I think if they wanted to establish further validation of the TIL biomarker assay, they could potentially randomize metastatic melanoma stage 3 and 4 patients into two separate arms, each using the assay to select for hypothetical non-responders. One arm in the registration trial could be EP il-12 concurrent with anti-pd-1 antibody treatment whereas the other would be monotherapy anti-pd-1. This setup would further verify the biomarker assay and solidify efficacy evidence for EP il-12 when it is used in combination with anti-pd-1 drugs.
The company's current phase 2 combination melanoma trial, I believe, is a major inflection point with international significance. Efficacy in screened non-responders changes everything for anti-pd-1 treatments. It appears as though only a few of us can see what is on the nearby horizon.
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