Bavarian Nordic A/S announced 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.