Tonix In-licenses New Monoclonal Antibody for Seasonal Lyme Prevention

Lead Tonix Pharmaceuticals announced today it has acquired worldwide rights to TNX-4800, a Phase 2/3-ready monoclonal antibody designed to prevent Lyme disease with a single spring dose, aiming to protect through fall’s tick season in the U.S.

Nut Graf With no FDA-approved vaccines or prophylactics currently available, TNX-4800 could fill a critical gap in Lyme prevention. The in-licensing from UMass Chan Medical School highlights growing public health efforts to curb the rising incidence of this tick-borne infection across endemic regions.

Clinical Collaboration and Licensing

  • Tonix secured exclusive rights to TNX-4800 (formerly mAb 2217LS), developed by researchers at UMass Chan Medical School.
  • TNX-4800 targets the outer-surface protein A (OspA) of Borrelia burgdorferi, blocking bacterial maturation and transmission from infected deer ticks.
  • A single subcutaneous administration in spring is engineered to maintain protective antibody levels throughout the entire tick season, simplifying prevention compared to multi-dose vaccines.

Expert Perspectives

  • “Preventing Lyme disease is an urgent public health priority,” said Mark Klempner, M.D., UMass Chan professor and lead developer of mAb 2217LS.
  • Terence R. Flotte, M.D., Provost and Executive Deputy Vice Chancellor of UMass Chan, added that TNX-4800 exemplifies translational research addressing unmet medical needs.

Development Plan Tonix plans an adaptive Phase 2/3 trial to evaluate TNX-4800’s efficacy and safety. Success could lead to a Biologics Licensing Application submission, offering pre-exposure prophylaxis without relying on host immune response.

Lyme Disease Context Lyme disease, caused by Borrelia burgdorferi transmitted via Ixodes ticks, remains the most common vector-borne illness in the U.S., with cases rising in endemic states. Typical symptoms include fever, headache, fatigue, and characteristic erythema migrans rash; untreated infections can spread to joints, heart, and nervous system. Current prevention relies on tick avoidance and prompt antibiotic treatment after exposure.