Bavarian Nordic Reaches Enrollment Target in the Pivotal Phase 3 Study of PROSTVAC® in Prostate Cancer

Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) announced today that it has reached the planned enrollment of 1,200 patients in the PROSPECT Phase 3 clinical study of its targeted active immunotherapy candidate, PROSTVAC®, in the treatment of asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC). Patients were enrolled at 214 sites in 15 countries.

 "We believe that PROSTVAC immunotherapy has the potential to become an important and foundational therapy for men with advanced prostate cancer, based on its ability to mobilize the immune system and stimulate T cell immunity to tumors. Bavarian Nordic wishes to thank the patients who are participating in the Phase 3 PROSPECT study, the Investigators and their study teams, and our NCI and academic collaborators for making today's key achievement possible," said James B. Breitmeyer, M.D., Ph.D., President of the Cancer Immunotherapy Division of Bavarian Nordic. "We will remain in close contact with the PROSPECT investigators as the patients complete treatment and results become available through interim and final analysis of the study. In parallel we are also continuing to explore the potential for synergistic combination of PROSTVAC with other treatments including immunotherapies."

The PROSPECT Phase 3 global study is being executed under the leadership of principal investigators James L. Gulley, M.D., Ph.D., Chief Genitourinary Malignancies Branch, Head, Immunotherapy Section, Center for Cancer Research, National Cancer Institute and Phil Kantoff, MD., Chief, Division of Solid Tumor Oncology, Director, Lank Center for Genitourinary Oncology at the Dana-Farber Cancer Institute and Professor of Medicine at Harvard Medical School. "Reaching the Phase 3 enrollment target marks a major milestone in the development of PROSTVAC, which we have been excited to participate in from its early stages of development, and which we hope will replicate the promising survival results seen in Phase 2. If proven effective, a generally well tolerated, ready to use subcutaneous immunotherapy like PROSTVAC would be an important foundational treatment option for oncologists and urologists and their prostate cancer patients," said Dr. Kantoff.