Bavarian Nordic Announces First Patient Treated in a Phase 1 Study of MVA-BN® Brachyury in Advanced Cancer

KVISTGAARD, Denmark, July 24, 2014 – Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) announced today that the first patient has been treated in an NCI-sponsored Phase 1 study of MVA-BN Brachyury in patients with advanced cancer. 

MVA-BN Brachyury is a novel, active immunotherapy developed using Bavarian Nordic’s proprietary validated MVA platform. This immunotherapy is designed to induce a robust immune response against Brachyury, a tumor-associated antigen which is overexpressed in every major solid tumor setting. Brachyury is believed to play a key role in both the metastasis and progression of tumors. Tumors which overexpress Brachyury are believed to be highly resistant to current therapies and are associated with decreased survival rates.

Paul Chaplin, President and CEO of Bavarian Nordic said: “Brachyury is an exciting and novel target which in recent years has come to be associated with highly difficult to treat, aggressive tumors, and we are pleased to introduce our newest pipeline candidate into the clinic. These tumors either fail to respond to current cancer treatments, or have metastasized beyond localized therapies. Using our proprietary and specialized immunotherapy platform, we created a drug candidate which can harness the immune system to target Brachyury and may offer a treatment option to those patients with aggressive or late stage disease. We are proud to be working with the NCI to become one of the leaders in this exciting space as Brachyury continues to gain interest with both investigators and drug developers.”

The study is an open label, Phase 1 trial that will enroll patients with advanced cancer into three cohorts (6 patients per dose cohort) with dose escalation of MVA-BN Brachyury. Additional patients may be enrolled at the maximum tolerated dose. The objective of the study is to determine the safety and tolerability of escalating doses of MVA-BN Brachyury and to evaluate immunologic responses as measured by an increase in Brachyury-specific T cells. Principal Investigator is Christopher R. Heery, M.D., NCI. Full details for the study can be found here:

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 MVA-BN Brachyury
Brachyury is a transcription factor that is involved in mesodermal development in the embryo, and involved in epithelial–mesenchymal transition (EMT) in tumor cells, a key step in tumor invasion and metastasis. MVA-BN Brachyury is based on MVA-BN (Modified vaccinia Ankara Bavarian Nordic), which has been clinically tested in more than 7,300 subjects, including cancer patients, and has shown to be well-tolerated and to induce a strong immune response. The product candidate also employs the TRICOM technology (human T cell costimulatory molecules; B7.1, ICAM-1 and LFA-3), which has been extensively studied in both preclinical and clinical studies and have demonstrated their ability to induce robust T-cell activation and provide evidence of clinical benefit. TRICOM is employed in the Company’s other active immunotherapy candidates, PROSTVAC and CV-301.

MVA-BN Brachyury has been shown to be a good target for active T cell immunotherapy in preclinical models.

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. 

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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. 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. 16 / 2014