Tonix Pharmaceuticals Announces Collaboration with Kenya Medical Research Institute to Develop TNX-801 in Kenya as a Vaccine for the Prevention of Monkeypox and Smallpox Infection
July 28 2022 - 07:00AM
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Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced a collaboration with the Kenya Medical Research Institute (KEMRI) to plan, seek regulatory approval for and conduct a Phase 1 clinical study in Kenya to develop TNX-8011 as a vaccine to protect against monkeypox and smallpox. The study is expected to start in the first half of 2023.
“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,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “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. TNX-801 is a live virus vaccine that we believe is closer to the smallpox vaccines used in the U.S. and Europe before 1900 than the modern vaccinia smallpox vaccines. TNX-801 has reduced virulence in animals, and we believe it has the potential for widespread use to protect against monkeypox.”
“KEMRI is excited to plan this clinical trial with Tonix, and ultimately to lead the trial,” said Professor Samuel Kariuki, Director General and CEO of KEMRI. “Monkeypox has spread in Central and West Africa, and there’s a concern that we could begin seeing cases in the Eastern and Central Africa or from foreign travelers. Recently, monkeypox has been reported in over 30 countries outside of Africa that were not endemic for monkeypox virus. We are grateful that Tonix is committed to sponsoring clinical studies and making TNX-801 available for this important problem.”
Professor Matilu Mwau, PhD, of KEMRI said, “The recent global outbreak of monkeypox has exemplified the need to be prepared with a vaccine that is efficacious, that provides for durable immunity and that blocks forward transmission. Tonix’s live virus vaccine technology is designed to achieve these outcomes. The West African strain which has recently spread outside of Africa has a low fatality rate, but the Central African strain is reportedly fatal in approximately 10% of infected individuals. We want Kenya to be prepared with a vaccine that provides protection and can be widely deployed without the need for sterile injections or ultra-cold shipping and storage.”
About TNX-801
TNX-801 is a live virus vaccine based on synthesized horsepox2,3. Tonix is developing TNX-801 for percutaneous administration as a vaccine to protect against monkeypox and smallpox. TNX-801 was developed as part of research collaboration between Tonix and Professor David Evans, Ph.D. and Ryan Noyce, Ph.D., the Department of Cell Biology, University of Alberta. Tonix has previously reported positive data from a monkeypox challenge study in non-human primates4. Tonix’s TNX-801 was synthesized2 based on the sequence of the 1976 natural isolate Mongolian horsepox clone MNR-763. Molecular analysis of DNA sequences suggests that TNX-801 is closer than modern smallpox vaccines to the vaccine discovered and disseminated by Dr. Edward Jenner in 17986-8. For example, recent studies9,10 have shown approximately 99.7% colinear identity between TNX-801 and the circa 1860 U.S. smallpox vaccine VK0511. The small plaque size in culture of TNX-801 appears identical to the U.S. Centers for Disease Control publication of the natural isolate12. Relative to vaccinia, horsepox has substantially decreased virulence in mice2. Dr. Edward Jenner invented vaccination in 1798 and the procedure was called “vaccination” because ‘cow’ is ‘vacca’ in Latin and the inoculum material was initially obtained from lesions on the udders of cows affected by a mild disease known as cowpox. However, Dr. Jenner suspected that cowpox originated from horses8. Subsequently, Dr. Jenner and others immunized against smallpox using material directly obtained from horses. The use of vaccines from horses was sometimes called ‘equination’ from the Latin ‘equus’ which means ‘horse’13. Equination and vaccination were practiced side-by-side in Europe13,14.
About Monkeypox
Monkeypox15 is a contagious disease caused by infection with monkeypox virus, a virus closely related to variola virus, which causes smallpox. Monkeypox virus belongs to the Orthopoxvirus genus in the family Poxviridae. The Orthopoxvirus genus also includes variola virus (which causes smallpox), vaccinia virus (used in the smallpox vaccine), and cowpox virus. After routine smallpox vaccination was stopped in about 1970, monkeypox has become a growing problem in Africa. Recently more than 16,000 cases have been identified outside of Africa17.
About the Kenya Medical Research Institute (KEMRI)
The Kenya Medical Research Institute is a State Corporation established in 1979 as a Research Institute under the Science and Technology (Repealed) Act, Cap 250 Laws of Kenya and operates as such under Legal Notice No. 35 of March 2021. KEMRI’s vision is to be the leading centre of excellence in research for human health. The mission is to improve human health and quality of life through research, capacity building, innovation and service delivery. KEMRI has grown from its humble beginning over 40 years ago to become a regional leader in human health research. KEMRI is the Medical Research arm of the Government of Kenya.
