Photo: Bryan Goodchild
UMass Chan Medical School has licensed worldwide rights to a long-lasting human monoclonal antibody, designated TNX-4800, that prevents Lyme disease to Chatham, N.J.-based Tonix Pharmaceuticals Holding Corp.
“Preventing Lyme disease is an urgent public health priority and more than 30 years of clinical experience confirms that monoclonal antibodies can be delivered safely and are effective in preventing infections,” said Mark Klempner, MD, professor of medicine at UMass Chan and leader of the research team that discovered and developed the preventive medicine. “We are delighted to be collaborating with Tonix on the development of this program. Unlike vaccine programs in development, TNX-4800 is a single dose and provides immediate immunity to the bacteria that causes Lyme disease.”
Lyme disease is transmitted to humans through the bite of infected deer ticks (Ixodes scapularis). Lyme, however, is not caused by the tick directly. It is caused by the bacterium Borrelia burgdorferi present in the gut of infected ticks. When an infected tick bites someone and begins to feed on their blood, Lyme-causing bacteria can slowly travel from the tick’s gut to its salivary glands and then transfer to the site of the bite.
Typical symptoms of Lyme disease include fever, headache, fatigue and a characteristic skin rash called erythema migrans. If left untreated, infection can spread to the joints, heart and nervous system. Lyme disease is diagnosed based on symptoms, physical findings (e.g., rash) and the possibility of exposure to infected ticks. Laboratory testing is helpful if used correctly and performed with FDA-cleared tests. Most cases of Lyme disease can be treated successfully with antibiotics. Currently, the only way to prevent infection is to prevent tick bites by using insect repellent and removing ticks promptly.
TNX-4800 is a fully human monoclonal antibody with an engineered extended half-life that targets the outer-surface protein A (OspA) on the Lyme-causing Borrelia burgdorferi bacteria. By binding OspA, TNX-4800 blocks the maturation of Borrelia burgdorferi in the mid-gut of infected deer ticks. This inactivates the bacteria in the tick before it ever reaches the skin at the site of the tick bite.
Administered once a year in the early spring before ticks are at their most active, TNX-4800 provides immediate protection from Borrelia burgdorferi bacteria-caused Lyme disease. A single springtime injection is designed to maintain protective antibody titers for the entire tick season, providing pre-exposure prophylaxis against Lyme disease without relying on the recipient’s immune system to generate antibodies.
“Lyme disease remains the most common vector-borne infection in the United States and its incidence is climbing each year,” said Seth Lederman, MD, chief executive officer of Tonix Pharmaceuticals. “Licensing TNX-4800 expands our infectious disease pipeline with a differentiated, single-injection approach that can be given each spring to provide protection throughout the entire tick season. We believe TNX-4800 can transform prevention for millions of people who live, work and vacation in regions endemic for Lyme disease. Long-acting monoclonal antibody prophylaxis is available for RSV prevention, and we believe TNX-4800 can play an important role for preventing Lyme. We look forward to advancing the TNX-4800 program into a late-stage clinical study.”
Terence R. Flotte, MD, the Elisabeth Chair for the Dean of Medicine, executive deputy chancellor, provost and dean of the T.H. Chan School of Medicine, said, “We are proud to partner with Tonix Pharmaceuticals to advance the development of our novel monoclonal antibody as a prophylactic for Lyme disease, which is an urgent and growing public health challenge in the United States and around the world. This collaboration reflects UMass Chan’s enduring commitment to translational research that addresses unmet medical needs, and we are excited to work with Tonix to bring forward science-driven solutions that have the potential to prevent infection and protect vulnerable populations.”
Tonix, a fully integrated biotech company focused on transforming therapies for pain management and preventative medicines for public health challenges, intends to advance TNX-4800 through additional clinical trials with the goal of submitting a Biologics Licensing Application.
This partnership was facilitated by BRIDGE Innovation and Business Development at UMass Chan, which connects Medical School investigators with global partners to drive translational research and accelerate innovation with real-world impact. In 2023, this project received funding from BRIDGE to advance the technology to commercialization.
