Bristol-Myers Squibb has signed an exclusive option to license and commercialize Prostvac, Bavarian Nordic's investigational Phase III prostate-specific antigen (PSA)-targeting cancer immunotherapy in development for the treatment of asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC) in a deal potentially valued up to $1 billion. Bavarian Nordic is a biotechnology specializing in developing immunotherapies and vaccines

Under the agreement, Bavarian Nordic will receive an upfront payment of $60 million. Bristol-Myers Squibb can exercise the option in its sole discretion within a designated time after data is available from the ongoing Phase III trial. Bavarian Nordic would be entitled to a payment of $80 million upon exercise of the option plus additional incremental payments starting at $50 million, but with a potential to exceed $230 million should the median overall survival benefit of Prostvac exceed the efficacy seen in Phase II results. Furthermore, Bavarian Nordic could receive regulatory milestone payments of $110 million, up to $495 million in sales milestones as well as tiered double-digit royalties on future sales of Prostvac. The parties have also agreed to enter into a supply contract, under which Bavarian Nordic will undertake the future commercial manufacturing of Prostvac.

An investigator sponsored Phase II study is currently in the planning stages to investigate the combination of Bristol-Myers Squibb's Yervoy (ipilimumab) and Prostvac. Yervoy, which is a recombinant, human monoclonal antibody, is approved by the US Food and Drug Administration as a monotherapy for patients with unresectable or metastatic melanoma; it posted 2014 sales of $1.3 billion.The companies have also entered into an agreement by which they may conduct one or more exploratory combination studies of Prostvac, and agents from Bristol-Myers Squibb's immuno-oncology portfolio.Bristol-Myers Squibb 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 Bristol-Myers Squibb's immuno-oncology portfolio.

Prostvac is a ready-to-use immuno-oncology agent that stimulates an immune response that attacks prostate cancer cells. Administered subcutaneously, Prostvac employs Bavarian Nordic's active immunotherapy (vaccinia-fowlpox/TRICOM) technology platform. When PSA-TRICOM is presented to the immune system in the Prostvac regimen, cytotoxic T lymphocytes (CTLs) are generated that may recognize and kill PSA-expressing cancer cells and trigger an immune response to other tumor antigens.

Source: Bristol-Myers Squibb