Bavarian Nordic said Friday that it has kicked off a clinical trial of BN-Brachyury, a novel cancer immunotherapy candidate designed to target brachyury.
The open-label Phase 1 trial for, as BN calls it, a key driver of cancer metastasis in several tumor types, 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.
Paul Chaplin, President and Chief Executive Officer of Bavarian Nordic, said: “The brachyury target represents an exciting new approach to attacking multiple cancers and deadly metastasis. 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.”