Drug intelligence / Profile preview

TNX-801

Development stage
Discontinued
Lead developer
Tonix Pharmaceuticals
Modality
Split/Subunit Vaccines → Inactivated Vaccines → Prophylactic Vaccines → Vaccines & Immunotherapeutics, Live Attenuated Vaccines → Live Vaccines → Prophylactic Vaccines → Vaccines & Immunotherapeutics, Peptide-based Cancer Vaccines → Cancer Vaccines → Therapeutic Vaccines → Vaccines & Immunotherapeutics, Viral Vector Vaccines → Recombinant Vaccines → Prophylactic Vaccines → Vaccines & Immunotherapeutics
Administration
Intradermal
01

Overview

TNX-801 is a live attenuated, synthetic version of the horsepox virus (HPXV) developed as a single-dose vaccine candidate for the prevention of mpox (monkeypox) and smallpox. It is designed to be safer and better tolerated than older vaccinia-based smallpox vaccines while providing durable immunity through robust T-cell responses. Preclinical studies have demonstrated that TNX-801 can induce potent immunity with a single dose, protect non-human primates from lethal mpox challenge, prevent clinical disease and lesions, reduce viral shedding in mucosal tissues (suggesting potential to block transmission), and display significantly greater attenuation compared to traditional vaccinia strains. The vaccine’s formulation allows for easier storage and distribution without ultra-cold chain requirements[1][3][5][7][8][9].

Brand names
TNX-801TNX801TNX 801
Other names
recombinant horsepox virussynthetic horsepox virus vaccinesmallpox and monkeypox vaccines - Tonix Pharmaceuticals/University of Alberta

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