Tonix Pharmaceuticals Initiates Mpox Vaccine Development with BBio
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Tonix Pharmaceuticals and Bilthoven Biologicals Collaboration
Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP), a leading biopharmaceutical company, has entered into a significant collaboration with Bilthoven Biologicals (BBio). This partnership is aimed at advancing the development of TNX-801, an innovative vaccine intended to combat mpox and smallpox. This initiative responds to the urgent need for effective vaccines following the recent declaration of a public health emergency due to mpox outbreaks globally.
Understanding the Mpox Vaccine Candidate TNX-801
TNX-801 is designed based on a recombinant horsepox virus and is considered a live, attenuated viral vaccine. This candidate is currently in preclinical development with the objective of providing protective measures against mpox and smallpox. Notably, TNX-801 has shown promising results in animal studies, demonstrating better tolerability compared to traditional vaccines derived from vaccinia viruses that were used in the 20th century.
Efficacy and Safety Profile
In preclinical trials, TNX-801 has exhibited substantial efficacy, effectively shielding non-human primates from lethal challenges posed by Clade 1 monkeypox virus. A single-dose vaccination resulted in the prevention of clinical disease, reductions in lesions, and decreased viral shedding. These findings suggest that TNX-801 could establish a robust mucosal immunity, thereby blocking further transmission of the virus.
The Global Mpox Public Health Emergency
The World Health Organization recently recognized the resurgence of mpox as a significant public health threat, declaring it a public health emergency of international concern. This declaration marks the second such recognition within two years, driven by the alarming spread of the virus in numerous countries, particularly in Africa, where Clade 1 monkeypox is noted for its high mortality rates.
Critical Importance of Vaccine Readiness
Jurgen Kwik, CEO of Bilthoven Biologicals, emphasized the necessity of being prepared for pandemics through their 'ever-warm' manufacturing facility. This facility is designed to ensure that vaccines can be produced rapidly and efficiently in response to emerging health crises. The collaboration with Tonix Pharmaceuticals strengthens their efforts in public health preparedness.
Future Prospects for Vaccine Development
Tonix CEO, Seth Lederman, expressed optimism about accelerating TNX-801's development. He noted the vaccine's single-dose regimen could increase acceptance and improve community protection by eliminating the risks of incomplete vaccination related to two-dose regimens. The simplified storage and distribution requirements are expected to facilitate its global reach, addressing the urgent need for mpox and smallpox vaccines.
Expansion of the Viral Vector Platform
Beyond addressing mpox, Tonix Pharmaceuticals is exploring the potential to expand the viral vector platform of TNX-801. Successful development may lead to recombinant versions capable of protecting against additional infectious diseases, thereby enhancing global health security.
About Bilthoven Biologicals
Bilthoven Biologicals, based in the Netherlands, is a prominent end-to-end vaccine manufacturer specializing in both viral and bacterial vaccines. Their established history includes successful partnerships with global health organizations like UNICEF and WHO, contributing significantly to vaccine production aimed at eradicating diseases, including polio.
About Tonix Pharmaceuticals
Tonix Pharmaceuticals is dedicated to developing and commercializing therapeutics that aim to alleviate human suffering. Their extensive portfolio includes a variety of candidates targeting infectious diseases, central nervous system disorders, and more. Recently, they received a substantial contract from the U.S. Department of Defense to further their work in antiviral agents.
Frequently Asked Questions
What is TNX-801?
TNX-801 is a vaccine candidate based on a recombinant horsepox virus, currently in development to prevent mpox and smallpox.
What is the significance of the partnership with Bilthoven Biologicals?
The collaboration aims to advance the development and potential manufacturing of TNX-801, enhancing global health responses to mpox outbreaks.
Why is there a focus on a single-dose vaccine?
A single-dose vaccine like TNX-801 could improve public acceptance and reduce the risks associated with incomplete vaccination that occur with multi-dose regimens.
How does TNX-801 compare to traditional vaccines?
Preclinical studies show TNX-801 offers better safety and efficacy profiles compared to traditional 20th-century vaccinia virus-based vaccines.
What are the future goals for Tonix Pharmaceuticals?
Tonix aims to expand its vaccine platform to offer protection against various infectious diseases, enhancing global health security and pandemic preparedness.
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