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Bavarian Nordic Announces Initiation of Phase 2 Combination Trial of PROSTVAC, Ipilimumab and Nivolumab in Patients with Localized Prostate Cancer

  • Second trial investigating PROSTVAC in combination with checkpoint inhibitors from Bristol-Myers Squibb  

COPENHAGEN, Denmark, April 19, 2017 – Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) today announced the initiation of a Phase 2 clinical trial of its prostate cancer immunotherapy candidate, PROSTVAC (rilimogene), in combination treatment with YERVOY® (ipilimumab) and/or OPDIVO® (nivolumab), both of which are immune checkpoint inhibitors from Bristol-Myers Squibb, as neoadjuvant therapy in patients with localized prostate cancer. 

A lead-in stage will evaluate the safety of the combination of all three drugs in 10 patients with castration-resistant prostate cancer, followed by enrollment of up to 55 patients with localized prostate cancer in three cohorts, who will receive PROSTVAC in combination with either ipilimumab or nivolumab, or a combination of all three drugs prior to undergoing radical prostatectomy. The primary endpoint of the study is to evaluate and compare changes in T cell infiltration in the tumor after neoadjuvant treatment across the three different cohorts. The principal investigator of the study is James L. Gulley, MD, Senior Investigator, Center for Cancer Research, part of the National Cancer Institute (NCI), and the sponsor of the study. Detailed information on the trial can be found at http://clinicaltrials.gov/ct2/show/NCT02933255

“There are now eleven ongoing studies of PROSTVAC across various stages of prostate cancer. In recent years, there has been a growing interest in the evaluation of the immunotherapy candidate in earlier disease stages, where the cancer has not yet spread beyond the prostate. We are excited to learn more about the potential of PROSTVAC for treating this population, and to evaluate the potential synergistic effects of combining the vaccine with checkpoint inhibitors, as we believe PROSTVAC may enhance the clinical activity of these drugs,” said Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic. 

This is the second trial conducted in collaboration with Bristol-Myers Squibb. The first trial was initiated in October 2016, and is investigating the combination treatment of PROSTVAC and ipilimumab at the University of California, San Francisco (UCSF), also in a neoadjuvant setting. 

For patients interested in enrolling in this clinical trial, please call NCI’s toll-free number 1-800-4-Cancer (1-800-422-6237) (TTY:  1-800-332-8615) and/or see the website:  https://trials.cancer.gov/ and search for NCT02933255. 

About PROSTVAC
PROSTVAC (rilimogene galvacirepvec/rilimogene glafolivec or “rilimogene”) is a prostate specific antigen (PSA)-targeted immunotherapy candidate designed to enhance or stimulate the body’s immune response, specifically T cells that will target and kill prostate cancer cells, altering the course of the disease and improving overall survival (OS) of patients with prostate cancer. A robust data package has been established that includes 19 ongoing or completed clinical studies, comprising more than 2,000 patients of which more than 1,100 patients have been actively treated with PROSTVAC, which has been generally well-tolerated. A pivotal Phase 3 clinical trial in 1,297 patients, designed to determine if PROSTVAC extends the overall survival for patients with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC) has completed enrollment and top-line data are anticipated in 2017.

The combination of PROSTVAC and ipilimumab was previously investigated in an NCI-sponsored Phase 1 trial in mCRPC patients, indicating improved survival for the treatment regimen when compared to the predicted survival (J Clin Oncol 33, 2015 (suppl 7; abstr 172)). This improved effect is believed to be due to PROSTVAC's ability to stimulate an anti-prostate cancer immune response combined with the ability of checkpoint inhibitors to make the anti-cancer immune response more effective. 

PROSTVAC is being developed in collaboration with the Center for Cancer Research, part of the intramural research program of the National Cancer Institute under a Cooperative Research and Development Agreement. 

More information available at /pipeline/prostvac.aspx.

About ipilimumab and nivolumab
Ipilimumab and nivolumab are immune checkpoint inhibitors developed and marketed by Bristol-Myers Squibb. Ipilimumab is a CTLA-4 antibody, which is approved by the FDA for the treatment of melanoma. Nivolumab is a PD-1 antibody, which is approved for the treatment of patients with NSCLC in the second line setting, among other indications. These immune checkpoint inhibitors work by targeting molecules that serve as checks and balances in the regulation of immune responses. By blocking inhibitory molecules or, alternatively, activating stimulatory molecules, these treatments are designed to unleash and/or enhance pre-existing anti-cancer immune responses. 

About Bavarian Nordic
Bavarian Nordic is a fully integrated biotechnology company focused on the development, manufacturing and commercialization of cancer immunotherapies and vaccines for infectious diseases, based on the Company’s live virus vaccine platform. Through long-standing collaborations, including a collaboration with the U.S. government, Bavarian Nordic has developed a portfolio of vaccines for infectious diseases, including the non-replicating smallpox vaccine, IMVAMUNE®, which is stockpiled for emergency use by the United States and other governments. The vaccine is approved in the European Union (under the trade name IMVANEX®) and in Canada. Bavarian Nordic and its partner Janssen are developing an Ebola vaccine regimen, which has been fast-tracked, with the backing of worldwide health authorities, and a vaccine for the prevention and treatment of HPV. Additionally, in collaboration with the National Cancer Institute, Bavarian Nordic has developed a portfolio of active cancer immunotherapies, including PROSTVAC®, which is currently in Phase 3 clinical development for the treatment of advanced prostate cancer. The company has partnered with Bristol-Myers Squibb for the potential commercialization of PROSTVAC. For more information visit www.bavarian-nordic.com or follow us on Twitter @bavariannordic.

Forward-looking statements
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. All such forward-looking statements are expressly qualified by these cautionary statements and any other cautionary statements which may accompany the forward-looking statements. 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. 

Contacts
Rolf Sass Sørensen
Vice President Investor Relations (EU)
Tel: +45 61 77 47 43 

Seth Lewis
Vice President Investor Relations (US)
Tel: +1 978 341 5271

Press Release

Published on April 19, 2017, 13:00 CET