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
Tonix Pharmaceuticals (NASDAQ: TNXP) is advancing development of TNX-801, a single-dose live attenuated virus vaccine candidate for mpox and smallpox. This comes as the WHO declares the mpox outbreak in Africa a global health emergency. Key points:
1. TNX-801 demonstrated efficacy in protecting animals from lethal challenge with monkeypox virus.
2. The vaccine is designed to provide long-term protection with one dose.
3. Clade II mpox is now endemic in the U.S. with >30,000 cases since May 2022.
4. Tonix's vaccine platform has been selected by NIH's Project NextGen for clinical testing.
5. TNX-801 showed potential to prevent clinical disease, lesions, and decrease viral shedding in non-human primates.
Tonix Pharmaceuticals (NASDAQ: TNXP) sta portando avanti lo sviluppo di TNX-801, un candidato vaccinale a virus vivo attenuato in dose singola per mpox e vaiolo. Questo avviene in concomitanza con la dichiarazione dell'OMS che definisce l'epidemia di mpox in Africa un'emergenza sanitaria globale. Punti chiave:
1. TNX-801 ha dimostrato efficacia nel proteggere gli animali da sfide letali con il virus monkeypox.
2. Il vaccino è progettato per fornire protezione a lungo termine con una sola dose.
3. La clade II di mpox è ora endemica negli Stati Uniti con oltre 30.000 casi da maggio 2022.
4. La piattaforma vaccinale di Tonix è stata selezionata dal progetto NextGen del NIH per test clinici.
5. TNX-801 ha mostrato potenziale per prevenire malattie cliniche, lesioni e ridurre la diffusione virale nei primati non umani.
Tonix Pharmaceuticals (NASDAQ: TNXP) está avanzando en el desarrollo de TNX-801, un candidato a vacuna de virus vivo atenuado en una sola dosis para mpox y viruela. Esto ocurre mientras la OMS declara que el brote de mpox en África es una emergencia de salud global. Puntos clave:
1. TNX-801 demostró eficacia en la protección de animales contra desafíos letales con el virus monkeypox.
2. La vacuna está diseñada para proporcionar protección a largo plazo con una sola dosis.
3. La clade II de mpox es ahora endémica en EE. UU. con más de 30,000 casos desde mayo de 2022.
4. La plataforma de vacunas de Tonix ha sido seleccionada por el Proyecto NextGen del NIH para pruebas clínicas.
5. TNX-801 mostró potencial para prevenir enfermedades clínicas, lesiones y disminuir la eliminación viral en primates no humanos.
Tonix Pharmaceuticals (NASDAQ: TNXP)는 mpox 및 천연두에 대한 단일 복용량 생백신 후보인 TNX-801의 개발을 진행하고 있습니다. 이는 WHO가 아프리카의 mpox 발생을 세계 보건 비상 사태로 선언하면서 이루어졌습니다. 주요 내용:
1. TNX-801은 동물들이 치명적인 원숭이두창 바이러스 도전에 대해 효과를 보였습니다.
2. 이 백신은 한 번의 투여로 장기적인 보호를 제공하도록 설계되었습니다.
3. clade II mpox는 이제 미국에서 발생하고 있으며, 2022년 5월 이후로 30,000건 이상의 사례가 발생했습니다.
4. Tonix의 백신 플랫폼은 NIH의 프로젝트 NextGen에 의해 임상 시험을 위해 선택되었습니다.
5. TNX-801은 임상 질병, 병변을 예방하고 비인간 영장류의 바이러스 배출을 감소시킬 가능성을 보였습니다.
Tonix Pharmaceuticals (NASDAQ: TNXP) avance dans le développement de TNX-801, un candidat vaccin à virus vivant atténué en dose unique contre le mpox et la variole. Cela se produit alors que l'OMS déclare l'épidémie de mpox en Afrique comme une urgence de santé publique mondiale. Points clés:
1. TNX-801 a démontré son efficacité à protéger les animaux contre des défis létaux avec le virus monkeypox.
2. Le vaccin est conçu pour fournir une protection à long terme avec une seule dose.
3. La clade II de mpox est maintenant endémique aux États-Unis avec plus de 30 000 cas depuis mai 2022.
4. La plateforme vaccinale de Tonix a été sélectionnée par le projet NextGen du NIH pour des tests cliniques.
5. TNX-801 a montré un potentiel pour prévenir les maladies cliniques, les lésions et réduire l'excrétion virale chez les primates non humains.
Tonix Pharmaceuticals (NASDAQ: TNXP) treibt die Entwicklung von TNX-801 voran, einem einmalig verabreichbaren Lebendvirus-Impfstoffkandidaten gegen mpox und Pocken. Dies geschieht, während die WHO den mpox-Ausbruch in Afrika als globale Gesundheitsnotlage erklärt. Wichtige Punkte:
1. TNX-801 zeigte Wirksamkeit beim Schutz von Tieren vor letalen Herausforderungen durch das Monkeypox-Virus.
2. Der Impfstoff soll mit einer Dosis langfristigen Schutz bieten.
3. Die Clade II mpox ist mittlerweile endemisch in den USA mit über 30.000 Fällen seit Mai 2022.
4. Die Impfstoffplattform von Tonix wurde vom NIH-Projekt NextGen für klinische Tests ausgewählt.
5. TNX-801 zeigte Potenzial zur Verhinderung klinischer Erkrankungen, Läsionen und zur Verringerung der Virusauscheidung bei nichtmenschlichen Primaten.
- TNX-801 demonstrated efficacy in protecting animals from lethal challenge with monkeypox virus
- Tonix's vaccine platform selected by NIH's Project NextGen for clinical testing
- TNX-801 designed to provide long-term protection with a single dose
- Preclinical trials show TNX-801 combines immune protection with improved tolerability and safety
- TNX-801 potentially prevents clinical disease, lesions, and decreases viral shedding in non-human primates
- No human clinical trial data available yet for TNX-801
- Competing with established mpox vaccines already in the market
- Potential challenges in scaling up production and distribution of a new vaccine
The WHO's declaration of mpox as a global health emergency underscores the critical need for effective vaccines. Tonix's TNX-801 shows promise with its single-dose administration and potential for long-term protection. The vaccine's demonstrated efficacy against lethal Clade 1 monkeypox challenge in animal studies is particularly significant, given the higher fatality rates associated with this strain. The mucosal immunity observed suggests a potential to reduce transmission, a important factor in controlling outbreaks.
However, it's important to note that while preclinical results are encouraging, human trials are still needed to confirm safety and efficacy. The selection of Tonix's platform for NIH's Project NextGen adds credibility but doesn't guarantee success. Investors should monitor the progress of clinical trials and regulatory approvals closely.
The recent mpox outbreaks highlight a shifting epidemiological landscape. The spread of Clade IIb to non-endemic regions and the potential for Clade I to follow is concerning. TNX-801's potential to provide protection against both clades could be a significant advantage. The single-dose regimen and improved stability without ultra-cold storage requirements make it particularly suitable for deployment in resource- settings, which are often epicenters of outbreaks.
However, the evolving nature of the virus and potential for new strains pose ongoing challenges. The vaccine's effectiveness against future variants will be crucial. Additionally, the global vaccination strategy and equitable distribution will be key factors in preventing future outbreaks and potential pandemics.
From a financial perspective, Tonix's focus on mpox vaccine development presents both opportunities and risks. The global health emergency status could accelerate regulatory pathways and increase demand, potentially leading to faster market entry and significant revenue streams if TNX-801 proves successful. The vaccine's advantages in storage and administration could give Tonix a competitive edge in the market.
However, investors should be aware of the substantial costs associated with clinical trials and the uncertain timeline to market. The company's ability to secure funding and partnerships will be crucial. Additionally, the volatile nature of vaccine markets, dependent on outbreak patterns and public health policies, introduces uncertainty. While the potential market is significant, revenue projections should be cautious until more data on efficacy and regulatory approval becomes available.
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 population.
“The recent WHO declaration underscores the urgent need for additional treatments to stop these outbreaks and save lives,” said Seth Lederman, M.D., Chief Executive Officer of Tonix. “We are motivated to advance development for our mpox vaccine with urgency given the global public health emergency. Preclinical trials demonstrate that TNX-801 combines immune protection with improved tolerability and safety compared to other vaccines based on orthopoxviruses, and is administered with a single dose which has advantages over two-dose regimens. The durability of protection from 19th century live virus vaccinia vaccines suggests that our attenuated TNX-801 will not require multiple repeated doses at six-month intervals like mRNA vaccines. Also, the stability of live virus vaccines eliminates the need for ultra-cold storage which complicates the widespread use of mRNA vaccines in Africa, where they are needed most right now.”
The global mpox outbreak, which commenced in 2022, has affected over 90,000 persons in countries where mpox had previously not been endemic, including Europe and the U.S. The spread of Clade IIb strain mpox in 2022 underscores the pandemic potential of mpox. Unlike Clade IIb mpox, the Clade I strain of mpox appears to be spreading to countries neighboring the Democratic Republic of the Congo. Clade I mpox is typically associated with approximately 20 times the case fatality rates than Clade IIb mpox in Africa. According to the U.S. Centers for Disease Control and Prevention (CDC), and other experts, there is a significant risk that the deadlier Clade I strain may appear in the U.S.2,8
Further, the Bipartisan Commission on Biodefense recently highlighted the renewed dual threats of a more virulent mpox epidemic and a smallpox re-introduction from lab accidents or bad actors9. The National Academies of Science, in its review of smallpox preparedness, highlighted the need for new single dose vaccines, like TNX-801 against smallpox10.
About TNX-801* and Tonix’s RPV Platform
TNX-801 (recombinant horsepox virus) is a live virus vaccine for percutaneous administration that is being developed to target smallpox, and mpox (monkeypox). TNX-801 is also the basis of the RPV platform based on a horsepox vector, which is being adapted as a COVID-19 vaccine, term TNX-1800*. Horsepox is a live replicating, attenuated virus that has been shown to be >1,000-fold more attenuated than 20th century vaccinia (VACV) strains in immunocompromised mice. Horsepox and the vaccinia vaccine viruses are closely related orthopoxviruses that are believed to share a common ancestor. Molecular analysis shows that horsepox is closer than modern vaccinia vaccines in DNA sequence to the vaccine discovered and disseminated by Dr. Edward Jenner. Live replicating orthopoxviruses, like vaccinia or horsepox, can be engineered to express foreign genes and have been explored as platforms for vaccine development because they possess; (1) large packaging capacity for exogenous DNA inserts, (2) precise virus-specific control of exogenous gene insert expression, (3) lack of persistence or genomic integration in the host, (4) strong immunogenicity as a vaccine, (5) ability to rapidly generate vector/insert constructs, (6) readily manufacturable at scale, and (7) ability to provide direct antigen presentation. Relative to vaccinia, horsepox has substantially decreased virulence in mice. The current formulation is a frozen liquid, but we believe that future lyophilized versions can be stored and shipped at standard refrigeration. Horsepox-based vaccines are designed to be single dose, vial-sparing vaccines that can be administered without sterile injection, manufactured using conventional cell culture systems with the potential for mass scale production, and packaged in multi-dose vials.
Tonix Pharmaceuticals Holding Corp.*
Tonix is a fully-integrated biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix recently announced the U.S. Department of Defense (DoD), Defense Threat Reduction Agency (DTRA) awarded it a contract for up to
*Tonix’s product development candidates are investigational new drugs or biologics and have not been approved for any indication.
Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.
This press release and further information about Tonix can be found at www.tonixpharma.com.
1WHO Press Release August 14, 2024. “WHO Director-General declares mpox outbreak a public health emergency of international concern”. URL: www.who.int/news/item/14-08-2024-who-director-general-declares-mpox-outbreak-a-public-health-emergency-of-international-concern (accessed 8-15-24)
2McQuiston JH, et al. U.S. Preparedness and Response to Increasing Clade I Mpox Cases in the Democratic Republic of the Congo. 2024, MMWR Morb Mortal Wkly Rep: United States. p. 435-440
3CDC. 2022-2023 Mpox: US Map and Case Count. https://www.cdc.gov/poxvirus/mpox/response/2022/us-map.html
4Noyce RS, et al. Viruses. 2023 Jan 26;15(2):356. doi: 10.3390/v15020356
5Trefry, SV et al. bioRxiv 2023.10.25.564033; https://doi.org/10.1101/2023.10.25.564033
6Awasthi M, et al. Viruses. 2023 Oct 21;15(10):2131. doi: 10.3390/v15102131.
7Awashti M et al Vaccines (Basel). 2023 Nov 2;11(11):1682. doi:10.3390/vaccines11111682.
8World Health Organization SAGE meeting highlights on updated mpox vaccine recommendations. 2024, March
9Bipartisan Commission on Biofense. Box the Pox: Reducing the risk of Smallpox and Other Orthopoxviruses, Washington: 2024
10U.S. National Academies of Science. Future State of Smallpox Medical Countermeasures. Washington: 2024
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, and periodic reports filed with the SEC on or after the date thereof. All of Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.
Investor Contact
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FAQ
What is TNX-801 and how does it differ from other mpox vaccines?
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Why is Tonix Pharmaceuticals (TNXP) developing TNX-801 now?