Bavarian Nordic Reaches Enrollment Target in the Pivotal Phase 3 Study of PROSTVAC® in Prostate Cancer
KVISTGAARD, Denmark, December 10, 2014 – 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.
About the PROSPECT Phase 3 study
The PROSPECT study is a global randomized, double-blind, placebo-controlled study in patients with asymptomatic or minimally symptomatic mCRPC. The trial is being conducted under a Special Protocol Assessment agreement with the FDA. The primary objective of the study is to determine whether the overall survival of patients receiving PROSTVAC (with or without the addition of granulocyte macrophage colony-stimulating factor; GM-CSF), is superior to that of patients receiving placebo. The final analysis of the study will occur when 534 deaths have occurred in either one or both comparisons of the treatment arms vs. placebo. Integrated in the statistical plan are pre-specified interim analyses of data which will evaluate whether the trial should continue as planned or potentially be stopped early for efficacy. In such case, a Biologics License Application may be filed at an earlier stage, potentially shortening the overall development.
PROSTVAC is a PSA-targeted, ready-to-use active immunotherapy for the treatment of prostate cancer. Administered subcutaneously, it induces a specific, targeted immune response that attacks prostate cancer cells. A robust data package has been established through 12 ongoing and completed clinical Phase 1 and Phase 2 trials, where more than 300 patients have been treated, and the immunotherapy candidate has been generally well-tolerated. A randomized, placebo-controlled Phase 2 trial demonstrated the potential of PROSTVAC to extend the median overall survival by 8.5 months in patients with advanced prostate cancer. These results led to the initiation of the PROSPECT pivotal Phase 3 clinical trial study.
Concurrently with the Phase 3 study, PROSTVAC is also being clinically investigated in both metastatic and non-metastatic prostate cancer, in combination with enzalutamide (Xtandi®). Previous clinical studies combining PROSTVAC with other anti-androgen therapies or radiation therapy, either concomitantly or sequentially have indicated possible therapeutic synergies for these treatment combinations. In addition, preliminary evidence from pre-clinical and early clinical studies suggests potential for therapeutic synergy of combining PROSTVAC with immune checkpoint inhibitors, and Bavarian Nordic is working further to explore this opportunity.
PROSTVAC is being developed in collaboration with the National Cancer Institute under a Cooperative Research and Development Agreement. In April 2010, PROSTVAC was granted Fast Track designation by the FDA for the treatment of men with asymptomatic or minimally symptomatic mCRPC.
Rolf Sass Sørensen, Vice President Investor Relations (EU). Phone +45 61 77 47 43
Seth Lewis, Vice President Investor Relations (US). Phone + 1 978-298-5654
About Bavarian Nordic
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 3 clinical trial, and IMVAMUNE®, a non-replicating smallpox vaccine candidate in Phase 3 development, which is being developed and supplied for emergency use to the U.S. Strategic National Stockpile under a contract with the U.S. Government. The vaccine is approved in Canada under the trade name IMVAMUNE and in the European Union under the trade name IMVANEX. Bavarian Nordic's shares are listed on NASDAQ OMX Copenhagen under the symbol BAVA (Reuters: BAVA.CO, Bloomberg: BAVA.DC). The company has a sponsored Level 1 ADR program listed in the US (OTC) under the symbol BVNRY. For more information, visit www.bavarian-nordic.com.
This announcement includes forward-looking statements that involve risks, uncertainties and other factors, many of which are outside of our control that could cause actual results to differ materially from the results discussed in the forward-looking statements. Forward-looking statements include statements concerning our plans, objectives, goals, future events, performance and/or other information that is not historical information. We undertake no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances after the date made, except as required by law.
Company Announcement no. 33 / 2014