AVEO Pharmaceuticals, Inc.
) entered into an agreement with Biodesix, Inc., a molecular
diagnostics company, to develop and commercialize AVEO's oncology
candidate, ficlatuzumab with Biodesix' companion diagnostic test,
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Ficlatuzumab works by inhibiting the hepatocyte growth factor
HGF/c-Met pathway. AVEO has evaluated the candidate in two phase
I studies and a phase II study so far. The phase II study
evaluating ficlatuzumab in combination with
) Iressa (gefitinib) in treatment-naive non-small cell lung
cancer (NSCLC) patients failed to meet its primary endpoint.
Statistically significant improvement in overall response rate or
progression-free survival (PFS) in treatment-naïve NSCLC patients
was not observed by adding ficlatuzumab to Iressa.
However, an exploratory analysis using VeriStrat identified a
patient sub-population that experienced a PFS and overall
survival benefit after using ficlatuzumab plus Iressa. Thus, we
are positive on AVEO's deal with Biodesix. We note that AVEO had
been looking for a partner to pursue further development of
ficlatuzumab for quite some time now.
Terms of the Deal
As per the terms of the deal, AVEO will initiate a
proof-of-concept study later this year, evaluating ficlatuzumab
in combination with
Astellas Pharma, Inc.
) Tarceva (erlotinib) in patients suffering from advanced NSCLC,
selected using VeriStrat.
AVEO will receive up to $15 million funding from Biodesix for the
study. The companies will share profits and development,
regulatory and commercial costs for ficlatuzumab beyond the
proof-of-concept study equally.
While Biodesix will be responsible for all development activities
and sales and marketing costs for VeriStrat, AVEO will undertake
the global commercialization responsibility of ficlatuzumab.
Biodesix will record all revenues related to VeriStrat.
We note that several other companies are developing oncology
candidates targeting the HGF/c-Met pathway.
AVEO carries a Zacks Rank #3 (Hold). Some better-ranked stocks
include Astellas carrying a Zacks Rank #2 (Buy).