On August 12, 2019 Heat Biologics, Inc. (NASDAQ:HTBX), a clinical-stage biopharmaceutical company specialized in the development of therapeutics designed to activate a patient’s immune system against cancer, reported that the U.S. Food & Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) 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 (Press release, Heat Biologics, AUG 12, 2019, View Source [SID1234538595]).
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HS-130 is Heat’s allogeneic ("off-the-shelf") cell line engineered to express the extracellular domain of OX40 ligand fusion protein (OX40L-Fc), 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 (TCAP)," 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."
"HS-130 is the first cell-based approach that utilizes OX40 co-stimulation," said Jeff Hutchins, Ph.D., Heat’s Chief Scientific and Operating Officer. "In our first-in-human dose escalation study, we are evaluating the potential synergy of combining HS-130 with HS-110, our NSCLC cell line that secretes up to 90 "neoantigens" combined with gp96, the body’s most powerful natural immune adjuvant. Once the optimal dose and ratio of OX40L-Fc and GP96-Fc are confirmed clinically, our future development plan includes engineering a single cell line that secretes both agents."
About T-Cell Activation Platform (TCAP)
Heat Biologics’ proprietary TCAP is an allogenic ("off-the-shelf"), cell-based system. This platform enables the combination of multiple T cell stimulators and/ or activators within a single cell system. Currently HS-110 and HS-130 are in clinical development with engineered gp96-Fc and OX40L-Fc, respectively.
About HS-110
HS-110 is the company’s lead product candidate utilizing TCAP. This product candidate is designed by engineering gp96-Fc to deliver 78 cancer antigens to stimulate the patients’ immune system and activate a robust cytotoxic T cell response. HS-110 is currently being evaluated 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).
About HS-130
HS-130 is a new cell line developed using TCAP that is expected to be entering clinical trials in Q4/19. HS-130 is designed to secrete OX40L-Fc, 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.