BOSTON, Oct. 29, 2025 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, today announced its participation as a presenting company at BIO-Europe 2025. The event, Europe’s premier life sciences partnering conference, will take place November 3–5, 2025, at the Vienna Exhibition and Congress C ...

Core Insights - Tiziana Life Sciences has been invited to the J.P. Morgan Asset Management Life Science Innovation Forum 2025, highlighting its position in the biotechnology sector [1][2][3] Company Overview - Tiziana Life Sciences is a clinical-stage biopharmaceutical company focused on developing innovative therapies using transformational drug delivery technologies [5] - The company's lead candidate, intranasal foralumab, is the only fully human anti-CD3 monoclonal antibody currently in clinical development [4][5] Product Development - Foralumab has shown promise in stimulating T regulatory cells when administered intranasally, with positive outcomes observed in patients with Non-Active Secondary Progressive Multiple Sclerosis (na-SPMS) [3][4] - In an open-label intermediate sized Expanded Access Program, all 14 patients treated exhibited either improvement or stability of disease within 6 months [3] - Foralumab is also undergoing a Phase 2a randomized, double-blind, placebo-controlled trial for na-SPMS [3] Industry Context - The Life Science Innovation Forum aims to accelerate the transition of life science research into market-ready solutions and strengthen the biotechnology value chain [2] - The event is aligned with Saudi Arabia's National Biotechnology Strategy, promoting a thriving ecosystem for life sciences [2]

Core Viewpoint - Tiziana Life Sciences is presenting a scientific poster on its Phase 2a clinical trial of intranasal foralumab for treating non-active secondary progressive multiple sclerosis at the ECTRIMS Congress, highlighting its innovative approach in immunomodulation therapies [1][2][4]. Company Overview - Tiziana Life Sciences is a clinical-stage biopharmaceutical company focused on developing breakthrough therapies using novel drug delivery technologies, particularly intranasal delivery for immunotherapy [6][8]. - The company’s lead candidate, intranasal foralumab, is the only fully human anti-CD3 monoclonal antibody currently in clinical development, showing a favorable safety profile and clinical response in preliminary studies [5][8]. Clinical Trial Details - The poster presentation titled "Study Design of a Phase 2a Double-Blind Placebo-Controlled Trial of Nasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis" outlines the trial's design and objectives [2][7]. - The Phase 2a trial aims to evaluate the efficacy and safety of nasal foralumab in patients with non-active secondary progressive multiple sclerosis, a group with limited treatment options [4][5]. Event Information - The ECTRIMS Congress, where the poster will be presented, is the largest annual international conference dedicated to multiple sclerosis research, taking place from September 24-26, 2025, in Barcelona, Spain [1][4][7].

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Core Viewpoint - Tiziana Life Sciences has received a research grant from the U.S. Department of Defense to study intranasal anti-CD3 therapy for traumatic spinal cord injury, expanding its therapeutic potential into significant neurological conditions [1][2][3]. Group 1: Research and Development - The DoD grant will fund a three-year study focusing on the acute phase of spinal cord injury, targeting patients who arrive at the hospital immediately after injury [2]. - A complementary two-year Stepping Strong Breakthrough Award will investigate the chronic phase of spinal cord injury, concentrating on patients with ongoing neurological deficits [2]. - Tiziana's lead candidate, intranasal foralumab, is a fully human anti-CD3 monoclonal antibody that has shown promise in stimulating T regulatory cells and improving disease stability in patients with non-active secondary progressive multiple sclerosis [6][7]. Group 2: Market Opportunity - Traumatic spinal cord injury affects nearly 300,000 Americans with permanent disabilities and sees over 17,000 new injuries each year, representing a significant unmet medical need [3]. - Current treatments are primarily supportive, with no approved therapies that enhance neurological recovery or prevent chronic complications from spinal cord inflammation, indicating a substantial commercial opportunity for Tiziana [3]. Group 3: Mechanism and Benefits - Intranasal anti-CD3 therapy aims to rebalance the immune system, reduce inflammation in the injured spinal cord, and support functional recovery, potentially benefiting other acute central nervous system injuries [4][5]. - Preclinical results have indicated that this non-invasive therapy could improve motor outcomes, enhancing independence and quality of life for patients [4].

Core Insights - Tiziana Life Sciences has initiated a Phase 2a clinical trial for intranasal foralumab in patients with Multiple System Atrophy (MSA), marking a significant step in developing therapies for this rare neurodegenerative disorder [1][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 [9]. - The company’s lead candidate, intranasal foralumab, is the only fully human anti-CD3 monoclonal antibody currently in clinical development, demonstrating a favorable safety profile and clinical response in prior studies [9][7]. Clinical Trial Details - The Phase 2a trial will evaluate the efficacy of foralumab in reducing neuroinflammation and aims to determine its potential to slow disease progression and improve quality of life for MSA patients [3][4]. - The trial involves a six-month open-label study with participants receiving treatment over eight dosing cycles [3]. Disease Context - Multiple System Atrophy is a rare and rapidly progressive neurodegenerative disorder affecting an estimated 15,000–50,000 individuals in the U.S., with no FDA-approved treatments available to alter its course [2][5]. - The disease leads to severe movement, balance, and autonomic function issues, with most patients surviving only 6–9 years post-diagnosis [5]. Mechanism of Action - Foralumab works by stimulating T regulatory cells through a novel, non-systemic delivery approach, targeting the immune processes that may drive neurodegeneration [4][6]. - Early studies have indicated potential benefits of foralumab in stabilizing or improving function in other neuroinflammatory conditions, such as multiple sclerosis [4][6].

Core Viewpoint - Tiziana Life Sciences has received FDA approval for the IND of its Phase 2a clinical trial of intranasal foralumab for treating Multiple System Atrophy (MSA), addressing an unmet medical need in this orphan disease [1][4]. Company Overview - Tiziana Life Sciences is a clinical-stage biopharmaceutical company focused on developing innovative therapies using alternative drug delivery technologies, particularly intranasal administration [6][7]. - The company's lead candidate, intranasal foralumab, is the only fully human anti-CD3 monoclonal antibody currently in clinical development, showing a favorable safety profile and clinical response in previous studies [6][7]. Clinical Trial Details - The Phase 2a study is a six-month, open-label trial aimed at evaluating the effects of intranasal foralumab on microglial activation, clinical outcomes, and safety in MSA patients [2]. - Foralumab is administered via nasal spray in eight 3-week dosing cycles, targeting T-cell mediated neuroinflammation [2]. Disease Context - Multiple System Atrophy is a rapidly progressive neurodegenerative disorder with a mean incidence of 0.6 per 100,000 person-years in the US, increasing to 3 per 100,000 for individuals aged 50 and older [3]. - The disease leads to severe disability and has a poor prognosis, with a median survival of 6-9 years [3]. Mechanism of Action - Foralumab induces regulatory T cells and modulates T-cell-driven inflammation, potentially slowing neuronal damage in neuroinflammatory and degenerative diseases [4]. - The therapy aims to impact microglial activity and clinical outcomes significantly over the trial period [4].

Core Insights - Tiziana Life Sciences announced significant immunologic findings from the treatment of a moderate Alzheimer's Disease patient with intranasal foralumab, indicating its potential as a breakthrough therapy [1][5] Immunologic Findings - Transcriptional analysis of white blood cells before and after foralumab therapy showed profound immune modulatory effects, with significant changes in CD4 cells, CD8 cells, and monocytes, linking immune effects to reduced brain inflammation [2] - An unexpected increase in phagocytosis markers in classical monocytes suggests that nasal foralumab may enhance the clearance of amyloid plaques, potentially opening new treatment avenues for Alzheimer's Disease [3] Expert Commentary - Dr. Howard Weiner highlighted the promising reduction in microglial inflammation and unique immune changes observed in the treated Alzheimer's patient, indicating a step forward in understanding foralumab's therapeutic role in neuroinflammatory diseases [4] - Ivor Elrifi, CEO of Tiziana, emphasized the dual benefits of nasal foralumab in reducing brain inflammation and influencing amyloid pathology, with the treatment being well tolerated and continued by the patient [4] Company Commitment - The findings represent a significant milestone in developing novel therapies for Alzheimer's Disease, underscoring Tiziana Life Sciences' commitment to advancing transformative treatments for neurodegenerative disorders [5] About Foralumab - Foralumab is a fully human anti-CD3 monoclonal antibody that stimulates T regulatory cells when dosed intranasally, with ongoing studies showing improvements or stability in patients with Non-Active Secondary Progressive Multiple Sclerosis [6][7] - It is the only fully human anti-CD3 monoclonal antibody currently in clinical development, representing a novel approach for treating neuroinflammatory and neurodegenerative diseases [7] Company Overview - Tiziana Life Sciences is a clinical-stage biopharmaceutical company focused on developing breakthrough therapies using innovative drug delivery technologies, with intranasal foralumab demonstrating a favorable safety profile and clinical response in studies [8][9]

Core Viewpoint - Tiziana Life Sciences has commenced dosing in a Phase 2 clinical trial for intranasal foralumab, targeting non-active Secondary Progressive Multiple Sclerosis (na-SPMS) at Weill Cornell Medicine, expanding its research efforts in this area [1][2][3]. Company Overview - Tiziana Life Sciences is a clinical-stage biopharmaceutical company focused on developing innovative therapies using alternative drug delivery technologies, particularly intranasal administration [7]. - The company’s lead candidate, intranasal foralumab, is the only fully human anti-CD3 monoclonal antibody currently in clinical development, demonstrating a favorable safety profile and clinical response in prior studies [7][6]. Clinical Trial Details - The Phase 2 trial aims to evaluate the safety and efficacy of intranasal foralumab in treating multiple sclerosis, a chronic autoimmune disease affecting the central nervous system [2]. - The trial includes multiple prestigious sites, with Weill Cornell Medicine being the latest addition, enhancing the collaborative effort in MS research [1][2][3]. - Following the blinded phase, all participants will have the opportunity to receive intranasal foralumab during a six-month open-label extension phase to assess long-term safety and sustained benefits [3]. Product Information - Foralumab is designed to engage regulatory T cells through a non-systemic approach, promoting immune tolerance while minimizing systemic immune suppression [4]. - Initial results from an open-label Expanded Access Program indicated that 10 patients with na-SPMS experienced either improvement or stability of disease within six months [5]. Industry Context - The development of intranasal foralumab represents a novel approach in the treatment of neuroinflammatory and neurodegenerative diseases, positioning Tiziana Life Sciences at the forefront of innovative therapies in this field [6].