Tonix Pharmaceuticals Announces Research Agreement with Kenya Medical Research Institute (KEMRI) to Design, Plan and Seek Regulatory Approval for a Phase I Clinical Study of TNX-801 for Mpox in Kenya
Tonix Pharmaceuticals (TNXP) has partnered with Kenya Medical Research Institute (KEMRI) to develop a Phase I clinical study for TNX-801, a vaccine candidate for mpox prevention. The study will evaluate the safety, tolerability, and immunogenicity of TNX-801 in Kenya. The vaccine, which showed promising preclinical results, aligns with WHO's preferred target product profile for mpox vaccines, featuring single-dose administration and ambient temperature stability. This development comes as WHO declared mpox a public health emergency, with new Clade Ib cases detected across multiple countries. Tonix also announced a collaboration with Bilthoven Biologics for GMP manufacturing processes.
Tonix Pharmaceuticals (TNXP) ha stretto una partnership con il Kenya Medical Research Institute (KEMRI) per sviluppare uno studio clinico di Fase I per TNX-801, un candidato vaccinale per la prevenzione dell'mpox. Lo studio valuterà la sicurezza, la tollerabilità e l'immunogenicità di TNX-801 in Kenya. Il vaccino, che ha mostrato risultati preclinici promettenti, è in linea con il profilo di prodotto target preferito dall'OMS per i vaccini contro l'mpox, caratterizzato da somministrazione in un'unica dose e stabilità a temperatura ambiente. Questo sviluppo arriva dopo che l'OMS ha dichiarato l'mpox un'emergenza sanitaria pubblica, con nuovi casi di Clade Ib rilevati in diversi paesi. Tonix ha anche annunciato una collaborazione con Bilthoven Biologics per i processi di produzione GMP.
Tonix Pharmaceuticals (TNXP) se ha asociado con el Instituto de Investigación Médica de Kenia (KEMRI) para desarrollar un estudio clínico de Fase I para TNX-801, un candidato a vacuna para la prevención de mpox. El estudio evaluará la seguridad, la tolerabilidad y la inmunogenicidad de TNX-801 en Kenia. La vacuna, que mostró resultados preclínicos prometedores, está alineada con el perfil de producto preferido por la OMS para las vacunas contra mpox, que incluye administración en una sola dosis y estabilidad a temperatura ambiente. Este desarrollo se produce después de que la OMS declarara el mpox como una emergencia de salud pública, con nuevos casos de Clade Ib detectados en varios países. Tonix también anunció una colaboración con Bilthoven Biologics para procesos de fabricación GMP.
Tonix Pharmaceuticals (TNXP)는 케냐 보건 연구소(KEMRI)와 협력하여 TNX-801의 1상 임상 연구를 개발합니다. 이는 mpox 예방을 위한 백신 후보입니다. 이 연구는 케냐에서 TNX-801의 안전성, 내약성 및 면역원성을 평가할 것입니다. promising preclinical results를 보였던 이 백신은, 단일 용량 투여 및 실온 안정성을 특징으로 하는 WHO가 선호하는 mpox 백신 제품 프로필과 일치합니다. 이 개발은 WHO가 mpox를 공공 건강 비상사태로 선언한 후 이루어졌으며, 여러 국가에서 Clade Ib의 새로운 사례가 발견되었습니다. Tonix는 GMP 제조 공정을 위한 Bilthoven Biologics와의 협력도 발표했습니다.
Tonix Pharmaceuticals (TNXP) a établi un partenariat avec l'Institut de recherche médicale du Kenya (KEMRI) pour développer une étude clinique de Phase I pour TNX-801, un candidat vaccin pour la prévention de l'mpox. L'étude évaluera la sécurité, la tolérabilité et l'immunogénicité de TNX-801 au Kenya. Le vaccin, qui a montré des résultats précliniques prometteurs, est en accord avec le profil de produit cible préféré par l'OMS pour les vaccins contre l'mpox, comprenant une administration en dose unique et une stabilité à température ambiante. Ce développement intervient alors que l'OMS a déclaré l'mpox comme une urgence de santé publique, avec de nouveaux cas de Clade Ib détectés dans plusieurs pays. Tonix a également annoncé une collaboration avec Bilthoven Biologics pour les processus de fabrication GMP.
Tonix Pharmaceuticals (TNXP) hat eine Partnerschaft mit dem Kenya Medical Research Institute (KEMRI) geschlossen, um eine Phase-I-Studie für TNX-801, einen Impfstoffkandidaten zur Prävention von mpox, zu entwickeln. Die Studie wird die Sicherheit, Verträglichkeit und Immunogenität von TNX-801 in Kenia bewerten. Der Impfstoff, der vielversprechende präklinische Ergebnisse gezeigt hat, entspricht dem bevorzugten Zielproduktprofil der WHO für mpox-Impfstoffe mit einer Einzeldosisverabreichung und Stabilität bei Raumtemperatur. Diese Entwicklung erfolgt, nachdem die WHO mpox zu einem öffentlichen Gesundheitsnotfall erklärt hat und in mehreren Ländern neue Fälle des Clade Ib festgestellt wurden. Tonix gab auch eine Zusammenarbeit mit Bilthoven Biologics für GMP-Herstellungsprozesse bekannt.
- TNX-801 demonstrated efficacy against mpox in preclinical animal models
- Vaccine aligns with WHO's preferred target product profile requirements
- Partnership secured with world's largest vaccine manufacturer for GMP production
- Product features include single-dose administration and ambient temperature stability
- Product still in early development phase (pre-Phase I)
- Regulatory approval for clinical trial still pending
- No human efficacy data available yet
Insights
This research agreement with KEMRI marks a significant milestone in TNX-801's development pathway, particularly as it aligns with WHO's preferred target product profile for mpox vaccines. The key differentiators of TNX-801 include its single-dose administration, potential for durable protection and ambient temperature stability - critical advantages for global distribution.
The collaboration with Bilthoven Biologics, part of the Cyrus Poonawalla Group, provides robust manufacturing capabilities that could enable large-scale production. The timing is strategic, considering the recent detection of new Clade Ib mpox cases across multiple countries. However, investors should note that as a Phase I trial, significant regulatory hurdles and clinical validations remain before potential commercialization.
For a micro-cap company with a market cap of
The alignment with WHO's TPP could accelerate regulatory pathways and market acceptance if successful. However, current market valuation suggests investors remain cautious about execution risks and future capital requirements typical for early-stage biotech companies.
Proposed clinical study in Kenya intended to test the safety, tolerability, and immunogenicity of TNX-801, a vaccine being developed to prevent mpox (formerly called monkeypox)
The World Health Organization (WHO) declared mpox a public health emergency of international concern (PHEIC) 1-4: cases of the new Clade Ib mpox detected in Sweden, Thailand, Singapore, India, Germany and England
In preclinical data, TNX-801, Tonix’s attenuated live-virus vaccine candidate, demonstrated efficacy as a vaccination against mpox in animal models
CHATHAM, N.J., Nov. 04, 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, today announced that it has entered into a sponsored research agreement with the Kenya Medical Research Institute (KEMRI) to design, plan and seek regulatory approval for a Phase I clinical study in Kenya to test the safety, tolerability, and immunogenicity of TNX-801 (horsepox, live virus) as a vaccine to prevent mpox and smallpox. Tonix will be the sponsor and KEMRI will lead the execution of the proposed clinical trial.
“We are excited to advance development of TNX-801 under this research agreement with KEMRI,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “There is an urgent need for the worldwide availability of a single dose mpox vaccine with durable protection. TNX-801 has demonstrated encouraging preclinical data and was recently shown to align with the World Health Organization’s (WHO’s) newly issued preferred target product profile (TPP) for mpox vaccines. Further, TNX-801 can be scaled up for manufacturing, distribution and storage without a costly supply chain. We believe TNX-801 has the potential to address and help interrupt the spread of mpox worldwide.”
In September 2024, Tonix announced that the preferred target product profile (TPP), released at the WHO sponsored Mpox Research and Innovation Scientific Conference, aligns with the potential characteristics of TNX-801. Key elements of the WHO draft TPP include single-dose, durable protection, administration without special equipment, and stability at ambient temperature. Other potential beneficial characteristics include the ability to limit forward transmission, use in case-contact vaccination strategies and suitability for use in immunocompromised individuals.
In August 2024, Tonix announced a collaboration with Bilthoven Biologics (Bbio) to develop GMP manufacturing processes for TNX-801. Bbio is part of the world’s largest vaccine manufacturer, the Cyrus Poonawalla Group, which also includes the Serum Institute of India.
About TNX-801*
TNX-801 is a live minimally-replicating attenuated horsepox vaccine that is believed to provide immune protection against mpox in animals with better tolerability than 20th century vaccinia viruses. Vaccinia vaccines from the 20th century are descendants of Edward Jenner’s circa 1800 that have become more virulent in connection with losing regulatory elements in their genomes. Given the modern understanding that Jenner’s circa 1800 vaccine would be called “horsepox” today, TNX-801 was designed to be similar to Jenner’s vaccine. After a single dose vaccination, TNX-801 protected animals against lethal challenge with intratracheal Clade Ia monkeypox virus.5 In this experiment, TNX-801 vaccination prevented clinical disease and skin lesions and also decreased shedding in the mouth and lungs. The findings are consistent with mucosal immunity and suggest the ability to block forward transmission. In addition, TNX-801 has decreased virulence in immunocompromised animals relative to 20th Century vaccinia viruses.6 Based on animal studies, TNX-801 combines immune protection with improved tolerability compared to live-virus vaccinia vaccines. TNX-801 is administered with a single dose which has advantages over two-dose regimens. The focus on single-dose vaccines confirms early recommendations by the Bipartisan Commission on Biodefense, 7 and the U.S. National Academies of Science.7,8 The National Academies of Science (NAS) report highlights the difficulty of a ring vaccination strategy with even a two-dose regimen.7 TNX-1800 is an engineered version of horsepox that expresses the spike protein of SARS-CoV-2. 9,10 The U.S. National Institutes of Health (NIH) selected Tonix’s COVID-19 vaccine, TNX-1800 for Project NextGen.
About Mpox*
On August 14, 2024, the WHO determined that the upsurge of mpox in a growing number of countries in Africa constitutes a PHEIC, the second such declaration in the past two years called in response to an mpox outbreak.1 The current outbreak is caused by Clade Ib monkeypox virus while the 2022 outbreak was caused by Clade IIb monkeypox virus. The 2022 global mpox outbreak, which is ongoing, has affected over 90,000 persons in countries where mpox had previously not been endemic, including Europe and the US. The rapid spread of Clade IIb strain mpox in 2022 underscores the pandemic potential of mpox. Unlike Clade IIb mpox, the Clade Ib strain of mpox appears to be spreading in Africa, particularly those neighboring the Democratic Republic of the Congo, including Burundi, Rwanda, and Uganda, but now affecting 16 countries. According to the U.S. Centers for Disease Control and Prevention (CDC), and other experts, there is a significant risk that the Clade Ib monkeypox may appear in the U.S.2,3
Tonix Pharmaceuticals Holding Corp.*
Tonix is a fully integrated biopharmaceutical company focused on transforming therapies for pain management and modernizing solutions for public health challenges. Tonix’s development portfolio is focused on central nervous system (CNS) disorders, and its priority is to progress TNX-102 SL, a product candidate for which an NDA was submitted based on two statistically significant Phase 3 studies for the management of fibromyalgia. The FDA has granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic in Phase 2 development designed to treat cocaine intoxication that has FDA Breakthrough Therapy designation and its development is supported by a grant from the U.S. National Institude of Drug Abuse and Addiction. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is an Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease, including TNX-2900 for Prader-Willi syndrome, and infectious disease, including a vaccine for mpox, TNX-801. Tonix has a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to
* Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established 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 outbrfeak 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 Morbi 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
4World Health Organization SAGE meeting highlights on updated mpox vaccine recommendations. 2024, March
5Noyce RS, et al. Viruses. 2023 Jan 26;15(2):356. Doi: 10.3390/v15020356. PMID: 36851570; PMCID: PMC9965234
6Trefry, SV et al. bioRxiv 2023.10.25.564033; doi: https://doi.org/10.1101/2023.10.25.564033
7Bipartisan Commission on Biodefense. Box the Pox: Reducing the risk of Smallpox and Other Ortho poxviruses, Washington:2024
8U.S. National Academies of Science. Future State of Smallpox Medical Countermeasures. Washington:2024
9Awasthi M, et al. Viruses. 2023 Oct 21;15(10):2131. Doi: 10.3390/v15102131. PMID: 37896908; PMCID: PMC10612059.
10Awasthi M et al Vaccines (Basel). 2023 Nov 2;11(11):1682. Doi: 10.3390/vaccines11111682.PMID: 38006014
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 Toni’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 Toni’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
Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182
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ICR Westwicke
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Media Contact
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FAQ
What is the purpose of Tonix Pharmaceuticals' (TNXP) Phase I study in Kenya?
What are the key features of TNXP's TNX-801 mpox vaccine?
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