Teplizumab

Favourable trends seen in stability of disability and clinically meaningful improvements in fatigue. BOSTON, May 19, 2026 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA ) ("Tiziana"), a biotechnology company developing its lead candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, announces updated clinical data from its ongoing Expanded Access ("EA") Program evaluating intranasal foralumab in 14 patients with non-active Secondary Progressive Multiple Sclerosis (na-SPMS). The data, updated from March 2025 to as of March 2026, demonstrate that intranasal foralumab continues to be extremely well tolerated over extended treatment durations. Patients showed encouraging trends in stabilization of disability as measured by the Expanded Disability Status Scale (EDSS) and meaningful improvements in fatigue as measured by the Modified Fatigue Impact Scale (MFIS). Study Highlights: Safety: Foralumab was well tolerated with no new safety signals identified. EDSS Stabilization: We observed a favorable trend toward disease stabilization (i.e., reduced Confirmed Disability Progression (CDP)). Fatigue Improvement: 64% of patients achieved a clinically meaningful improvement of ≥4 points in their MFIS score. Figure 1. Foralumab Expanded Access Program vs. HERCULES Reference Arms The graph titled "Foralumab Expanded Access Program vs Hercules Reference Arms" compares the cumulative incidence of disability progression events in the foralumab EA cohort against the placebo and tolebrutinib arms from the Phase 3 HERCULES non-relapsing SPMS trial ( DOI: 10.1056/NEJMoa2415988 ). The foralumab line shows only a single event, indicating strong stabilization in the majority of treated patients. An "event" is defined per the Sanofi NEJM publication as a sustained increase in EDSS of ≥1.0 point if baseline EDSS <5.0, or ≥0.5 points if baseline EDSS ≥5.0. Figure 2. Modified Fatigue Impact Scale (MFIS) Score The graph titled "Modified Fatigue Impact Scale (MFIS) Score" shows 9 out of 14 participants (64%) achieved a clinically meaningful improvement of ≥4 points on the MFIS, consistent with criteria established by Rooney et al. ( DOI: 10.1016/j.msard.2019.07.028 ). Due to the small sample size in the Expanded Access Program, foralumab data shown in Figs 1 and 2 are not statistically significant and represent a trend analysis only. Dr. Howard L. Weiner, Director of the Ann Romney Center for Neurologic Diseases at Brigham and Women’s Hospital, and Chair of the Scientific Advisory Board of Tiziana Life Sciences, commented: "These longer-term results from the Expanded Access SPMS Program continue to support the potential of intranasal foralumab as a novel, immunomodulatory therapy for patients with non-active SPMS. The excellent tolerability pro with trends toward disability stabilization and fatigue improvement is highly encouraging and warrants further investigation." Ivor Elrifi, CEO of Tiziana Life Sciences, added: "We are pleased with the continued positive safety and clinical trend data from our Expanded Access Program. Intranasal foralumab's unique mechanism, which reduces neuroinflammation, positions it as a potential new treatment paradigm for progressive forms of multiple sclerosis where treatment options remain limited. We look forward to advancing this program to approval." About Foralumab Foralumab, a fully human anti-CD3 monoclonal antibody, is a biologic candidate that has been shown to stimulate T regulatory cells when dosed intranasally. Currently, 14 patients with Non-Active Secondary Progressive Multiple Sclerosis (na-SPMS) have been dosed in an open-label intermediate sized Expanded Access (EA) Program ( NCT06802328 ) with either an improvement or stability of disease seen within 6 months in all patients. In addition, intranasal foralumab is currently being studied in a Phase 2a, randomized, double-blind, placebo-controlled, multicenter, dose-ranging trial in patients with non-active secondary progressive multiple sclerosis ( NCT06292923 ). Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) currently in clinical development. Immunomodulation by intranasal foralumab represents a novel avenue for the treatment of neuroinflammatory and neurodegenerative human diseases. [1],[2] ,[3] About Tiziana Life Sciences Tiziana is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy. Tiziana’s innovative nasal approach has the potential to provide an improvement in efficacy as well as safety and tolerability compared to intravenous (IV) delivery. Tiziana’s lead candidate, intranasal foralumab, which is the only fully human anti-CD3 mAb currently in clinical development, has demonstrated a favorable safety pro clinical response in patients in studies to date. Tiziana’s technology for alternative routes of immunotherapy has been patented with several applications pending and is expected to allow for broad pipeline applications. For more information about Tiziana and its innovative pipeline of therapies, please visit . Forward-Looking Statements Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Tiziana's current expectations, estimates, and projections about its industry, its beliefs, and assumptions. Words such as 'anticipates,' 'expects,' 'intends,' 'plans,' 'believes,' 'seeks,' 'estimates,' and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Tiziana's control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. Tiziana cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of Tiziana only as of the date of this announcement. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Tiziana’s Annual Report on Form 20-F for the year ended December 31, 2025, and other periodic reports filed with the Securities and Exchange Commission. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. Tiziana will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority. For further inquiries: Tiziana Life Sciences Ltd Paul Spencer, Business Development, and Investor Relations +44 (0) 207 495 2379 email: info@tizianalifesciences.com [1] [2] [3] Photos accompanying this announcement are available at

出海机会来了！ 现征集天然免疫领域的口服小分子创新药，适应症为炎症或免疫，要求中美已申报IND或处于I期临床。需机制新颖、靶点明确、差异化显著，知识产权清晰，数据完整可快速推进临床。 欢迎感兴趣的药企立即联系药时代BD团队！ BD@drugtimes.cn 继FDA局长马卡里（Marty Makary）本周辞职之后，其亲密盟友药物评价与研究中心（CDER）代理主任特蕾西·贝丝·赫格（Tracy Beth Høeg）也步其后尘。2026年5月15日，赫格在社交媒体X上发文称：“今天，我被解雇了。我学到了很多，离开时毫无遗憾。” 这位以疫苗怀疑论著称、在特朗普第二任期内执掌美国药品审评核心部门仅五个月的医生科学家，成为CDER自2025年1月以来第五位离任的负责人。与此同时，生物制品评价与研究中心（CBER）代理主任凯瑟琳·萨拉马（Katherine Szarama）也将被去年才加入FDA的前生物制药高管卡里姆·米哈伊尔（Karim Mikhael）取代。据内部消息，包括机构幕僚长在内的其他高层职位同样在动荡之中。 对于密切关注FDA过去一年多来走向的观察者而言，赫格的离任并不令人意外。 宾夕法尼亚大学医学院医学伦理学家及监管专家霍利·费尔南德斯·林奇（Holly Fernandez Lynch）向Fierce直言：“鉴于马卡里的离职以及赫格与他的同盟关系，这一消息并不令人意外。任何机构如果所有领导者都离职，情况都会非常糟糕，因为这会带来巨大的不确定性，甚至连日常工作都难以开展。” 赫格与马卡里的渊源可以追溯到新冠疫情时期。作为一名医生和流行病学博士，赫格因挑战美国主流疫苗政策而声名鹊起。2022年，她与马卡里及另一位近期离职的FDA争议人物：前CBER主任维奈·普拉萨德（Vinay Prasad）合著论文，质疑新冠疫苗加强针对于年轻人的风险收益比。这一立场使她迅速进入保守派卫生政策的核心圈层，在2025年3月作为特别助理加入FDA，并于2025年12月出任CDER的代理主任。 赫格在FDA任职期间最具标志性的行动，莫过于主导对美国儿童免疫接种计划的全面调整。2026年1月5日，美国卫生与公众服务部（HHS）和疾病控制与预防中心（CDC）的确宣布了对儿童疫苗接种指南的重大修订，将普遍推荐的疫苗种类从17种减少到了11种。然而，这一举措遭到主流公共卫生机构美国HHS和CDC的强烈批评，称这是“历史性的倒退”，警告称缩减疫苗推荐将导致儿童罹患可预防传染病的风险上升。 如果说疫苗政策的调整尚在其“专业舒适区”内，那么赫格在药品审评决策中的角色，则引发了跨国药企（MNC）的怀疑与不满。 赫格离职前最受关注的争议，围绕赛诺菲的1型糖尿病药物teplizumab（商品名Tzield，替利珠单抗）展开。据此前报道，FDA审评团队希望扩大该药的适应症范围，但赫格对此持不同意见。她质疑该药的获益并未大于风险，特别指出存在爱泼斯坦-巴尔病毒（EBV）感染及癌症等潜在安全性信号。据称，赫格计划召开专家咨询委员会（AC）会议来否决该项批准。 面对这一僵局，赛诺菲做出了一项堪称“割席”的决绝之举：主动要求FDA将teplizumab从局长国家优先审评券（CNPV）项目中撤出，宁愿放弃快速通道的“特权”，也不愿在政治干预的阴影下换取一纸匆忙的批准。赛诺菲的选择，在一定程度上可以折射出业界对当前FDA新政可靠性的深度担忧。 赫格的离职并非孤立的机构内部调整。路透社分析认为，这一变动预示着美国卫生机构更广泛的人事洗牌。 据报道，白宫正试图在FDA事务中扮演更积极的角色，以期在今年秋季中期选举前规避围绕疫苗等问题引发的政治争议。具体而言，在HHS部长小罗伯特·F·肯尼迪（Robert F. Kennedy Jr.）之下任职的联邦医疗保险（Medicare）主任兼CMS副主任克里斯·克隆普（Chris Klomp）一直在寻求以更传统的领导层人选来充实联邦卫生机构，并在马卡里离职后，清除FDA内部有争议的任命者。 这意味着，赫格的离职可能并非单纯源于个人能力或决策争议，而是一场自上而下的政治“清理”行动的一部分。白宫希望在中选前稳定卫生监管机构的形象，避免FDA成为疫苗争议等敏感话题的新火线。 对于生物制药行业而言，马卡里和普拉萨德的离职甚至受到了部分人士的欢迎，前者因在电子烟、堕胎药米非司酮等议题上的争议性决策受到批评，后者则以其在监管决策中注入的“不可预测性和不一致性”而闻名。然而，领导层的集体出走所带来的，远不止是人事变动的混乱。 费尔南德斯·林奇指出，这一系列离职背后的模糊原因，使得外界无法了解FDA的总体愿景。“我们不知道白宫是否在示意调整疫苗政策，还是希望对罕见病或米非司酮采取不同态度。”她坦言：“我认为在相当长一段时间内，我们都看不到所期望的可预测性。” 这种可预测性的缺失，已经在企业的实际行动中显现。尽管Regenxbio公司报告了其杜氏肌营养不良基因疗法的2期试验取得积极成果，但首席医疗官史蒂夫·帕科拉（Steve Pakola）明确表示，公司将等待FDA的“尘埃落定”后再与监管机构接洽。“很显然，FDA目前正处于相当动态的时期，”他如此评价。对于一家需要规划数亿美元研发投入、制定长达数年临床开发策略的生物制药企业而言，动态时期所面临的是无法估量的商业风险与决策成本。 小结： 据《Pink Sheet》报道，CDER副主任迈克尔·戴维斯（Michael Davis）博士可能接替赫格的职位。与赫格不同，戴维斯是FDA内部成长起来的资深技术型人才，他的接任或许能在一定程度上稳定军心。 据CNN报道，白宫仍在物色新的FDA局长人选，可能要到6月初才能确定。局长以下的常任职位接替者预计将在之后到位。这意味着，在可预见的未来，FDA的核心决策层将继续由代理负责人拼凑而成。 对于等待新药上市的患者、投入巨资研发的企业，以及整个依赖FDA科学信誉的公共卫生体系而言，稳定与可预测性的回归尚需时日。 参考资料： 1.https://www.biospace.com/fda/interim-cder-head-h%C3%B8eg-is-out-days-after-makary-report 2.https://endpoints.news/cder-chief-hoeg-expected-to-leave-fda-according-to-source/ 3.https://www.fiercepharma.com/pharma/after-makary-departure-cder-chief-tracy-beth-hoeg-headed-out-door-fda-report?_gl=1*eyhck3*_gcl_au*MTU5MTI4NDQ3LjE3NzE5MDk2ODY.*_ga*MTYxMzAzMzg2OC4xNzQ3NzA0NDY3*_ga_KG49J84SR4*czE3NzkwNzQ2MjIkbzMxMiRnMCR0MTc3OTA3NDYyMiRqNjAkbDAkaDA. 4.其他公开资料 封面图来源：即梦AI II期临床失利，Biogen为何选择火速推进？ 2026-05-16 自免CAR-T破晓之战：首张入场券花落谁手？ 2026-05-15 至多1.8亿美元首付款 ！复星医药再度加码阿尔茨海默病 2026-05-14 FDA局长“闪电”离职！原因为何？ 2026-05-13 版权声明/免责声明 本文为原创文章。 本文仅作信息交流之目的，不提供任何商用、医用、投资用建议。 文中图片、视频、字体、音乐等素材或为药时代购买的授权正版作品，或来自微信公共图片库，或取自公司官网/网络，部分素材根据CC0协议使用，版权归拥有者，药时代尽力注明来源。 如有任何问题，请与我们联系。 衷心感谢! 药时代官方网站:www.drugtimes.cn 联系方式: 电话:13651980212 微信:27674131 邮箱:contact@drugtimes.cn 点击查看更多精彩内容！