Core Article Summary - The article highlights the therapeutic potential of intranasal Foralumab, a fully human anti-CD3 monoclonal antibody, for treating neurodegenerative diseases such as Multiple Sclerosis (MS), Alzheimer’s disease, ALS, and Parkinson’s disease [1][8] - Foralumab works by dampening microglial activation, a key driver of disease in these neurological conditions, and has shown no apparent side effects with easy administration [1] - The review article emphasizes the role of the immune system in neurodegenerative diseases, with microglia being a common therapeutic target [4][9] Clinical Development and Trials - Foralumab is currently being studied in a Phase 2a trial for non-active secondary progressive multiple sclerosis (NCT06292923), with 10 patients already dosed in an Expanded Access Program showing improvement or stability within 6 months [5] - The FDA has allowed an additional 20 patients to be enrolled in the Expanded Access Program [5] - The Phase 2 trial for non-active SPMS began screening patients in November 2023 [2] Company Overview - Tiziana Life Sciences is a clinical-stage biopharmaceutical company focused on developing innovative immunomodulation therapies using alternative drug delivery technologies, such as intranasal administration [6] - The company’s lead candidate, intranasal Foralumab, is the only fully human anti-CD3 monoclonal antibody in clinical development and has demonstrated a favorable safety profile and clinical response in studies [6] - Tiziana’s technology for alternative routes of immunotherapy has been patented, with several applications pending, enabling broad pipeline applications [6] Scientific Insights - The review article discusses how microglia, monocytes, and T cells contribute to the pathogenesis of neurodegenerative diseases and their potential as shared therapeutic targets [9] - The microbiome is highlighted as an emerging therapeutic target that indirectly modulates the immune system [9] - Foralumab modulates T cell function by binding to the T cell receptor, dampening inflammation and suppressing effector features in immune cells [10] Industry Implications - Immunotherapeutic approaches targeting the adaptive and innate immune systems are being explored for the treatment of neurological diseases, with common targets and approaches across diseases [4] - The intranasal delivery of Foralumab represents a promising therapeutic avenue for patients with limited treatment options, particularly in progressive MS and other neurological diseases [1][6]
Tiziana Life Sciences Announces Review Article Published in Nature Highlighting Foralumab's Potential in the Treatment of Neurological Disease
Tiziana Life Sciences (TLSA) GlobeNewswire·2025-01-08 12:00