Bavarian Nordic has secured orphan drug designation from the US Food and Drug Administration (FDA) for its BN-Brachyury vaccine to treat chordoma, a rare form of cancer.
Developed in alliance with the National Cancer Institute, BN-Brachyury is a prime-boost cancer immunotherapy product which consists of MVA-BN (prime) and a booster dose of fowlpox/FPV.
MVA-BN, the company’s live virus vaccine platform technology, and fowlpox/FPV are altered to express brachyury, a tumour-related antigen, and to encode three costimulatory molecules called TRICOM.
Bavarian Nordic president and CEO Paul Chaplin said: “We are very happy to obtain orphan status for our chordoma programme, given the severe lack of effective therapies for this population of patients.
“Chordoma is a unique tumour where the brachyury protein is universally overexpressed; which presents us with an exceptional opportunity to use our vaccine in an optimally targeted manner.”
Tumours that overexpress brachyury are often highly resistant to standard therapies, including radiation and chemotherapy, and are associated with decreased survival rates.
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The company is planning to launch a Phase II clinical trial in the second half of this year to evaluate the BN-Brachyury vaccine in combination with radiation therapy in 25 subjects with metastatic chordoma.
Aimed at enhancing overall response rates, the Phase II trial follows an open-label Phase I study earlier this year that assessed the safety and tolerability of the vaccine in up to ten patients suffering from metastatic or unresectable, locally advanced malignant solid tumours.
The study will also examine other factors such as immunologic responses measured by a surge in brachyury-specific T-cells and additional tumour-associated antigens.