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Tiziana Life Sciences (Nasdaq: TLSA) has released new preclinical data demonstrating that its intranasal anti-CD3 therapy, foralumab, may help reverse key aspects of brain aging and improve cognition. The findings highlight the drug’s potential to target neuroinflammation—one of the primary drivers of age-related cognitive decline.
Targeting Inflammation at the Source
First, the study showed that nasal anti-CD3 significantly reduced microglial activation, a key contributor to chronic neuroinflammation in the aging brain. By dampening this inflammatory response, the therapy may lower the biological stress that accelerates cognitive decline.
At the same time, researchers observed that the treatment enhanced neurogenesis in the hippocampus, the brain region responsible for learning and memory. In addition, the therapy reduced cellular senescence by downregulating inflammatory markers and age-associated genes. Together, these effects suggest a dual mechanism: reducing damage while promoting repair.
A Novel Immunological Approach
According to Dr. Howard L. Weiner, Chairman of Tiziana’s Scientific Advisory Board, the results reinforce the therapeutic potential of targeting immune pathways in neurological aging.
“Our findings continue to show that nasal foralumab modulates the immune system to reduce neuroinflammation,” Weiner said. “By influencing T cells and altering microglial behavior, this approach not only limits inflammation but also promotes brain repair mechanisms such as neurogenesis.”
Expanding Clinical Momentum
Building on these findings, Tiziana is advancing intranasal foralumab across multiple clinical programs. CEO Ivor Elrifi emphasized that the therapy’s mechanism—stimulating regulatory T cells—offers a differentiated and non-invasive strategy for treating neurodegenerative conditions.
“These results further validate how intranasal foralumab reduces neuroinflammation through immune modulation,” Elrifi said. “We are actively progressing clinical trials in several indications, including non-active secondary progressive multiple sclerosis, multiple system atrophy, ALS, and Alzheimer’s disease, while also expanding into aging-related applications.”
Clinical Progress to Date
So far, Tiziana has treated 14 patients with non-active secondary progressive multiple sclerosis (na-SPMS) under an Expanded Access Program. Notably, all patients demonstrated either disease stability or improvement within six months.
Meanwhile, the company continues to evaluate foralumab in a Phase 2a randomized, placebo-controlled trial in na-SPMS patients, further strengthening its clinical development pipeline.
A Platform with Broad Potential
Unlike traditional intravenous biologics, foralumab uses an intranasal delivery method, which may improve both safety and tolerability. Moreover, as the only fully human anti-CD3 monoclonal antibody currently in clinical development, the therapy represents a unique approach to immunomodulation.
Looking ahead, Tiziana plans to leverage this platform across a wide range of neuroinflammatory and neurodegenerative diseases. If successful, intranasal foralumab could open a new frontier in treating conditions linked to aging and immune dysfunction.
About Foralumab
Foralumab is a fully human anti-CD3 monoclonal antibody designed to stimulate regulatory T cells when administered intranasally. This novel delivery method offers a non-invasive alternative to traditional intravenous (IV) therapies. In an open-label Expanded Access Program (NCT06802328), 14 patients with Non-Active Secondary Progressive Multiple Sclerosis showed either improvement or disease stability within six months of treatment. Additionally, foralumab is being evaluated in a Phase 2a randomized, double-blind, placebo-controlled trial (NCT06292923) for na-SPMS.
As the only fully human anti-CD3 monoclonal antibody currently in clinical development, foralumab represents a groundbreaking approach to treating neuroinflammatory and neurodegenerative diseases.
About Tiziana Life Sciences
Tiziana Life Sciences is a clinical-stage biopharmaceutical company dedicated to developing transformative therapies through innovative drug delivery technologies. The company’s intranasal approach aims to improve both efficacy and safety compared to traditional IV delivery methods. With a favorable safety profile and promising clinical responses, Tiziana’s lead candidate, intranasal foralumab, is paving the way for a broad range of applications in immunotherapy. The company’s patented technology for alternative drug delivery routes underscores its commitment to revolutionizing treatment options for patients worldwide.
Tiziana’s latest findings mark a significant step forward in the fight against cognitive decline and neuroinflammation, offering hope for improved quality of life in aging and neurodegenerative conditions.
To find out more investor relations information about Tiziana Life Sciences please visit www.ir.tizianalifesciences.com.
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