Heat Biologics announces FDA clearance of application to start Phase 1 trial
Heat Biologics announced that the U.S. Food & Drug Administration has cleared the company's Investigational New Drug application to initiate a Phase 1 clinical trial of HS-130, in combination with HS-110, for patients with advanced solid tumors refractory to standard of care. HS-130 is Heat's allogeneic cell line engineered to express the extracellular domain of OX40 ligand fusion protein, a key costimulator of T cells, with the potential to augment antigen-specific CD8+ T cell response. HS-130 was manufactured by utilizing the company's proprietary process of reprogramming a live, genetically modified cell line. Improved efficacy and safety were demonstrated in multiple preclinical scenarios using OX40L-Fc via cell-based delivery compared to systemic delivery of an OX40 agonist antibody in combination with HS-110. "HS-130 represents a major advance in the broad utility and versatility of our T-Cell Activation Platform," said Jeff Wolf, Founder & CEO of Heat. "We are leveraging the scientific, clinical and manufacturing expertise that we refined in the development of our HS-110 program in our effort to advance multiple cell-based cancer therapeutics for the activation of patients' immune system. We look forward to providing further updates on both the upcoming trial and clinical enrollment, which we expect to commence in the fourth quarter of 2019."