Oncobiologics announces bevacizumab biosimilar meets primary and secondary endpoints in Phase I clinical trial

October 6, 2015 7:15 AM

Oncobiologics, Inc. 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. This first-in-human study for ONS-1045 was conducted by the Centre for Human Drug Research (CHDR) in Leiden, The Netherlands.

ONS-1045 is being developed as a biosimilar to bevacizumab, an anti-vascular endothelial growth factor-A (VEGF-A) monoclonal antibody (“mAb”), which is approved in many countries for the treatment of a variety of metastatic cancers. 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.


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