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Bavarian Nordic initiates Phase 2 trial

The first patient has been dosed in a Phase 2 study evaluating the company’s cancer immunotherapy, BN-Brachyury, and radiation in patients with advanced chordoma.

Chordoma is a rare cancer that occurs in the bones of the skull base and spine, resulting in approximately 1,000 new cases being diagnosed in the United States and Europe annually. The brachyury protein has been shown to be universally overexpressed in chordoma tumors, while not being found in most normal tissue. The presence of brachyury in epithelial solid tumors has been highly correlated with metastatic disease, multi-drug resistance and decreased survival rates. BN-Brachyury’s prime-boost vaccination regimen has been optimized to include the gene for brachyury, as well as costimulatory molecules (TRICOM) known to increase immune activation. Prior data suggests that BN-Brachyury can safely target brachyury and induce brachyury-specific T-cell immune responses.

About the trial

The Phase 2, multiple-site trial will assess the effectiveness of BN-Brachyury and radiation therapy in patients with advanced chordoma. The study is expected to enroll up to 29 patients, in a two-stage design. If the threshold of activity is reached in stage 1, the study will proceed to stage 2 and full enrollment. Patients will be administered a primer of the highly attenuated, non-replicating vaccinia virus MVA-BN-Brachyury, followed by a booster of the recombinant fowlpox virus FPV-Brachyury and radiation therapy. The study aims to determine if the combination therapy results in a clinically meaningful objective response rate (ORR) within 12 months of radiation therapy, a timeframe during which historical controls show an ORR of less than 5% with radiation alone.

Orphan drug designation

In May 2018, the FDA granted orphan drug designation to BN-Brachyury for the treatment of chordoma. The FDA’s Office of Orphan Drug Products grants orphan status to support development of medicines for safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States. Orphan drug designation may provide certain benefits, including a seven-year period of market exclusivity if the drug is approved, tax credits for qualified clinical trials and an exemption from FDA application fees.

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