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Abstract: PO1843

Results of a Phase 1 Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BION-1301 in Healthy Volunteers

Session Information

Category: Glomerular Diseases

  • 1203 Glomerular Diseases: Clinical, Outcomes, and Trials


  • Lo, Jeannette, Aduro BioTech Inc, Berkeley, California, United States
  • Yavrom, Sharon, Aduro BioTech Inc, Berkeley, California, United States
  • Fan, Jessy, Aduro BioTech Inc, Berkeley, California, United States
  • Endsley, Aaron N., Certara LP, Princeton, New Jersey, United States
  • Schroeder, Tamara, Aduro BioTech Inc, Berkeley, California, United States
  • Barratt, Jonathan, University of Leicester, Leicester, Leicestershire, United Kingdom
  • Essayan, David M., ONCORD, Inc., Westlake Village, California, United States

IgA nephropathy (IgAN) is an autoimmune disease with no approved treatments1. Key steps in IgAN pathogenesis are the production of galactose-deficient IgA1 (Gd-IgA1), the generation of anti-Gd-IgA1 autoantibodies and the formation of immune complexes resulting in kidney inflammation and damage2. Patients with IgAN have elevated levels of A proliferation-inducing ligand (APRIL) which regulates B cell differentiation and proliferation3. In a study of patients with IgAN, those with high plasma APRIL levels had elevated levels of Gd-IgA1 and proteinuria and lower eGFR3. BION-1301, a first-in-class humanized anti-APRIL antibody, was well-tolerated with no dose-limiting toxicities in a Phase 1/2 first-in-human study in multiple myeloma4. This 3-part Phase 1 trial characterizes the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of BION-1301 in healthy volunteers (HV) and patients with IgAN.


(NCT03945318) Parts 1 and 2 are double-blind, randomized, placebo-controlled single and multiple ascending dose studies, respectively. Part 1 enrolled 36 HV in 5 dose cohorts, randomized in a 3:1 ratio to receive a single dose of BION-1301 or placebo delivered by IV infusion. Part 2 enrolled 27 HV in 3 dose cohorts, randomized in a 2:1 ratio to receive 3 doses of BION-1301 or placebo delivered by IV infusion every two weeks. Part 3 assesses a multiple dose regimen in patients with IgAN and is currently enrolling.


BION-1301 was well-tolerated with low incidence of non-neutralizing ADAs in HVs. The PK profile was well behaved with a half-life supporting monthly dosing. Durable target engagement, suppression of IgA and IgM, and to a lesser extent IgG were observed following BION-1301 administration. IgG values remained in normal ranges with no increase of infections post-treatment. Updated data will be presented including B cell immunophenotyping of HVs and results from patients with IgAN, if available.


BION-1301, an anti-APRIL antibody, offers a pharmacodynamic window to exploit IgA suppression while tempering impact to IgG. BION-1301 may provide a novel approach to address the pathophysiology of IgAN.


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