AVEO, Biodesix To Develop & Commercialize Ficlatuzumab With Companion Diagnostic

(RTTNews) - AVEO Oncology (AVEO) and Biodesix, Inc. have reached a worldwide agreement to co-develop and commercialize AVEO's hepatocyte growth factor or HGF inhibitory antibody ficlatuzumab, with a Biodesix companion diagnostic test. This deal and the clinical development program would leverage VeriStrat, a serum protein test that is commercially available to help physicians guide treatment decisions for patients with advanced non-small cell lung cancer or NSCLC, according to AVEO Oncology. VeriStrat would be used as the selection assay to identify NSCLC patients most likely to benefit from ficlatuzumab.

Ficlatuzumab is a humanized IgG1? antibody that binds to the HGF ligand with high affinity and specificity to inhibit the biological activities of the HGF/c-Met pathway. Ficlatuzumab is showed to be well tolerated as a single agent as well as in combination with EGFR TKIs.

According to an exploratory analysis from AVEO's Phase 2 trial in first-line NSCLC, VeriStrat was prognostic for outcome in the epidermal growth factor receptor tyrosine-kinase inhibitor or TKI-treated patients and predicted differential treatment benefit for the combination of ficlatuzumab plus TKI over TKI alone.

As part of the agreement, AVEO would conduct a proof of concept study of ficlatuzumab in combination with erlotinib in advanced NSCLC patients selected using the VeriStrat test. Biodesix would fund up to $15 million of the cost of the study. The companies anticipate to initiate this study later this year. AVEO would lead worldwide commercialization of ficlatuzumab, and Biodesix would be held responsible for all development, including FDA engagement activities, sales and marketing costs for VeriStrat, and would retain total revenues for sales of VeriStrat.