Boston, MA, USA – April 1, 2026
In a promising development for age-related cognitive decline and neurodegenerative disorders, Tiziana Life Sciences has announced compelling preclinical data demonstrating that its intranasal anti-CD3 therapy, foralumab, significantly improves cognition and reverses key markers of brain aging. The findings highlight a novel, non-invasive immunotherapy approach targeting neuroinflammation, a major contributor to cognitive impairment associated with aging.
Nasal Anti-CD3 Shows Strong Neuroprotective Effects
The study revealed that intranasal anti-CD3 therapy effectively reduces chronic neuroinflammation, a key driver of cognitive decline in aging populations. By modulating immune system activity through T cells, the therapy demonstrated the ability to dampen microglial activation, which is widely recognized as a central mechanism behind neuroinflammatory damage in the brain.
This reduction in inflammation is particularly significant, as chronic neuroinflammation has been strongly linked to diseases such as Alzheimer’s and other neurodegenerative conditions. By targeting this pathway, foralumab offers a differentiated therapeutic strategy that goes beyond symptomatic relief, potentially addressing the underlying causes of cognitive decline.
In addition to reducing inflammation, the therapy showed the ability to enhance neurogenesis in the hippocampus, the region of the brain responsible for learning and memory. The study also demonstrated reduced cellular senescence, achieved through the downregulation of inflammatory markers and aging-related genes, further supporting its role in reversing aspects of brain aging.
Advertisement
Innovative Mechanism Positions Foralumab as Breakthrough Therapy
Foralumab, a fully human anti-CD3 monoclonal antibody, is uniquely designed for intranasal delivery, enabling direct modulation of the immune system without the need for intravenous administration. This innovative approach stimulates regulatory T cells (Tregs), which play a crucial role in maintaining immune balance and reducing inflammation.
The ability to activate Tregs through a nasal route represents a major advancement in immunotherapy, offering improved safety, tolerability, and patient convenience compared to traditional delivery methods. Experts emphasize that this mechanism not only reduces harmful inflammation but also promotes brain repair processes, including neurogenesis and tissue recovery.
Importantly, foralumab is currently the only fully human anti-CD3 monoclonal antibody in clinical development, positioning it as a first-in-class therapy in the neuroimmunology space. The growing body of evidence supporting its mechanism strengthens its potential across a wide range of neurodegenerative and neuroinflammatory diseases.
Expanding Clinical Pipeline Across Neurological Disorders
Building on these encouraging preclinical results, Tiziana Life Sciences is advancing multiple clinical programs evaluating intranasal foralumab across several indications. The therapy is currently being studied in Non-Active Secondary Progressive Multiple Sclerosis (na-SPMS), with early data showing disease stability or improvement in all treated patients within six months under an Expanded Access program.
In parallel, the company is conducting a Phase 2a randomized, placebo-controlled trial in SPMS patients, further validating the clinical potential of this innovative therapy. Additional programs are exploring its application in Alzheimer’s disease, Amyotrophic Lateral Sclerosis (ALS), Multiple System Atrophy (MSA), and other neurodegenerative conditions.
The expansion into aging-related cognitive impairment marks a strategic broadening of Tiziana’s pipeline, reflecting the therapy’s versatility and potential to address multiple high-burden neurological diseases. By targeting core inflammatory pathways shared across these conditions, intranasal foralumab could emerge as a platform therapy for brain health and neuroprotection.
The company’s proprietary drug delivery technology, which enables alternative routes of immunotherapy, is also expected to play a critical role in enhancing treatment outcomes. Intranasal delivery not only improves efficacy but also minimizes systemic side effects, making it particularly suitable for long-term use in chronic conditions.
As the global burden of neurodegenerative diseases continues to rise, innovations like nasal anti-CD3 therapy represent a transformative shift toward precision immunotherapy in neurology. With strong preclinical validation and advancing clinical programs, Tiziana Life Sciences is positioning itself at the forefront of next-generation treatments aimed at preserving cognitive function and improving quality of life in aging populations.
Source: Tiziana Life Sciences press release
