Tiziana Life Sciences (TLSA) GlobeNewswire·2025-02-21 13:00Core Viewpoint - Tiziana Life Sciences has entered into a product development services agreement with Renaissance Lakewood LLC to optimize and scale up the production of intranasal foralumab, a novel immunomodulation therapy aimed at treating neurodegenerative and inflammatory diseases [1][2]. Company Overview - Tiziana Life Sciences is a clinical-stage biopharmaceutical company focused on developing innovative therapies using alternative drug delivery technologies, particularly intranasal routes [9]. - The lead candidate, intranasal foralumab, is a fully human anti-CD3 monoclonal antibody currently in clinical development, showing promise in treating conditions like Alzheimer's disease and multiple sclerosis [3][9]. Collaboration Details - The agreement with Renaissance will leverage their expertise in nasal drug delivery to ensure high-quality production and regulatory compliance for intranasal foralumab [2][4]. - This partnership is seen as a critical step in expediting the clinical development and potential commercialization of the therapy [2][4]. Product Development and Clinical Trials - Intranasal foralumab has shown potential in activating regulatory T cells and reducing neuroinflammation, which is crucial in the progression of neurodegenerative diseases [3][6]. - Currently, 10 patients with Non-Active Secondary Progressive Multiple Sclerosis (na-SPMS) have been dosed, with positive outcomes observed within six months [5]. - The FDA has approved the enrollment of an additional 20 patients in the Expanded Access Program, and a Phase 2a trial is underway [5][6]. Market Position and Future Prospects - Tiziana's innovative nasal approach is expected to improve efficacy, safety, and tolerability compared to traditional intravenous delivery methods [9]. - The collaboration with Renaissance is viewed as a significant milestone in Tiziana's mission to address unmet medical needs through innovative therapies [4].