A Sea Change in Sepsis Management from Horseshoe Crab Innovation

GREENSBORO, N.C. – December 13, 2022 – Kepley Biosystems, a North Carolina biotechnology company located at Gateway Research Park, has been awarded a $1 million National Science Foundation (NSF) Small Business Innovation Research (SBIR) Phase II grant to continue product development in sepsis diagnosis and management. The grant, entitled, “A Rapid, Sensitive Pathogen Typing and Antibiotic Sensitivity Test for Bloodstream Infections (COVID-19)” improves infectious disease management and would transform the current standard of care. Sepsis takes a life every 2.8 seconds and is the leading cause of hospital mortality, annually taking some 49 million lives, worldwide. Now ranked as the most expensive healthcare challenge, its US toll exceeds $62 billion per year. Yet the disease has continued to pose management and prevention challenges, to which one out of three sepsis patients succumbs.

Rapid detection of bloodborne infections prior to the onset of sepsis is critical, as the risk of mortality increases 8% every hour without appropriate treatment. However, when suspected from clinical symptoms that often mimic other causes, empiric antibiotic therapy has given rise to antimicrobial resistant microbes or ‘superbugs’ due to lengthy, established test methods. As such, overuse of antibiotics has been declared one of the top ten threats to humanity by the World Health Organization.

This Kepley BioSystems NSF grant will support Phase II development of a rapid bloodstream infection detection technology. The innovation employs a component of horseshoe crab blood, Limulus amebocyte lysate (LAL), which reacts with pathogens at parts per trillion levels. “Such sensitivity is comparable to a single drop of water in 20 Olympic size pools,” said Kepley director of Scientific Communications and Operations, Lee Robertson.

“Infectious disease complexities in a respiratory pandemic have highlighted how early diagnosis in 1-3 hours with small sample volumes and pathogen differentiation could make an outsized contribution to healthcare. The infection sequelae are similar, but treatment differs significantly. Proof of these parameters is also in our Phase II goals,” said Kepley director of Research and Development, Dr. Rachel Tinker-Kulberg. She added, “If we can impact the entire continuum of care, from admissions through patient care and discharge – by identifying infections early and optimizing treatment, this work could save lives.”

In a recent statement by the Centers for Disease Control and Prevention (CDC), the agency reported that “historic progress made in antibiotic prescribing was reversed during the pandemic.” Overall, it has been estimated that antimicrobial resistance contributes to approximately 10% of sepsis deaths. The Kepley Biosystem Phase II NSF diagnostic and infectious disease surveillance research would also seek to answer this call to address critical health care gaps and slow the spread of resistance.

Kepley BioSystems president, Dr. Anthony L. Dellinger asked, “If not LAL – then what – as the scourge of bloodborne disease overwhelms governments, science and industry? Sepsis morbidity is projected to lead all causes of death in my lifetime.”

Their Phase I research demonstrated the potential for a screening assay that would be more affordable than molecular assays and provide same-day treatment guidance without waiting days for traditional clinical microbiology. Phase II development will focus on alignment with existing hospital workflows and infectious disease management protocols. In addition to the $1 million dollar Phase II contract, Kepley is eligible to receive an additional $500,000 in matching funds with a qualifying third-party investment.

Kepley scientists have established significant expertise in horseshoe crab husbandryoptimizing critical components of their nutrition, and resulting in a sustainable aquaculture platform. Phase I efforts produced lysate (LAL) that was more reactive and consistent than commercial materials collected from the wild, while monitoring and ensuring the wellbeing of the husbanded crabs.

Dellinger concluded, “We are seeking a partnership with a global industry leader to bring this technology to hospitals that urgently need new sepsis management tools while mitigating risks of antimicrobial resistance. That has been and continues to be a serious threat lurking behind COVID-19 and many other viral pathologies not suitable for antibiotic administration.”

About Kepley Biosystems, Inc.

Kepley Biosystems is a North Carolina-based biotech company founded in 2013, with partnerships with the Joint School of Nanoscience and Nanoengineering (JSNN), North Carolina Agriculture and Technical State University (NCA&T) and the University of North Carolina at Greensboro (UNCG). The Kepley mission is to address globally significant opportunities through IP development, research and disruptive innovation. This NSF Phase II SBIR is the 3rd research grant unique to horseshoe crabs and by extension, the practicality of scalable aquaculture of the invertebrate for captive, repetitive bleeding compared to wild capture and an estimated 30% morbidity annually for for biomedical bacterial endotoxin testing (BET). Horseshoe crab ranching at Kepley has been proven over a 6-year period with healthy animals, survival, and proven sustainability advantages. The necessity for captive/aquaculture derived LAL and hemocyanin substrates are vital beyond BET, moving into clinical screening of human blood to detect and type pathogens for preventing and mitigating sepsis, and most recently, a patent grant using hemocyanin as an additive for tissue transplants and a biologic preservative (Innocuous sterilant using hemocyanin and functionalized fullerenes with broad-spectrum intracellular and interstitial microbiocidal and radical scavenging effects for packaged matter, biologics and organics, cells, and limbs with cooper mediated oxygenation for viability and preservation, Brady, et.al., #11452288; 9/27/2022).

Website: www.kepleybiosystems.com

About the National Science Foundation’s Small Business Programs

America’s Seed Fund powered by NSF awards $200 million annually to startups and small businesses, transforming scientific discovery into products and services with commercial and societal impact. Startups working across almost all areas of science and technology can receive up to $2 million to support research and development (R&D), helping de-risk technology for commercial success. America’s Seed Fund is congressionally mandated through the Small Business Innovation Research (SBIR) program. The NSF is an independent federal agency with a budget of about $8.5 billion that supports fundamental research and education across all fields of science and engineering.

Website: https://seedfund.nsf.gov

Anthony L. Dellinger, PhD
President at Kepley BioSystems Inc.
Email: adellinger@kepleybiosystems.com
Phone (Office): +1-336-217-5163
Address: 2901 East Gate City Blvd, Suite 2400, Greensboro, North Carolina 27401

SOURCE: Kepley BioSystems Inc.