Heat Biologics, Inc. Commences Patient Dosing Of Phase 2 Clinical Study Of Vesigenurtacel-L For The Treatment Of Bladder Cancer

Heat Biologics, Inc. HTBX, a clinical stage biopharmaceutical company focused on the development of cancer immunotherapies, announced today that it has initiated patient dosing in its Phase 2 clinical trial of vesigenurtacel-L (HS-410) in subjects with high-risk, non-muscle invasive bladder cancer. Vesigenurtacel-L is Heat's investigational drug in a series of proprietary Immune Pan Antigen Cytotoxic Therapy ("ImPACT") based allogeneic cell lines designed to direct killer T cells to attack cancer. The primary endpoint for the Phase 2 portion of the bladder cancer study is one-year disease-free survival. The multi-center Phase 2 portion of Heat's bladder cancer study is designed to determine whether vaccination with one of two doses of vesigenurtacel-L in combination with Bacillus Calmette-Guérin (BCG) after transurethral resection of bladder tumor (TURBT) increases disease-free survival at one year compared to BCG in combination with placebo. The blinded, randomized placebo-controlled study will enroll approximately 75 patients. Heat expects to complete patient enrollment of the Phase 2 study in the third quarter of 2015 and report topline results in third quarter of 2016. "We have made substantial progress executing on our clinical strategy over the course of the year, specifically advancing our two lead product candidates for lung and bladder cancers into Phase 2 development," said Jeff Wolf, Chief Executive Officer of Heat Biologics. "The start of patient dosing of vesigenurtacel-L for bladder cancer, a full quarter ahead of schedule, is a major milestone for Heat and a clear example of the team's commitment to operational excellence." Mr. Wolf concluded, "By accelerating the bladder cancer program into Phase 2, we are now well positioned to provide the disease-free survival data ahead of schedule and are another step closer to fulfilling a true unmet need for bladder cancer patients with the potential of providing a new, viable and effective treatment." Patient enrollment and dosing in the vesigenurtacel-L Phase 2 study for the treatment of bladder cancer is expected to be completed in the third quarter of 2015. The Company anticipates reporting top-line results in the third quarter of 2016 after the study's twelve-month patient observation period concludes. For patients and physicians interested in enrollment information for the Phase 2 portion of the study of vesigenurtacel-L in patients with high-risk non-muscle invasive bladder cancer, please visit clinicaltrials.gov and use Identifier NCT02010203.