Date: 2014-07-24
Type of information: Treatment of the first patient
phase: 1
Announcement: treatment of the first patient
Company: Bavarian Nordic (Denmark)
Product: MVA-BN Brachyury
Action
mechanism: Brachyury is a transcription factor that is involved in mesodermal development in the embryo, and involved in epithelial–mesenchymal transition (EMT) in tumor cells, a key step in tumor invasion and metastasis. MVA-BN Brachyury is based on MVA-BN (Modified vaccinia Ankara Bavarian Nordic), which has been clinically tested in more than 7,300 subjects, including cancer patients, and has shown to be well-tolerated and to induce a strong immune response. The product candidate also employs the TRICOM technology (human T cell costimulatory molecules; B7.1, ICAM-1 and LFA-3), which has been extensively studied in both preclinical and clinical studies and have demonstrated their ability to induce robust T-cell activation and provide evidence of clinical benefit.
Disease: advanced cancer
Therapeutic area: Cancer - Oncology
Country: USA
Trial
details: The study is an open label, Phase 1 trial that will enroll patients with advanced cancer into three cohorts (6 patients per dose cohort) with dose escalation of MVA-BN Brachyury. Additional patients may be enrolled at the maximum tolerated dose. The objective of the study is to determine the safety and tolerability of escalating doses of MVA-BN Brachyury and to evaluate immunologic responses as measured by an increase in Brachyury-specific T cells. Principal Investigator is Christopher R. Heery, M.D., NCI. (NCT02179515)
Latest
news: * On July 24, 2014, Bavarian Nordic announced that the first patient has been treated in an NCI-sponsored Phase 1 study of MVA-BN Brachyury in patients with advanced cancer. MVA-BN Brachyury is a novel, active immunotherapy designed to induce a robust immune response against Brachyury, a tumor-associated antigen which is overexpressed in every major solid tumor setting. Tumors which overexpress Brachyury are believed to be highly resistant to current therapies and are associated with decreased survival rates.
