Heat Biologics Closes HS-410 Manufacturing To Start Phase1/2Bladder Cancer Trial

(RTTNews) - Heat Biologics Inc. (HTBX) announced Monday that it has successfully completed the manufacture of the first GMP-grade batch of its HS-410 investigational drug, a fully-allogeneic, "off-the-shelf" live-cell cancer immunotherapy, for its planned Phase 1/2 bladder cancer trial. The company stated that it remains on track to commence patient enrollment before year-end.

Heat Biologics' allogeneic approach means that its live cell-based vaccines can be mass-produced and stockpiled for use on all patients, even before patients are identified and enrolled. The company noted that its drug is capable of being produced and administered at a fraction of the cost of autologous or "personalized" therapies. Unlike the current autologous cancer immunotherapies, Heat Biologics' proprietary, patented technology requires no invasive procedures to remove and re-deliver tumor or immune cells and therefore there are far fewer logistical hurdles in its production and delivery.

Heat's proprietary Immune Pan Antigen Cytotoxic Therapy or "ImPACT" reprograms live cancer cells from a single tumor source to continually secrete gp96, a chaperone protein found in all human cells. In turn, gp96 chaperones tumor antigens to T-cells, which is designed to activate a robust, pan-antigen T-cell immune response and direct killer T-cells to attack the patient's cancer. Heat's "ImPACT" technology holds promise for treating a wide variety of different cancers.