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# FDA Lifts Hold on Heat Biologics Bladder Cancer Therapy
- URL: https://www.fdaweb.com/fda-lifts-hold-on-heat-biologics-bladder-cancer-therapy/
- Published: 2016-02-10T12:00:00.000Z
- Updated: 2026-09-15T02:34:45.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5134730

> FDA has lifted a partial clinical hold against Heat Biologics’ Phase 2 clinical trial evaluating HS-410 either alone or in combination with standard of care Bacillus Calmette-Guérin (BCG) for treating non-muscle invasive bladder cancer. Heat says it will now resume patient enrollment. “Our clinical timelines remain materially unchanged with top-line data expected in the fourth quarter of 2016 for the Phase 2 randomized trial arms evaluating HS-410 in combination with BCG,” the company says. HS-410 is an investigational product candidate based on Heat’s proprietary ImPACT immunotherapy platform, which it says is designed to generate CD8+ “killer” T cells that attack cancer cells.