As tick season worsens each year in the Northeast and cases of Lyme disease trend upward, researchers at the UMass Chan Medical School say they've reached a new milestone in developing a potential solution.
It's a seasonal treatment that could prevent the tick-based bacterial infection happening in humans altogether, for practically a year at a time. The Massachusetts research school has now partnered with a pharmaceutical company to advance its development and with further testing and approvals, it could soon be a regular shot that takes some of the bite out of tick bites.
To learn more, WAMC spoke with both UMass Chan’s Dr. Mark Klempner and Dr. Seth Lederman, CEO of Tonix Pharmaceuticals.
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Following extensive research and studies, UMass Chan says it's recently nailed down a major licensing deal with the New Jersey-based Tonix. At the center of the agreement: TNX-4800.
“We know that the bacteria that causes Lyme disease is wearing on its outer surface - one of its outer surface proteins - a particular protein called ‘outer-surface protein A,’” Klempner tells WAMC. “… when it is neutralized or bound-up, the bacteria is very, very vulnerable, unhappy, dies, doesn't mature and that all happens right in the midgut of the tick. And so, we sought out to find a single antibody that we could provide to individuals that would neutralize that Outer-surface protein A while the bacteria was still in the midgut of the tick.”
“We did a search of a whole bunch of human antibodies that were directed against OspA and we found about 600 of them. What we did then was … “down select” or reduce the number to the one or two or three that were the most potent in doing that job, of inactivating the bacteria in the midgut of the tick. We ultimately found one of those antibodies, now known as TNX-4800, that we said should protect animals and people from getting Lyme disease.”
Klempner tells WAMC that during testing, TNX-4800 was able to block the transmission of Lyme disease from a tick to a mouse and also effectively block transmission from many infected ticks to a primate. Administering it to humans was also a success. One of the most important findings, he notes - a lack of serious side effects.
“The next step in all of this is to say, ‘Okay, we have a potential medicine that can prevent Lyme disease - we now need to make sure that we can manufacture it to the quality that it needs to be to be administered to humans’ and we then proceeded to do that,” he explains. “Then the next big step is to show that it is nontoxic, because when you're going to give a medicine to normal people to prevent an infection - not to treat a disease, but to prevent an infection - you have to have, as your highest, highest priority: safety.”
“We've known that for over 40 years, little babies have been given human monoclonal antibodies to prevent respiratory syncytial virus infection (RSV) and there have been virtually no important side effects of giving a human monoclonal antibody to the most vulnerable population in the world - premature babies,” Klempner adds. “We are confident that this human monoclonal antibody will have the similar safety profile. We went about proving that - that involves another human trial as well … we did a phase one trial on the manufactured medicine and showed that in human beings, it was extremely safe. We didn't see, really, any serious adverse effects and the only adverse effects that we did see were little injection site things that were no different than in people who received the placebo injected into their skin.”
“We were able to measure that protective antibody [in] these volunteers and saw that, within a day or so, they achieved levels that we believed would be protective and that lasted a very long time,” he adds. “That's the development pathway that brings us to now, where we are about to embark on with the partnership of Tonix.”
This past month, the university announced a major step in the treatment's development: licensing its worldwide rights to Tonix Pharmaceuticals based out of Chatham, New Jersey. The company just shepherded a treatment for fibromyalgia through the FDA approval process, CEO Dr. Seth Lederman tells WAMC – one of the upcoming hurdles the Lyme disease treatment will face.
Lederman notes a significant preventative treatment for Lyme comes at a time when the disease isn't showing any signs of abating.
“First of all, Lyme is an enormous problem - there's 70 million people in the United States who live in areas where infected-ticks are common. The second problem with Lyme is that people normally do not make protective immunity,” he explains. “With most other infections, if you've had it once, you're not going to get it again: that's not the case with Lyme. [People can] keep getting it over and over and over, and the immunity that that is developed is not protective - it's really like playing Russian roulette - maybe you won't get Chronic Lyme this time, but if you keep getting Lyme and keep getting sick, at some point, you'll become one of the 20 percent who develops Chronic Lyme.”
“Why is that? Because the target of our antibody - and the target of vaccines under development - is a protein called OspA, and that's only expressed by the bacteria that causes Lyme when it's in the belly of the tick,” Lederman says. “… humans, even if they're infected, don't make antibodies to OspA - they need either a vaccine to force them to make antibodies, or, in our case, an antibody to be administered to do the work for them.”
“There's more than one vaccine under development, and that's a vaccine directed against OspA - there was a vaccine that was formerly approved and then withdrawn from the market because of side effects, and that was directed against OspA,” he adds. “I think there's generally agreement that OspA is the target of either active vaccination or passive immunity with our antibody, but as far as I know, we are the only ones at this stage of development with an active antibody like this, that has been through all of the extensive animal and Phase 1 testing that UMass has done with our product.”
Ideally, Lederman says someone could receive a single injection of the treatment in the spring, and with the antibody doing its thing, Lyme disease protection would run all the way through the summer and fall.
Klempner says the treatment is coming about as the population of ticks only continues to grow.
“There's no question that there is an increasing burden of ticks in not just the Northeast, but widely, across the United States, and especially concentrated in our area as well as the Upper Midwest and also globally: Lyme disease is present in the temperate zones around the world and there's Lyme disease in Europe, as well,” Klempner tells WAMC. “There's no question that we are seeing increasing numbers of cases, we're seeing a wider-range of populations that are living in endemic areas, and climate change is expanding the range of this tick that likes to live in sort of temperate areas and… that temperate zone is going ever-north. We’re seeing lots of cases in what we would consider more northern climes… in the Scandinavian-area of the world as well as the upper parts [of] Maine and areas of Canada, etc. [It’s a] big problem there as well.”
He says he's hopeful clinical trial work will wrap up by the end of 2027. Applying for FDA approval would come soon afterwards, and if granted, the treatment could conceivably be made available by the end of 2028 or early 2029.
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This piece originally aired on Thursday, Oct. 2, 2025.
