On December 16, 2019 Heat Biologics, Inc. (NASDAQ:HTBX), a clinical-stage biopharmaceutical company specialized in the development of therapeutics designed to activate patients’ immune systems against cancer, reported that the Company has dosed the first patient in the first Phase 1 clinical trial of HS-130, in combination with HS-110, for patients with advanced solid tumors refractory to standard of care (Press release, Heat Biologics, DEC 16, 2019, View Source [SID1234552383]).
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HS-130 is Heat’s allogeneic cell line engineered to locally secrete the extracellular domain of OX40 ligand fusion protein (OX40L-Fc), a key costimulator of T cells, designed to augment antigen-specific CD8+ T cell response. HS-130 was manufactured by utilizing the Company’s proprietary process to reprogram a live, genetically modified cancer cell line. In multiple preclinical models, these responses have demonstrated improved efficacy and safety using OX40L-Fc via cell-based delivery compared to systemic delivery of an OX40 agonist antibody in combination with HS-110.
The first-in-human study is expected to enroll up to 30 patients under the supervision of lead investigator Dr. Rachel Sanborn, Director of the Phase 1 Clinical Trials Program at the Earle A. Chiles Research Institute, a division of Providence Cancer Institute in Portland, Oregon. In this study, patients will receive escalating doses of HS-130 in combination with HS-110. The objectives of the study are to evaluate patient safety and to determine the optimal dose for a subsequent Phase 2 trial.
Jeff Wolf, Heat’s CEO, commented, "We are pleased to announce the initiation of this combination study, which marks a key milestone for Heat as we advance our latest asset into clinical development. We look forward to sharing clinical proof of concept data to enable the development of a new generation of allogeneic therapy drug candidates in 2020."
About HS-110
HS-110 is designed by engineering gp96-Fc to deliver more than 70 cancer testis antigens to stimulate the patients’ immune system and activate a robust cytotoxic T cell response. HS-110 has completed enrollment in a Phase 2 clinical trial for advanced non-small cell lung cancer, in combination with Bristol-Myers Squibb’s nivolumab (Opdivo) or with Merck’s pembrolizumab (Keytruda) (NCT 02439450).
About HS-130
HS-130 is designed with the same parent cell line as HS-110 but is engineered to secrete OX40L-Fc fusion protein, a potent inducer of antigen-specific CD8+ T cell proliferation. The first-in-human study aims to evaluate the safety and dose-response of HS-130 in combination with HS-110 in patients with advanced solid tumors (NCT04116710).