Modern Twist to Centuries-Old Smallpox Vaccine Poised to Combat Deadly Mpox Strain as WHO Declares Global Emergency

Rhea-AI Summary

Tonix Pharmaceuticals (NASDAQ:TNXP) is developing TNX-801, a vaccine candidate to combat the escalating mpox global health crisis. The vaccine is based on Edward Jenner's smallpox vaccine technology from the 1700s, which successfully eradicated smallpox. TNX-801 has shown promise in non-human primate studies, protecting against lethal doses of the Clade 1 monkeypox virus.

Key features of TNX-801 include:

• Single-dose administration
• Potential for long-term immunity
• Ability to prevent forward transmission
• No need for complex cold-chain storage

The vaccine platform has also been selected for the NIH's NextGen program for COVID-19 vaccine development. Tonix's technology recently received a $34 million contract from the U.S. Department of Defense for developing a broad-spectrum antiviral against potential biowarfare agents.

Positive

• TNX-801 showed protection against lethal doses of Clade 1 monkeypox virus in non-human primate studies
• Tonix's vaccine technology selected for NIH's NextGen program for COVID-19 vaccine development
• $34 million contract awarded by U.S. Department of Defense for broad-spectrum antiviral development
• TNX-801 designed for single-dose administration with potential for long-term immunity
• TNX-801 does not require complex ultra cold-chain storage, facilitating global distribution

Negative

• TNX-801 still requires human clinical trials
• Mpox vaccine market may become competitive with other manufacturers stepping up efforts

Insights

Medical Research Analyst

The development of TNX-801 by Tonix Pharmaceuticals represents a significant advancement in the fight against mpox. The vaccine's design, based on Edward Jenner's smallpox vaccine, offers several potential advantages:

• Single-dose administration for long-term immunity
• Potential to prevent forward transmission
• Robust T-cell response for durable protection
• No ultra-cold storage requirements, facilitating global distribution

However, it's important to note that while preclinical results are promising, human trials are still pending. The vaccine's effectiveness and safety profile in humans remain to be determined. The WHO's emergency declaration underscores the urgent need for such solutions, potentially accelerating the development process.

Financial Analyst

Tonix Pharmaceuticals' (NASDAQ:TNXP) mpox vaccine candidate, TNX-801, could represent a significant market opportunity given the WHO's recent emergency declaration. Key financial considerations include:

• Potential for expedited regulatory pathways, possibly leading to faster market entry
• Competitive advantage in the vaccine market due to single-dose administration and simpler storage requirements
• $34 million contract from the U.S. Department of Defense for a related technology
• Selection for NIH's NextGen program, potentially opening doors for additional funding and collaborations

However, investors should be cautious as the vaccine is still in early stages and success in animal studies doesn't guarantee human efficacy or regulatory approval. The company's ability to scale production and navigate regulatory processes will be critical for realizing the potential value of TNX-801.

Public Health Expert

The resurgence of mpox highlights a critical gap in global health strategy following the cessation of routine smallpox vaccinations. Tonix's TNX-801 could potentially address this gap, offering several public health benefits:

• Possible prevention of forward transmission, important for epidemic control
• Simplified logistics due to no ultra-cold storage requirements, facilitating distribution in resource- settings
• Potential for long-term immunity, reducing the need for repeated vaccination campaigns

However, it's important to note that vaccine hesitancy and equitable global distribution remain significant challenges. The success of TNX-801 in combating mpox will depend not only on its efficacy but also on effective public health strategies for deployment and acceptance. The WHO's emergency declaration may help mobilize resources and political will to address these challenges.

This post was written and published as a collaboration between the in-house editorial team at Benzinga and Tonix Pharmaceuticals Holding Corp. with financial support from Tonix. The two organizations work to ensure that any and all information contained within is true and accurate as of the date hereof to the best of their knowledge and research. This content is for informational purposes only and not intended to be investing advice.

CHATHAM, NJ / ACCESSWIRE / August 23, 2024 / Following an upsurge of cases in the Democratic Republic of the Congo and several other countries in Africa, the World Health Organization (WHO) declared mpox a public health emergency of international concern on Aug. 14 - the second such declaration in two years. The WHO has called on vaccine manufacturers to step up efforts to curb the spread of a new, more deadly strain of the virus.

The WHO also is asking companies and organizations to bring in their vaccines, inviting developers of mpox vaccines to submit an Expression of Interest for Emergency Use Listing (EUL).

Amid this backdrop, Tonix Pharmaceuticals (NASDAQ:TNXP) is developing a vaccine candidate, called TNX-801, that could play a role in combating this escalating global health crisis. Tonix has successfully completed non-human primate studies showing protection from challenge with lethal doses of the Clade 1 monkeypox virus that is driving the new epidemic.

Clearly more testing is ahead for TNX-801, but the technology behind it is rooted in the science of Edward Jenner's smallpox vaccine of the late 1700s, the only vaccine to successfully eradicate a contagious viral pathogen.

These credentials have earned the vaccine technology platform upon which TNX-801 is based a competitive spot in the NIH's NextGen program for a more effective, single-dose COVID-19 vaccine to potentially provide durable protection instead of the every-six month booster strategy of mRNA vaccines.

Last month, another of Tonix's technologies was awarded a contract for up to $34 million by the U.S. Department of Defense to develop a single broad spectrum antiviral that would work against multiple potential biowarfare agents.

An Historical Approach to Modern Challenges
The current mpox crisis can be traced back to a decision made in the 1970s to discontinue routine smallpox vaccinations after smallpox was successfully eradicated. Research shows that the smallpox vaccine also provided immunity against mpox. In retrospect, smallpox vaccination kept mpox out of the human population in Africa. So an unintended consequence of stopping vaccinations for smallpox meant that mpox, then known as monkeypox (which is still the name of the virus), was able to reemerge in the human population.

Tonix's mpox vaccine is believed to be closely related to the original smallpox vaccine invented by British physician Edward Jenner in 1796. Jenner's vaccine is credited with being the first and only vaccine to successfully eradicate a viral pathogen. This triumph depended on several important attributes of the vaccine, including that it was generally well-tolerated, provided long-term immunity with a single dose, prevented forward transmission and provided a simple biomarker confirmation of protective immunity known as a "take".

TNX-801 is designed to have these same attributes; it is delivered in a single dose that provides protective immunity to animals that is marked by a "take". It is believed to have a high likelihood of providing durable immunity and preventing forward transmission. Furthermore, unlike many other vaccines, TNX-801 does not require complex ultra cold-chain storage, making it a strong candidate for global distribution.

The Science Behind TNX-801
Unlike mRNA vaccines, which primarily elicit an antibody response that requires frequent booster shots, TNX-801 is designed to trigger a robust T-cell response. T-cells have the ability to recognize and remember internal parts of viral proteins, not just those on the surface. T-cell memory lasts for years - even decades - providing long-term immunity and potentially eliminating the need for repeated boosters.

In preclinical trials, Tonix says TNX-801 demonstrated the ability to prevent death, clinical disease and lesions caused by a lethal challenge of monkeypox virus in non-human primates. Similar to Jenner's smallpox vaccine, TNX-801 also significantly reduced viral shedding, suggesting that it can block forward transmission,. Tonix is rushing to manufacture vaccine suitable for Phase 1 human trials.

Beyond Mpox: A Platform for Future Pandemics
The vaccine platform on which TNX-801 is based has potential applications beyond mpox. The company says the TNX-1800 version of the platform, for example, is designed to protect against COVID-19 and has shown promise in preclinical studies. The U.S. National Institute of Health has recognized the potential of Tonix's platform by selecting it for Project NextGen, aimed at developing next-generation COVID-19 vaccines and pandemic platform technologies.

As the world faces the growing threat of mpox and other infectious diseases, Tonix Pharmaceuticals is not only attempting to address the current crisis with TNX-801, but also potentially contributing to a future where pandemics can be more predictably contained.

Featured photo by Gilnature on iStock.

This post contains sponsored content. This content is for informational purposes only and not intended to be investing advice.

Click here for more information on Tonix Pharmaceuticals: https://redingtonvirtual.com/tnxp-aw-24082/

Investor Contact
Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182

SOURCE: Tonix Pharmaceuticals Holding Corp.

View the original press release on accesswire.com

FAQ

What is Tonix Pharmaceuticals' (TNXP) mpox vaccine candidate called?

Tonix Pharmaceuticals' mpox vaccine candidate is called TNX-801.

Has TNX-801 been tested in human clinical trials for mpox?

No, TNX-801 has not yet been tested in human clinical trials for mpox. It has completed non-human primate studies showing protection against lethal doses of the Clade 1 monkeypox virus.

What recent contract did Tonix Pharmaceuticals (TNXP) receive from the U.S. Department of Defense?

Tonix Pharmaceuticals received a contract for up to $34 million from the U.S. Department of Defense to develop a single broad spectrum antiviral against multiple potential biowarfare agents.

How is Tonix Pharmaceuticals' (TNXP) TNX-801 vaccine different from mRNA vaccines?

Unlike mRNA vaccines that primarily elicit an antibody response, TNX-801 is designed to trigger a robust T-cell response, potentially providing longer-lasting immunity without the need for frequent booster shots.