TNX-4800
Preclinical
Phase I
Phase II
Phase III
Prevention of Lyme Disease in the U.S.
Adaptive Phase 2 field study planned 1H’27 pending FDA agreement
Phase 2
TNX-48001 is a Phase 2 ready, long-acting, bactericidal (or borreliacidal), human monoclonal antibody (mAb) to prevent Lyme disease in the United States. There are currently no FDA-approved vaccines or prophylactics to protect against Lyme disease. Approximately 87 million people are at high risk of contracting the disease because they live, work, or vacation in an endemic area.2
TNX-4800 has an engineered crystallizable fragment (Fc) domain for an extended half-life that targets the outer surface protein A (OspA) of Borrelia burgdorferi, which causes 99.9% of Lyme disease cases in the U.S.3,4 When TNX-4800-containing blood is ingested by the tick, TNX-4800 kills and blocks the maturation of Borrelia burgdorferi in the mid-gut of infected deer ticks. TNX-4800 is designed to provide passive immunity against Lyme disease within two days without relying on the recipient’s immune system to generate antibodies.
Pending FDA agreement, the Company plans to initiate an adaptive Phase 2 field study in the first half of 2027. The Company expects to have GMP investigational product available for clinical testing in early 2027.
The Company in-licensed TNX-4800 from UMass Chan Medical School in 2025.
1. TNX-4800 is an investigational biologic and is not approved for any indication.
2. Kugeler KJ, et al. Emerg Infect Dis. 2021. 27(2):616-619.
3. Marques AR, et al. Emerg Infect Dis. 2021. 27(8):2017-2024.
4. Pritt BS, et al. Lancet Infect Dis. 2016. 6(5):556-564.