Date: 2015-10-05
Type of information: Results
phase: 1
Announcement: results
Company: Oncobiologics (USA - NJ)
Product: ONS-1045 (biosimilar version of bevacizumab - Avastin®)
Action
mechanism: biosimilar/monoclonal antibody. monoclonal antibody. Bevacizumab is a humanized antibody to vascular endothelial growth factor (VEGF). It binds VEGF and prevents the interaction of VEGF to its receptors on the surface of endothelial cells. The interaction of VEGF with its receptors leads to endothelial cell proliferation and new blood vessel formation.
Disease:
Therapeutic area: Cancer - Oncology
Country: The Netherlands
Trial
details: ONS-1045 is being studied in a 3-arm single-dose PK study in healthy male volunteers to compare it against both the US- and EU-sourced Avastin® reference products, and the two reference products to each other. This 3-way PK assessment, designed to assess PK, safety and tolerability, is the first step in the global clinical development program for Oncobiologics’ second of eleven biosimilar candidates.
Latest
news: * On October 5, 2015, Oncobiologics announced that its bevacizumab (Avastin®) biosimilar candidate, ONS-1045, met the primary and secondary endpoints in a Phase 1 clinical trial. A 3-arm single-dose pharmacokinetic (PK) study was performed in 135 healthy male volunteers to compare ONS-1045 to both the U.S.- and EU-sourced Avastin® reference products, and the two reference products to each other. All of the PK endpoints met the bioequivalency criteria of the geometric mean ratios within 90% confidence interval of 80-125%. These included the primary endpoint of area under the time-concentration curve from first time point extrapolated to infinity (AUC0-inf), and the two secondary endpoints: maximum serum concentration (Cmax), and area under the time-concentration curve from first to last time point measured (AUC0-t). Safety and immunogenicity were similar and no neutralizing antibodies were detected across the three arms. Oncobiologics has begun both in-house manufacturing of Phase 3 clinical trial material and clinical site assessment in preparation for the initiation of the global confirmatory Phase 3 clinical trial. * On April 15, 2015, Oncobiologics announced that clinical development for ONS-1045, an Avastin®/bevacizumab biosimilar candidate, is underway with dosing completed in its pivotal pharmacokinetic (PK) study. This study is currently being conducted at the Center for Human Drug Research (CHDR) in Leiden, The Netherlands. The company has begun preparing for the global Phase III program and expects the PK study results to be available in time to enable initiation of a Phase III study in Q4 2015.
