Bavarian Nordic Announces Initiation of Clinical Trial with Novel Cancer Immunotherapy Targeting Brachyury in Cancer Metastasis

• Brachyury plays a key role in metastasis and progression of tumors and is overexpressed in several major, as well as orphan cancers

COPENHAGEN, Denmark, January 19, 2018 - Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) announced today the initiation of a clinical trial of BN-Brachyury, a novel cancer immunotherapy candidate designed to target brachyury, a key driver of cancer metastasis in several tumor types. The open-label Phase 1 trial will evaluate the safety and tolerability of the MVA-BN^® Brachyury vaccine, followed by a Brachyury encoded fowlpox (FPV) booster in patients.

The trial will enroll up to 10 patients with metastatic or unresectable, locally advanced malignant solid tumors. Patients will receive two prime doses of MVA-BN Brachyury, followed by multiple booster doses with FPV-Brachyury. The primary endpoint of the study is safety and tolerability, and secondary endpoints include immunologic responses as measured by an increase in brachyury-specific T-cells and other tumor-associated antigens, as well as evidence of clinical benefit such as progression-free survival (PFS) and objective response (OR). The priming vaccine alone, MVA-BN Brachyury, was previously investigated in a Phase 1 study in 38 patients with chordoma or metastatic solid cancers, and was shown to be well-tolerated and to induce brachyury-specific T-cell immune responses in the vast majority of patients.

"The brachyury target represents an exciting new approach to attacking multiple cancers and deadly metastasis," commented Paul Chaplin, President and Chief Executive Officer of Bavarian Nordic. "Based on clinical results to date, we believe that BN-Brachyury may be a viable treatment option for patients with various forms of cancer. We look forward to further expanding the program with a Phase 2 study later this year in patients with chordoma - a rare tumor of the spine known to overexpress brachyury, for which there are currently no systemic treatments of proven efficacy available."

About BN-Brachyury
BN-Brachyury is a novel prime-boost cancer immunotherapy candidate, developed in collaboration with the National Cancer Institute (NCI). The product candidate consists of a prime (MVA-BN) and a booster dose (fowlpox or FPV), which have been modified to express brachyury and to encode three costimulatory molecules, known as TRICOM. Brachyury is a tumor-associated antigen that is overexpressed in major solid tumor indications, as well as several rare, ultra-orphan cancer indications, and is reported to play a key role in the metastasis and progression of tumors. Tumors that overexpress brachyury are believed to be highly resistant to standard therapies, including radiation and chemotherapy, and are associated with decreased survival rates.