Researcher's Lyme disease intervention headed to market

On one wall in the modest office of Maria Gomes-Solecki, DVM, a professor in the Department of Microbiology, Immunology & Biochemistry at the University of Tennessee Health Science Center, hangs a framed letter that is the culmination of more than 20 years of work.

Dated April 27, the letter is from the U.S. Department of Agriculture with notification that an animal vaccine for Lyme disease that she conceived, funded with federal grants for development, and field tested has been conditionally approved for commercialization. Dr. Gomes-Solecki is also a co-founder of the Memphis-based company, US Biologic Inc., which holds the license to bring the oral vaccine designed to block the spread of Borrelia burgdorferi, the bacterium that causes Lyme disease, to market.

"This is a professional accomplishment that fills me with great joy," Dr. Gomes-Solecki said. "This was a goal I had from my early days as a rookie scientist. There's a nice little document over there that I've framed to remind me of that on the days I have to check my grant scores."

The big idea

In 2002, Dr. Gomes-Solecki had the idea for what today is the vaccine called Borrelia Burgdorferi Bacterin, which is now being marketed by US Biologic. At that time, a vaccine for Lyme disease that had been approved for human use was being discontinued. Dr. Gomes-Solecki felt that this vaccine could still be used for a different purpose. With some tweaks she turned the injectable vaccine for humans into an oral vaccine that could be delivered to an animal population, in this case mice, which carry the Borrelia burgdorferi (B. burgdorferi) bacterium.

"The vaccine is designed to be administered to mice in the form of pellets," Dr. Gomes-Solecki explained. "When the mice eat the pellets, they produce antibodies in their blood to the B. burgdorferi protein contained in the pellets. When deer ticks (traditional carriers of this bacterium) take a blood meal from vaccinated mice, the antibodies in the mouse blood neutralize B. burgdorferi inside the tick, thus, no Lyme disease transmission occurs if the tick feeds on humans. So, what we're doing indirectly is reducing the infection rate of the ticks that can transmit Lyme disease."

In reducing the B. burgdorferi infection rate of the ticks, that should theoretically reduce human exposure to Lyme disease, lowering the incidence of the disease in humans, which the Centers for Disease Control and Prevention estimates affects approximately 476,000 people a year in the United States.

"I had this idea in 2002 and I did the experiments for about two years to acquire data to write the first grant," Dr. Gomes-Solecki said. When she got the first grant in 2004, she brought in Luciana Richer, DVM, MSc, who did much of the work in the laboratory, first when the two researchers were at New York Medical College, and later at UTHSC. Dr. Gomes-Solecki also partnered with several other institutions to field test an early version of the vaccine from 2007-2011 in the woods in upstate New York. That test showed a reduction in tick infections and moved the project forward.

From promise to production

Once the preclinical work on the vaccine was accomplished in 2012, she stepped back, and enabled the technology transfer from Biopeptides, Corp. (the company that held the patent) to the new company she co-founded (US Biologic), which has been shepherding the vaccine through the complex USDA regulatory process for the last 11 years. This month, US Biologic is poised to send pellets coated with the vaccine through the vast distribution network of pest-management professionals located in the 15 states in the upper northeast, upper Midwest, and the Atlantic Seaboard, where Lyme disease infection rates are highest.

"Luciana Richer, is a person I would like to share credit with, as she rendered this vaccine to practice in the long run, and she worked relentlessly at US Biologic to get this vaccine through the USDA approval process," Dr. Gomes-Solecki said. Dr. Richer is now the laboratory director and senior scientist at US Biologic.

"The vaccine going to market is personally satisfying for me, to translate basic technology into an important product," Dr. Richer said.

Mason Kauffman, chief executive officer for US Biologic, is excited not only about the potential for the product to impact Lyme disease infection rates, but also about the future of Memphis as a hub of public-private partnerships like this for the development and distribution of vaccines to combat pathogens that cause disease outbreaks.

Kauffman said Memphis presents the perfect blend of academic medicine, biological science technology companies, business incubators and support services, and a strong logistics network to encourage similar success stories in the future. He said Memphis could one day be a "world vaccine platform" for exporting disease prevention technology.

US Biologic is now working with the USDA for full approval.

The next big idea

Dr. Gomes-Solecki is back in the laboratory working on an intranasal Lyme disease vaccine for humans. She also has submitted two grants to the National Institutes of Health through UTHSC for basic research, one on leptospirosis, and one, developed by a collaborator, to test probes for imaging Borrelia burgdorferi.

Essentially, not much has changed since the conditional approval of the drug she invented two decades ago. She is quick to say that researchers do not work for accolades or to get rich when their work goes to market.

"I don't think people that do what I do, do it for money," she said. "We pursue science because we have to. It's a calling, you just do it. I enjoy doing it."

"The idea was good, and I've been able to write grants on it, and the reviewers of these grants appreciated the impact of the research," she continued. "Like any other scientist, my salary comes mostly from my grants, so that's what we get paid to do and what we're supposed to do. People going off thinking that they're going to launch companies and that they're going to make a lot of money, it is unlikely to happen."

Still, she is excited to see her vaccine concept moving into commercial use, thanks to the combined effort of the US Biologic team, and she keeps her eye on the good it stands to produce.

"I am very happy, and I hope the vaccine will help," she said. "I mean, the goal is to have an impact on reducing Lyme disease cases in humans."

Provided by University of Tennessee Health Science Center