Bavarian Nordic has initiated a Phase I clinical trial of its new immunotherapy vaccine candidate, MVA‑BN Brachyury, designed to target the brachyury antigen in cancer metastasis.
Brachyury antigen is believed to be involved in the metastasis and progression of tumours, and is found to be over-expressed in multiple cancer types.
Developed in collaboration with the National Cancer Institute (NCI), MVA‑BN Brachyury consists of prime (MVA-BN) and booster (fowlpox or FPV) doses modified to express brachyury and to encode three costimulatory molecules called TRICOM.
In the Phase I trial, two prime doses of the investigational vaccine will be followed by several booster doses.
The open-label trial will assess the safety and tolerability of the vaccine candidate in up to ten subjects suffering from metastatic or unresectable, locally advanced malignant solid tumours.
In addition, the trial will also measure secondary endpoints such as immunologic responses, progression-free survival (PFS) and objective response (OR).
Bavarian Nordic president and CEO Paul Chaplin said: “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 programme with a Phase II study later this year in patients with chordoma: a rare tumour of the spine known to over-express brachyury, for which there are currently no systemic treatments of proven efficacy available.”
During a previous Phase I trial in 38 patients having chordoma, MVA-BN Brachyury alone was reported to have been well-tolerated and demonstrated the ability to trigger brachyury-specific T-cell immune responses in the majority of participants.