Aveo Oncology and Biodesix said today they will co-develop Aveo’s ficlatuzumab with a Biodesix companion diagnostic already on the market, VeriStrat®, to identify patients with advanced non-small cell lung cancer (NSCLC) who would be most likely to benefit from the hepatocyte growth factor (HGF) inhibitory antibody.
The total value of the deal was not disclosed. However, the companies did say Biodesix will spend up to $15 million toward the cost of a proof of concept study of ficlatuzumab in combination with Tarceva® (erlotinib).
Tarceva is a once-daily pill already approved for advanced NSCLC, and jointly marketed in the U.S. by Astellas Pharma and Genentech, a member of the Roche Group.
Aveo and Biodesix said they expect to launch the study later this year. Any additional development, regulatory and commercial costs for ficlatuzumab beyond the proof of concept study will be shared equally, as will any potential profits, according to the companies.
Subject to regulatory approval, Aveo will lead worldwide commercialization of ficlatuzumab, while Biodesix will oversee all development, including FDA engagement activities, sales, and marketing costs for VeriStrat, and will retain total revenues for sales of VeriStrat.
Aveo and Biodesix said they decided to pursue the ficlatuzumab-Tarceva combination after an exploratory analysis from Aveo’s Phase II study in first-line NSCLC suggested that VeriStrat could predict both outcome in patients treated with an epidermal growth factor receptor (EGFR) tyrosine-kinase inhibitor (TKI)—as well as the treatment benefit for the combination of ficlatuzumab plus TKI over TKI alone. The predictive effect was observed in both progression-free survival and overall survival endpoints, the companies said.
"Ficlatuzumab is targeting an oncogenic pathway that we believe may be important in certain patient subsets,” Biodesix CEO David Brunel said in a statement. “By leveraging our multiplexed platform and advanced analytics, we hope to identify those patients who gain substantial benefit from ficlatuzumab. We believe our initial work with Aveo is very encouraging.”
Added Tuan Ha-Ngoc, Aveo’s president and CEO: "This agreement accomplishes a key strategic objective of advancing our pipeline assets through external collaborations and funding.”
The deal with Biodesix fulfills a commitment made by Ha-Ngoc last year to seek external partners to develop ficlatuzumab. The commitment was made at the time Aveo announced plans to eliminate 140 jobs, or 62% of its workforce after the FDA rejected approving a further-along experimental cancer treatment, tivozanib, Aveo was co-developing with Astellas. In February, Aveo and Astellas ended their three-year collaboration to develop tivozanib.