This is a prospective observational phase IV study of a novel, replication-deficient smallpox vaccine that has been recently been approved by FDA. The purpose of this study is to determine if there are any abnormalities detected by electrocardiographic testing and/or blood tests within 35 days of receiving the second dose of smallpox vaccine either alone or co-administered with other vaccines that may/may not be suggestive of myopericarditis.

开始日期2029-03-01

申办/合作机构

Womack Army Medical Center

[+1]

NCT05745987 / Not yet recruiting临床4期IIT

SMART (Smallpox Vaccine for Mpox Post-Exposure Prophylaxis: A Cluster Randomized Controlled Trial)

A cluster randomized controlled trial to determine if smallpox vaccine reduces secondary cases and symptom severity in persons exposed to mpox.

开始日期2024-09-01

申办/合作机构

McMaster University

NCT06366672 / Recruiting早期临床1期IIT

Evaluating the Durability of the Human Immune Response to the JYNNEOS Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) Vaccine

This study is designed to evaluate the magnitude and duration of the human adaptive immune response to the JYNNEOS Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) vaccine in the blood, lung mucosa, skin and bone marrow.

开始日期2024-06-10

申办/合作机构

Washington University School of Medicine

100 项与天花疫苗(Bavarian Nordic A/S) 相关的临床结果

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100 项与天花疫苗(Bavarian Nordic A/S) 相关的专利（医药）

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1,425

项与天花疫苗(Bavarian Nordic A/S) 相关的文献（医药）

2108-11-15·Psychiatria Danubina4区 · 医学

NON-SUICIDAL SELF-INJURY AMONG UNIVERSITY STUDENTS IN TURKEY: THE EFFECT OF GENDER AND CHILDHOOD ABUSE

4区 · 医学

Article

作者: Idig-Camuroglu, Meltem ; Gölge, Z Belma

BACKGROUND:

The purpose of this study was to explore the effect of gender and childhood abuse on non-suicidal self-injurious (NSSI) behaviors among university students in Turkey.

SUBJECTS AND METHODS:

In this study convenience sampling technique was used, the sample consisted of 1000 young adults who were from the eight universities in two big cities; Istanbul and Ankara. Besides with demographic questionnaire, Inventory of Statements about Self-Injury and Childhood Trauma Questionnaire were used.

RESULTS:

The prevalence of NSSI was 28.5% and the most prevalent three self-injurious behaviors were wound picking, banging/hitting and pinching self. There was not a gender difference in NSSI behavior frequency but in the type of behavior; males had significantly higher percentages of hitting and burning behavior. Examining the intrapsychic and interpersonal functions of NSSI, "affect regulation" and "toughness" functions were the most used ones among the participants. In terms of gender differences, "revenge" function was used by females more than males. Self-injurers had higher childhood abuse scores on sexual, physical, and emotional abuse and neglect subscales than non self-injurers, and males were significantly more abused than females.

CONCLUSIONS:

Accepting childhood abuse as an important predictor of NSSI behavior, screening and assessment of abused children and adolescents can help to prevent the onset of the behavior.

2024-12-31·Expert review of vaccines

Immunogenicity and safety of ebolavirus vaccines in healthy adults: a systematic review and meta-analysis of randomized controlled trials

Review

作者: Miao, Mingsan ; Qin, Changjiang ; Wang, Chaoyang ; Zhang, Liang ; Yin, Juntao

BACKGROUND:

This review aimed to systematically evaluate the immunogenicity and safety of the candidate Ebola virus vaccine (EVV).

METHODS:

We searched five databases for randomized controlled trials (RCTs) evaluating the effects of EVV on healthy adults. The primary outcomes were relative risk (RR) of sero-conversion or sero-response of EVV in healthy adults between the groups that received EVV and the controls.

RESULTS:

Twenty-nine RCTs (n = 23573) were included. There was a significant difference in RR of sero-conversion of EVV (RR 13.18; 95% CI 11.28-15.41; I² = 33%; P < 0.01) between the two groups. There was a significant difference in RR of adverse events (AEs) of EVV (RR 1.49; 95% CI 1.27-1.74; I² = 88%; P < 0.01), although no difference in RR of serious AE (SAE) between the two groups. Subgroup analysis showed that there was no significant difference in RR of AEs for DNAEBO, EBOV-GP, MVA, and rVSVN4CT1 vaccines, compared with controls.

CONCLUSIONS:

The DNAEBO, EBOV-GP, MVA, and rVSVN4CT1 vaccines are likely to be safe and immunogenic, tending to support the vaccination against Ebola disease. These findings should provide much-needed evidence for public health policy makers to develop preventive measures based on disease prevalence features and socio-economic conditions.

2024-03-26·The Journal of infectious diseases

Epidemiology of the 2022 Mpox Outbreak in the US Veterans Health Administration

Article

作者: Trevino, Christina ; Oda, Gina ; Schirmer, Patricia ; Holodniy, Mark ; Elbeik, Tarek ; Edson, Connor ; Lucero-Obusan, Cynthia

Abstract:

Background:

In May 2022, mpox cases were reported in nonendemic countries, including the United States. We examined mpox infections in the Veterans Health Administration (VHA).

Methods:

Mpox diagnostic and whole genome sequencing (WGS) results, demographics, risk factors, hospitalizations, exposures, deaths, and pharmacy and immunization data were obtained from VHA data sources (23 May 2022–31 May 2023).

Results:

Of 1144 Veterans tested, 251 (21.9%) were presumptive positive for nonvariola orthopoxvirus (NVO) or confirmed positive for NVO and Monkeypox virus (MPXV). Incidence rate was 7.5 per 100 000 Veterans in care, with the highest rate observed in Veterans aged 25–34 years (13.83 cases per 100 000). Higher odds of NVO or NVO/MPXV positivity was associated with male sex; non-Hispanic Black race/ethnicity; syphilis or human immunodeficiency virus (HIV) positivity; or genital/rectal sample site, whereas older age and vaccination with JYNNEOS or vaccinia (smallpox) had lower odds. Among 209 with confirmatory testing, 90.4% reported intimate contact and/or an epidemiological link, 84.5% were men who have sex with men (MSM), 24.2% received tecovirimat, and 8.1% were hospitalized with 1 death. Eighty-six sequenced samples had evaluable WGS results. All were clade IIb, representing 10 different lineages from 20 states and the District of Columbia.

Conclusions:

Mpox affected younger, MSM, non-Hispanic Black, and HIV/syphilis-positive men among US Veterans. Viral diversity was noted across geographic regions. At-risk Veterans would benefit from vaccination and risk reduction strategies for mpox and other sexually transmitted infections.

275

项与天花疫苗(Bavarian Nordic A/S) 相关的新闻（医药）

2024-06-28

·GlobeNewswire-Health Care

Bavarian Nordic Joins Global Efforts to Fight Mpox Outbreak in Africa

Bavarian Nordic is committed to support global efforts to address the mpox situation in Africa through a donation of 15,000 doses of mpox vaccineEmergency Use Authorization for the MVA-BN vaccine has been issued in the DR Congo COPENHAGEN, Denmark, June 28, 2024 – Bavarian Nordic A/S (OMX: BAVA) today announced an extended commitment to help fight the current mpox outbreak in Africa. The Company’s MVA-BN vaccine, the only FDA and EMA-approved mpox vaccine, which served as an important tool during the 2022-2023 mpox outbreak, could soon also become available in the DR Congo (DRC) and other countries in Africa. Mpox is on the rise in African countries with increasing incidence of the more severe clade I. So far in 2024, more than 9,000 mpox cases and over 400 deaths have been reported across seven African countries of which the vast majority (96%) having occurred in the DRC1. Earlier this week, the regulatory authorities in the DRC, ACOREP (Autorité Congolaise de Réglementation Pharmaceutique), issued an Emergency Use Authorization allowing for the use of the MVA-BN vaccine for individuals at risk of mpox. Locally, in the DRC, clinical studies are also planned to support a full regulatory approval of the MVA-BN vaccine, as recently announced by Bavarian Nordic. To further strengthen the response in the DRC and throughout the African region, Bavarian Nordic will collaborate with global health partners, including WHO, UNICEF and Gavi. Bavarian Nordic applauds Gavi’s Board decision to approve a new Vaccine Investment Strategy which includes the establishment of a global mpox vaccine stockpile. In the near term, Bavarian Nordic is committed to work in partnership with Gavi, WHO and UNICEF to coordinate dose donations in response to the ongoing outbreak in the DRC and other African countries. To support these efforts, Bavarian Nordic has committed to donating 15,000 doses of its MVA-BN mpox vaccine to the African response. “The spread of mpox in the Democratic Republic of the Congo and elsewhere is highly concerning and could pose a global threat if it is not urgently contained,” said Dr Sania Nishtar, CEO of Gavi, the Vaccine Alliance. “Gavi and its partners welcome Bavarian Nordic’s resolve to help fight this outbreak and its contribution in doses. Our Alliance welcomes the availability of new vaccines for countries and is committed to working with Bavarian Nordic and the relevant authorities to facilitate their arrival and timely administration in line with country plans.” “Mpox has been a public health threat in several African countries for more than 50 years and is now spreading across the continent with higher incidence and severity. Global partners are uniting to build a stronger public health response throughout the affected region. and we are proud to contribute through a donation of our mpox vaccine,” said Paul Chaplin, President and Chief Executive Officer of Bavarian Nordic. About mpox in the DRC and other African countriesAfrica is currently tackling one of the largest and deadliest known mpox outbreak to date. Over 8,700 mpox cases and 408 deaths have been reported in the DRC this year alone, with children accounting for the majority of infections and deaths. Cases have also been confirmed in the Republic of Congo, Cameroon, Central African Republic, Ghana, Liberia and South Africa. Mpox was first identified in the DR Congo in 1970. In most cases, mpox symptoms - typically fever and headache, followed by painful lesions - resolve within a few weeks. However, for some, mpox can lead to medical complications, such as bronchopneumonia, sepsis, encephalitis, loss of vision, or death. The mpox virus strain behind the current outbreak, known as clade I, is estimated to be fatal in up to 10% of cases. About the smallpox/mpox vaccineMVA-BN or Modified Vaccinia Ankara-Bavarian Nordic is a non-replicating smallpox vaccine and the only mpox vaccine approved in the U.S. and Switzerland (marketed as JYNNEOS®), Canada (marketed as IMVAMUNE®), and the EU/EEA and United Kingdom (marketed as IMVANEX®). Originally developed 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 adult population (18 years and older) in individuals considered at risk for smallpox or mpox. During the 2022-2023 mpox outbreak, the vaccine was granted an Emergency Use Authorization by the U.S. FDA for both pre- and post-exposure use in adolescents. Bavarian Nordic has been a long-term supplier of the vaccine to the U.S. and Canada as well as several other countries as part of their national biological preparedness. During the 2022-2023 mpox outbreak, Bavarian Nordic has furthermore supported governments and supranational organizations by expanding access to the vaccine to more than 70 countries worldwide. About Bavarian NordicBavarian Nordic is a fully integrated vaccine company with a mission to protect and save lives through innovative vaccines. We are a global leader in smallpox and mpox vaccines, supplied to governments to enhance public health preparedness and have a strong portfolio of vaccines for travelers and endemic diseases. For more information visit www.bavarian-nordic.com. 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. ContactsEurope: Rolf Sass Sørensen, Vice President Investor Relations, rss@bavarian-nordic.com, Tel: +45 61 77 47 43US: Graham Morrell, Paddock Circle Advisors, graham@paddockcircle.com, Tel: +1 781 686 9600 1 https://africacdc.org/download/africa-cdc-weekly-event-based-surveillance-report-june-2024/ Attachment 2024-06-28-en

上市批准疫苗加速审批

2024-06-27

·CPHI制药在线

T细胞免疫：引领预防与治疗疾病的疫苗新纪元

关注并星标CPHI制药在线前言人类面临的疾病挑战，特别是传染病的肆虐和癌症的侵袭，已对全球公共卫生和经济构成了严峻威胁。作为抗击这些疾病的重要防线，预防性和治疗性疫苗的开发成为了当务之急。本文综合梳理了疫苗载体的免疫学基础、T细胞载体疫苗的设计方略以及疫苗研究的新动态，旨在为新型疫苗的研发提供创新思路。在机体受到感染后，T细胞能够分化成多样化的效应T细胞亚群，它们担当着清除病原体的重任。因此，深入研究效应T细胞的功能与机制，对于设计出能够激活T细胞免疫反应的疫苗至关重要。目前，针对多种病毒（如HIV、HCMV等）以及肿瘤疾病的疫苗研发，均聚焦于T细胞疫苗的开发。在这些疫苗中，能够激活T细胞免疫反应的载体疫苗显示出了显著的优势。疫苗载体种类繁多，包括病毒载体、细菌载体和核酸载体等，它们各自在抗原呈递能力、免疫原性和保护效果方面均表现出色。在T细胞载体疫苗的设计过程中，我们需要采取一系列策略，包括确定最佳的抗原呈递方式和载体传递路径、确保生物安全性、选择合适的疫苗载体，并权衡各种载体疫苗的利弊。值得一提的是，mRNA疫苗在抗击新冠疫情中发挥了举足轻重的作用，展现了其独特的优势。疫苗载体的免疫学原理载体疫苗在递送异源抗原至MHCⅠ类限制性抗原加工途径中发挥着关键作用。这一策略的目标在于诱发对病毒株或肿瘤抗原中高度保守蛋白质的免疫反应，从而实现对不同个体中病毒和肿瘤的广泛防御。虽然直接引入蛋白质至MHCⅠ类加工途径的方法，例如乙型肝炎表面抗原颗粒，已被采用，但最新研究显示，通过向细胞内递送编码抗原的基因，其效果更为显著。这种方式允许MHCⅠ类分子提呈相关表位肽，包括直接细胞转染和借助各种载体（如病毒载体、细菌以及质粒DNA）实现。设计病毒疫苗载体的思路 · 腺病毒载体腺病毒作为非包膜双链DNA病毒，广泛感染哺乳动物，可诱导强免疫反应。其载体分为复制性和复制缺陷性两类，后者因安全性高成为疫苗开发重点。通过删除E1和E3区域，可制备复制缺陷性病毒，具有感染多种细胞、易纯化等优势，但高免疫原性限制其应用。AdV载体技术成熟，已用于制备新冠病毒等疫苗。我国首个新冠重组腺病毒载体疫苗Ad5-nCoV表现优异，接种28天后对新冠感染保护效力显著，为抗击疫情提供了有力支持。 · 痘病毒载体痘病毒，作为最大的包膜DNA病毒，已成功用于根除天花，并作为转基因表达载体。其特点包括高稳定性、低成本、灵活的基因表达和持久的免疫力，使其成为疫苗载体的优秀候选。第三代痘病毒载体如MVA，通过高度衰减保证安全性，同时保持强大的抗原表达能力。MVA作为天花疫苗已在德国广泛应用，并显示出良好的安全性和免疫原性。针对埃博拉病毒，重组痘病毒载体疫苗如MVA-BN-Filo与腺病毒载体疫苗Ad26.ZEBOV联合使用，能有效激发免疫反应，且未显示严重不良反应。这些发现表明痘病毒载体疫苗在防治严重传染病方面具有巨大潜力。 · 水疱性口炎病毒载体水疱性口炎病毒（VSV）载体在疫苗开发中展现出显著优势，包括高效表达外源蛋白、无宿主基因重组风险、基因组易于修饰、低预存免疫、强免疫应答和泛宿主嗜性。FDA已批准基于VSV的重组疫苗，为其在疫苗领域的应用铺平了道路。然而，VSV疫苗载体在拯救和安全性方面仍面临挑战。尽管如此，VSV作为工具载体在病毒中和测定、基因治疗等领域有广泛应用。VSV疫苗载体能刺激强烈的免疫反应，已被用于开发针对肺结核、HIV和埃博拉等疾病的疫苗。此外，VSV还能有效启动和增强对肿瘤抗原的免疫反应，作为癌症疫苗载体具有潜力。细菌载体疫苗的应用细菌，尤其是减毒细菌和分泌的蛋白质，在疫苗载体中扮演重要角色。沙门氏菌、志贺氏菌和牛分枝杆菌等细菌可通过口服途径传递抗原，诱导宿主细胞产生免疫反应。细菌载体通过递送抗原至细胞质内，进一步由MHCⅠ类途径处理，激活体液和细胞免疫应答。针对疫苗载体的潜在问题，如基因转移，科学家已转向细菌分泌的蛋白，如CRM197，这是一种经改造的白喉毒素，保留了免疫原性而安全性大幅提升。CRM197与肺炎球菌多糖抗原的结合疫苗已被FDA批准上市，其EGF样结合位点还赋予其抗癌疗法的前景。CRM197在癌症免疫治疗中的应用显示出其潜力，尤其在针对HER2的B细胞肽癌症治疗中，可显著提高抗体滴度。此外，CRM197还被评估为HCMV T细胞疫苗的潜在载体。该疫苗通过激活巨噬细胞表面的TLR4和NF-κB信号通路，引发强烈的先天免疫应答，包括促炎细胞因子的分泌和MHC-肽抗原复合物的形成。这些复合物被T细胞识别，诱导CD8和CD4 T细胞的激活，并促进Th1型HCMV特异性IgG2a抗体的产生。总之，细菌载体在疫苗研发中具有独特的优势，CRM197作为细菌分泌蛋白的代表，不仅在预防感染性疾病方面取得显著进展，还在癌症免疫治疗领域展现出广阔的应用前景。疫苗研究的未来和展望疫苗载体技术的多样化展现了在免疫学领域的巨大潜力和应用前景。病毒载体疫苗，如腺病毒、痘病毒和水疱性口炎病毒，通过插入病原体基因或替换病毒糖蛋白来诱导免疫反应，其中腺病毒和痘病毒在疫苗研发中尤为突出，已成功应用于多种病原体，包括新冠病毒和埃博拉病毒的疫苗开发。细菌载体疫苗则利用细菌如沙门氏菌、志贺氏菌等通过口服或质粒递送编码抗原，引发免疫反应。白喉毒素突变体CRM197作为细菌载体疫苗的代表，展现了良好的安全性和免疫原性。DNA疫苗和mRNA疫苗作为新型疫苗技术，分别通过直接转染质粒DNA和注射mRNA到动物体内来引发免疫反应。其中，mRNA疫苗避免了基因整合和突变的风险，其代表性产品如辉瑞BioNTech和Moderna的COVID-19疫苗，已在全球范围内广泛应用。这些载体疫苗技术不仅应用于传染病预防，还扩展到癌症免疫治疗、过敏和自身免疫性疾病治疗等多个领域，突显了免疫机制的多样性和复杂性。随着研究的深入，载体疫苗在开发新型疫苗和免疫疗法、以及深入理解免疫系统中的作用将具有更大的潜力。参考文献： [1] CROTTY S. Follicular helper CD4 T cells (TFH) [J]. Annual Review of Immunology, 2011, 29: 621-663 [2] ZHU J F, YAMANE H, PAUL W E. Differentiation of effector CD4 T cell populations* [J]. Annual Review of Immunology, 2010, 28: 445-489. [3] SALLUSTO F, LANZAVECCHIA A, ARAKI K, et al. From vaccines to memory and back. [J]. Immunity, 2010, 33(4): 451-463 [4]《合成生物学》期刊来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com ▼更多制药资讯，请关注CPHI制药在线▼ 点击阅读原文，进入智药研习社~

疫苗

2024-06-25

·BioSpace

Tonix Pharmaceuticals Presents Vaccine Platform Data in Keynote Talk at the Vaccine Congress 2024

Tonix’s live virus vaccine 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 Clade II mpox is now endemic in the U.S. with >30,000 cases reported since May 20221 and Clade I mpox is endemic in the Democratic Republic of the Congo2 Tonix’s vaccine platform has been selected by NIH’s Project NextGen for clinical testing CHATHAM, N.J., June 25, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals, Inc. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced data presented at an oral Keynote Talk at the Vaccine Congress 2024 held June 24-25, 2024 in Prague, Czech Republic. A copy of the Company’s presentation is available under the Scientific Presentations tab of the Tonix website at . The presentation titled, “A New Live Virus, One Dose Vaccine Platform for Mpox, Smallpox and COVID-19”, detailed the Company’s vaccine platform, including TNX-801 (horsepox, live virus) vaccine for preventing mpox (formerly known as monkeypox) and smallpox and TNX-1800 (horsepox expressing SARS-CoV-2 spike protein) for protecting against COVID-19. TNX-801 and TNX-1800 are live replicating attenuated vaccines based on horsepox that are believed to provide immune protection with better tolerability than modern vaccinia viruses. In the presentation, Tonix highlighted positive preclinical efficacy data, demonstrating that TNX-801 protected non-human primates against lethal challenge with intratracheal Clade 1 monkeypox virus3. After a single dose vaccination, TNX-801 prevented clinical disease and lesions and also decreased shedding in the mouth and lungs of non-human primates. 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. “We are excited for the prospects of our live virus vaccine platform and look forward to advancing development for our vaccine candidates to prevent mpox, smallpox, COVID and other infectious diseases,” said Seth Lederman, M.D., Chief Executive Officer of Tonix. “TNX-801 combines immune protection with improved tolerability compared to other vaccines based on orthopoxviruses. TNX-801 is administered with a single dose which has advantages over two-dose regimens. We believe TNX-801 can be rapidly scaled up for manufacturing and can be distributed and stored without a costly and cumbersome ultra-cold supply chain. TNX-801 also has the potential to be used as a viral vector platform, for which recombinant versions can be developed to protect against other infectious diseases. Tonix developed TNX-1800 as a vaccine to protect against COVID-19. We are excited that TNX-1800 was selected for the U.S. National Institute of Health’s (NIH’s) Project NextGen and we look forward to providing updates on the program.” The presentation noted that 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 US. 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 remains restricted to several Central African countries, including the Democratic Republic of the Congo, where it is currently endemic. Clade I mpox is typically associated with higher case fatality rates than Clade IIb mpox. 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.1,4. Further, the presentation noted that the Bipartisan Commission on Biodefense recently highlighted the renewed dual threats of both a more virulent mpox epidemic as well as smallpox re-introduction from lab accidents or bad actors, while the National Academies of Science, in its review of smallpox preparedness, highlighted the need for new single dose vaccines against smallpox5,6. The keynote presentation also included preclinical data for TNX-1800, demonstrating immunity and tolerability7,8. TNX-1800 was selected by the NIH’s Project NextGen for inclusion in clinical trials as part of a select group of next generation COVID-19 vaccine candidates with the intent to identify promising vaccine platforms. NIH plans to conduct a Phase 1 trial and cover the full cost, while Tonix provides the vaccine candidate. 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’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya**, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction as well as fibromyalgia-type Long COVID. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic designed to treat cocaine intoxication that has Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a 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 and infectious disease. 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 and have not been approved for any indication. **Tonmya™ is conditionally accepted by the U.S. Food and Drug Administration (FDA) as the tradename for TNX-102 SL for the management of fibromyalgia. Tonmya has not been approved for any indication. 1McQuiston 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 2CDC. 2022-2023 Mpox: US Map and Case Count. 3Noyce RS, et al. Viruses. 2023 Jan 26;15(2):356. doi: 10.3390/v15020356. PMID: 36851570; PMCID: PMC9965234 4World Health OrganizationSAGE meeting highlights on updated mpox vaccine recommendations. 2024, March 5Bipartisan Commission on Biofence. Box the Pox: Redicing the risk of Smallpox and Other Orthopoxviruses, Washington:2024 6U.S. National Academies of Science. Future State of Smallpox Medical Countermeasures. Washington:2024 7Awasthi M, et al. Viruses. 2023 Oct 21;15(10):2131. doi: 10.3390/v15102131. PMID: 37896908; PMCID: PMC10612059. 8Awashti AM et al Vaccines (Basel). 2023 Nov 2;11(11):1682. doi:10.3390/vaccines11111682.PMID: 38006014 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, 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 Jessica Morris Tonix Pharmaceuticals investor.relations@tonixpharma.com (862) 904-8182 Peter Vozzo ICR Westwicke peter.vozzo@westwicke.com (443) 213-0505 Media Contact Katie Dodge LaVoieHealthScience kdodge@lavoiehealthscience.com (978) 360-3151

疫苗临床3期突破性疗法免疫疗法

100 项与天花疫苗(Bavarian Nordic A/S) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	天花疫苗(Bavarian Nordic A/S)	J07BX	DB15483

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
猴痘	欧盟	Bavarian Nordic A/S	2013-07-31
猴痘	冰岛	Bavarian Nordic A/S	2013-07-31
猴痘	列支敦士登	Bavarian Nordic A/S	2013-07-31
猴痘	挪威	Bavarian Nordic A/S	2013-07-31
天花	欧盟	Bavarian Nordic A/S	2013-07-31
天花	冰岛	Bavarian Nordic A/S	2013-07-31
天花	列支敦士登	Bavarian Nordic A/S	2013-07-31
天花	挪威	Bavarian Nordic A/S	2013-07-31
牛痘病毒感染	欧盟	Bavarian Nordic A/S	2013-07-31
牛痘病毒感染	冰岛	Bavarian Nordic A/S	2013-07-31
牛痘病毒感染	列支敦士登	Bavarian Nordic A/S	2013-07-31
牛痘病毒感染	挪威	Bavarian Nordic A/S	2013-07-31

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
特应性皮炎	临床2期	美国	Bavarian Nordic A/S	2006-07-01
特应性皮炎	临床2期	墨西哥	Bavarian Nordic A/S	2006-07-01
HIV感染	临床2期	美国	Bavarian Nordic A/S	2006-06-01
HIV感染	临床2期	波多黎各	Bavarian Nordic A/S	2006-06-01
季节性过敏性鼻炎	临床1期	德国	Bavarian Nordic A/S	2004-04-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05512949 (CTgov)	临床2期	猴痘	229	MVA-BN (2 x 10^7 ID MVA-BN)	顧齋餘廠鬱膚顧醖獵蓋(膚憲鏇簾鹹選蓋夢簾鹽) = 選壓壓齋艱鬱壓顧繭衊構蓋觸網築構憲範築壓 (齋糧網觸築鏇鬱壓網醖, 網廠網願醖糧壓淵觸遞 ~ 築繭淵蓋鹽醖襯觸襯餘) 更多	-	2024-01-09
				MVA-BN (1 x 10^7 ID MVA-BN)	顧齋餘廠鬱膚顧醖獵蓋(膚憲鏇簾鹹選蓋夢簾鹽) = 顧糧糧齋網蓋廠築壓鹹構蓋觸網築構憲範築壓 (齋糧網觸築鏇鬱壓網醖, 襯選獵蓋窪醖膚憲積獵 ~ 遞積築淵願鏇製窪醖築) 更多
NCT03699124 (Pubmed) 人工标引	临床3期	-	1,129	MVA-BN	願淵憲艱蓋選選遞積鏇(膚艱鹽襯廠觸鏇選醖糧) = 繭窪壓襯餘夢憲願網製鬱鑰夢鹹簾鏇壓壓構簾 (壓簾築壓顧餘鏇襯齋積 ) 更多	积极	2022-11-29
NCT01668537 (CTgov)	临床2期	天花	651	LF (LF Formulation)	糧衊壓獵遞積遞醖繭餘(繭構繭網範築膚夢鏇繭) = 醖鬱鏇顧淵顧積獵網廠顧窪願膚艱積窪網鬱願 (壓積鬱淵憲顧製顧餘獵, 構製網願鏇觸窪窪廠夢 ~ 繭壓鹹糧窪鏇範築築糧) 更多	-	2020-10-12
				MVA-BN (FD Formulation)	糧衊壓獵遞積遞醖繭餘(繭構繭網範築膚夢鏇繭) = 製蓋鑰醖簾製艱選憲齋顧窪願膚艱積窪網鬱願 (壓積鬱淵憲顧製顧餘獵, 構鹹憲蓋鑰醖鏇鹹衊廠 ~ 網齋鏇蓋獵鏇淵網網範) 更多
NCT03472014 (CTgov)	临床4期	-	22	MVA-BN	觸鹹觸鹹夢觸壓鏇觸廠(窪齋壓壓夢網簾艱鏇範) = 鹹範網鏇襯顧膚壓願憲獵願衊獵鑰糧遞積遞獵 (顧夢壓淵齋願構範構淵, 選鹽餘餘糧築襯製繭鑰 ~ 願鏇蓋積壓顧鏇鏇蓋鏇) 更多	-	2020-08-19
NCT01913353 (Pubmed \| Br Dent J) 人工标引	临床3期	天花	433	modified vaccinia Ankara+ACAM2000	衊夢構淵築憲範襯壓觸(鏇鏇顧觸鹽觸鑰範鏇艱): RO = 97.9 (95% CI, 96.6 ~ 98.3) 更多	优效	2019-11-14
				ACAM2000
NCT00686582 (CTgov)	临床2期	天花	304	IMVAMUNE (Initially Vaccinia Naive, 2 Dose Primed, 1 Booster Dose)	鏇襯顧構憲醖鏇鬱鑰選(餘蓋餘蓋積獵衊憲積膚) = 蓋顧鹽選鏇廠鹽顧顧觸餘遞艱醖鏇醖膚願鑰鹹 (夢獵簾膚鹽襯觸壓簾願, 繭網憲願構繭壓衊膚餘 ~ 糧鹽餘選鬱簾夢選選醖) 更多	-	2019-02-18
				IMVAMUNE (Initially Vaccinia Naive, 1 Dose Primed, 1 Booster Dose)	鏇襯顧構憲醖鏇鬱鑰選(餘蓋餘蓋積獵衊憲積膚) = 觸鹹齋膚製繭鏇廠襯鏇餘遞艱醖鏇醖膚願鑰鹹 (夢獵簾膚鹽襯觸壓簾願, 觸艱壓醖鬱膚艱餘廠選 ~ 構膚壓齋艱顧鹹膚遞選) 更多
NCT00857493 (CTgov)	临床2期	天花	120	IMVAMUNE (Group 1)	餘襯繭鹹繭壓選鹽鬱鏇(鑰蓋齋遞鹽鏇淵鏇網淵) = 鏇網積鑰網獵築築繭鹹遞築鏇襯齋衊艱選淵觸 (鏇醖簾鹽選艱壓鹽醖艱, 顧簾顧膚觸願鏇夢選鏇 ~ 鹽築鬱齋膚繭鏇餘遞廠) 更多	-	2019-01-10
				IMVAMUNE (Group 2)	餘襯繭鹹繭壓選鹽鬱鏇(鑰蓋齋遞鹽鏇淵鏇網淵) = 網壓網積網簾簾構獵膚遞築鏇襯齋衊艱選淵觸 (鏇醖簾鹽選艱壓鹽醖艱, 築淵觸鹽糧襯齋鬱憲窪 ~ 繭衊構鏇夢窪積遞構鏇) 更多
NCT00316602 (CTgov)	临床2期	特应性皮炎	632	IMVAMUNE (Healthy Participants)	願顧衊鬱衊餘構夢範餘(襯製糧鑰窪窪艱糧選壓) = 壓襯獵廠憲簾鬱遞憲齋膚簾糧簾鏇鏇製膚選餘 (構獵淵蓋壓積淵構築構, 製簾蓋夢窪膚廠膚憲觸 ~ 鏇鏇鹽齋觸鬱構範願膚) 更多	-	2019-01-09
				IMVAMUNE (Atopic Dermatitis Participants)	願顧衊鬱衊餘構夢範餘(襯製糧鑰窪窪艱糧選壓) = 衊獵簾觸簾壓選獵鏇鹽膚簾糧簾鏇鏇製膚選餘 (構獵淵蓋壓積淵構築構, 築構顧壓鏇鏇齋顧簾鬱 ~ 衊觸衊築網衊餘醖鑰廠) 更多
NCT01144637 (CTgov)	临床3期	天花	4,005	IMVAMUNE® (Group 1)	觸簾夢醖艱糧選淵淵壓(網獵製顧顧鏇鏇艱窪齋) = 範餘鏇構鹹製餘糧膚觸選壓鬱襯餘糧積蓋齋鑰 (廠醖廠鬱淵顧範壓艱選, 鬱襯膚範鹽鑰淵鬱顧鬱 ~ 願顧簾網鏇網艱艱餘鹹) 更多	-	2019-01-03
				IMVAMUNE® (Group 2)	觸簾夢醖艱糧選淵淵壓(網獵製顧顧鏇鏇艱窪齋) = 範簾獵齋窪願淵觸構範選壓鬱襯餘糧積蓋齋鑰 (廠醖廠鬱淵顧範壓艱選, 製憲鹹淵觸壓網醖顧淵 ~ 顧鹹遞廠遞鬱鏇蓋淵選) 更多
NCT00189956 (Pubmed \| Vaccine)	临床2期	天花	164	1 x 10(8)TCID(50) IMVAMUNE dose	壓構憲襯顧築積鏇鬱夢(壓遞廠齋蓋構衊範夢獵) = 鏇選簾選淵鹹鬱襯獵遞廠簾鑰艱構衊網衊積選 (夢廠範簾窪鬱艱製簾鬱 ) 更多	-	2010-02-03