Bavarian Nordic A/S (CPH:BAVA) (OTC: BVNRY), a fully integrated biotechnology company, announced on Friday that it has initiated a clinical trial of BN-Brachyury, a novel cancer immunotherapy candidate designed to target brachyury, a key driver of cancer metastasis in several tumour types.

This 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.

Reportedly, this trial will enrol up to 10 patients with metastatic or unresectable, locally advanced malignant solid tumours. Patients will receive two prime doses of MVA-BN Brachyury, followed by multiple booster doses with FPV-Brachyury.

According to the company, the primary endpoint of the study is safety and tolerability, while secondary endpoints include immunologic responses as measured by an increase in brachyury-specific T-cells and other tumour-associated antigens, as well as evidence of clinical benefit such as progression-free survival (PFS) and objective response (OR).

MVA-BN Brachyury, the priming vaccine alone, 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.

BN-Brachyury is a novel prime-boost cancer immunotherapy candidate, developed in collaboration with the National Cancer Institute (NCI).

Bavarian Nordic is focused on the development of innovative and safe therapies against cancer and infectious diseases.