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news.Bristol-Myers Squibb has entered into a $975m option and licensing deal with Danish biotech firm Bavarian Nordic for its prostate-cancer vaccine candidate Prostvac.
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Under the deal, BMS will have an exclusive option to license and commercialize Prostvac, which is being developed to treat asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC).
Prostvac is an investigational Phase III prostate-specific antigen (PSA)-targeting cancer immunotherapy.
The deal will see BMS pay $60m upfront to Bavarian Nordic, with the remaining money being dependent on how Prostvac gets through its ongoing phase III trial and the FDA approval process.
Bavarian Nordic will also be entitled to a payment of $80m upon exercise of the option plus additional incremental payments starting at $50m, but with a potential to exceed $230m should the median overall survival benefit of Prostvac exceed the efficacy seen in Phase II trial results.
In addition, the Danish firm could receive regulatory milestone payments of $110m, up to $495m in sales milestones as well as tiered double-digit royalties on future sales of the product.
The two firms have also agreed to enter into a supply contract, under which Bavarian Nordic will undertake the future commercial manufacturing of Prostvac.
Bristol-Myers Squibb Oncology Development head Michael Giordano said: "While additional treatment options have become available, metastatic castration-resistant prostate cancer remains largely incurable.
"Our agreement with Bavarian Nordic reflects our commitment to following the emerging science in immuno-oncology and supports our strategy to transform the treatment of cancer across multiple tumor types, lines of therapy and stages of disease."
Currently, an investigator sponsored Phase II trial is in the planning stages to investigate the combination of BMS’ Yervoy (ipilimumab) and Prostvac.
The parties have also entered into an agreement under which they may conduct one or more exploratory combination trials of Prostvac and agents from BMS’ immuno-oncology portfolio.
BMS has an ongoing Phase III program for Yervoy in prostate cancer, and scientific rationale exists to evaluate Prostvac in combination with Yervoy, and other agents from its immuno-oncology portfolio.