On February 10, 2016 Heat Biologics, Inc. ("Heat") (Nasdaq:HTBX), an immuno-oncology company developing novel therapies that activate a patient’s immune system against cancer, reported trial evaluating HS-410 either alone or in combination with standard of care Bacillus Calmette-Guérin (BCG), for the treatment of non-muscle invasive bladder cancer (NMIBC) (Press release, Heat Biologics, FEB 10, 2016, View Source [SID:1234509028]). Heat will resume patient enrollment.

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"We appreciate the FDA’s expedited review and resolution of this matter as we resume enrollment in our Phase 2 monotherapy trial arm. We are encouraged by the positive results reported to-date and believe HS-410 represents a potential treatment option for patients suffering with non-muscle invasive bladder cancer," said Jeff Wolf, Heat’s Founder and Chief Executive Officer. "Our clinical timelines remain materially unchanged with topline data expected in the fourth quarter of 2016 for the Phase 2 randomized trial arms evaluating HS-410 in combination with BCG. We are grateful for the ongoing support of the patients and their physicians participating in our clinical trial."

About HS-410 (vesigenurtacel-L)

HS-410 is an investigational product candidate for NMIBC based on Heat’s proprietary ImPACT immunotherapy platform, designed to generate CD8+ "killer" T cells that attack cancer cells. HS-410 is currently being evaluated in a Phase 2, placebo-controlled, 100-patient NMIBC trial at multiple centers and has been granted U.S. FDA Fast Track Designation for the treatment of NMIBC.