Tonix Pharmaceuticals Holding Corp (NASDAQ: TNXP) has announced a partnership with the Kenya Medical Research Institute (KEMRI) to plan, get regulatory authorization for, and carrying Phase 1 clinical trial in Kenya for TNX-801 development as a vaccine protecting against smallpox and monkeypox. The study is likely to begin in 1H of 2023.
Tonix is developing TNX-801 for smallpox and monkeypox
CEO Seth Leaderman said, “We are excited to collaborate with KEMRI on the clinical development of TNX-801 as a vaccine to protect against monkeypox and smallpox in Kenya. Since ending routine vaccination for smallpox in the 1960’s, monkeypox has emerged as a growing problem among people in West and Central Africa. People who received the live virus vaccine for smallpox prior to eradication appear to maintain durable protective immunity against monkeypox.”
Leaderman said that TNX-801, a live viral vaccine, is more analogous to the smallpox vaccinations that were administered in the United States and Europe before 1900 than the current vaccinia smallpox vaccines. TNX-801 has the capability to be widely used to prevent monkeypox because it has decreased virulence in animals.
TNX-801 to help address the spread of monkeypox in Africa
The Director General and CEO of KEMRI, Professor Samuel Kariuki, expressed excitement about the organization’s decision to work with Tonix to prepare the clinical research and ultimately to lead it. Since monkeypox has expanded throughout West and Central Africa, there is fear that cases may emerge from foreign tourists or in Central and Eastern Africa. More than 30 nations outside of Africa where the monkeypox virus is not prevalent have recently reported cases of monkeypox.
Tonix is creating TNX-801, a vaccine against smallpox and monkeypox, for percutaneous administration. The business has previously released optimistic findings from a nonhuman primates monkeypox challenge study. The genome of the 1976 natural isolation Mongolian horsepox clone MNR-763 served as the basis for the synthesis of Tonix’s TNX-801. Molecular examination of DNA sequences indicates that TNX-801 is more similar to the vaccine developed and distributed by Dr. Edward Jenner in 1798 than modern smallpox vaccinations.
