Group 1 - Proactive provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The news team covers medium and small-cap markets, as well as blue-chip companies, commodities, and broader investment stories [3] - Proactive's content includes insights across various sectors such as biotech, pharma, mining, natural resources, battery metals, oil and gas, crypto, and emerging technologies [3] Group 2 - Proactive is committed to adopting technology to enhance workflows and content production [4] - The company utilizes automation and software tools, including generative AI, while ensuring all content is edited and authored by humans [5]

Core Viewpoint - Tiziana Life Sciences has announced a significant study demonstrating that its intranasal anti-CD3 monoclonal antibody, foralumab, effectively reduces neuroinflammation and improves recovery in traumatic brain injury (TBI) models, indicating a promising therapeutic approach for TBI patients [1][3]. Group 1: Study Findings - The landmark study published in Nature Neuroscience shows that nasal administration of foralumab significantly reduces neuroinflammation and correlates with improved neurological outcomes, including reduced anxiety, cognitive decline, and enhanced motor skills in preclinical TBI models [1][2]. - The therapy induces IL-10 producing regulatory T cells (Tregs) that migrate to the brain, modulating microglia activity and reducing chronic inflammation, which is crucial for mitigating CNS damage and behavioral deficits associated with TBI [2][3]. - Blocking the IL-10 receptor negated the benefits of nasal anti-CD3 therapy, confirming IL-10's critical role in the therapeutic effect, while the adoptive transfer of IL-10 producing Tregs restored the benefits, validating the mechanism of action [3]. Group 2: Implications for Treatment - The positive results support advancing foralumab as a novel treatment for TBI, with potential applications in various settings, including hospitals and emergency situations [4]. - Tiziana's proprietary nasal anti-CD3 monoclonal antibody platform has shown potential in treating multiple neuroinflammatory and autoimmune diseases, reinforcing the commitment to develop transformative therapies for conditions like Multiple Sclerosis, Alzheimer's disease, and ALS [4][9]. - The company believes that nasal foralumab could be a game-changer in addressing the critical unmet medical need for effective TBI treatments [4][9]. Group 3: Company Overview - Tiziana Life Sciences is a clinical-stage biopharmaceutical company focused on developing innovative therapies using alternative drug delivery technologies, particularly through nasal administration, which may enhance efficacy and safety compared to traditional intravenous methods [9]. - Foralumab is the only fully human anti-CD3 monoclonal antibody currently in clinical development, demonstrating a favorable safety profile and clinical response in ongoing studies [9].

Company Overview - Proactive is a financial news publisher that provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The company has a team of experienced and qualified news journalists who produce independent content [2] Market Focus - Proactive specializes in medium and small-cap markets while also covering blue-chip companies, commodities, and broader investment stories [3] - The news team delivers insights across various sectors including biotech and pharma, mining and natural resources, battery metals, oil and gas, crypto, and emerging digital and EV technologies [3] Technology Adoption - Proactive is recognized for its forward-looking approach and enthusiastic adoption of technology to enhance workflows [4] - The company utilizes automation and software tools, including generative AI, while ensuring that all content is edited and authored by humans [5]

Core Viewpoint - Tiziana Life Sciences is advancing its lead candidate, intranasal foralumab, as a potential treatment for long COVID by targeting microglial activation, which is linked to persistent brain inflammation and associated symptoms [1][2][5]. Group 1: Company Overview - Tiziana Life Sciences is a biotechnology company focused on developing innovative immunomodulation therapies, with intranasal foralumab being its lead candidate [1][8]. - The company utilizes a unique nasal delivery method for its therapies, which may enhance efficacy and safety compared to traditional intravenous methods [8]. Group 2: Product Development - Foralumab is a fully human anti-CD3 monoclonal antibody that has shown promise in reducing microglial activation in preclinical studies and has been well-tolerated in human trials [1][4][6]. - A previous clinical study demonstrated that intranasal foralumab significantly reduced lung inflammation in patients with mild to moderate COVID-19 [3]. - The company is currently conducting a Phase 2a trial for foralumab in patients with non-active secondary progressive multiple sclerosis, with positive early results reported [6][7]. Group 3: Long COVID Context - Long COVID affects millions globally, characterized by symptoms such as fatigue, cognitive impairment, and psychiatric issues, which are linked to sustained brain inflammation [2]. - The medical community recognizes the urgent need for targeted therapies to address the complexities of long COVID, making Tiziana's approach particularly relevant [5].

Company Overview - Proactive is a financial news publisher that provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The company has a team of experienced and qualified news journalists who produce independent content [2] Market Focus - Proactive specializes in medium and small-cap markets while also covering blue-chip companies, commodities, and broader investment stories [3] - The news team delivers insights across various sectors including biotech and pharma, mining and natural resources, battery metals, oil and gas, crypto, and emerging digital and EV technologies [3] Technology Adoption - Proactive is recognized for its forward-looking approach and enthusiastic adoption of technology to enhance workflows [4] - The company utilizes automation and software tools, including generative AI, while ensuring that all content is edited and authored by humans [5]

Core 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].

Group 1 - Proactive provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The company focuses on medium and small-cap markets while also covering blue-chip companies, commodities, and broader investment stories [3] - Proactive's news team delivers insights across various sectors including biotech, pharma, mining, natural resources, battery metals, oil and gas, crypto, and emerging technologies [3] Group 2 - Proactive is committed to adopting technology to enhance workflows and improve content production [4] - The company utilizes automation and software tools, including generative AI, while ensuring all content is edited and authored by humans [5]

Core Viewpoint - Tiziana Life Sciences is advancing its investigational therapy, intranasal foralumab, for patients with non-active secondary progressive multiple sclerosis (na-SPMS) through an expanded access program, demonstrating positive early results in patient outcomes [1][3][4]. Group 1: Expanded Access Program - The na-SPMS expanded access program allows patients who do not qualify for the ongoing Phase 2a clinical trial to receive treatment with intranasal foralumab, aiming to provide therapeutic benefits to those lacking access to promising treatments [2][4]. - A total of 14 patients have been enrolled in the expanded access program, with the first 10 patients showing either improvement or stability of disease within 6 months of treatment [1][4]. Group 2: Drug Candidate Overview - Foralumab is a fully human anti-CD3 monoclonal antibody that stimulates T regulatory cells when administered intranasally, with positive outcomes observed in patients with na-SPMS [4][5]. - The FDA has approved the enrollment of an additional 20 patients in the expanded access program, indicating regulatory support for the therapy's development [4]. Group 3: Company Commitment and Future Directions - The CEO of Tiziana Life Sciences emphasized the company's commitment to addressing unmet medical needs in na-SPMS and advancing its therapies through both expanded access and clinical trials [3]. - Tiziana Life Sciences is focused on developing novel treatments for neuroinflammatory disorders, including Alzheimer's Disease and ALS, leveraging its innovative drug delivery technologies [3][6].

Group 1 - Proactive provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The news team covers medium and small-cap markets, as well as blue-chip companies, commodities, and broader investment stories [3] - Proactive focuses on sectors such as biotech and pharma, mining and natural resources, battery metals, oil and gas, crypto, and emerging digital and EV technologies [3] Group 2 - Proactive has a strong emphasis on technology adoption, utilizing various tools to enhance workflows [4] - The company employs automation and software tools, including generative AI, while ensuring all content is edited and authored by humans [5]

Core Viewpoint - Tiziana Life Sciences is advancing intranasal foralumab as a promising therapy for moderate Alzheimer's disease, which currently lacks effective treatment options [2][4]. Company Overview - Tiziana Life Sciences, Ltd. is a biotechnology company focused on developing innovative immunomodulation therapies, with intranasal foralumab as its lead candidate [2][10]. - The company utilizes a novel nasal delivery method for its therapies, which may enhance efficacy and safety compared to traditional intravenous methods [10]. Product Development - Intranasal foralumab is a fully human anti-CD3 monoclonal antibody designed to modulate the immune system and reduce inflammation associated with neurodegenerative diseases [4][6]. - The drug has shown efficacy in reducing microglial activation and improving cognitive function in preclinical and clinical settings [6][9]. - An expanded access program has been initiated, allowing patients with moderate Alzheimer's to receive treatment outside of clinical trials [4][8]. Clinical Insights - The first patient in the expanded access program shared positive experiences, highlighting the potential benefits of foralumab for individuals with moderate Alzheimer's [2][3]. - The drug has demonstrated a favorable safety profile and clinical response in patients with non-active secondary progressive multiple sclerosis (na-SPMS) [8][10]. - The FDA has approved the enrollment of an additional 20 patients in the expanded access program, indicating growing interest and confidence in the therapy [8]. Mechanism of Action - Foralumab works by inducing T regulatory cells (Tregs) that travel to the brain, modulating neuroinflammation and potentially slowing disease progression [4][6]. - The therapy targets immune system dysregulation, which is a critical factor in the pathogenesis of Alzheimer's disease [4][5]. Market Context - The increasing recognition of microglial activation as a key component in neurodegenerative diseases underscores the need for treatments that go beyond traditional amyloid-targeting therapies [5][7]. - Tiziana's innovative approach positions it favorably within the competitive landscape of Alzheimer's and neurodegenerative disease therapies [10].