Design-Zyme, KU collaboration results in $3 million SBIR award for Lyme disease vaccine development

LAWRENCE — The woods can be a place of adventure and beauty, a peaceful escape for a walk. But sitting among the leaves and grass, the invisible threat of ticks can turn an outdoor hike into a health-altering encounter with Lyme disease. A recent $3 million Small Business Innovation Research (SBIR) award will fund the research and development of a vaccine to stop Lyme disease in its tracks. 

Peter Petillo, the founder and CEO of Design-Zyme, and P. Scott Hefty, professor of molecular biosciences and director of the National Institutes of Health-funded Center of Biomedical Research Excellence in Chemical Biology of Infectious Disease at the University of Kansas, are collaborating on the project. The vaccine uses hyaluronic acid as an adjuvant, a substance added to vaccines to help the body create a stronger immune response. It will target multiple strains of the pathogen Borrelia burgdorferi, the primary bacterium that causes the disease. It is spread to humans through the bite of infected black-legged ticks, also known as deer ticks. 

“The idea of using hyaluronic acid as an adjuvant against a bacterial target, which Lyme disease is, is something that has never been investigated,” Petillo said. “The idea was to take our existing Lyme disease vaccine and apply a new adjuvanting strategy. It is designed to work against all forms of Lyme disease that we know of.”

A rising threat

Over 63,000 cases of Lyme disease were reported to the Centers for Disease Control & Prevention in 2022. Between 2016 and 2021, the Kansas Department of Health & Environment reported an average of 31 cases annually. However, many cases can go undetected, and recent estimates suggest that upward of 476,000 people in the U.S. may be diagnosed and treated each year. It can cause acute disorders and is also associated with chronic issues like arthritis. A previous vaccine was discontinued in 2002, and no other approved vaccine is currently on the market. 

“Phylogenetically, it’s very distant from many other bacteria,” Hefty said. “Given the public health significance and the challenges associated with it, it became a really intriguing question and problem that I wanted to help commit my professional career to better understand.” 

Preliminary data around the vaccine's efficacy, developed in Hefty’s lab in partnership with Petillo, was supported by a J.R. & Inez Jay Fund research award in 2023. 

That data led to the SBIR award, which is a Direct to Phase II (D2P2) award. Petillo and Hefty showed sufficient data to bypass Phase I, funding meant to generate preliminary results. The SBIR contract is from the National Institute of Allergy & Infectious Diseases, part of the National Institutes of Health.

The hyaluronic hype

Hyaluronic acid might sound familiar to anyone who has spent time in a store's skincare or supplements aisle. It’s produced naturally in the body, mainly in the eyes, joints and skin. Products boast of its benefits, ranging from anti-aging results and moisturizing skin to alleviating acid reflux and treating burns and wounds. Petillo has been working on hyaluronic acid since the late 1980s and says the molecule is near and dear to his heart. As a linear carbohydrate, it has different functions as its length changes. 

“As you reduce the size of the hyaluronic acid, you can find this sweet spot, which is what we’ve done with our adjuvanting strategy,” Petillo said. “You can boost the immune response of something that is already slightly immunogenic on its own.” 

The ultimate goal of the SBIR grant is to have a self-adjuvanting Lyme disease vaccine ready for preclinical development. Ideally, the vaccine wouldn’t need an additional adjuvant to increase its effectiveness. 

“If you can package the adjuvant with the vaccine itself, you may be able to reduce the dose of either the adjuvant or the vaccine, or hopefully, both,” Petillo said.

A collaborative success

Both Petillo and Hefty attribute the success of this project to the ongoing collaboration between Design-Zyme, located at KU Innovation Park’s west facility, and KU researchers. Design-Zyme’s very first intern from KU now serves as the company’s chief science officer. Both sides of the partnership — industry and academia — serve a purpose. 

“For the most part, individual faculty at an academic institution are really good at basic discovery, basic characterization, a lot of the preliminary research that goes on,” Hefty said. “Most of us are not trained or have the expertise in how to translate that information into a commercial sector component. This is a great example of how a local company and Pete’s expertise marries with the scientific expertise and resources at the university.” 

On the other side of the equation, Petillo said small companies can’t do it all. 

“These strategic partnerships — in this case, with Scott and his colleagues — have been incredibly fruitful for us,” Petillo said. “It allows us to tap into expertise that we don’t have and allows us to move forward an asset like this Lyme disease vaccine in a way that would not be possible in the absence of collaboration.” 

Hefty enlisted Kathryn Reif, associate professor and Bailey-Goodwin Endowed Chair in parasitology in the College of Veterinary Medicine at Auburn University, and Robin Orozco, assistant professor in molecular biosciences at KU, to complete the team. Hefty and Reif are focused on challenge studies, while Orozco provides her expertise in immunology. 

“This relationship has long-standing benefits not only with our graduate training but also with our junior faculty,” Hefty said.

Stopping the uptick

A quick online search about the 2024 tick season shows similar results — ticks are thriving. This season got off to a record start in the northeast, Wisconsin and California, among other places. Data from the Environmental Protection Agency shows that the incidence of Lyme disease in the U.S. has nearly doubled since 1991, noting that the life cycle and prevalence of black-legged ticks are strongly influenced by temperature. And as temperatures stay warmer for longer, ticks are becoming increasingly active. 

“It has been argued that it’s not necessarily a real public health crisis yet,” Petillo said. “I think it is already. This is one of the reasons why we’ve chosen Lyme disease as a target.”