- Tonix Pharmaceuticals (TNXP, Financial) unveiled promising preclinical data on TNX-801, a potential single-dose mpox vaccine.
- TNX-801 showcased protective immunity in immunocompromised animals and durability up to six months.
- The vaccine aligns with WHO standards for single-dose, stable, and durable protection.
Tonix Pharmaceuticals Holding Corp. (TNXP) presented encouraging data for its TNX-801 mpox vaccine candidate during the World Vaccine Congress Washington 2025. The preclinical studies revealed that this single-dose, live virus vaccine achieves protective immunity against both monkeypox (mpox) and smallpox.
Key findings demonstrated that TNX-801 effectively protected immunocompromised animals from a lethal monkeypox clade IIa virus challenge. Moreover, the vaccine extended protection to six months against a severe rabbitpox challenge. It displayed a favorable tolerability profile, preventing virus dissemination into blood or tissues even when administered in high doses.
This vaccine candidate addresses the critical need for effective solutions amid ongoing mpox outbreaks, such as those identified in 2022 (clade IIb) and 2024 (clade Ib), both of which have been classified by the World Health Organization (WHO) as Public Health Emergencies of International Concern. TNX-801's features, such as its single-dose administration, stable ambient temperature storage, and suitability for immunocompromised individuals, align closely with the WHO's preferred target product profile.
Tonix's advancement to clinical trials will be pivotal in confirming TNX-801's efficacy and safety in humans. The company has initiated collaboration with the Kenya Medical Research Institute to design and pursue regulatory approval for a Phase I clinical trial in Kenya, underscoring its commitment to addressing public health challenges worldwide.
