Heat Biologics, Inc. (“Heat”) (NASDAQ:HTBX), a clinical-stage biopharmaceutical company specialized in the development of novel therapeutic and prophylactic vaccines, including one for coronavirus COVID-19, announced that it is collaborating with Waisman Biomanufacturing to establish a partnership for the manufacture of Heat’s COVID-19 vaccine.
Waisman specializes in the manufacture of cellular therapeutics and other biologics for early-stage clinical trials and is part of the University of Wisconsin (Madison, Wisconsin). It has manufactured over 320 clinical grade products, earning a reputation for cost-effective and timely production of quality biologics.
Heat Biologics previously worked with Waisman to manufacture Heat’s HS-130, which is currently in a Phase 1 clinical trial, and is collaborating with Waisman to support the manufacturing of its COVID-19 vaccine for expected Phase 1 trials in humans. The vaccine leverages Heat’s proprietary gp96 platform to target the SARS-CoV-2 coronavirus that causes COVID-19. Heat’s unique approach is designed to induce a multi-epitope specific memory CD8 T-cell response that protects against multiple, distinct coronavirus strains and against potential future mutations of SARS-CoV-2 and other coronaviruses.
Jeff Wolf, Chief Executive Officer of Heat, stated, “We continue to advance our COVID-19 vaccine and are pleased to be working with Waisman to assist our manufacturing efforts. We remain encouraged by the potential of our platform to provide broad protection against COVID-19, particularly for elderly patients and those with underlying health conditions that have an increased risk of complications and death from COVID-19. Our confidence is reinforced by numerous National Institutes of Health (NIH) and U.S. Department of Defense (DOD)-funded mice and primate trials utilizing our gp96 platform to generate vaccines against SIV/HIV, malaria, zika and other infectious diseases. These trials have demonstrated gp96 is a powerful platform with antiviral activity in the lungs, as evidenced by a potent immune response and effectiveness in the induction of mucosal immunity in several infectious disease models.”
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Carl Ross, Managing Director of Waisman Biomanufacturing, commented, “We are honored to partner with Heat again on the development of this very unique COVID-19 approach. We believe our unique capabilities and expertise, as well as the experience that we gained working with Heat to manufacture their HS-130, which is based upon the same gp96 platform, will help further the manufacturing timeline for this potentially life-saving COVID-19 vaccine.”