Heat Biologics Reports Amendment of Bladder Cancer Protocol for Early Advance Into Phase 2 Clinical Trial

Heat Biologics, Inc. ("Heat Biologics", "Heat" or the "Company")

, a clinical stage biopharmaceutical company focused on the development of novel cancer immunotherapies, announced today that it has amended the Phase 1/2 clinical protocol for Vesigenurtacel-L (HS-410) in patients with high-risk non-muscle invasive bladder cancer after transurethral resection of bladder tumor (TURBT). The modified treatment regimen facilitates a more robust dose-response analysis and will permit Heat to advance directly into Phase 2 trials following enrollment of a single cohort of Phase 1 data rather than the two cohorts required by the original trial design. Heat expects to complete enrollment of the Phase 1 portion of the study in the third quarter of 2014 and anticipates the Phase 2 study will commence in the fourth quarter of 2014, one quarter earlier than initially expected. The original Phase 1/2 bladder cancer trial protocol called for evaluation of two doses of monotherapy Vesigenurtacel-L after induction bacillus Calmette Guérin (BCG) to assess initial safety and determine the best dose to advance to Phase 2. The amended protocol changes the treatment regimen from monotherapy Vesigenurtacel-L following BCG to combination with BCG based on proposed synergy with the combination. This new regimen will start treatment with Vesigenurtacel-L earlier in the disease process and enable concurrent administration of BCG and HS-410 throughout the adjuvant therapy period. Furthermore, the revision advances both doses into Phase 2 to correlate the dose with recurrence rate. Heat's management team worked closely in consultation with its Clinical Advisory Board to develop this combination study with a clinically more meaningful and efficient design. The protocol revision is expected to allow for expedited advancement into Phase 2 and is accompanied by robust safety evaluation during the Phase 2 study. In the first seven patients treated to date, there have been no reported serious adverse events. Gary Steinberg, M.D., the Lead Principal Investigator for the trial and The Bruce and Beth White Family Professor and Director of Urologic Oncology at the University of Chicago Medical Center, commented, "To date, the positive safety data for Heat's immuno-oncology treatment is promising. There is a clear rationale for patients to receive treatment with Vesigenurtacel-L earlier in the disease process and we believe the amended regimen to start treatment closer to TURBT will better optimize patient outcomes. We are very interested in advancing into Phase 2 studies so we can begin to assess the response to Vesigenurtacel-L in high-risk patients in desperate need of viable treatment options for non-muscle invasive bladder cancer." Melissa Price, Ph.D., Heat's Vice President of Clinical and Regulatory Affairs, commented, "We are very pleased to be moving forward with this revised protocol. After careful consideration for safety, it was important for us to provide combination therapy at an earlier stage of disease progression with the optimal standard of care. We strongly believe that the redesign of the Phase 2 portion of our Vesigenurtacel-L study will produce more meaningful safety and efficacy results." The primary endpoint for the Phase 2 bladder study is one-year recurrence-free survival. The Company expects to complete patient enrollment and dosing in the third quarter of 2015. Following a twelve-month observation period of all patients in the trial, Heat expects to report top-line results in the third quarter of 2016. For patients and physicians interested in enrollment information for the Phase 1/2 study of Vesigenurtacel-L in patients with high-risk non-muscle invasive bladder cancer, please visit clinicaltrials.gov and use Identifier NCT02010203.