Bristol-Myers Squibb Signs Exclusive Agreement with Bavarian Nordic

Bavarian Nordic and Bristol-Myers Squibb Company recently announced an agreement that provides Bristol-Myers Squibb 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).

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 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. 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.

“While additional treatment options have become available, metastatic castration-resistant prostate cancer remains largely incurable,” said Michael Giordano, Head of Development, Oncology, Bristol-Myers Squibb. “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.”

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.

“We are proud to partner with Bristol-Myers Squibb whose excellence and leadership in immuno-oncology provides a strong foundation for advancing PROSTVAC, which has the potential to become an essential component in the treatment of prostate cancer,” said Paul Chaplin, PhD, and Chief Executive Officer 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 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 III 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.

Bavarian Nordic is an international biotechnology company developing and manufacturing novel cancer immunotherapies and vaccines for infectious diseases. Lead product candidates are PROSTVAC, an immunotherapy product candidate for advanced prostate cancer that is the subject of an ongoing pivotal Phase III clinical trial, and IMVAMUNE, a non-replicating smallpox vaccine candidate in Phase III development, which is being developed and supplied for emergency use to the US. For more information, visit www.bavarian-nordic.com or follow them on Twitter at http://twitter.com/bavariannordic.