Heat Biologics' lead product candidate flunks mid-stage bladder cancer study; shares plummet 56%

|By:, SA News Editor

Nano cap Heat Biologics (HTBX -55.7%) gets slammed on double normal volume in response to its announcement that lead product candidate HS-410 (vesigenurtacel-L) failed to beat placebo in a Phase 2 study in non-muscle invasive bladder cancer. The data were presented at the Society of Urologic Oncology Annual Meeting in San Antonio, TX.

The company says HS-410 generated a robust antigen-specific immune response to multiple tumor-associated peptides (compared to zero for placebo) but the responses did not translate into clinical outcomes. There was no statistically significant difference in the primary endpoint (proportion of recurrence-free survival at year 1) between the treatment and placebo arms.

CEO Jeff Wolf says, "We are actively pursuing new programs to complement our existing platforms, which we expect to announce in early 2017. Moreover, we look forward to examining the additional top-line data that will be reported next week for our combination trial of HS-110 with Bristol-Myers Squibb's (BMY -1.1%) Opdivo (nivolumab) in lung cancer."

HS-410, based on the company's proprietary ImPACTimmunotherapy platform, is designed to generate certain immune cells, CD8+ killer T cells, that attack cancer cells.