A possible preventive shot for Lyme disease has passed through an initial and successful human test phase and could go before federal regulators in the next few years.
The so-called TNKX-4800 can now move towards the final two clinical phases after a partnership was announced between the team behind the medicine and a pharmaceutical company.
Mark Klempner, a physician scientist with the University of Massachusetts Chan Medical School and who has studied various infectious diseases for almost 40 years with a focus on Lyme, said that monoclonal antibodies could promise immunity of Lyme disease for the entirety of peak tick season through a single shot.
Klempner, who’s worked next to the discoverer of the disease Willy Burgdorfer, has studied how the bacteria in infected ticks causes Lyme disease, how the disease can be treated acutely and chronically, and has focused research on the original vaccine studies.
While at the Chan Medical School, unlike the LYMERix® drug that was approved and taken off the market in 2002, Klempner’s focused on a prevention that isn’t a vaccine but a monoclonal antibody. (Reasons behind the discontinuation include a “lukewarm endorsement” for the vaccine by an “influential panel” at the Center for Disease Control and a series of claims, which turned out to be unfounded, that the vaccine caused adverse side effects, Klempner said.)
The product that Klempner and his team has worked on for around a decade, is now known as TNX-4800 after the recent partnership was established with Tonix Pharmaceuticals, clinical-stage biopharmaceutical company based in Massachusetts, to further develop the medicine.
The shot takes a different approach than typical vaccines and uses monoclonal antibodies, which are human antibodies, safe enough that they’re used for premature babies to prevent respiratory syncytial virus, or RSV.
“One of the beauties of [monoclonal antibodies] is that it doesn’t depend on the person’s immune system,” Klempner said. The antibody is pre-formed, put underneath the skin and then absorbed over a period of 24 to 48 hours. The person would then be immune to Lyme disease for the entirety of the tick season.
This preventative medicine is almost instantaneous and present in the bloodstream within a couple of days, whereas in the case of Lyme vaccines, Klempner said, immunity can take months and requires multiple doses.
Lyme disease is caused by the bacterium Borrelia burgdorferi that is present in the gut of infected ticks, so that when an infected tick bites someone and feeds on their blood, the Lyme-causing bacteria slowly travels from the tick’s gut and is transferred to the site of the bite.
Klempner said he and his team identified the most potent antibody that neutralizes bacteria in the tick gut on mice then non-human primates. It protected the animals from Lyme disease at the right dosage, he said.
The medicine was then manufactured to a high-quality standard, and his team conducted an initial human phase study between 2022 and 2024 in Lincoln, Nebraska to determine safety and longevity. Their results, which found that the antibody was safe and lasted long enough for the entirety of the tick season (from around April or May through October or November), were presented to Tonix Pharmaceuticals, which has the resources and expertise to take the studies through the next phases.
The next steps include two more phases that expand the number of people who receive the shot and discern the efficacy of the medicine as well as a continued look at safety.
The current plan, Klempner said, though the decisions are up to Tonix Pharmaceuticals, is that phase two and phase three clinical trials occur in 2027. That would occur over the course of the year, and especially in the tick season, and then an application for licensure could conceivably go before the federal Food and Drug Administration in 2028.
There are a few other approaches under investigation to prevent Lyme disease. One vaccine by Pfizer is in clinical trials and included the Island as a participant in the studies. Other approaches include genetic-engineering of mice to make them resistant to the bacteria that infects ticks as well as a diagnostic test and vaccines for tick-borne diseases out of Yale University’s School of Medicine.
