BioAegis Awarded BARDA Contract to Advance Development of a Novel Host-Directed Human Protein for Patients With Sepsis & Severe Infection

BioAegis Therapeutics Inc. recently announced it was awarded a contract from Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services, to further develop the company’s novel host-directed therapy for the critically ill sepsis patient population.

The DRIVe (BARDA’s Division of Research, Innovation and Ventures) Solving Sepsis initiative seeks innovative host-based approaches for the development of diagnostics, devices, and therapeutics. BioAegis offers a novel recombinant protein therapy with the potential to broadly treat inflammatory disorders, like sepsis, that can arise from injury or infection. Given the current lack of FDA-approved sepsis host targeted therapeutic products, recombinant human plasma gelsolin (rhu-pGSN) has the potential to address the major clinical need to restore immune balance in this patient population. Rather than suppressing the immune system, this protein therapy supplementation approach is designed to normalize the patient’s immune response. The product is the recombinant form of a naturally occurring human host protein with a benign safety profile in clinical trials. Rhu-pGSN is currently being studied in the EU in severe COVID-19 and this program will support further studies in the US.

Rhu-pGSN is a broad-acting threat-agnostic product that improves immune cell function at sites of injury by enhancing pathogen killing while also resolving inflammation. The product will target severe systemic inflammatory responses due to infection or injury to mitigate poor outcomes.

The partnership will support regulatory activities and manufacturing readiness in preparation for future clinical evaluation of the technology in a sepsis patient population. These activities will position this technology for potential use as a host-based treatment of sepsis and other acute inflammatory indications.

“We are excited to begin this collaboration with BARDA to advance our unique, host-targeted approach to address the most serious issues associated with infection, injury and inflammatory disease,” said Susan Levinson, PhD, co-founder and CEO of BioAegis.

BioAegis Therapeutics Inc. is a NJ-based clinical stage, private company whose mission is to capitalize on a key component of the body’s innate immune system, gelsolin, to prevent adverse outcomes in diseases driven by inflammation and infection.

BioAegis’ platform is built upon the recombinant form of plasma gelsolin, a highly conserved abundant human protein in healthy individuals. Its role is to keep inflammation localized to the site of injury and to boost the body’s ability to clear pathogens, but normal levels are depleted by diverse inflammatory conditions. Restoring gelsolin levels with the human recombinant form helps immune cells fight infection and controls inflammation so it does not spread and cause damage.

BioAegis has the exclusive license to broad, worldwide intellectual property through Harvard-Brigham and Women’s Hospital. It holds over 40 patents issued for coverage of infection, inflammatory disease, renal failure, multiple sclerosis and other neurologic diseases. BioAegis will also have US biologics exclusivity and has recently filed new IP in areas of unmet need.