UMass Chan Licenses Novel Lyme Disease Prevention Antibody to Tonix Pharmaceuticals

Tonix Pharmaceuticals Licenses Monoclonal Antibody TNX-4800 for Lyme Disease Prevention

Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), based in Chatham, N.J., has acquired worldwide rights to TNX-4800, a long-acting human monoclonal antibody developed by UMass Chan Medical School. This innovative treatment is designed for the seasonal prevention of Lyme disease, offering a single-dose approach to pre-exposure prophylaxis.

On September 17, 2025, Tonix Pharmaceuticals announced the in-licensing of worldwide rights to TNX-4800, a significant step in addressing the growing concern surrounding Lyme disease prevention. This move positions Tonix to advance TNX-4800 through clinical trials, aiming for a Biologics Licensing Application submission to the FDA.

The Science Behind TNX-4800

TNX-4800 is a fully human monoclonal antibody engineered with an extended half-life. It targets the outer-surface protein A (OspA) on the Borrelia burgdorferi bacteria, which causes Lyme disease. By binding to OspA, TNX-4800 effectively blocks the maturation of the bacteria within the mid-gut of infected deer ticks, inactivating it before it can be transmitted to humans.

This mechanism sidesteps the multi-dose schedules required for some Lyme disease vaccines currently in development and previously approved vaccines that were later withdrawn from the market due to concerns about autoimmunity. A positive Phase 1 study demonstrated safety, tolerability, and a linear pharmacokinetic: pharmacodynamic: efficacy relationship (1:1:1).

Immediate Protection with a Single Dose

Administered once a year in the early spring before tick season, TNX-4800 provides immediate protection against Lyme disease. This single injection is designed to maintain protective antibody titers throughout the entire tick season, offering pre-exposure prophylaxis without requiring the recipient's immune system to generate antibodies.

Dr. Mark Klempner, MD, professor of medicine at UMass Chan and leader of the research team, emphasized that more than 30 years of clinical experience confirm that monoclonal antibodies can be delivered safely and are effective in preventing infections. “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,” he said.

Lyme Disease: A Growing Public Health Concern

Lyme disease, transmitted to humans through infected deer ticks (Ixodes scapularis), is the most common vector-borne infection in the United States, with incidence climbing annually. Typical symptoms include fever, headache, fatigue, and a characteristic skin rash called erythema migrans. Untreated, the infection can spread to the joints, heart, and nervous system.

Currently, the primary methods of prevention involve avoiding tick bites through the use of insect repellent and promptly removing ticks. TNX-4800 offers a promising new approach to protecting millions of people living, working, and vacationing in Lyme-endemic regions.

Tonix's Vision for TNX-4800

Seth Lederman, MD, chief executive officer of Tonix Pharmaceuticals, stated that licensing TNX-4800 expands their infectious disease pipeline with a differentiated, single-injection approach. He believes that TNX-4800 can transform prevention for millions of people in Lyme disease endemic regions, much like long-acting monoclonal antibody prophylaxis is available for RSV prevention. Tonix intends to advance TNX-4800 through additional clinical trials with the goal of submitting a Biologics Licensing Application (BLA).

“Lyme disease remains the most common vector-borne infection in the United States and its incidence is climbing each year,” 2 said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “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.

UMass Chan's Commitment to Translational Research

Terence R. Flotte, MD, Provost, Dean and Executive Deputy Vice Chancellor of UMass Chan Medical School, expressed pride in partnering with Tonix Pharmaceuticals to advance the development of their novel monoclonal antibody as a prophylactic for Lyme disease. This collaboration, facilitated by BRIDGE Innovation and Business Development at UMass Chan, reflects their enduring commitment to translational research that addresses unmet medical needs.

“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,” said Terence R. Flotte, MD.

About Tonix Pharmaceuticals

Tonix Pharmaceuticals Holding Corp. is a fully-integrated biotechnology company focused on transforming therapies for pain management and preventative medicines for public health challenges. Their pipeline includes marketed products and development candidates targeting central nervous system (CNS) disorders, immunology, immuno-oncology, and infectious diseases. Tonix recently received FDA approval for Tonmya TM , a first-in-class, non-opioid analgesic medicine for the treatment of fibromyalgia.