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 ; Murphy, Liam ; Weiner, Howard L ; Paul, Anu ; Kuchroo, Vijay ; Izzy, Saef ; Rezende, Rafael M ; Gauthier, Christian D ; Lanser, Toby B ; 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.

192

项与 Foralumab 相关的新闻（医药）

2026-02-25

·BioSpace

Tiziana Life Sciences Announces New Biomarker Data Showing Nasal Foralumab Downregulates CSF Inflammation, Upregulates Neuroprotective Pathways, and Correlates with Reduced Microglial Activation on PET Scans in na-SPMS Patients with PIRA

BOSTON, Feb. 25, 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 positive new biomarker data from a late-breaking poster titled “Nasal foralumab downregulates CSF inflammation and upregulates CSF neuroprotective proteomic pathways which correlate with [F-18]PBR06-PET imaging in na-SPMS with PIRA,” which was presented by investigators from Brigham and Women’s Hospital, Boston, MA. In multiple sclerosis (MS), an autoimmune disease involving inflammation, demyelination, and neurodegeneration in the CNS, Cerebrospinal fluid (CSF) plays a crucial role in diagnosis, understanding disease mechanisms, and monitoring progression, especially in progressive forms like non-active secondary progressive MS (na-SPMS) with progression independent of relapse activity (PIRA). CSF analysis, typically obtained via lumbar puncture, provides direct insight into CNS-specific processes because it reflects the local environment around the brain and spinal cord, unlike blood which can be influenced by systemic factors. The late-breaking poster reports results from 10 patients with non-active secondary progressive multiple sclerosis (na-SPMS) and progression independent of relapse activity (PIRA) treated with nasal foralumab in an open-label expanded-access program. Patients underwent 14 paired evaluations of [F-18]PBR06-PET scans (measuring microglial activation via m-GALP z-scores) and untargeted data-independent acquisition CSF proteomics at baseline and during up to 6 months of treatment. Key findings include: Nasal foralumab treatment significantly reduced voxel-wise average [F-18]PBR06-PET m-GALP z-scores in white matter and global brain regions (p<0.05 at 3 months and later follow-up), confirming decreased microglial activation. CSF proteomics showed downregulation of inflammatory biomarkers (e.g., IFNAR1 in the interferon pathway and LY86 in the NF-κB pathway) and upregulation of neuroprotective proteins (e.g., MEG10). Strong positive correlations were observed between PET m-GALP z-scores and inflammatory CSF proteins (e.g., IFNAR1 in high-affinity TSPO binders across whole brain, cortex, and cerebellum; r values up to 0.896, p<0.05). Negative correlations were seen with neuroprotective proteins (e.g., MEG10 and COBA1 in fibrosis-related pathways; r values up to -0.931, p<0.05). These biomarker changes occurred alongside clinical stabilization or improvement, with no serious treatment-related adverse events. “This late-breaking poster provides the first direct link between reduced microglial PET signal and favorable CSF proteomic shifts during nasal foralumab treatment in na-SPMS with PIRA,” said Tarun Singhal, M.D., lead author and neurologist at Brigham and Women’s Hospital. “The correlations demonstrate that [F-18]PBR06-PET is biologically tied to the inflammatory and neurodegenerative processes driving progression in SPMS, and that CSF proteomics can serve as a practical biomarker of therapeutic response.” Howard L. Weiner, M.D., Chairman of Tiziana’s Scientific Advisory Board and co-director of the Ann Romney Center for Neurologic Diseases at Brigham and Women’s Hospital, added: “Nasal foralumab continues to show a unique ability to dampen smoldering CNS inflammation while promoting neuroprotection. These integrated imaging and proteomic results strengthen the mechanistic rationale for our ongoing Phase 2 program and offer new tools to monitor disease modification in progressive MS.” Tiziana is advancing intranasal foralumab in an ongoing randomized, double-blind, placebo-controlled Phase 2a trial ( NCT06292923 ) in na-SPMS, with top-line data expected in the first half of 2026. Nasal foralumab's innovative intranasal delivery modulates the immune system to suppress microglial-driven neuroinflammation without broad systemic immunosuppression, distinguishing it from existing MS therapies. The Company is also evaluating the therapy in additional neuroinflammatory indications such as MSA, Alzheimer’s and ALS. The poster can be found here: 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, 2024, 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]

临床2期临床结果免疫疗法

2026-01-21

·BioSpace

Tiziana Life Sciences Announces the Peer-Reviewed Publication of Clinical Study Results for Intranasal Foralumab

BOSTON, Jan. 20, 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 the peer-reviewed publication of its open-label study in patients with non-active secondary progressive multiple sclerosis (na-SPMS) in Neurology Neuroimmunology & Neuroinflammation , a prestigious journal of the American Academy of Neurology. The publication, titled “Nasal Foralumab for the Treatment of Progression Independent of Relapses in Patients with Non-active Secondary Progressive Multiple Sclerosis,” details the comprehensive positive results previously announced by the Company on May 6, 2025. This marks the first study to integrate TSPO-PET imaging, proteomics, and clinical assessments in na-SPMS, highlighting nasal foralumab's novel mechanism in addressing progression independent of relapse activity (PIRA)—a critical unmet need in multiple sclerosis (MS) treatment. Key Study Highlights: Ten patients with na-SPMS, progressing despite prior B-cell therapies, received nasal foralumab for at least six months. No serious or severe treatment-related adverse events occurred. All patients showed stabilization of Expanded Disability Status Scale (EDSS) scores; three of four treated for 12 months demonstrated improvement. Fatigue improved in six out of ten patients, as measured by the Modified Fatigue Impact Scale (MFIS)—a vital quality-of-life measure for MS patients. No new T2 lesions appeared on MRI. TSPO-PET imaging revealed significant reductions in microglial activation at three and six months (p<0.05). Single-cell RNA sequencing demonstrated sustained increases in regulatory T cells (Tregs) and TGFβ expression, supporting induction of regulatory immunity. “This peer-reviewed publication in a leading neurology journal represents a major milestone and external validation of intranasal foralumab's therapeutic potential in secondary progressive MS,” said Tanuja Chitnis, M.D., Principal Investigator and Senior neurologist at Brigham and Women’s Hospital, a founding member of Mass General Brigham healthcare system. “The integration of advanced imaging, immune profiling, and clinical outcomes underscores how nasal foralumab uniquely targets CNS inflammation through mucosal tolerance, offering hope for patients with limited options.” Dr. Howard L. Weiner, M.D., Chairman of Tiziana’s Scientific Advisory Board, co-director of the Ann Romney Center for Neurologic Diseases at Brigham and Women’s Hospital, a founding member of Mass General Brigham healthcare system, noted: “The observed clinical stabilization and microglial PET findings are supported by these new biomarker discoveries, providing compelling evidence of nasal foralumab's biological effects in addressing PIRA in na-SPMS.” Nasal foralumab's innovative intranasal delivery modulates the immune system to suppress microglial-driven neuroinflammation without broad systemic immunosuppression, distinguishing it from existing MS therapies. Tiziana is advancing intranasal foralumab in an ongoing randomized, double-blind, placebo-controlled Phase 2 trial in na-SPMS, with top-line data expected in 1H of 2026. “We are thrilled that these groundbreaking results have now been peer-reviewed and published, reinforcing our confidence in intranasal foralumab as a potential paradigm-shifting therapy for progressive MS and beyond,” said Ivor Elrifi, Chief Executive Officer of Tiziana Life Sciences. The full publication can be found here: 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] 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, 2024, 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]

临床2期临床结果免疫疗法

2026-01-19

·动脉网

Tiziana生命科学公司宣布鼻腔内Foralumab临床研究结果的同行评审出版物发布 Tiziana Life Sciences Announces the Peer-Reviewed Publication of Clinical Study Results for Intranasal Foralumab

BOSTON, MA, January 20, 2026 美国马萨诸塞州波士顿，2026年1月20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 the peer-reviewed publication of its open-label study in patients with non-active secondary progressive multiple sclerosis (na-SPMS) in ）（“Tiziana”），一家开发现阶段主导候选药物——鼻内给药的foralumab，一种全人源化抗CD3单克隆抗体的生物技术公司，宣布其在非活动性继发进展型多发性硬化症（na-SPMS）患者中的开放标签研究已经通过同行评审并发表在Neurology Neuroimmunology & Neuroinflammation 神经病学神经免疫学与神经炎症, a prestigious journal of the American Academy of Neurology. ，美国神经病学学会的权威期刊。The publication, titled “Nasal Foralumab for the Treatment of Progression Independent of Relapses in Patients with Non-active Secondary Progressive Multiple Sclerosis,” details the comprehensive positive results previously announced by the Company on May 6, 2025. This marks the first study to integrate TSPO-PET imaging, proteomics, and clinical assessments in na-SPMS, highlighting nasal foralumab’s novel mechanism in addressing progression independent of relapse activity (PIRA)—a critical unmet need in multiple sclerosis (MS) treatment.. 这篇题为《鼻用Foralumab治疗非活动性继发进展型多发性硬化症患者独立于复发的进展》的出版物详细介绍了公司于2025年5月6日先前宣布的全面积极结果。这是首个在非活动性继发进展型多发性硬化症（na-SPMS）中整合TSPO-PET成像、蛋白质组学和临床评估的研究，突显了鼻用Foralumab在解决独立于复发活动的进展（PIRA）方面的全新机制——这是多发性硬化症（MS）治疗中一个关键的未满足需求。Key Study Highlights: 关键研究亮点：Ten patients with na-SPMS, progressing despite prior B-cell therapies, received nasal foralumab for at least six months. 十名患有na-SPMS的患者在接受鼻腔给药foralumab至少六个月之前，尽管曾接受过B细胞疗法，病情仍在进展。No serious or severe treatment-related adverse events occurred. 未发生严重或重度的与治疗相关的不良事件。All patients showed stabilization of Expanded Disability Status Scale (EDSS) scores; three of four treated for 12 months demonstrated improvement. 所有患者的扩展残疾状态量表 (EDSS) 评分均保持稳定；治疗 12 个月的四名患者中有三名表现出改善。Fatigue improved in six out of ten patients, as measured by the Modified Fatigue Impact Scale (MFIS)—a vital quality-of-life measure for MS patients. 十名患者中有六名患者的疲劳症状有所改善，这一结果通过修正疲劳影响量表 (MFIS) 进行了测量，该量表是多发性硬化症 (MS) 患者生活质量的重要衡量标准。No new T2 lesions appeared on MRI. MRI上未出现新的T2病灶。TSPO-PET imaging revealed significant reductions in microglial activation at three and six months (p<0.05). TSPO-PET成像显示，三个月和六个月时小胶质细胞活化显著减少（p<0.05）。Single-cell RNA sequencing demonstrated sustained increases in regulatory T cells (Tregs) and TGFβ expression, supporting induction of regulatory immunity. 单细胞RNA测序显示调节性T细胞（Tregs）和TGFβ表达持续增加，支持了调节性免疫的诱导。“This peer-reviewed publication in a leading neurology journal represents a major milestone and external validation of intranasal foralumab’s therapeutic potential in secondary progressive MS,” said Tanuja Chitnis, M.D., Principal Investigator and Senior neurologist at Brigham and Women’s Hospital, a founding member of Mass General Brigham healthcare system. “这篇发表在领先神经学杂志上的同行评审文章代表了鼻内给药Foralumab在继发进展型多发性硬化症治疗潜力方面的一个重要里程碑和外部验证，”Brigham and Women's Hospital的首席研究员兼资深神经学家Tanuja Chitnis博士说道，该医院是Mass General Brigham医疗系统创始成员之一。“The integration of advanced imaging, immune profiling, and clinical outcomes underscores how nasal foralumab uniquely targets CNS inflammation through mucosal tolerance, offering hope for patients with limited options.”. “先进的成像、免疫分析和临床结果的整合，强调了鼻用foralumab如何通过黏膜耐受独特地靶向中枢神经系统的炎症，为选择有限的患者带来了希望。”Dr. Howard L. Weiner, M.D., Chairman of Tiziana’s Scientific Advisory Board, co-director of the Ann Romney Center for Neurologic Diseases at Brigham and Women’s Hospital, a founding member of Mass General Brigham healthcare system, noted: “The observed clinical stabilization and microglial PET findings are supported by these new biomarker discoveries, providing compelling evidence of nasal foralumab’s biological effects in addressing PIRA in na-SPMS.”. Tiziana科学顾问委员会主席、布里格姆妇女医院安·罗姆尼神经疾病中心联合主任、麻总百瀚医疗系统创始成员霍华德·L.韦纳博士指出：“这些新的生物标志物发现支持了观察到的临床稳定和小胶质细胞PET结果，为鼻腔给药的foralumab在治疗na-SPMS中的PIRA提供了令人信服的生物学效应证据。”Nasal foralumab’s innovative intranasal delivery modulates the immune system to suppress microglial-driven neuroinflammation without broad systemic immunosuppression, distinguishing it from existing MS therapies. 鼻用福拉鲁单抗的创新鼻腔递送方式通过调节免疫系统来抑制小胶质细胞驱动的神经炎症，而不会引起广泛的全身免疫抑制，这使其有别于现有的多发性硬化症疗法。Tiziana is advancing intranasal foralumab in an ongoing randomized, double-blind, placebo-controlled Phase 2 trial in na-SPMS, with top-line data expected in 1H of 2026. Tiziana公司正在na-SPMS患者中进行一项持续的随机、双盲、安慰剂对照的2期试验，以推进鼻内给药foralumab的研究，预计将在2026年上半年获得顶线数据。“We are thrilled that these groundbreaking results have now been peer-reviewed and published, reinforcing our confidence in intranasal foralumab as a potential paradigm-shifting therapy for progressive MS and beyond,” said Ivor Elrifi, Chief Executive Officer of Tiziana Life Sciences. “我们非常激动，这些突破性的结果已经过同行评审并发表，这进一步增强了我们对鼻内Foralumab作为潜在的变革性治疗方案用于进展型多发性硬化症及其他领域的信心，”Tiziana生命科学公司首席执行官Ivor Elrifi表示。The full publication can be found here: 完整出版物可以在这里找到：https://www.neurology.org/doi/10.1212/NXI.0000000000200543 https://www.neurology.org/doi/10.1212/NXI.0000000000200543About 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，已被证明在鼻内给药时能够刺激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）患者接受了该药物的给药。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 关于蒂齐亚纳生命科学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，预计可实现广泛的产品管线应用。For more information about Tiziana and its innovative pipeline of therapies, please visit 如需更多关于Tiziana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 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”以及类似表达的词语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 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业绩的保证，且受到已知和未知风险、不确定性及其他因素的影响，其中部分因素是Tiziana无法控制的，难以预测，并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, 2024, and other periodic reports filed with the Securities and Exchange Commission. 蒂齐亚娜提醒证券持有者和潜在证券持有者不要过分依赖这些前瞻性声明，这些声明仅反映蒂齐亚娜截至本公告日期的观点。实际结果可能与这些前瞻性声明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，这些因素在蒂齐亚娜截至2024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有更详尽的描述。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 除法律或任何其他规定要求外，不会承担公开发布对这些前瞻性陈述的任何修订或更新以反映本公告日期之后发生的事件、情况或意外事件的责任。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

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	構鑰繭膚廠齋糧鏇壓襯(築積壓蓋觸淵糧餘窪衊) = showing a marked reduction in microglia activation 範鏇範艱築鏇選築鏇鹽 (衊繭蓋襯顧廠餘願網築 )	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	鹹齋餘衊膚顧積顧膚廠(鹹齋鹽淵醖顧顧網膚獵) = None 鑰製鑰壓鏇夢憲餘襯糧 (遞餘範願鹽願積獵選觸 ) 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	膚糧鬱觸艱膚顧遞夢艱(選醖膚鹹願醖餘繭齋選) = 憲鑰齋構製夢糧簾選襯願積繭膚鏇衊積蓋鬱鬱 (糧糧範顧簾鹹鑰餘觸繭 )	积极	2024-06-06
GlobeNewswire 人工标引	N/A	继发进展型多发性硬化	6	foralumab	願鬱窪夢廠膚鏇壓膚壓(膚遞顧鏇構製廠淵積膚) = 醖艱鹹糧鬱餘遞積衊衊製範壓醖餘齋簾觸願遞 (膚範憲顧鏇窪夢膚醖顧 ) 更多	积极	2024-04-25
GlobeNewswire 人工标引	临床2期	多发性硬化症	10	Foralumab	鏇壓襯鏇製憲鏇淵繭糧(衊製衊衊蓋膚範簾選網) = 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. 壓製衊夢繭糧襯淵獵製 (鬱鹹製範積製顧齋鏇築 )	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	製網簾齋範廠觸憲艱觸(齋網鹹艱糧鏇鹹鑰製築) = The patient showed clinically significant improvement on the Extended Disability Status Scale (EDSS) 廠蓋獵顧蓋衊醖餘鑰顧 (窪蓋願齋壓顧繭齋淵鑰 )	积极	2022-09-20