Tonix Pharmaceuticals and Bilthoven Biologicals to Develop Mpox Vaccine TNX-801

On August 26, 2024, Tonix Pharmaceuticals Holding Corp., a biopharmaceutical company listed on Nasdaq (TNXP), announced a significant collaboration with Bilthoven Biologicals (BBio), part of the Cyrus Poonawalla Group, known for being the world's largest vaccine manufacturer. This partnership aims to advance TNX-801, Tonix's vaccine candidate for mpox (monkeypox), which is based on recombinant horsepox virus.

TNX-801 is a live replicating, attenuated virus vaccine. It has shown promise in preclinical trials for the prevention of both mpox and smallpox. The technology behind TNX-801 could potentially serve as a viral vector platform, allowing for the development of recombinant versions to protect against a variety of other infectious diseases. Bilthoven Biologicals, a global vaccine company, has been chosen by the European Union for its pandemic preparedness program and produces both prophylactic and therapeutic vaccines.

Animal model studies have demonstrated that TNX-801 offers immune protection with better tolerability compared to 20th-century vaccinia virus-based vaccines. Preclinical data showed positive efficacy, with TNX-801 protecting non-human primates from lethal intratracheal challenges with Clade 1 monkeypox virus. A single dose of TNX-801 was effective in preventing clinical disease and lesions, as well as reducing viral shedding in the mouth and lungs of the primates. These results suggest that TNX-801 could potentially block forward transmission of the virus, thanks to its mucosal immunity.

On August 14, 2024, the World Health Organization (WHO) declared the surge of mpox in multiple African countries a public health emergency of international concern (PHEIC) for the second time in two years. The current outbreak, caused by Clade 1 monkeypox virus, follows the 2022 outbreak caused by Clade 2 monkeypox virus. The 2022 outbreak affected over 90,000 individuals in countries where mpox was not previously endemic, including Europe and the U.S. This highlighted the pandemic potential of the disease. Clade 1, currently endemic in several Central African countries, including the Democratic Republic of the Congo, has a mortality rate of up to 10%.

Jurgen Kwik, CEO of Bilthoven Biologicals, emphasized the importance of the 'ever-warm' pandemic preparedness facility at BBio, which was built to ensure readiness in the face of global health emergencies. He noted that this collaboration underscores the critical role of such facilities in enhancing pandemic preparedness and response capabilities.

Dr. Seth Lederman, CEO of Tonix Pharmaceuticals, expressed optimism about the collaboration with BBio in accelerating the development of TNX-801. He highlighted that TNX-801 is a single-dose vaccine, which could improve acceptance and eliminate partial vaccinations compared to the current two-dose regimens. Furthermore, TNX-801 can be manufactured at scale and distributed without the need for an ultra-cold supply chain, making it more accessible.

Dr. Lederman also pointed out the urgent need for an affordable, safe, and effective single-dose mpox vaccine, given the disease's pandemic potential. Successful development of TNX-801 could pave the way for expanding the viral vector platform to develop vaccines against other infectious diseases and future outbreaks.

Tonix Pharmaceuticals has received positive feedback from a Type B pre-Investigational New Drug Application (IND) meeting with the U.S. Food and Drug Administration (FDA), which provides a path for the clinical development of TNX-801. The 2022-2023 mpox epidemic saw over 90,000 cases globally, with breakthrough cases reported even in vaccinated individuals. This highlights the need for a more effective vaccine like TNX-801, which is administered in a single dose and has the potential to achieve higher community protection rates.

BBio, based in the Netherlands, has a robust track record in vaccine manufacturing and supply, collaborating with global health partners such as UNICEF, PAHO, and WHO/GAVI. The company is integral to the global polio eradication program and also manufactures vaccines used in cancer treatment.

Tonix Pharmaceuticals operates a state-of-the-art infectious disease research facility and a Good Manufacturing Practice (GMP)-capable advanced manufacturing facility. The company is focused on developing therapeutics to treat and prevent human diseases, with a portfolio that includes products for central nervous system disorders, organ transplant rejection, autoimmunity, and rare diseases.

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