KVISTGAARD, Denmark—Prostate cancer is the second most frequently diagnosed cancer and the sixth most deadly cancer in men. Bavarian Nordic, an international biotechnology company developing and manufacturing novel cancer immunotherapies and vaccines for infectious diseases, and New York-based Bristol-Myers Squibb (BMS), a global biopharmaceutical company, are joining forces to fight it.
The two companies signed an agreement giving Bristol-Myers Squibb 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. Prostvac, a ready-to-use immuno-oncology agent, stimulates an immune response that attacks prostate cancer cells.
Under terms of the agreement, Bavarian Nordic could receive as much as $975 million, including an upfront payment of $60 million. Bristol-Myers Squibb can exercise the option at 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, with the potential to exceed $230 million if the median overall survival benefit of Prostvac exceeds the efficacy seen in Phase 2 results. Furthermore, Bavarian Nordic could receive regulatory milestone payments of $110 million and as much as $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.
The agreement the two companies signed is an option agreement, which allows Bavarian Nordic to continue its ongoing Phase 3 program for Prostvac. Data from this study will give BMS important clinical information and help to inform a decision on whether BMS will exercise its option, according to Michael Giordano, head of development for oncology at Bristol-Myers Squibb.
Giordano explained, “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.”
“Prostvac has the potential to become an essential component in the treatment of prostate cancer,” said Dr. Paul Chaplin, CEO of Bavarian Nordic. “Leveraging the capabilities of Bristol-Myers Squibb’s science, we look forward to exploring the full potential of Prostvac in the future treatment paradigm of prostate cancer.”
Prostvac is administered subcutaneously and is uniquely designed to initiate a robust immune response, specifically targeting prostate cancer cells, resulting in a T cell-mediated killing of cancer cells. Prostvac immunotherapy consists of a heterologous prime/boost regimen and has the potential to enhance antigen presentation and otherwise broaden the immune response to PSA-expressing tumor cells.
There is no specific time frame for the agreement and, as noted earlier, BMS can exercise the option at its sole discretion within a designated time after data is available from the ongoing Phase 3 trial.
Castration-resistant prostate cancer is defined by disease progression despite androgen-deprivation therapy and may present as one or any combination of a continuous rise in serum levels of prostate-specific antigen, progression of pre-existing disease or appearance of new metastases, according to Giordano. Most deaths will be caused by metastatic castration-resistant prostate cancer, which occurs when the cancer becomes resistant to standard hormonal treatment and spreads from the prostate to other organs in the body.
BMS is focusing on therapeutic vaccines with promising clinical data in strategically selected tumors with unmet need. Prostvac’s unique biology and promising clinical data from a controlled Phase 2 study present an opportunity to potentially license and commercialize a late-stage asset. Bristol-Myers Squibb also has an ongoing Phase 3 program for Yervoy (ipilimumab) in prostate cancer, and scientific rationale exists to potentially evaluate Prostvac in combination with Yervoy and other agents from Bristol-Myers Squibb’s immuno-oncology portfolio.