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

Trial is being conducted as part of clinical collaboration with Bristol-Myers Squibb  

COPENHAGEN, Denmark, October 10, 2016 - 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 ipilimumab (Yervoy®), an immune checkpoint inhibitor from Bristol-Myers Squibb, as neoadjuvant therapy in 75 patients with localized prostate cancer.

Patients will be randomized into three cohorts of 25 each to receive either PROSTVAC or ipilimumab or a combination of both. The primary endpoint of the study is to evaluate CD3+ T cell immune responses and secondary measures include immunologic infiltration, circulating effector T cells and regulatory T cells. The principal investigator of the study is Lawrence Fong, MD, Professor, Department of Medicine (Hematology/Oncology), University of California, San Francisco (UCSF) and UCSF is also sponsor of the study.  More information on the trial can be found at http://clinicaltrials.gov/ct2/show/NCT02506114

Checkpoint inhibitors continue to show impressive benefit for a number of cancers, said Dr. Fong. As we continue to explore the potential for benefit in a broader group of patients, we are looking toward combinations of therapies that may have the ability to enhance the clinical activity we have seen to date in certain cancers. Combining a cancer vaccine which specifically targets antigens against prostate cancer and has shown an ability to stimulate the body's T cell immune response, with a checkpoint inhibitor may enhance efficacy in attacking tumors. We look forward to evaluating this further in the trial.

The combination of PROSTVAC and ipilimumab was previously investigated in an NCI-sponsored Phase 1 trial in patients with metastatic castration-resistant prostate cancer, 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.

We are pleased to expand the scope of PROSTVAC trials into combinations with immunotherapies that have complementary mechanisms of action. Based on previously reported data from the combination treatment of PROSTVAC and ipilimumab, we believe this combination may generate synergistic effects which could improve the long-term outcome for the patients, said Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic.

This is the first trial conducted under the clinical collaboration with Bristol-Myers Squibb which was entered in 2015 upon signing of an option and license agreement for PROSTVAC. A second trial is planned in order to investigate the combination treatment of PROSTVAC, ipilimumab and nivolumab (Opdivo®), the latter also a checkpoint inhibitor product from Bristol-Myers Squibb's immuno-oncology portfolio.

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 home to 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 16 ongoing or completed clinical studies, comprising more than 1,800 patients of which more than 1,100 patients have been actively treated with PROSTVAC, which 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 in 1,297 patients, which has completed enrollment and top-line data are anticipated in 2017.

PROSTVAC is being developed in collaboration with the National Cancer Institute under a Cooperative Research and Development Agreement.

Latest review article:
PROSTVAC® targeted immunotherapy candidate for prostate cancer
ND Shore, Immunotherapy. 2014;6(3):235-47

More information available at http://www.bavarian-nordic.com/pipeline/prostvac.aspx.

About ipilimumab
Ipilimumab (Yervoy®) is an immune checkpoint inhibitor developed and marketed by Bristol-Myers Squibb. It is approved by the FDA for the treatment of melanoma.

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

2016-10-10-en


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Source: Bavarian Nordic A/S via Globenewswire

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