Tonix Study Reveals Mpox Clade IIb Far Less Virulent Than 2003 Strain — Tonix Pharmaceuticals Holding Corp.

Event summary

Tonix published research in the Journal of Virology showing mpox clade IIb is 100- to 100,000-fold less virulent than clade IIa from 2003.
Three new murine models were identified for studying mpox infection and pathogenesis.
TNX-801, a live attenuated horsepox-based vaccine candidate, is in pre-clinical development for mpox and smallpox prevention.
Tonix's Phase 1 study for TNX-801 is expected to begin in 2027 pending FDA clearance.

The big picture

Tonix's research underscores the evolving threat of mpox, particularly with the emergence of less virulent but more transmissible strains. The company is positioning TNX-801 as a potential solution in a market where existing vaccines may not fully address newer subclades. With increasing outbreaks and WHO declarations of public health emergencies, the demand for effective biodefense measures remains critical.

What we're watching

Vaccine Efficacy: How the reduced virulence of clade IIb will impact TNX-801's development and positioning as a preventive measure.
Regulatory Pathway: Whether Tonix can secure FDA clearance for Phase 1 trials by 2027, given the competitive landscape of mpox vaccines.
Market Demand: The pace at which global health authorities will adopt new vaccine candidates amid fluctuating mpox outbreak severity.