蒂齐亚纳宣布数据显示鼻用抗CD3改善与衰老相关的认知功能-动脉网

Tiziana Announces Data Showing Nasal Anti-CD3 Improves Cognition Associated with Aging

Tiziana Life Sciences 等信源发布 2026-04-01 20:19

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BOSTON, MA, April 1, 2026

美国马萨诸塞州波士顿，2026年4月1日

– Tiziana Life Sciences, Ltd. (Nasdaq:

– Tiziana Life Sciences, Ltd. (纳斯达克:

TLSA

) (“Tiziana”), a biotechnology company developing its lead candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, announces positive preclinical data highlighting nasal anti-CD3’s potential as a novel approach to address neuroinflammation associated with aging, which contributes to cognitive decline in age-related disorders.

）（“Tiziana”），一家开发现阶段主要候选药物——鼻腔给药的foralumab（一种全人源抗CD3单克隆抗体）的生物技术公司，宣布了临床前数据，这些数据突显了鼻用抗CD3作为应对与衰老相关的神经炎症的新方法的潜力，这种神经炎症会导致与年龄相关的认知能力下降。

In the study, nasal anti-CD3 reversed key aspects of brain aging, and improved cognition..

在研究中，鼻腔抗CD3逆转了大脑衰老的关键方面，并改善了认知能力。

Key study findings:

关键研究发现：

Nasal anti-CD3 dampens microglial activation that drives chronic neuroinflammation. This reduction in inflammation, which is strongly linked to cognitive decline, suggests the therapy could help mitigate the inflammatory burden and slow aspects of the aging process.

鼻用抗CD3药物可减轻驱动慢性神经炎症的小胶质细胞激活。这种炎症的减少与认知能力下降密切相关，表明该疗法可能有助于减轻炎症负担并延缓衰老过程的某些方面。

Nasal anti-CD3 enhances neurogenesis in the hippocampus, a region critical for learning and memory and reduces cellular senescence by down regulating inflammatory markers and age-related genes.

鼻腔抗CD3抗体可增强海马体（一个对学习和记忆至关重要的区域）中的神经发生，并通过下调炎症标志物和与年龄相关的基因来减少细胞衰老。

“These preclinical results are highly encouraging and build on our growing body of evidence that nasal foralumab modulates the immune system to reduce neuroinflammation,” said 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.

“这些临床前结果非常令人鼓舞，并且进一步增加了我们关于鼻腔给药的foralumab能够调节免疫系统以减少神经炎症的证据，”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霍华德·L·韦纳医学博士表示。

“By targeting T cells to influence microglial behavior and promote brain repair mechanisms like neurogenesis, nasal anti-CD3 offers a differentiated, non-invasive approach with potential applications in age related cognitive impairment.”.

“通过靶向T细胞来影响小胶质细胞行为并促进神经发生等大脑修复机制，鼻用抗CD3提供了一种差异化、非侵入性的方法，在与年龄相关的认知障碍方面具有潜在应用价值。”

“These aging model findings reinforce the mechanism of action of intranasal foralumab, which stimulates regulatory T cells that reduce neuroinflammation,” said Ivor Elrifi, CEO of Tiziana Life Sciences. “Tiziana continues to advance its clinical programs for intranasal foralumab, including ongoing trials in Non-Active Secondary Progressive Multiple Sclerosis, MSA, ALS, Alzheimer’s disease, and other neurodegenerative indications, while expanding preclinical research into additional areas such as aging.”.

“这些衰老模型的研究结果进一步证实了鼻腔给药Foralumab的作用机制，它能够刺激调节性T细胞，从而减轻神经炎症，”Tiziana生命科学公司首席执行官Ivor Elrifi表示。“Tiziana继续推进其鼻腔给药Foralumab的临床项目，包括正在进行的非活动性继发进展型多发性硬化症、MSA、ALS、阿尔茨海默病及其他神经退行性疾病的试验，同时还在扩展如衰老等其他领域的临床前研究。”

About Foralumab

关于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 (.

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

) 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

）。

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。

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About Tiziana Life Sciences

关于蒂齐亚娜生命科学公司

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，预计将会允许广泛的应用于产品管线。

For more information about Tiziana and its innovative pipeline of therapies, please visit

如需更多关于Tiziana及其创新疗法的信息，请访问

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”、“打算”、“计划”、“相信”、“寻求”、“估计”以及类似表达的词语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, 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度依赖这些前瞻性声明，这些声明仅反映了蒂齐亚娜在本公告发布当日的观点。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，例如与市场状况相关的不确定性以及其他因素，详见蒂齐亚娜截至2024年12月31日的年度报告中标题为“风险因素”部分的更详细描述，以及提交给证券交易委员会的其他定期报告。

The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. 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该陈述之日的事件有关。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

email:

电子邮件：

info@tizianalifesciences.com

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