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Clinical Trials

Date: 2018-11-01

Type of information: Treatment of the first patient

phase: 2

Announcement: treatment of the first patient

Company: Bavarian Nordic (Denmark)

Product: BN-Brachyury and radiation

Action mechanism:

  • immunotherapy product. BN-Brachyury is a novel prime-boost cancer immunotherapy candidate, developed in collaboration with the National Cancer Institute (NCI). The product candidate consists of two different vaccine components; MVA-BN and fowlpox or FPV, which have been modified to express brachyury and to encode three costimulatory molecules, known as TRICOM.
  • 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.
  • In May 2018, the FDA granted orphan drug designation to BN-Brachyury for the treatment of chordoma.

Disease: advanced chordoma

Therapeutic area: Cancer - Oncology - Rare diseases

Country:

Trial details:

  • 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.(NCT03595228)

Latest news:

  • • On November 1, 2018, Bavarian Nordic announced that the first patient has been dosed in a Phase 2 study evaluating its novel, targeted cancer immunotherapy, BN-Brachyury, and radiation in patients with advanced chordoma.
   

Is general: Yes