Assessment of Foralumab Safety and Modulation of Microglial Activation Evaluated by PET Imaging in Patients with Early Symptomatic Alzheimer's Disease

This phase 2a study will research the safety and tolerability of Foralumab, a human anti-CD3 antibody. An antibody is a molecule secreted by the immune system. These molecules are created to identify a specific pathogen. Previous data on experimental mice has suggested that Foralumab increases the immune system activity in the brain to reduce the inflammation of microglia, the brain's main immune cells. This combination of increased immune reactivity and less microglia inflammation may improve the immune response throughout the brain. Alzheimer's disease and other forms of dementia are characteristically known for the build-up of certain proteins in the brain. This trial will evaluate whether nasal Foralumab can improve cognition in participants with mild cognitive impairment due to early Alzheimer's or dementia.
The trial will ask participants to administer Foralumab nasally three times a week for eight weeks. The administration will occur intermittently, with breaks between each dosing cycle. Participants will also receive brain scans (Amyloid PET and MRI), undergo cognitive testing, blood draws, and physical, neurological, and nasal exams. Volunteers are expected to remain in the trial for six months.

开始日期2025-04-01

申办/合作机构

The Brigham & Women's Hospital, Inc.

[+1]

NCT06890923

/ Recruiting临床2期

An Open Label, Multicenter Study of Nasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis Patients

Only subjects that have completed TILS-021, a Phase 2a Randomized, Double-Blind, Placebo-Controlled, Multicenter Dose-Ranging Study of Nasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis Patients are eligible to be enrolled in TILS-022. TILS-022 is a 6-month open-label extension study with an opportunity for dose to be escalated based on the subject's clinical status.
All subjects initiate dosing in this trial at a dose of nasal foralumab 50 µg 3 days a week (Monday, Wednesday, and Friday) for 2 weeks, followed by a 1-week rest, comprising a 3-week cycle. At week 12, the dose may be escalated to 100 µg according to pre-defined dose escalation rules. Study TILS-022 is intended to ensure all participants in TILS-021, a placebo-controlled study, will be able to receive open-label nasal foralumab for 6 months. The option to extend this trial for longer than 6 months will be explored with FDA by the Sponsor.

开始日期2025-03-04

申办/合作机构

Tiziana Life Sciences Ltd.

100 项与 Foralumab 相关的临床结果

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100 项与 Foralumab 相关的转化医学

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100 项与 Foralumab 相关的专利（医药）

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项与 Foralumab 相关的文献（医药）

2025-08-01·CLINICAL NUCLEAR MEDICINE

Dampening of Microglial Activation With Nasal Foralumab Administration in Moderate Alzheimer’s Disease Dementia

Article

作者: Singhal, Tarun ; Cicero, Steven ; Gale, Seth A. ; Horan, Nicolas ; Weiner, Howard L. ; Dubey, Shipra ; Marshall, Gad A.

A 78-year-old man with moderate Alzheimer disease (AD) dementia was treated with nasal-foralumab, a fully human anti-CD3 monoclonal antibody, as part of a Food and Drug Administration expanded-access-program, based on previously demonstrated efficacy of anti-CD3 antibody in animal models. 18F-PBR06-PET, utilizing a second-generation 18-kDa-translocator-protein ligand targeting microglia, showed diffuse reduction of radiotracer uptake throughout the brain, following 3 months of nasal-foralumab compared with baseline. In particular, precuneus, posterior cingulate and anterior cingulate gyri, regions that had high levels of amyloid deposition on a baseline 18F-Florbetapir-PET scan, showed reduction in microglial activation after nasal-foralumab treatment for 3 months.

2023-03-14·Proceedings of the National Academy of Sciences of the United States of America1区 · 综合性期刊

Nasal administration of anti-CD3 mAb (Foralumab) downregulates NKG7 and increases TGFB1 and GIMAP7 expression in T cells in subjects with COVID-19

1区 · 综合性期刊

Article

作者: G Moreira, Thais ; Mangani, Davide ; Murphy, Liam ; Weiner, Howard L ; Paul, Anu ; Izzy, Saef ; Kuchroo, Vijay ; Rezende, Rafael M ; Lanser, Toby B ; Gauthier, Christian D ; Matos, Kimble T F ; Chitnis, Tanuja ; Healy, Brian C ; Baecher-Allan, Clare M

T cells are present in early stages of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and play a major role in disease outcome and long-lasting immunity. Nasal administration of a fully human anti-CD3 monoclonal antibody (Foralumab) reduced lung inflammation as well as serum IL-6 and C-reactive protein in moderate cases of COVID-19. Using serum proteomics and RNA-sequencing, we investigated the immune changes in patients treated with nasal Foralumab. In a randomized trial, mild to moderate COVID-19 outpatients received nasal Foralumab (100 μg/d) given for 10 consecutive days and were compared to patients that did not receive Foralumab. We found that naïve-like T cells were increased in Foralumab-treated subjects and NGK7 + effector T cells were reduced. CCL5,IL32,CST7,GZMH,GZMB,GZMA,PRF1 , and CCL4 gene expression were downregulated in T cells and CASP1 was downregulated in T cells, monocytes, and B cells in subjects treated with Foralumab. In addition to the downregulation of effector features, an increase in TGFB1 gene expression in cell types with known effector function was observed in Foralumab-treated subjects. We also found increased expression of GTP-binding gene GIMAP7 in subjects treated with Foralumab. Rho/ROCK1, a downstream pathway of GTPases signaling was downregulated in Foralumab-treated individuals. TGFB1,GIMAP7 , and NKG7 transcriptomic changes observed in Foralumab-treated COVID-19 subjects were also observed in healthy volunteers, MS subjects, and mice treated with nasal anti-CD3. Our findings demonstrate that nasal Foralumab modulates the inflammatory response in COVID-19 and provides a novel avenue to treat the disease.

2022-02-28·Journal of acupuncture and meridian studies

Injection Effect of Anti-CD3 Monoclonal Antibody on Primo Vessel in Lymph Vessel of Rabbit with Lipopolysaccharide-Induced Inflammation

Article

作者: Lee, Sang-Suk ; Choi, Jong-Gu ; Choi, Sang-Heon

Background:

The primo vascular system can be viewed as a circulatory system that plays a therapeutic function in regenerating the body tissue. The anti-CD3 monoclonal antibody was used as an immunotherapeutic agent to treat the novel coronavirus infection (COVID-19). Objectives: In this study, we observed the effect of injecting lymph nodes with Foralumab, an anti- human CD3 epsilon therapeutic monoclonal antibody, on primo vessels.

Methods:

The structure and atomic stoichiometry of the antibody were determined by transmission electron microscopy and energy dispersive spectroscopy. Alcian blue dying solution was injected into the lymph nodes of the abdominal vena cava of rabbits, and the solution further flowed into the lymph vessels.

Results:

A primo vessel with primo nodes stained with Alcian blue was clearly visible in the lymph vessel. By injecting Foralumab into lymph nodes of rabbits with lipopolysaccharide-induced inflammation, the floating primo vessel in the lymph vessel appeared thicker and was distinctly visible.

Conclusion:

The observation of the primo vessel post-treated with Foralumab in the inflamed lymphatic system suggests the possibility of a functional role of the primo vascular circulatory system in pathophysiological conditions.

175

项与 Foralumab 相关的新闻（医药）

2025-12-04

·生物制药小编

冷藏近9年的IL-6R，现在趁着诺华东风抬出来

2025年12月2日，Tiziana Life Sciences宣布，计划通过分拆成立独立上市公司，开发其全人抗IL-6受体（IL-6R）单克隆抗体TZLS-501及相关资产。根据报道，这是基于诺华近期以14亿美元收购专注于开发IL-6的Tourmaline Bio的战略决策，Tiziana认为这是业内对IL-6途径高度关注的标志性事件。因此，Tiziana决定分拆IL-6资产并成立独立企业，以提升其未来价值。 Tiziana的TZLS-501 TZLS-501是一款全人源抗IL-6R单抗，能够结合膜结合型和可溶型IL-6R，降低IL-6细胞因子的循环水平。 IL-6是一种细胞因子，能与细胞膜上的受体亚基IL-6Rα结合，是致病T细胞启动炎症反应的重要因素之一。受体IL-6Rα可以以可溶形式释放（被称为sIL6Rα），sIL6Rα能够与血液中的IL-6细胞因子结合，参与IL-6的信号传导过程并介导炎症性疾病的促炎效应。 TZLS-50通过抑制IL-6R信号和降低循环中的IL-6水平来抑制炎症反应，同时该机制赋予了TZLS-501的单药潜力与联合用药灵活性，在系统性炎症及相关疾病中具有广阔前景，包括特发性肺纤维化（IPF）、急性呼吸窘迫综合征（ARDS）、多发性骨髓瘤、关节炎、红斑狼疮及肿瘤适应症。值得注意的是，TZLS-50（原代号NI-1201）并非由Tiziana原研，而是Tiziana于2017年1月获得来自Novimmune SA的全球排他许可。Tiziana对TZLS-50最初的开发定位是主要作为Tiziana核心管线CD3单抗Foralumab的补充治疗方案。但根据查询，TZLS-501未在clinicaltrials.gov上登记任何临床研究。而根据Tiziana官网显示，TZLS-501已经进入1期临床研究。目前，Tiziana公司扩大IL-6R单抗的GMP生产规模，同时开发一种手持雾化器技术，用于将IL-6R直接递送至潜在适应症IPF的病灶中。 IL-6的热潮来了？ Tiziana的首席执行官Ivor Elrifi在一份声明中表示：“诺华最近以14亿美元收购Tourmaline Bio，凸显了IL-6途径在应对全身性炎症及相关疾病中的巨大价值和战略重要性。基于我们在9月份宣布推进TZLS-501的基础上，我们相信现在是将这一有前景的资产定位为独立实体的理想时机。”“此次分拆将为TZLS-501开发释放专用资源，同时Tiziana将继续专注于鼻内Foralumab的开发作为主导项目。” 延伸阅读：IL-6R信号通路、生理病理功能、药物开发实际上，IL-6途径开发历史已久。目前，全球范围内已有4款靶向IL-6/IL-6R的药物获批上市，包括托珠单抗（Tocilizumab）、萨瑞利珠单抗（Sarilumab）、司妥昔单抗（Siltuximab）和萨特利珠单抗（Satralizumab）。同时，随着IL-6途径在类风湿关节炎、巨细胞动脉炎、Castleman 病等多种疾病上的成功，IL-6已成为全球炎症性与免疫介导疾病领域最重要的靶点之一，吸引着越来越多各大药企和研究团队投身IL-6的研发中。最近的重磅消息就是诺华以14亿美元收购Tourmaline Bio，获得临床资产IL-6单抗pacibekitug。而此前2020年，诺和诺德更是以21亿美元收购Corvidia Therapeutics，获得IL-6单抗药物Ziltivekimab。此外，近年来关于IL-6的研究论文数量持续上升，同时显示出持续深入和复杂的研究趋势。几大巨头药企的深入布局和IL-6研究数量和质量的持续上涨，都表明了IL-6通路的潜力和前景。参考资料： 1.https://www.tizianalifesciences.com/tiziana-life-sciences-plans-to-spinout-il-6-asset-into-separate-listed-company/ 2.https://www.tizianalifesciences.com/drug-pipeline/anti-il-6r-tzls-501/ 3.https://www.fiercebiotech.com/biotech/tiziana-spin-out-il-6-drug-new-company-citing-pharmas-interest-modality

2025-12-03

·凤凰涅槃之路

Tiziana 的 IL-6 战略拆分：资产独立上市解读

点击上方蓝字·关注我们 Tiziana Life Sciences Plans to Spinout IL-6 Asset into Separate Listed Company 2025年12月2日，总部位于波士顿的临床阶段生物制药公司 Tiziana Life Sciences（纳斯达克：TLSA）宣布，将通过拆分（spinout）方式，将其全人源抗 IL-6 受体单克隆抗体 TZLS-501 及相关资产独立上市，形成新的上市公司。Tiziana 的股东将在确定的记录日保留 TZLS-501 的价值，通过新公司股份分配获得相应权益。 01 拆分背后的逻辑：战略聚焦与价值释放 Tiziana 表示，此次拆分的核心目的是让两条研发主线各自专注，提升战略清晰度。TZLS-501 作为一款双重作用机制的 IL-6R 抗体，能够同时阻断膜结合型 IL-6R 和可溶性 IL-6R，潜力巨大。公司认为，随着行业对 IL-6 通路的兴趣持续升温（例如诺华以14亿美元收购 Tourmaline Bio 的 IL-6 抑制剂 pacibekitug），TZLS-501 完全具备独立发展成为一个业务板块的条件。分析来看，这种拆分策略有几个关键价值点：资源专注化：独立公司能够将研发、临床和资本资源集中在IL-6 通路，避免与Tiziana 原有的鼻用抗 CD3 抗体 Foralumab 项目产生资源冲突。股东价值释放：通过 in specie 分配股份，现有股东直接受益于新公司的未来增值潜力。市场信号强化：独立上市有助于突出 TZLS-501 的商业和临床价值，同时吸引关注 IL-6 通路的投资者。 02 TZLS-501 的科学与市场潜力 IL-6 是重要的促炎细胞因子，参与 T 细胞介导的炎症反应，而其受体 IL-6R 可以以膜结合或可溶性形式存在。TZLS-501 通过“双机制”作用：阻断IL-6R 信号传导降低循环中的 IL-6 水平这种机制赋予了 TZLS-501 单药潜力与联合用药灵活性，在系统性炎症及相关疾病中具有广阔前景。值得注意的是，这类资产在资本市场上也极受关注：IL-6 通路抑制剂的高价收购案例频频出现，显示出巨大的商业潜力。 03 Foralumab 与 Tiziana 的核心技术布局与此同时，Tiziana 的另一核心资产 Foralumab，是一款全人源抗 CD3 单抗，通过鼻用给药刺激 T 调节细胞，针对非活动期继发进展型多发性硬化（na-SPMS）展现了积极信号。与传统静脉给药相比，鼻用给药可能改善安全性和耐受性，并为免疫调节提供新的途径。拆分 TZLS-501 后，Tiziana 将可以更专注于 Foralumab 的开发和技术平台建设，形成“独立研发+独立资本运作”的双轨模式。 04 行业视角与投资启示从行业角度看，IL-6 通路仍然是炎症和免疫调节领域的热点。独立上市的 TZLS-501 不仅有助于凸显其临床和商业价值，也让市场更清楚地看到 Tiziana 在鼻用免疫调节创新领域的专注布局。对于投资者和行业观察者而言，此次拆分提供了几个思考点：专注化研发趋势：未来生物科技公司可能更多采用拆分或子公司策略，将不同机制资产分开运作，以实现更高研发效率和更清晰的估值。资本运作与临床价值联动：临床前或早期资产，通过拆分独立上市，可提前释放股东价值，同时为后续融资和战略合作提供便利。技术平台与管线布局：Tiziana通过Foralumab 的鼻用给药技术，和 TZLS-501 的 IL-6 通路创新形成互补，展示了公司在免疫调节创新上的长期视角。总结 Tiziana 拆分 TZLS-501 的决定，既是科学与资本结合的战略选择，也是对 IL-6 通路价值的市场认可。通过独立上市，TZLS-501 将获得更多资源和关注，而 Tiziana 则能够专注于鼻用免疫调节技术的深耕。对于生物医药行业而言，这类拆分模式值得关注，它不仅关乎资产价值释放，更反映了研发聚焦与创新战略的新趋势。公司简介 Tiziana Life Sciences 是一家临床阶段生物制药公司，致力于为神经退行性和神经炎症性疾病设计和开发下一代免疫疗法。公司核心资产包括鼻用全人源抗 CD3 单抗 Foralumab（TZLS-401），用于非活动期继发进展型多发性硬化（NA-SPMS）、阿尔茨海默病及其他中枢神经系统疾病，是目前临床开发中唯一的全人源抗 CD3 单抗，能够在提高疗效的同时尽量降低不良免疫反应；以及全人源抗 IL-6R 单抗 TZLS-501，聚焦炎症和免疫调节领域。Tiziana 还就 Foralumab 在改善嵌合抗原受体 T 细胞（CAR-T）扩增和存活方面提交了专利申请，展现其技术在癌症和其他疾病治疗中的潜在应用。公司采用精简且虚拟化的研发模式，依托经验丰富的跨职能团队，将资源聚焦于药物发现和开发过程，以最大化研发价值和战略布局，体现了其在神经免疫和系统性炎症疾病领域的长期创新视角。 END 🌟我每周都会分享生物医药BD/VC与科研交叉领域的真实案例，如果你也在这条路上，欢迎关注，一起成长。🚀 点击下方“阅读原文”直达官网报道

并购

2025-12-02

·动脉网

Tiziana Life Sciences计划将 IL-6资产分拆为独立上市公司Tiziana Life Sciences Plans to Spinout IL-6 Asset into Separate Listed Company

BOSTON, MA, December 2, 2025 美国马萨诸塞州波士顿，2025年12月2日– Tiziana Life Sciences, Ltd. (Nasdaq: – Tiziana Life Sciences, Ltd. (纳斯达克:TLSA TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies today announced that that it intends to develop its fully human anti-IL-6 receptor (IL-6R) monoclonal antibody, TZLS-501, and related assets (together “TZLS-501”) via a spinout into a separate publicly traded company, to enhance the strategic focus of each company and to drive value for shareholders. ）（“Tiziana”或“公司”），一家开发突破性免疫调节疗法的生物技术公司，今天宣布其计划通过分拆将其全人源抗IL-6受体（IL-6R）单克隆抗体TZLS-501及相关资产（统称“TZLS-501”）转入一家独立的公开上市的公司，以增强各公司的战略聚焦并为股东创造价值。Tiziana shareholders at the record date will retain value from TZLS-501 through the distribution in specie of shares in the new TZLS-501 listed entity.. 记录日期的Tiziana股东将通过新上市的TZLS-501实体的实物分配保留TZLS-501的价值。The Company recently announced that it would advance development of TZLS-501, a dual-action IL-6R monoclonal antibody targeting both membrane-bound and soluble forms of IL-6R. This decision was based in part on heightened industry interest in the IL-6 pathway—underscored by Novartis’ recent $1.4 billion acquisition of Tourmaline Bio for its IL-6 inhibitor pacibekitug. The Company considers TZLS-501 as having the potential to be a standalone business. Accordingly, the Company intends to proceed with steps for a publicly listed immunology-focused spin-out company, centered on the IL-6 market. 公司近期宣布将加速开发TZLS-501，这是一种双重作用的IL-6R单克隆抗体，靶向膜结合型和可溶性IL-6R。这一决定部分基于行业对IL-6通路的浓厚兴趣——诺华近期以14亿美元收购Tourmaline Bio及其IL-6抑制剂pacibekitug便是明证。公司认为TZLS-501有潜力成为一项独立业务。因此，公司计划推进成立一家公开上市、专注于免疫学的分拆公司，核心围绕IL-6市场。The record date for this proposed transaction will be announced in the coming weeks and the transaction will formally be put to shareholders of Tiziana for approval. TZLS-501 will remain an asset of Tiziana Life Sciences until such time as shareholders formally approve proposals for the spin-out entity.. 此项拟议交易的记录日期将在未来几周内公布，交易将正式提交给Tiziana的股东以获得批准。在股东正式批准分拆实体的提案之前，TZLS-501仍将是Tiziana Life Sciences的一项资产。Ivor Elrifi, Chief Executive Officer of Tiziana Life Sciences, commented: “The recent Novartis acquisition of Tourmaline Bio for $1.4 billion highlights the tremendous value and strategic importance of IL-6 pathway therapeutics in addressing systemic inflammation and related diseases. Building on our September announcement to advance TZLS-501, we believe now is the ideal time to position this promising asset as a standalone entity. Tiziana生命科学公司首席执行官Ivor Elrifi评论道：“诺华最近以14亿美元收购Tourmaline Bio，突显了IL-6通路治疗药物在应对系统性炎症及相关疾病方面的巨大价值和战略重要性。基于我们9月宣布推进TZLS-501的计划，我们认为现在是将这一有前景的资产定位为独立实体的理想时机。”TZLS-501’s unique dual mechanism—blocking IL-6R signaling while reducing circulating IL-6 cytokines—offers significant potential as a monotherapy or in combination with other agents. This spin-out will unlock dedicated resources for its development, while allowing us to maintain focus on intranasal foralumab as our lead program.”. TZLS-501独特的双重机制——阻断IL-6R信号传导同时减少循环中的IL-6细胞因子——作为单一疗法或与其他药物联合使用具有显著潜力。此次分拆将为其开发释放专用资源，同时使我们能够继续专注于鼻腔给药的foralumab作为我们的主要项目。There can be no certainty that the transaction will proceed and any listing will be subject to meeting the required listing criteria. 无法确定该交易是否会进行，且任何上市均需符合所需的上市标准。About TZLS-501 关于TZLS-501TZLS-501, a fully human mAb, was licensed from Novimmune, SA, (Geneva, CH) in 2017. IL-6 is a cytokine that binds to its receptor subunit IL-6Rα on the cell membrane, and is a major determinant in priming of pathogenic T cells to produce an inflammatory response. The receptor IL-6Rα can be shed in soluble form, sIL6Rα, which binds to circulating IL-6 cytokine in the blood. TZLS-501，一种全人源单克隆抗体，于2017年从Novimmune, SA（瑞士日内瓦）获得许可。IL-6是一种细胞因子，可与其在细胞膜上的受体亚基IL-6Rα结合，是致病性T细胞引发炎症反应的主要决定因素。受体IL-6Rα可以以可溶形式脱落，即sIL6Rα，它与血液中的循环IL-6细胞因子结合。The downstream signaling from this complex mediates pro-inflammatory effects underlying inflammatory diseases. TZLS-501 acts via a dual mechanism by inhibiting IL-6R signaling and depleting circulating levels of IL-6.. 该复合物的下游信号介导了炎症性疾病背后的促炎效应。TZLS-501通过双重机制发挥作用，抑制IL-6R信号传导并降低循环中IL-6的水平。About Foralumab 关于ForalumabForalumab, a fully human anti-CD3 monoclonal antibody, is a biological drug candidate that has been shown to stimulate T regulatory cells when dosed intranasally. At present, 14 patients with Non-Active Secondary Progressive Multiple Sclerosis (na-SPMS) have been dosed in an open-label intermediate sized Expanded Access (EA) Program (. Foralumab是一种全人源抗CD3单克隆抗体，是一种生物药物候选物，已证明在鼻内给药时可刺激T调节细胞。目前，在一项开放标签的中等规模扩大使用（EA）项目中，已有14名非活动性继发进展型多发性硬化症（na-SPMS）患者接受了给药。NCT06802328 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 (. ）所有患者在6个月内病情均得到改善或稳定。此外，鼻内给药的foralumab目前正在进行一项针对非活动性继发进展型多发性硬化症患者的2a期、随机、双盲、安慰剂对照、多中心、剂量范围试验（。NCT06292923 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. Foralumab是目前临床开发中唯一的全人源抗CD3单克隆抗体（mAb）。通过鼻内给予foralumab进行免疫调节，代表了治疗神经炎症和神经退行性人类疾病的新途径。[1],[2] [1],[2]About Tiziana Life Sciences 关于蒂齐亚娜生命科学公司Tiziana Life Sciences 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生命科学公司是一家临床阶段的生物制药公司，利用变革性的药物递送技术开发突破性疗法，以实现免疫治疗的替代途径。Tiziana创新的鼻腔给药方法相比静脉注射（IV）有可能在疗效以及安全性和耐受性方面提供改善。Tiziana’s lead candidate, intranasal foralumab, which is the only fully human anti-CD3 mAb currently in clinical development, has demonstrated a favorable safety profile and 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.. Tiziana的主打候选药物——鼻腔给药的foralumab，是目前临床开发中唯一的全人源抗CD3单克隆抗体，在迄今为止的研究中已显示出良好的安全性和临床反应。Tiziana用于免疫治疗替代途径的技术已获得专利，还有多项申请正在审批中，预计可实现广泛的应用。For more information about Tiziana Life Sciences and its innovative pipeline of therapies, please visit 如需了解更多关于Tiziana Life Sciences及其创新疗法管道的信息，请访问www.tizianalifesciences.com www.tizianalifesciences.com. 。Forward-Looking Statements 前瞻性声明Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company’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. 本公告中的一些声明属于前瞻性陈述。这些前瞻性陈述并非历史事实，而是基于公司对其行业、信念和假设的当前预期、估计和预测。诸如“预期”、“预计”、“打算”、“计划”、“相信”、“寻求”、“估计”等词语以及类似表达旨在识别前瞻性陈述。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 Company’s control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. 这些陈述并非对未来业绩的保证，且受已知和未知风险、不确定性及其他因素的影响，其中部分因素超出公司的控制范围，难以预测，可能导致实际结果与前瞻性陈述中表达或预测的结果存在重大差异。The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company 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, 2024, and other periodic reports filed with the Securities and Exchange Commission. 公司告诫证券持有者和潜在证券持有者不要过分依赖这些前瞻性陈述，这些陈述仅代表公司截至本公告发布当日的观点。实际结果可能与这些前瞻性陈述所表明的结果存在重大差异，原因包括多种重要因素，例如与市场状况相关的不确定性及其他因素，详见Tiziana于2024年12月31日终了年度的Form 20-F年报中题为“风险因素”部分的详细描述，以及其他向证券交易委员会提交的定期报告。The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company 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 l. 本公告中作出的前瞻性陈述仅与作出该陈述之日的事件相关。公司不承担任何公开发布对这些前瞻性陈述的修订或更新的义务，以反映本公告日期之后发生的事件、情况或意外事件，除非法律要求。For further inquiries: 如有进一步查询：Tiziana Life Sciences Ltd 蒂齐亚娜生命科学有限公司Paul Spencer, Business Development, and Investor Relations 保罗·斯宾塞，业务发展与投资者关系 +44 (0) 207 495 2379 +44 (0) 207 495 2379email: 电子邮件：info@tizianalifesciences.com info@tizianalifesciences.com[1] [1]https://www.pnas.org/doi/10.1073/pnas.2220272120 https://www.pnas.org/doi/10.1073/pnas.2220272120[2] [2]https://www.pnas.org/doi/10.1073/pnas.2309221120 https://www.pnas.org/doi/10.1073/pnas.2309221120

100 项与 Foralumab 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	Foralumab	-	DB16170

研发状态

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
多系统萎缩	临床2期	美国	Tiziana Life Sciences Ltd.	2025-05-19
阿尔茨海默症	临床2期	美国	Tiziana Life Sciences Ltd.	2025-04-01
继发进展型多发性硬化	临床2期	美国	Tiziana Life Sciences Ltd.	2023-11-15
多发性硬化症	临床2期	英国	Tiziana Life Sciences Ltd.	2023-04-27
新型冠状病毒感染	临床2期	-	Tiziana Life Sciences Ltd.	2022-04-30
2型糖尿病	临床2期	-	Tiziana Life Sciences Ltd.	2017-12-01
代谢功能障碍相关脂肪性肝炎	临床2期	-	Tiziana Life Sciences Ltd.	2017-12-01
急性细胞移植排斥反应	临床2期	法国	NovImmune SA	2007-11-22
肾移植急性排斥反应	临床2期	法国	NovImmune SA	2007-08-01
克罗恩病	临床2期	-	NovImmune SA	2006-01-01

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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


NCT06489548 (Company_Website 1 \| Company_Website 2) 人工标引	临床2期	阿尔茨海默症	1	intranasal foralumab	觸網願顧選衊願餘顧鹹(蓋膚選夢襯鹹壓淵窪艱) = showing a marked reduction in microglia activation 衊衊艱遞積廠鹹窪範齋 (壓鏇窪積製膚網獵鹽膚 )	积极	2025-05-09
NCT06802328 (GlobeNewswire) 人工标引	N/A	继发进展型多发性硬化	10	Foralumab	齋壓築鹽鏇醖窪夢醖繭(繭積選願壓觸顧齋簾鹹) = None 網廠淵繭襯構積構淵憲 (艱廠鑰鏇範鬱選襯觸繭 ) 更多	积极	2025-05-06
GlobeNewswire 人工标引	N/A	继发进展型多发性硬化	-	Foralumab	鏇衊廠築淵壓淵鏇獵願(構膚築選製衊壓醖衊獵) = 製網選鹹遞鑰艱遞遞襯衊構築糧鑰衊壓糧鹹遞 (夢蓋選艱範衊鹹壓鑰鑰 )	积极	2024-06-06
GlobeNewswire 人工标引	N/A	继发进展型多发性硬化	6	foralumab	顧製鬱壓窪顧範襯艱鹹(簾憲憲艱蓋願範顧衊糧) = 窪窪淵壓顧襯衊範夢餘餘餘遞醖窪鹹遞簾繭夢 (醖窪鬱壓衊衊廠膚鹽範 ) 更多	积极	2024-04-25
GlobeNewswire 人工标引	临床2期	多发性硬化症	10	Foralumab	鹽夢夢築觸觸鑰簾淵鹹(繭憲廠齋憲獵顧淵鑰餘) = six out of eight Intermediate Size Patient Population Expanded Access (EA) patients have shown improvements in fatigue scores. PET scan findings showing a reduction in microglial activation was also seen in the six patients with MFIS score improvement at the three-month evaluation period. 膚糧築廠醖繭製餘獵顧 (構構鑰繭膚繭齋簾餘衊 )	积极	2024-01-08
NCT05029609 (Corporate Publications) 人工标引	临床1期	继发进展型多发性硬化	2	Foralumab	鹹簾廠鏇網淵鏇襯衊襯(壓廠獵廠範獵築鹹鹹齋) = The patient showed clinically significant improvement on the Extended Disability Status Scale (EDSS) 簾製繭鏇網遞網鏇蓋顧 (鏇壓繭齋膚構襯構製窪 )	积极	2022-09-20