Aduro Biotech Announces First Patient Dosed in Phase 1 Study of BION-1301 in IgA Nephropathy
June 24, 2020 at 08:15 AM EDT
BERKELEY, Calif., June 24, 2020 (GLOBE NEWSWIRE) -- Aduro Biotech, Inc. (NASDAQ: ADRO), a clinical-stage biopharmaceutical company focused on developing therapies targeting the Stimulator of Interferon Genes (STING) and A Proliferation Inducing Ligand (APRIL) pathways for the treatment of cancer, autoimmune and inflammatory diseases, today announced that the first patient with IgA nephropathy has been dosed in a Phase 1 clinical trial of BION-1301, an investigational humanized IgG4 monoclonal antibody that blocks APRIL binding to both the BCMA and TACI receptors.
“We are thrilled to have dosed the first patient with IgA nephropathy in the Phase 1 clinical study of our investigational anti-APRIL antibody, BION-1301,” said Dimitry S.A. Nuyten, M.D., Ph.D., chief medical officer of Aduro. “The data Aduro recently presented from Parts 1 and 2 of this study in healthy volunteers at the 57th ERA-EDTA Virtual Congress indicated BION-1301 was well-tolerated, had a half-life of approximately 33 days, achieved over 90% target engagement with a single 450 mg dose of BION-1301 and demonstrated dose-dependent and durable reductions in IgA and IgM levels, and to a lesser extent, IgG levels. We look forward to hopefully replicating this effect in addition to exploring BION-1301’s disease-modifying potential in patients with IgA nephropathy in Part 3 of the ongoing Phase 1 clinical study.”
Part 3 of the Phase 1 multi-center trial (see www.clinicaltrials.gov, identifier NCT03945318) is evaluating the safety and tolerability of BION-1301 in two cohorts of 20 total adult subjects with IgA nephropathy in an open-label multiple dose design. Cohort 1 will receive a 450 mg intravenous (IV) dose of BION-1301 every two weeks. The dose and regimen for Cohort 2 will be determined after an assessment of the first five patients dosed in Cohort 1 and will be based on all available data, including safety, pharmacokinetic, free-APRIL and pharmacodynamic data.
Parts 1 and 2 of the Phase 1 trial evaluated the safety and tolerability of BION-1301 in 63 healthy volunteers in double-blinded, placebo-controlled single-ascending dose (SAD) and multiple-ascending dose (MAD) settings. Healthy volunteers in the SAD portion of the study received placebo or a single IV dose of BION-1301 ranging from 10 mg to 1350 mg on day 1. Healthy volunteers in the MAD portion of the study received placebo or IV doses of BION-1301 ranging from 50 mg to 450 mg on days 1, 15 and 29 (three doses total).
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