Heat Biologics Issues New PTX-35 Preclinical Data In Organ Transplantation, Update On HS-110

Heat Biologics Inc HTBX announced promising preclinical data regarding PTX-35. The data has been accepted for publication in the American Journal of Transplantation.

• A single dose of the preclinical version of PTX-35 (mPTX-35) expanded regulatory T cells (Tregs) and significantly improved disease and graft survival outcomes.
• Chemically induced pancreatic failure (a model for type-1 diabetes) could be partially reversed when mice were transplanted with beta-cell islet allografts and treated with mPTX-35.
• Long-term surviving grafts showed a marked increase in Treg infiltration, directly correlated with mPTX-35 agonist activity. 
• PTX-35 is a novel, potential first-in-class antibody immunomodulator of TNFRSF25 (death receptor 3).
• Jeff Wolf, Chief Executive Officer, noted, "We are also making significant progress with HS-110 and expect to file for an End of Phase 2 meeting with the FDA this quarter. Our goal for this meeting is to discuss potential Phase 3 registration pathways for HS-110. Although this submission is taking longer than expected, we believe we have prepared a very comprehensive package and look forward to the FDA's feedback."
• HS-110 (viagenpumatucel-L) is the Company's first biologic product candidate in a series of proprietary ImPACT based immunotherapies designed to stimulate a patient's T-cells to destroy cancer.
• Price Action: HTBX shares are down 1.30% at $3.04 during the market session on the last check Wednesday.