Latest news with #mpox
Yahoo
07-07-2025
- Health
- Yahoo
Tonix Pharmaceuticals Announces Oral Presentation on Mpox and Smallpox vaccine candidate TNX-801 at the Vaccine Congress 2025
Single dose vaccination with TNX-801 protects animals from a lethal challenge with monkeypox, the causative agent of mpox TNX-801 confers durable protection after a single dose TNX-801 is well tolerated in immunocompromised animals, without evidence of spreading to blood or tissues even at high doses CHATHAM, N.J., July 07, 2025 (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 Sina Bavari, PhD, Executive Vice President of Infectious Disease Research and Development at Tonix Pharmaceuticals, will present new data on TNX-801 (recombinant horsepox virus, live vaccine) at the upcoming Vaccine Congress 2025. TNX-801 is a minimally replicative, attenuated live virus vaccine candidate designed to generate durable humoral and cellular immunity after a single dose. Preclinical results in animals have demonstrated protection against mpox and other orthopoxviruses, supporting further clinical evaluation. TNX-801 also serves as an orthopoxvirus vaccine platform that can deliver multiple protective antigens against diverse viral pathogens. Dr. Bavari will present the safety, immunogenicity, and efficacy findings to date and describe Tonix's plans to advance the TNX-801 platform into clinical trials to protect against mpox and other viral diseases. Presentation details Location: Vienna, AustriaPresentation Date / Time: July 10th / 11:20am GMT+2Title: TNX-801, a single-dose live vaccine platform for Mpox and other emerging viral diseases: Safety, Immunogenicity, and Efficacy Speaker: Sina Bavari, PhD, Tonix Pharmaceuticals A copy of the presentation will be posted in the Scientific Presentations section of the Tonix website following the session. Tonix Pharmaceuticals Holding Corp.* Tonix is a fully-integrated biotech company focused on transforming therapies for pain management and vaccines for public health challenges. Tonix's development portfolio is focused on central nervous system (CNS) disorders. Tonix's priority is to advance TNX-102 SL, a product candidate for the management of fibromyalgia, for which an NDA was submitted based on two statistically significant Phase 3 studies for the management of fibromyalgia and for which a PDUFA (Prescription Drug User Fee act) goal date of August 15, 2025 has been assigned for a decision on marketing authorization. The FDA has also 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 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's infectious disease portfolio includes TNX-801, a vaccine in development for mpox and smallpox, as well as TNX-4200 for which Tonix has a contract with the U.S. DoD's Defense Threat Reduction Agency (DTRA) for up to $34 million over five years. TNX-4200 is a small molecule broad-spectrum antiviral agent targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults. * 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 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, 2024, as filed with the Securities and Exchange Commission (the 'SEC') on March 18, 2025, 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 Jessica Morris Tonix Pharmaceuticals 799-8599 Brian Korb astr partners (917) 653-5122 Media Contact Ray Jordan Putnam Insights ray@ Indication and Usage Zembrace® SymTouch® (sumatriptan succinate) injection (Zembrace) and Tosymra® (sumatriptan) nasal spray are prescription medicines used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine. Zembrace and Tosymra are not used to prevent migraines. It is not known if Zembrace or Tosymra are safe and effective in children under 18 years of age. Important Safety Information Zembrace and Tosymra can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs of a heart attack: discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw pain or discomfort in your arms, back, neck, jaw or stomach shortness of breath with or without chest discomfort breaking out in a cold sweat nausea or vomiting feeling lightheaded Zembrace and Tosymra are not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam shows no problem. Do not use Zembrace or Tosymra if you have: history of heart problems narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease) uncontrolled high blood pressure hemiplegic or basilar migraines. If you are not sure if you have these, ask your provider. had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation severe liver problems taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your provider for a list of these medicines if you are not sure. are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure. an allergy to sumatriptan or any of the components of Zembrace or Tosymra Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements. Zembrace and Tosymra can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert. Zembrace and Tosymra may cause serious side effects including: changes in color or sensation in your fingers and toes sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever cramping and pain in your legs or hips; feeling of heaviness or tightness in your leg muscles; burning or aching pain in your feet or toes while resting; numbness, tingling, or weakness in your legs; cold feeling or color changes in one or both legs or feet increased blood pressure including a sudden severe increase even if you have no history of high blood pressure medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider. serotonin syndrome, a rare but serious problem that can happen in people using Zembrace or Tosymra, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking. hives (itchy bumps); swelling of your tongue, mouth, or throat seizures even in people who have never had seizures before The most common side effects of Zembrace and Tosymra include: pain and redness at injection site (Zembrace only); tingling or numbness in your fingers or toes; dizziness; warm, hot, burning feeling to your face (flushing); discomfort or stiffness in your neck; feeling weak, drowsy, or tired; application site (nasal) reactions (Tosymra only) and throat irritation (Tosymra only). Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Zembrace and Tosymra. For more information, ask your provider. This is the most important information to know about Zembrace and Tosymra but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit or call 1-888-869-7633. You are encouraged to report adverse effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088.
Zawya
03-07-2025
- Health
- Zawya
World Health Organization (WHO) donates medical supplies and equipment to boost mpox response
As part of its continued support to Sierra Leone's health sector, the World Health Organization (WHO) has donated essential medical supplies, mpox test kits, and laboratory equipment, including five medical-grade refrigerators valued at over USD 126,000 to the Ministry of Health. The handover ceremony took place at the Hastings Treatment Centre, with WHO Country Representative Dr George Ameh officially handing over the supplies to Deputy Chief Medical Officer Dr Mustapha Kabba. The donation comes at a critical time as the country continues to respond to the ongoing mpox outbreak, with over 4,000 confirmed cases to date. The supplies will strengthen diagnostic and case management capacity at key treatment and testing sites: Lakka Hospital, Benguema Reference Laboratory, and Hastings Treatment Centre. 'Our support today reflects WHO's commitment to ensuring that frontline health workers have the tools they need to manage cases effectively and reduce transmission,' said Dr George Ameh, WHO Representative in Sierra Leone. 'These supplies will help improve the quality of care and expand diagnostic capabilities at a time when rapid response remains crucial.' Receiving the supplies, Deputy Chief Medical Officer Dr Mustapha Kabba expressed deep appreciation for WHO's ongoing support and used the occasion to commend frontline healthcare workers at Hastings. 'We are sincerely grateful to WHO for their continued and timely support throughout this mpox response,' said Dr Kabba. 'I want to encourage the hardworking team at Hastings Treatment Centre to continue the work. Your dedication is making a real difference, and we thank you for your tireless efforts in protecting the health of our communities.' The Hastings Treatment Centre, one of the designated facilities for mpox case management, is expected to receive a share of the supplies and equipment, which will be used to bolster patient care and improve cold chain storage for samples and medicines. 'With these additional resources, we can ensure better storage of lab reagents, enhance patient care, and maintain the quality of our services,' said Dr Darlinda Jiba, the facility In-charge at Hastings Treatment Centre. 'WHO's continued support is a true morale booster for our clinical teams.' The support is part of WHO's continued commitment to strengthening Sierra Leone's health system and response capacity. Distributed by APO Group on behalf of World Health Organization - Sierra Leone.
Zawya
01-07-2025
- Health
- Zawya
Sierra Leone bolters mpox response: World Health Organization (WHO) leads groundbreaking genomic surveillance and bioinformatics training
In a strategic initiative aimed at enhancing mpox outbreak response and genomic surveillance capacity, the Central Public Health Reference Laboratory (CPHRL) in Freetown hosted the mpox Genomics and Bioinformatics training workshop from 23rd – 27th June 2025. The event was organized under the theme: 'Strengthening Genomic Surveillance Capacity for mpox Response in Sierra Leone,' with technical and financial support from the World Health Organization (WHO AFRO and WHO Sierra Leone). The training program targeted 15 participants, including laboratory scientists, public health professionals, and epidemiologists from across Sierra Leone. Despite reporting over 4,400 confirmed cases of mpox as of 27th June 2025, Sierra Leone has performed genomic characterization on only approximately 2.5% of these cases (108 sequences), representing a significant limitation in understanding viral evolution and informing targeted public health interventions. Currently, these genomic data are deposited in international repositories such as Pathoplexus, GISAID, and NCBI Virus; however, the disparity between outbreak detection and genomic data generation hampers real-time surveillance efforts. The Ministry of Health and Sanitation (MoHS) and the Sierra Leone National Public Health Agency (SLNPHA) of Sierra Leone have prioritized strengthening genomic surveillance to enable rapid outbreak detection, track viral transmission, and inform policy decisions. Allan Campbell, Laboratory Lead at CPHRL, emphasized the significance of this training, stating, 'This marks a pivotal moment in Sierra Leone's national response to mpox. The initiative addresses the substantial bioinformatics capacity gap and establishes a foundation for sustainable genomic surveillance that can directly inform public health actions.' The workshop aligns with the objectives outlined in the WHO African Region (AFRO) Joint Continental mpox Response Plan 2.0, focusing on intensification, integration, and establishing a sustainable legacy in genomic epidemiology. The week-long workshop employed a multidisciplinary, hands-on approach combining didactic instruction, practical exercises, and group data analysis. The curriculum included: Day 1: Introduction to genomic surveillance principles, sequencing technologies, and foundational bioinformatics tools such as Linux and Conda environments. Day 2: Emphasis on sequencing data quality control (FastQC, MultiQC), read trimming (Fastp, Hostile), and genome assembly techniques utilizing reference-based (BWA, Cutadapt) and de novo (SPAdes) approaches. Day 3: Variant detection and analysis (SAMtools, FreeBayes, Snippy), consensus sequence generation (Bcftools), and genome annotation (SnpEff, VEP). Day 4: Phylogenetic analysis, clade classification (Nextclade, Nextstrain), and visualization using platforms such as GISAID, Pathoplexus, NCBI Virus, Microreact, iTOL, and Galaxy. Day 5: Integration of all components through a case study simulating mpox outbreak response, culminating in data interpretation and strategic planning. Walter Oguta, WHO AFRO EPI Analytics Specialist and the Lead Bioinformatics Trainer, underscored the practical value of the training, stating, 'Translating genomic data into actionable public health strategies is the ultimate goal. Our aim was to equip participants with both technical proficiency and confidence to utilize these tools effectively.' Doris Harding, Laboratory Pillar Lead at the SLNPHA, highlighted the broader implications: 'Strengthening our capacity for genomic surveillance is no longer optional—it is essential. This initiative empowers our scientists to respond more effectively to mpox and other emerging pathogens.' Similarly, Jonathan Greene, WHO Sierra Leone Laboratory Lead, articulated the importance of workforce development, asserting, 'Building a skilled, locally capable workforce is central to WHO's strategy for resilient health systems. The use of genomics is transforming outbreak intelligence, enabling a shift from reactive to proactive responses.' Dr. Ameh George, WHO Representative in Sierra Leone, emphasized the strategic importance of institutionalizing genomic surveillance: 'Genomics is redefining outbreak science. Sierra Leone must lead in generating and utilizing genomic data to inform policy and strengthen global health security. WHO remains committed to supporting this transformation.' Participants and stakeholders concurred that this training initiative constitutes a long-term investment in Sierra Leone's epidemic preparedness, response and resilience. By decentralizing sequencing capabilities and integrating genomic data into national decision-making processes, the program aspires to support regional efforts for early detection and rapid response to outbreaks. The workshop concluded with the issuance of certificates of completion and a networking session aimed at fostering collaboration and innovation in public health genomics. As Sierra Leone advances its surveillance infrastructure, the overarching goal remains to elevate genomic data from an underutilized resource to a central element of outbreak response and epidemic intelligence, thereby strengthening national and regional health security. Distributed by APO Group on behalf of World Health Organization - Sierra Leone.
Yahoo
26-06-2025
- Health
- Yahoo
Bavarian Nordic Announces the Initiation of Clinical Trials of Mpox Vaccine in Infants and Pregnant Women
First studies to evaluate MVA-BN in infants under 2 years of age and pregnant and breastfeeding women. The multi-partner research project is aimed at expanding access to mpox vaccines for vulnerable populations. COPENHAGEN, Denmark, June 26, 2025 – Bavarian Nordic A/S (OMX: BAVA) announced today the initiation of the first of two clinical trials designed to support approval and use of the MVA-BN® mpox/smallpox vaccine in vulnerable populations: infants under 2 years of age and pregnant and breastfeeding women The first participants have been vaccinated in a study (NCT06844487), evaluating the safety and immunogenicity of MVA-BN in 344 infants aged 4-24 months. Recruitment has also started in a second study (NCT06844500), which is planned to enrol 359 women (pregnant or breastfeeding), also to be evaluated for safety and immunogenicity of MVA-BN. Both studies are conducted in the Democratic Republic of Congo (DRC), the epicentre of the ongoing mpox outbreak, where infants and pregnant women remain highly vulnerable to mpox. Paul Chaplin, President & CEO of Bavarian Nordic, said: 'Through partnerships we have made significant advances already by expanding access to our mpox vaccine for children and adolescents. These new studies will fill the gap by providing important data about the use of MVA-BN in infants and pregnant women, and we applaud the study partners as well as the funding partners, EDCTP3 and CEPI for supporting this important work which could help support a label expansion for MVA-BN to include the most vulnerable populations.' Both studies are part of the PregInPoxVac research project, led by the University of Antwerp and the University of Kinshasa. The project is further supported by partners in Kenya (ACE Research) and Italy (Penta Foundation), funded by the European Union Global Health EDCTP3, the Coalition for Epidemic Preparedness Innovations (CEPI), and Bavarian Nordic. In addition, Bavarian Nordic is sponsoring a trial of MVA-BN in children aged 2-11 years, which has received funding support from CEPI. Topline results from this trial (NCT06549530) are anticipated in the third quarter of 2025. Once full results become available, these could potentially support regulatory approval of MVA-BN for younger children. About the mpox vaccineMVA-BN or Modified Vaccinia Ankara-Bavarian Nordic is the only non-replicating mpox vaccine approved in the U.S., Switzerland, Singapore and Mexico (marketed as JYNNEOS®), Canada (marketed as IMVAMUNE®), and the EU/EAA and United Kingdom (marketed as IMVANEX®). Originally developed as a smallpox vaccine in collaboration with the U.S. government to ensure the supply of a smallpox vaccine for the entire population, including immunocompromised individuals who are not recommended vaccination with traditional replicating smallpox vaccines, MVA-BN has been indicated for use in the general population in individuals considered at risk for smallpox or mpox infection. About Bavarian NordicBavarian Nordic is a global vaccine company with a mission to improve health and save lives through innovative vaccines. We are a preferred supplier of mpox and smallpox vaccines to governments to enhance public health preparedness and have a leading portfolio of travel vaccines. For more information, visit Forward-looking statements This announcement includes forward-looking statements that involve risks, uncertainties and other factors, many of which are outside of our control, that could cause actual results to differ materially from the results discussed in the forward-looking statements. Forward-looking statements include statements concerning our plans, objectives, goals, future events, performance and/or other information that is not historical information. All such forward-looking statements are expressly qualified by these cautionary statements and any other cautionary statements which may accompany the forward-looking statements. We undertake no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances after the date made, except as required by law. Contact investors:Europe: Rolf Sass Sørensen, Vice President Investor Relations, rss@ Tel: +45 61 77 47 43US: Graham Morrell, Gilmartin Group, graham@ Tel: +1 781 686 9600 Contact media:Nicole Seroff, Vice President Corporate Communications, nise@ Tel: +45 53 88 06 03 Attachment 2025-06-26-enError in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Telegraph
26-06-2025
- Health
- Telegraph
Hoping that viruses will go away is not enough – what is needed is continuous vigilance
In the public debate about pandemics, there is a belief as persistent as it is dangerous: the idea that epidemics end, that viruses – once contained – will disappear like a summer storm. But virology and epidemiology teach us that viruses do not disappear. Viruses adapt and mutate. They lurk in the folds of health inequalities and gaps in global surveillance. The latest alarm comes from Sierra Leone, which, after reporting its first two cases of mpox (formerly known as monkeypox) in January and declaring a public health emergency, is now facing a significant expansion of the epidemic. According to official sources, the country has reported over 3,000 confirmed cases and at least 15 deaths, with infections concentrated particularly in Western Area Urban, Western Area Rural, and Bombali. National health authorities, assisted by the WHO, Unicef, Africa CDC, and Gavi, have implemented a comprehensive emergency plan: strengthening surveillance, isolating cases, contact tracing, and launching awareness campaigns in schools and rural communities. As a result, 61,300 doses of the MVA-BN vaccine are expected to arrive in the coming weeks, and hundreds of health workers are being trained on diagnostic, treatment, and prevention protocols. This outbreak is becoming particularly worrisome due to the high vulnerability of children, who face a mortality risk up to four times higher than adults, especially in conditions of malnutrition or poor hygiene. On a continental scale, Africa is witnessing a rise in cases, with over 50,000 reported since the beginning of the year and more than 1,700 deaths. A critical factor is the viral clade involved. While full genomic mapping is still underway, the Africa CDC has reported that clade IIb, which has been associated with faster human-to-human transmission and potentially exponential spread, is likely the dominant strain in Sierra Leone. Despite Sierra Leone's improved emergency response capacity, gained during the 2014-2016 Ebola outbreak, healthcare infrastructure remains under strain. Patients often share beds, and clinical recognition delays persist, reflecting systemic pressures that could hamper containment efforts. Viruses return when the world 'moves on' Recent history, from Covid-19 to polio, shows that viruses do not 'die out' with a decree or a short-lived vaccination campaign. Zoonotic viruses, in particular, have an inherent ability to remain in circulation between animal and human hosts, often with different symptomatologies, and to re-emerge under favourable conditions. When surveillance loosens, when public health is underfunded, when the world 'moves on,' viruses return. Mpox is emblematic in this regard. For decades considered a virus confined to parts of central Africa, it has found new vectors, new susceptible populations, and new routes of transmission. Its recent mutations – linked to clade IIb – suggest adaptations to human infection that could make it endemic even in hitherto unaffected areas. Its apparent disappearance in high-income countries after the 2022-2023 wave is illusory: it was not a biological defeat, but a logistical suspension. Yet there are examples of good health behaviour from which the whole world should draw inspiration. In Tanzania in 2023, a small outbreak of Marburg virus – one of the world's deadliest pathogens, belonging to the same family as Ebola – was contained through a timely, transparent and coordinated response. The Tanzanian Ministry of Health quickly put in place measures for contact tracing, case isolation, effective public communication and cooperation with WHO. Similar efficiency was demonstrated in Rwanda, where preparedness for potential Marburg cases became a pillar of public health strategy, despite the fact that no outbreaks had occurred. Both countries invested in decentralised surveillance systems, widespread health training, and integration of human and veterinary medicine-embodying the concept of 'One Health'. These examples show that prevention is not a luxury of rich countries, but a strategic choice that is possible everywhere if supported by political will and real, non-paternalistic international cooperation. The new mpox outbreak in Sierra Leone must be interpreted in light of a fundamental fact: the transmissibility of viruses knows no geopolitical boundaries. Emerging diseases are now more than ever a global health security issue. A delay in diagnosis in Freetown can trigger an infection in Paris, London or Toronto within days. Yet funding for surveillance and diagnostic laboratories remains concentrated in a few areas. Large regions of Africa, Asia, and Latin America lack sentinel systems capable of detecting new threats in real time. Where the first patient is not identified, the virus has already won the first round. Continuing to hope that 'it won't happen here,' or that 'this time it is just a small outbreak,' is a mistake we have already paid dearly for. The mpox emergency in Sierra Leone is not yet a pandemic, but it is already an opportunity: to invest, to coordinate, to train. Epidemiological surveillance must become a structural and continuous investment, not an emergency response. We need a global network that not only responds, but predicts. One that recognises the global potential in seemingly minor outbreaks, and that funds local health systems not just to treat, but to monitor and to anticipate. Hoping that viruses will disappear is an understandable but naive wish. The only scientifically sound response is permanent, equitable, multilevel surveillance. We can no longer afford to ignore weak signals. Every contained outbreak is a shared victory; every ignored outbreak is a global defeat waiting to happen. Francesco Branda is an Adjunct professor at the Faculty of Medicine and Surgery at Campus Bio-Medico University of Rome Protect yourself and your family by learning more about Global Health Security
