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2025-09-16

申办/合作机构

The Brigham & Women's Hospital, Inc.

[+1]

NCT06868628

/ Recruiting临床2期

A Phase 2a Study to Evaluate Microglial Activation, Safety, and Clinical Effects of Foralumab Nasal in Patients With Multiple System Atrophy (MSA)

A Phase 2a Study of Foralumab Nasal in Patients with Multiple System Atrophy (MSA)

开始日期2025-05-19

申办/合作机构

Tiziana Life Sciences Ltd.

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

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.

205

项与 Foralumab 相关的新闻（医药）

2026-05-19

·动脉网

Tiziana宣布鼻腔给药 Foralumab在非活动性继发进展型多发性硬化症中的新阳性临床数据Tiziana Announces New Positive Clinical Data for Intranasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis

Favourable trends seen in stability of disability and clinically meaningful improvements in fatigue. 残疾状况的稳定性以及疲劳方面有临床意义的改善趋势良好。BOSTON, MA, May 19, 2026 美国马萨诸塞州波士顿，2026年5月19日– Tiziana Life Sciences, Ltd. (Nasdaq: – Tiziana Life Sciences, Ltd. (纳斯达克:TLSA 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). ）（“Tiziana”），一家开发现阶段主导候选药物——鼻腔给药的foralumab（一种全人源化抗CD3单克隆抗体）的生物技术公司，宣布了其正在进行的扩大使用（“EA”）计划的最新临床数据，该计划正在评估鼻腔给药的foralumab在14名非活动性继发进展型多发性硬化症（na-SPMS）患者中的效果。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).. 数据显示，从2025年3月更新至2026年3月的数据表明，长期治疗中，鼻腔给药的foralumab仍然具有极好的耐受性。患者在扩展残疾状态量表（EDSS）测量的残疾稳定方面表现出令人鼓舞的趋势，并在修正疲劳影响量表（MFIS）测量的疲劳方面显示出有意义的改善。Study Highlights: 研究亮点：Safety: Foralumab was well tolerated with no new safety signals identified. 安全性：Foralumab 耐受性良好，未发现新的安全信号。EDSS Stabilization: We observed a favorable trend toward disease stabilization (i.e., reduced Confirmed Disability Progression (CDP). EDSS稳定：我们观察到疾病稳定化的良好趋势（即，确诊残疾进展（CDP）减少）。Fatigue Improvement: 64% of patients achieved a clinically meaningful improvement of ≥4 points in their MFIS score. 疲劳改善：64%的患者在MFIS评分中实现了≥4分的临床显著改善。Figure 1. Foralumab Expanded Access Program vs. HERCULES Reference Arms 图1. Foralumab扩大使用计划与HERCULES参考组对比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 ( 图表标题为“Foralumab扩大使用计划与Hercules参考组的对比”比较了Foralumab扩大使用（EA）队列与第三阶段HERCULES非复发性SPMS试验中的安慰剂和托勒布替尼组的残疾进展事件的累积发生率（DOI: 10.1056/NEJMoa2415988 数字对象标识符：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 (Nasdaq: ）。foralumab 线条仅显示单一事件，表明大多数接受治疗的患者病情得到了显著稳定。 “事件”是根据赛诺菲（纳斯达克：定义的。SNY 索尼) 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. NEJM 发表的文章中定义为：如果基线 EDSS <5.0，则 EDSS 持续增加 ≥1.0 分；如果基线 EDSS ≥5.0，则持续增加 ≥0.5 分。Figure 2. Modified Fatigue Impact Scale (MFIS) Score 图 2. 改良疲劳影响量表 (MFIS) 评分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. ( 标题为“改良疲劳影响量表（MFIS）得分”的图表显示，14名参与者中有9人（64%）在MFIS上达到了≥4分的临床显著改善，这与Rooney等人建立的标准一致。DOI: 10.1016/j.msard.2019.07.028 数字对象标识符：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. 由于扩大使用计划中的样本量较小，图1和图2中展示的foralumab数据在统计学上不显著，仅代表一种趋势分析。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. 布拉姆和妇女医院安·罗姆尼神经疾病中心主任、蒂齐亚纳生命科学公司科学顾问委员会主席霍华德·L·韦纳博士评论道：“扩展使用SPMS计划的这些较长期结果继续支持鼻腔给药foralumab作为一种新型免疫调节疗法对非活动性SPMS患者的潜力。”The excellent tolerability profile combined with trends toward disability stabilization and fatigue improvement is highly encouraging and warrants further investigation.”. 优异的耐受性特征，结合趋于稳定的残疾状况和疲劳改善的趋势，令人备受鼓舞，并值得进一步研究。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. Tiziana生命科学公司首席执行官Ivor Elrifi补充道：“我们很高兴看到我们的扩大使用计划持续传来积极的安全性和临床趋势数据。鼻腔给药的foralumab凭借其减少神经炎症的独特机制，有望成为治疗选择仍然有限的进展型多发性硬化症的一种潜在新疗法。”We look forward to advancing this program to approval.”. 我们期待推进该计划获得批准。About Foralumab 关于ForalumabForalumab, 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 (. Foralumab是一种全人源抗CD3单克隆抗体，作为一种生物候选药物，已被证明在鼻内给药时能够刺激T调节细胞。目前，已有14名非活动性继发进展型多发性硬化症（na-SPMS）患者在一个开放标签的中等规模扩大使用（EA）项目中接受了给药。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、剂量范围试验中进行研究（。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）。通过鼻内给药的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],[3] [1],[2],[3]About Tiziana Life Sciences 关于蒂齐亚娜生命科学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——鼻内给药的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，预计可广泛应用于多种研发管线。For more information about Tiziana and its innovative pipeline of therapies, please visit 有关Tiziana及其创新疗法管道的更多信息，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 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. 本公告中作出的某些声明为前瞻性声明。这些前瞻性声明并非历史事实，而是基于Tiziana当前对其行业、信念和假设的预期、估计和预测。诸如“预期”、“预计”、“意图”、“计划”、“相信”、“寻求”、“估计”等词语及类似表达旨在识别前瞻性声明。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. 这些声明并非对未来表现的保证，且受到已知和未知风险、不确定性及其他因素的影响，其中部分因素超出Tiziana的控制范围，难以预测，可能导致实际结果与前瞻性声明中表达或预测的结果存在重大差异。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. Tiziana警告证券持有者和潜在证券持有者不要过度依赖这些前瞻性陈述，这些陈述仅反映Tiziana截至本公告日期的观点。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：与市场状况相关的不确定性以及其他因素，详见Tiziana截至2025年12月31日的年度报告中标题为“风险因素”的章节以及提交给证券交易委员会的其他定期报告中更全面描述的内容。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. 本公告中作出的前瞻性陈述仅与作出这些陈述之日的事件相关。Tiziana 不会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，以反映在本公告日期之后发生的事件、情况或意外事件，除非法律或任何其他规定要求。For further inquiries: 如需进一步查询： 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[3] [3]https://www.neurology.org/doi/10.1212/NXI.0000000000200543 https://www.neurology.org/doi/10.1212/NXI.0000000000200543

临床结果临床研究

2026-05-19

·BioSpace

Tiziana Announces New Positive Clinical Data for Intranasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis

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

临床2期临床结果免疫疗法临床3期

2026-05-15

·吸入制剂Co.Lab

Tiziana 公布：鼻内给药 Foralumab 治疗多系统萎缩患者可降低脑部炎症

Foralumab 是首个进入多系统萎缩患者临床试验的鼻内免疫调节剂马萨诸塞州波士顿，2026 年 5 月 14 日——Tiziana Life Sciences, Ltd.（纳斯达克：TLSA）（下称 “Tiziana”）是一家专注开发核心候选药物鼻内给药 Foralumab（一种全人源抗 CD3 单克隆抗体）的生物技术公司，今日公布其 2 期临床试验中首批两名接受鼻内 Foralumab 治疗的多系统萎缩（MSA）患者的初步定量 PET 影像学结果。这是鼻内 Foralumab 治疗后经 PET 扫描显示炎症显著降低的第三个适应症。对 PET 扫描的定量分析显示，经鼻内 Foralumab 治疗后，多系统萎缩特征性受累的关键脑部临床相关区域炎症活性下降。在前两名接受治疗的患者中，研究者观察到脑部受累区域标准摄取值（SUV）最高下降约 35%，标准摄取值比率（SUVR）下降约 24%。图 1. 接受鼻内 Foralumab 治疗的第二名多系统萎缩患者鼻内 Foralumab 给药后，基底节及丘脑区域摄取显著降低图 2. 接受鼻内 Foralumab 治疗的第二名多系统萎缩患者鼻内 Foralumab 给药后，小脑白质区域摄取显著降低图 3. 接受鼻内 Foralumab 治疗的第一名多系统萎缩患者鼻内 Foralumab 给药后，基底节区域摄取显著降低上述摄取降低现象出现在基底节、小脑白质等区域，这些区域已知参与多系统萎缩的神经退行性病理过程。麻省总医院布莱根医疗体系、布莱根妇女医院 Ann Romney 神经疾病中心神经 PET 项目创始主任 Tarun Singhal, MBBS, M.D. 表示：“这些早期 PET 影像学发现为鼻内 Foralumab 在多系统萎缩患者中具备生物学活性提供了定量证据。在我们评估的前两名多系统萎缩患者中，受累脑区标准摄取值最高下降约 35%，标准摄取值比率下降 24%。我们重点关注了多系统萎缩中受累最严重、具有临床意义的核心区域。基于现有数据，这些定量结果可靠性较高，与此前鼻内 Foralumab 治疗多发性硬化患者中观察到的结果相近，尽管研究方法存在差异。” Tiziana Life Sciences 首席执行官 Ivor Elrifi 表示：“这是我们观察到鼻内 Foralumab 治疗后经 PET 扫描证实炎症显著降低的第三个适应症。基于此前在非活动性继发性进展型多发性硬化和中度阿尔茨海默病中公布的积极结果，本次多系统萎缩初步数据进一步凸显了本公司疗法在多种存在高度未满足临床需求的神经退行性疾病中有效改善神经炎症的潜力。” 治疗前后的 PET 影像学对比显示，多个疾病相关脑区放射性示踪剂摄取均显著下降。该结果提示，鼻内给予 Foralumab 可降低神经炎症活性。鼻内 Foralumab 是一种全人源抗 CD3 单克隆抗体，其设计机制为通过黏膜耐受调节免疫系统、减轻炎症，同时避免传统抗 CD3 疗法相关的全身性毒性。多系统萎缩是一种罕见的进行性神经退行性疾病，临床表现为自主神经功能障碍、帕金森综合征及小脑共济失调。目前尚无获批用于该疾病的疾病修正治疗药物。 Tiziana 计划继续在更多患者中评估鼻内 Foralumab，以进一步验证上述早期发现，并更全面地阐明该疗法在多系统萎缩中减轻神经炎症的潜在作用。关于 Foralumab Foralumab 为全人源抗 CD3 单克隆抗体，是一种生物制品候选药物，研究显示其经鼻内给药可诱导调节性 T 细胞活化。目前，一项开放标签、中等规模扩大准入（EA）项目（NCT06802328）已纳入 14 例非活动性继发性进展型多发性硬化（na-SPMS）患者给药，所有患者在 6 个月内均呈现病情改善或稳定状态。此外，鼻内 Foralumab 目前正开展一项针对非活动性继发性进展型多发性硬化患者的 2a 期、随机、双盲、安慰剂对照、多中心剂量探索临床试验（NCT06292923）。 Foralumab 是目前唯一处于临床开发阶段的全人源抗 CD3 单克隆抗体（mAb）。鼻内 Foralumab 介导的免疫调节为治疗人类神经炎症与神经退行性疾病开辟了全新路径。关于 Tiziana Life Sciences Tiziana 是一家临床阶段生物制药公司，依托颠覆性药物递送技术开发突破性疗法，实现免疫治疗的新型给药途径。相较于静脉（IV）给药，Tiziana 创新的鼻内给药方案有望在提升疗效的同时，改善药物的安全性与耐受性。公司核心候选药物鼻内 Foralumab 是目前唯一处于临床开发阶段的全人源抗 CD3 单克隆抗体，截至目前的各项研究已证实其具备良好的安全性特征及临床应答。Tiziana 的免疫治疗新型给药途径技术已获得专利授权，多项专利申请在审，预计可支持广泛的管线应用。 ▲ 免责声明本文旨在促进科研信息的沟通和交流，仅供专业人士参阅，非广告用途。我们尊重原创作品，选取的文章已明确注明来源和作者，版权归原作者所有，如涉及侵权或其他问题，请联系：龙猫18660885531（微信同号）。本文仅作信息分享，不代表吸入制剂Co.Lab立场和观点，也不作治疗方案推荐和介绍。如有需求，请咨询和联系正规医疗机构。本文仅供参考，不构成投资建议。投资者在做出任何投资决策前，应自行进行研究并咨询专业顾问。 →AI问答，调用吸入制剂Co.Lab资料库，点击使用吸入制剂智能体 →行业风向标，吸入圈资讯站，加入抖音群：867501256618 →技术研讨经验交流，吸入圈研讨社，加入QQ群：962276980

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
阿尔茨海默症	临床2期	美国	Tiziana Life Sciences Ltd.	2025-09-16
多系统萎缩	临床2期	美国	Tiziana Life Sciences Ltd.	2025-05-19
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
1型糖尿病	临床2期	奥地利	NovImmune SA	2009-10-13
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

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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	衊齋餘廠鬱鬱壓憲壓襯(鏇觸窪築廠鏇夢壓窪構) = showing a marked reduction in microglia activation 鹹繭鏇鹹鹽淵淵鏇廠衊 (鬱衊鬱憲齋選糧蓋淵糧 )	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	憲廠醖鏇構艱鏇餘鹹夢(膚膚繭選鑰糧鑰積齋鏇) = None 鏇壓繭顧壓顧築艱艱糧 (蓋鏇醖淵鏇淵膚壓鏇餘 ) 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	廠顧觸壓鏇憲餘製顧糧(蓋蓋鏇齋顧遞鏇觸築鹹) = 網遞選夢鹹遞遞衊簾顧顧壓衊鬱鬱淵鹽醖餘廠 (壓積觸網憲繭觸窪鏇觸 )	积极	2024-06-06
GlobeNewswire 人工标引	N/A	继发进展型多发性硬化	6	foralumab	齋窪齋繭觸艱壓簾壓獵(醖壓憲範衊網壓獵構網) = 糧窪齋蓋襯積繭鏇鹽選獵願壓衊齋遞窪遞醖顧 (願願繭鏇齋鹹餘鹹膚範 ) 更多	积极	2024-04-25
GlobeNewswire 人工标引	临床2期	多发性硬化症	10	Foralumab	壓遞壓積鑰觸蓋遞膚襯(鑰顧廠鏇襯網衊齋齋齋) = 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. 顧遞鏇齋顧鬱積壓願觸 (鹹廠襯糧選廠淵願顧艱 )	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	鬱齋願餘鹹衊蓋構網製(築積鹹獵憲廠衊鬱觸築) = The patient showed clinically significant improvement on the Extended Disability Status Scale (EDSS) 製繭鑰鹹鑰膚淵淵壓餘 (膚範選選窪顧廠願蓋鬱 )	积极	2022-09-20