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Tuesday, September 06, 2016 5:43:00 PM
I asked about proprietary rights to the Bio-Marker test for screening patients for the combo trial.
Their response:
"We will not be developing a companion diagnostic in parallel with our commercialization strategy for ImmunoPulse IL-12. The current biomarker assay has proven to be a very strong surrogate for the low-TIL (anti-PD1 resistant) patient population that we are focusing on with ImmunoPulse Il-12.
This was nicely highlighted in the Journal of Clinical Investigation (http://www.jci.org/articles/view/87324) showing that this biomarker assay can accurately predict patients who will and will not respond to checkpoint therapies. The data published provides evidence of the strong predictive value to stratify patients and will be able to robustly identify a combination efficacy signal in our ongoing single-arm trial. Our planned melanoma registration study will be treating patients that fail anti-PD1 therapy.
My take is that they will not owe any royalties or fees for the use of the Bio-Marker test.
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