I think the term biomarker is a somewhat non typical in this case, Rather than a molecular driver such as BRAF, RAS, EGFR he is referring to ALC acting a a coarse indicator of a functioning immune system. 818 use for ITK inhibition requires a functional immune response,
" We now know that 818 induces a host antitumor cell mediated response that requires normal functioning T-cells. We have observed that a minimum absolute lymphocyte count or ALC above 900 per cubic millilitre of blood is required for response. Normal ALC ranges from 1,000 to 4,000."
In any case the Phase IB enrollment continues using this indicator so it should become apparent whether the use of this indicator helps better target the ongoing trial.
Miller has an impressive record of bring drugs to market. However, I doubt that the FDA sought him out to design the Phase 3 trial. He has likely exploited long term relationships since he is approaching a rather desperate period (risk of delisting. only a year of cash, etc.). I view CRVS as some what of a long shot lottery ticket, unless they announce a deep pocketed partner in the next couple months.
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