Novartis offloads failed cancer drug to Oncology Venture

Novartis
Novartis' headquarters (Novartis)

Oncology Venture has licensed a once-failed cancer drug from Novartis. The Swedish biotech picked up small molecule multi-kinase inhibitor dovitinib after an analysis of historic trial data suggested its drug response predictor will increase the likelihood of success.

Novartis touted dovitinib as a highly promising kidney cancer drug around the start of the decade on the strength of mid-phase data. But the candidate was unable to outperform Bayer’s Nexavar in a phase 3 trial of metastatic renal cell cancer patients previously failed by anti-angiogenic therapies. The failure marked the beginning of the end for dovitinib at Novartis.

Now, OV is giving the drug a second chance. OV has licensed the asset from Novartis in return for an upfront fee and milestone commitments of undisclosed size. 

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The decision to license the candidate follows the analysis of biopsies taken during Novartis’ clinical trial program, which spanned multiple cancer indications. OV applied its drug response predictor (DRP) to the samples in a blinded to proof-of-concept study to assess its ability to identify likely responders to dovitinib. 

The study found “a consistent signal” OV sees as indicative of the biomarker’s ability to spot responders. When combined with changes in the therapeutic landscape since dovitinib flamed out, OV sees the finding as encouraging enough to warrant restarting clinical development of the kinase inhibitor. 

“We are confident that, by using our DRP biomarker for dovitinib to select likely responder patients—and the recent success with a combination of a TKI and a PD-1 inhibitor in renal cancer—we will raise the chances of success for dovitinib in further clinical development,” OV CEO Peter Buhl Jensen, M.D., saId in a statement.

RELATED: Novartis buries a Phase 3 kidney cancer failure behind Q2 successes

OV is now working to improve its DRP biomarker by turning the technology on more biopsies and genomic data. The diagnostic approach is designed to show which tumor types are susceptible to a drug. Once OV has improved the DRP test, it will use it to assess whether breast and liver cancer patients are eligible to join a phase 2 trial of dovitinib.

The deal and R&D plan follow the blueprint established by OV, which thinks DRP can breathe new life into failed cancer drugs through better patient selection. That thinking has seen OV pick up a PARP drug from Eisai and liposomal doxorubicin from 2BBB Medicines. In the case of dovitinib, OV housed the asset in an asset-centric spinout to insulate it from the fallout of failure. 

OV first released news of a TKI licensing deal at the start of the year but that statement was light on details. The earlier release didn’t refer to dovitinib or Novartis by name, although OV had long since revealed the Swiss company to be the Big Pharma company on the other side of the deal table.