Abstract

3081 Background: Saccharomyces cerevisiae has been genetically modified to express Brachyury (Br) protein and developed under a CRADA with GlobeImmune/NCI as a heat-killed immune-stimulating therapeutic cancer vaccine (GI-6301). Br is a member of the T-box family of transcription factors and is a key factor in embryonic (mesoderm) development. Chordoma, a rare tumor of the notochord (derived from mesoderm) is known to overexpress Br while expression in normal adult tissue is minimal or not present. Preclinical work has demonstrated Br specific T cells can lyse human Chordoma cells expressing Br in an MHC restricted fashion. Methods: We enrolled a cohort of 7 pts with advanced Chordoma on an expansion cohort of a phase I study (NCT01519817) and evaluated their clinical and immunologic outcomes. All pts had undergone previous radiation (median 470 days since radiation: range 111-1883). All received 40 yeast units of vaccine every 2 weeks x 7 with first restaging at day 85. If stable, pts went on to monthly ...

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