Tonix Secures Exclusive Rights to TNX-4800 for Seasonal Lyme Disease Protection.

Tonix Pharmaceuticals Holdings has acquired global rights to TNX-4800, a single-dose investigational therapy for seasonal protection against Lyme disease. TNX-4800 blocks the maturation of Borrelia burgdorferi bacteria in infected deer ticks, preventing transmission to animals. The treatment is intended for a single subcutaneous dose in the spring, offering protection through the entire tick season. No FDA-approved vaccines or prophylactic treatments currently exist for Lyme disease, making TNX-4800 a potentially transformative approach to prevention.

Tonix Pharmaceuticals Holdings has acquired global rights to TNX-4800, an investigational therapy designed for seasonal protection against Lyme disease. TNX-4800, a long-acting human monoclonal antibody, targets the outer surface protein A (OspA) of Borrelia burgdorferi, the bacteria causing Lyme disease. The treatment is intended for a single subcutaneous dose in the spring, providing protection through the entire tick season Tonix Pharmaceuticals Holding Corp. Announces In-licensing Phase 2/3-Ready Monoclonal Antibody Designed for Seasonal Prevention of Lyme Disease (TNX-4800)^[1].

Currently, there are no FDA-approved vaccines or prophylactic treatments for Lyme disease, making TNX-4800 a potentially transformative approach to prevention. The treatment works by blocking the maturation of Borrelia burgdorferi in infected deer ticks, preventing transmission to animals. TNX-4800 is being developed by researchers at UMass Chan Medical School, which is licensing the technology to Tonix Tonix Pharmaceuticals Announces In-licensing Phase 2/3-Ready Monoclonal Antibody Designed for Seasonal Prevention of Lyme Disease (TNX-4800)^[2].

The acquisition of TNX-4800 expands Tonix's infectious disease pipeline with a potentially differentiated product addressing a significant unmet medical need. The market opportunity appears substantial, with approximately 70 million people living in Lyme disease endemic areas in the U.S. The convenience of a single spring dose providing protection through the entire tick season represents a compelling value proposition compared to vaccine approaches requiring multiple administrations Tonix Pharmaceuticals Announces In-licensing Phase 2/3-Ready Monoclonal Antibody Designed for Seasonal Prevention of Lyme Disease (TNX-4800)^[2].

Positive Phase 1 results showed safety, tolerability, and a linear pharmacokinetic: pharmacodynamic: efficacy relationship (1: 1: 1), suggesting predictable dosing and efficacy relationships. Tonix plans to advance the treatment through additional clinical trials with the goal of submitting a Biologics Licensing Application (BLA) Tonix Pharmaceuticals Announces In-licensing Phase 2/3-Ready Monoclonal Antibody Designed for Seasonal Prevention of Lyme Disease (TNX-4800)^[2].

The collaboration with UMass Chan Medical School brings valuable institutional expertise, as the antibody was developed by researchers with deep knowledge in this therapeutic area. The market opportunity appears substantial, with seasonal prevention targeting the millions who live, work, or vacation in Lyme-endemic regions Tonix Pharmaceuticals Announces In-licensing Phase 2/3-Ready Monoclonal Antibody Designed for Seasonal Prevention of Lyme Disease (TNX-4800)^[2].