Business
Tonix Pharmaceuticals Provides Update on the Development of Its Single Dose Live Attenuated Virus Vaccine Candidate for Mpox, TNX-801, as WHO Declares Mpox Outbreak a Global Health Emergency
World Health Organization (WHO) has declared spread of mpox in multiple African countries a public health emergency of international concern (PHEIC) 1 Tonix’s
About this update from Tonix Pharmaceuticals Holding Corp.
[{"type":"text","content":"World Health Organization (WHO) has declared spread of mpox in multiple African countries a public health emergency of international concern (PHEIC) 1 Tonix’s live virus vaccine candidate, TNX-801, is designed to provide long-term protection from mpox and smallpox with one dose TNX-801 vaccination demonstrated efficacy in protecting animals from lethal challenge with intratracheal monkeypox virus Clade II mpox is now endemic in the U.S. with >30,000 cases reported since May 20222 and Clade I mpox is endemic in the Democratic Republic of the Congo3 Tonix’s vaccine platform has been selected by NIH’s Project NextGen for clinical testing CHATHAM, N.J., Aug. 16, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, has reiterated its commitment to advance development of its live attenuated virus vaccine, TNX-801 (recombinant horsepox virus), for preventing mpox (formerly known as monkeypox) and other infectious diseases. On August 14, 2024, the World Health Organization (WHO) determined that the upsurge of mpox in a growing number of countries in Africa constitutes a public health emergency of international concern, the second such declaration in the past two years called in response to an mpox outbreak. The current outbreak was caused by Clade 1 monkeypox virus, while the 2022 outbreak was Clade 2 monkeypox virus. TNX-801 is a live replicating attenuated vaccine candidate based on horsepox that is believed to provide immune protection with better tolerability than 20th century vaccinia viruses. The same vaccine platform upon which TNX-801 is based was selected by the U.S. National Institutes of Health (NIH) for Project NextGen for an engineered version that expresses the spike protein of SARS-CoV-2. As previously disclosed, TNX-801 protected animals against lethal challenge with intratracheal Clade 1 monkeypox virus4. After a single-dose vaccination, TNX-801 prevented clinical disease and lesions and also decreased shedding in the mouth and lungs of non-human primates4. These findings are consistent with mucosal immunity and suggest the ability to block forward transmission, similar to Dr. Edward Jenner’s vaccinia vaccine, which eradicated smallpox and kept mpox out of the human...