Heat Biologics (HTBX) Issued Key Patent on Combination Platform Therapy

Heat Biologics, Inc. ("Heat") (NASDAQ: HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, including multiple oncology product candidates and a novel COVID-19 vaccine, today announced it has been issued a patent (US Patent No. 10,758,611) by the U.S. Patent and Trademark Office (USPTO) covering compositions of matter that are part of Heat's gp96 platform in combination with a T cell costimulatory agonist in a single therapy. This newly issued US patent compliments Heat's growing patent estate on this platform technology, which also includes US Patent No. 10,046,047, with claims to compositions of matter covering Heat's gp96 platform in combination with OX40L, a T cell costimulatory agonist.

Pre-clinical studies combining Heat's secreted gp96 plus OX40L T cell co-stimulator in a single therapy, administered locally, have demonstrated superior activity in preclinical studies compared to gp96 in combination with conventional OX40 antibody administered systemically by IV infusion. Additional potential advantages of this novel combination approach include enhanced memory T cell response, limited systemic toxicity and cost advantages compared to multiple systemic therapies.

Jeff Wolf, Chief Executive Officer of Heat, commented, "This newly issued patent represents a potential breakthrough in combination drug development. Current combination approaches under development hold significant promise but also face meaningful challenges such as systemic toxicity and a lack of measurable synergistic effect. In contrast, we have developed a unique approach, combining the strengths of our gp96 platform (including antigen presentation, T cell activation, and TLR activation) with an immune booster (providing, for instance, localized T cell co-stimulation) in a single therapy. We believe this combination therapy holds enormous promise in the treatment of cancer and infectious diseases, potentially including COVID-19."

"Specifically, our preclinical studies have demonstrated more pronounced CD8+ T cell prime and memory response; increased antigen specificity; no off-target systemic inflammatory cytokines; greater anti-tumor immunity; and increased overall survival. Our Phase 1 trials with gp96 (HS-110) in combination with OX40L (HS-130) and checkpoint inhibition are now underway, and we look forward to providing further clinical updates."

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