapies in CNS autoimmunity: differentiating CD19 and CD20 as therapeutic targets.Ther Adv Neurol Disord. 2018 Mar 21;11:1756286418761697.
Patra, K, et al. Statistical Considerations for an Adaptive Design for a Serious Rare Disease. Ther Innov Regul Sci. 2016 May;50(3):375-384. doi: 10.1177/2168479015619203.
Cree, BA et al. Placebo-controlled study in neuromyelitis optica-Ethical and design considerations. Mult Scler. 2016 Jun;22(7):862-72. doi: 10.1177/1352458515620934.
Karnell, J. et al. 2017 Role of CD11c+Tbet+ B cells in human health and disease. Cell Immunol. Cell Immunol. 321 40-45
Cree B et al. A Double-masked, Placebo-controlled Study with Open-label Period to Evaluate the Efficacy and Safety of Inebilizumab in Adult Subjects with Neuromyelitis Optica Spectrum Disorders– Top line efficacy and safety results. American Academy of Neurology Annual Meeting, Philadelphia, PA, USA; May 5-10, 2019.
Oganesyan V et al. Fibronectin type III domains engineered to bind CD40L: cloning, expression, purification, crystallization and preliminary X-ray diffraction analysis of two complexes. Acta Crystallogr Sect F Struct Biol Cryst Commun. 2013 Sep;69(Pt 9):1045-8.
Mahmoud TI et al. Autoimmune manifestations in aged mice arise from early-life immune dysregulation. Sci Transl Med. 2016 Oct 19;8(361):361ra137.
Voynova E. et al. Requirement for CD40/CD40L Interactions for Development of Autoimmunity Differs Depending on Specific Checkpoint and Costimulatory Pathways 2018. ImmunoHorizons. 2 (1) 54-66.
Karnell JL et al. A CD40L-targeting protein reduces autoantibodies and improves disease activity in patients with autoimmunity. Sci Transl Med. 2019 Apr 24;11(489).
Karnell JL et al. Targeting the CD40-CD40L pathway in autoimmune diseases: Humoral immunity and beyond. Adv Drug Deliv Rev. 2018 Dec 13.
Ettinger R et al. VIB4920, a Novel CD40L Antagonist, Decreased Disease Activity and Improved Biomarkers of Immune Activation in a Phase 1b, Proof-of-Concept Study in Rheumatoid Arthritis. FASEB Autoimmunity Conference, Pacific Grove CA, July 7th -12th 2019
Ettinger R et al. VIB4920, a Novel CD40L Antagonist, Decreased Disease Activity and Improved Biomarkers of Immune Activation in a Phase 1b, Proof-of-Concept Study in Rheumatoid Arthritis. B cell-T cell interactions Keystone symposia, Keystone CO, February 10-14, 2019
Albulescu M et al. Safety, Tolerability, and Dose-Dependent Inhibition of T-Cell-Dependent Antibody Response with MEDI4920, a Novel, Engineered CD40L Antagonist: Results of a Single-Ascending Dose Study in Healthy Volunteers. American College of Rheumatology/Association of Rheumatology Health Professionals Annual Meeting, Washington, DC, USA; November 11–16, 2016.
Li J et al. Pharmacokinetics, Pharmacodynamics, and Immunogenicity of MEDI4920, a Novel, Engineered CD40L Antagonist in Healthy Volunteers. American College of Rheumatology/Association of Rheumatology Health Professionals Annual Meeting, Washington, DC, USA; November 11–16, 2016.
Albulescu M et al. Safety, Pharmacokinetics, Pharmacodynamics and Inhibition of T-Cell Dependent Antibody Response with MEDI4920, a Novel, Engineered CD40 Ligand Antagonist: Results of a First-Time-in-Human Study. Annual European Congress of Rheumatology, Madrid, Spain; June 14–17, 2017.
Albulescu M et al. VIB4920, a Novel, Engineered CD40L Antagonist Decreased Disease Activity and Improved Biomarkers of Immune Activation in Patients with Active Rheumatoid Arthritis in a Phase 1b, Multiple-Ascending Dose Proof-of-Concept Study. Annual Meeting of the American College of Rheumatology, Chicago, USA; October 19–24, 2018.
Panda SK et al. Plasmacytoid dendritic cells in autoimmunity. Curr Opin Immunol. 2017 Feb;44:20-25.