On February 03, 2016 Heat Biologics, Inc. ("Heat") (Nasdaq:HTBX), an immuno-oncology company developing novel therapies that activate a patient’s immune system against cancer, reported that the company has recently concluded that the cell line on which HS-410 is based had been previously misidentified(Press release, Heat Biologics, FEB 3, 2016, View Source [SID:1234508949]). Schedule your 30 min Free 1stOncology Demo! Heat has advised the U.S. Food and Drug Administration (FDA) of this conclusion, and the FDA has placed Heat’s HS-410 Phase 2 clinical trial on partial clinical hold while they review the updated documentation provided by Heat. Heat believes the partial clinical hold does not relate to concerns regarding the safety of HS-410. All currently enrolled patients can continue receiving HS-410 treatment, or comparator drugs, as per the current study protocol, but no new patients can be enrolled in Heat’s open-label, monotherapy arm until the partial clinical hold is lifted. Heat will amend all necessary documents including the related investigator brochure, study protocol and informed consent document.
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Heat is working diligently in collaboration with the FDA to resume enrollment in its clinical trial. Heat has confirmed that HS-410 drug product has remained consistent throughout all clinical trials and anticipates continuing development of HS-410 for the treatment of non-muscle invasive bladder cancer (NMIBC) with the existing cell line, contingent upon FDA’s removal of the partial clinical hold. All data generated and reported to date remains unchanged, including HS-410’s positive safety profile, immune response and shared antigenic profile with patient tumors. Heat anticipates that the partial clinical hold will be resolved quickly and that enrollment timelines for its Phase 2 trial evaluating HS-410 either alone or in combination with standard of care, Bacillus Calmette-Guérin (BCG), for the treatment of NMIBC will remain materially unchanged. As previously announced, Heat completed enrollment for the trial’s randomized, combination arms in October 2015 and continues to expect to report topline efficacy, immune-response and safety data in the fourth quarter of 2016.
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.