Lyme disease is a bacterial infection, primarily Borrelia burgdorferi, transmitted to humans by the bite of infected ticks, commonly found in woodland and grassy areas. Lyme disease is the most common tick-borne illness in the U.S., prevalent in the Northeast, mid-Atlantic, and upper Midwest.
Typical symptoms include fever, headache, fatigue, and a characteristic skin rash called erythema migrans. If left untreated, infection can spread to joints, the heart, and the nervous system. Laboratory testing is helpful if used correctly and performed with FDA-cleared tests.
Although many cases of Lyme disease can be treated successfully with antibiotics, diagnosis and treatment are often delayed or missed, and even with treatment, up to 20% of cases may progress to a Post-Treatment Lyme Disease Syndrome (PTLDS) called “Chronic Lyme” or “Long Lyme”. Chronic Lyme is considered an Infection Associated Chronic Illness (IACI), and is a chronic, debilitating disease state characterized by joint and muscle pain, fatigue and other symptoms.
No U.S. FDA-approved prophylactic for Lyme is currently available. However, a new medication has the potential to fill this public health gap, which will be of potential benefit to those living in Lyme-endemic regions. This development comes from Tonix Pharmaceuticals (Nasdaq: TNXP) in the form of licensing TNX-4800, a monoclonal antibody designed to provide season-long protection against Lyme disease with a single spring injection.
TNX-4800 is a long-acting human monoclonal antibody that targets the outer surface protein A (OspA) of B. burgdorferi. TNX-4800 is being developed for annual seasonal use, in the form of one subcutaneous dose administered in the Spring to protect the recipient against Lyme disease. Specifically, during a tick bite Borrelia downregulates OspA, upregulates OspC, and activates motility genes. Borrelia undergoes a metamorphic-like transformation becoming highly flagellated and mobile, which facilitates migration to the salivary glands and invasion of human host tissues. The mAb 2217LS blocks the metamorphic-like transformation of Borrelia in the tick’s midgut preventing transmission of the bacteria.
The medication was developed by researchers at UMass Chan Medical School, led by Mark Klempner, which is licensing the technology to Tonix. This is part of UMass Chan’s commitment to translational research that addresses unmet medical needs.
TNX-4800 is a fully human monoclonal antibody with an engineered extended half-life that targets the outer-surface protein A (OspA) of the bacterium. By binding OspA, TNX-4800 blocks the maturation of the microbial cell in the mid-gut of infected deer ticks.
Tests have demonstrated how a single administration in the Spring is designed to maintain protective antibody titres for the entire tick season, providing pre-exposure prophylaxis against Lyme disease without relying on the recipient’s immune system to generate antibodies. By delivering a well-characterized antibody directly, TNX-4800 blocks transmission of the major Borrelia genospecies from ticks to animals.
Seth Lederman, M.D., the firm’s CEO, tells Drug Discovery World: “Lyme disease remains the most common vector-borne infection in the United States and its incidence is climbing each year. Licensing TNX-4800 expands our infectious disease pipeline with a potentially differentiated, single-dose approach that can be given each Spring to provide protection within two days and protect through Fall, which is the entire tick season in the U.S.”
Lederman adds: “We believe TNX-4800’s long-acting monoclonal antibody prophylaxis could play an important role for preventing Lyme for millions of people who live, work, and vacation in regions endemic for Lyme disease. TNX-4800’s novel mechanism of blocking the maturation of Borrelia in the midgut of infected ticks is consistent with Tonix’s focus on innovation. We look forward to advancing the TNX-4800 program.”
