TNX-801
Preclinical
Phase I
Phase II
Phase III
Smallpox and Monkeypox Preventing Vaccine
Phase I start — targeting 1Q 2024
Preclinical
TNX-801 is a novel, live virus vaccine based on synthesized horsepox (sHPXV). It is being developed as a potential smallpox preventing vaccine for widespread immunization and national stockpile. Though it shares structural characteristics with vaccinia-based vaccines, TNX-801 has unique properties that Tonix believes it may lower toxicity and offer potential safety advantages over existing vaccinia-based vaccines, which have been associated with adverse side effects such as myocarditis/pericarditis2.
Molecular analysis suggests that TNX-801 is closer than modern vaccines in DNA sequence1,2 to the vaccine discovered and disseminated by Dr. Edward Jenner. Molecular analysis indicates that HPXV has “complete” left and right inverted terminal repeats (ITRs) while different VACV isolates have a variety of deletions in the left and right ITRs. Therefore, TNX-801 has additional genes, relative to VACV vaccines, that may play roles in host immune interactions and one or more or such proteins may serve as antigens for protective immunity. TNX-801 has been assembled using synthetic DNA fragments1.