Date: 2015-03-04
Type of information: Licensing agreement
Compound: Prostvac®
Company: BMS (USA - NY) Bavarian Nordic (Denmark)
Therapeutic area: Cancer - Oncology
Type agreement: licensing commercialisation
Action mechanism: 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. Prostvac® is currently being evaluated in a global, randomized, double-blind, placebo-controlled phase 3 study (PROSPECT), that has fully enrolled at 1,298 patients with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC). Previous clinical studies of Prostvac®, either as single-agent therapy or in combination with anti-androgen therapies, radiation therapies or immune checkpoint inhibitors have indicated possible therapeutic synergies for these treatment combinations and PROSTVAC has been generally well-tolerated.
Disease: asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC)
Details: * On March 4, 2015, Bavarian Nordic and BMS announced an agreement that provides BMS an exclusive option to license and commercialize Prostvac®, Bavarian Nordic’s investigational Phase 3 prostate-specific antigen (PSA)-targeting cancer immunotherapy in development for the treatment of asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC). 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 2 study is currently in the planning stages to investigate the combination of BMS’s Yervoy® (ipilimumab) and Prostvac®. 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.
Financial terms: Under terms of 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 3 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 2 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®.
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