Five years after Novartis $NVS abruptly dumped a program for its TKI dovitinib after it failed to beat sorafenib in a head-to-head Phase III showdown on metastatic renal cell carcinoma, a Danish biotech outfit is taking it on to see if they can get it off the shelf and across the finish line.
Oncology Venture — which prefers to see the Phase III data as proof that their drug was no worse than sorafenib — has followed up on an option deal to take on the drug, signing off on an unspecified list of upfront fee, milestones and royalties. And the biotech now plans to pursue a biomarker approach to identify patients most likely to respond favorably to the drug.
“We are confident that, by using our Drug Response Predictor biomarker for dovitinib to select likely responder patients — and the recent success with a combination of a TKI and a PD-1 inhibitor (Keytruda) in renal cancer – we will raise the chances of success for dovitinib in further clinical development. The dovitinib DRP biomarker could then be consequentially filed together with the Marketing Authorization Application and used as a predictive companion diagnostic to select likely responders,” said Peter Buhl Jensen, CEO of Medical Prognosis Institute. MPI and Oncology Venture are close affiliates that announced a merger plan last month.
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