Galena stops late-stage study of NeuVax in breast cancer due to lack of efficacy; shares off 70% premarket

• Based on the recommendation from the Independent Data Monitoring Committee, Galena Biopharma (GALE) discontinues its Phase 3 PRESENT study assessing Fast Track-tagged NeuVax (nelipepimut-S) to prevent breast cancer recurrence in the adjuvant setting. An interim analysis of 71 qualifying disease-free survival events failed to show a significant effect from treatment with NeuVax.
• The trial remains blinded. The company says it will host a conference call next week after evaluating the data.
• NeuVax is an HER2-directed immunotherapy being investigated for the prevention of breast cancer recurrence after standard-of-care treatment in the adjuvant setting. Adjuvant therapy is any treatment given after primary (first-line) therapy.
• Shares are down 70% premarket on robust volume.
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