Tiziana Life Sciences Ltd. is a clinical-stage biotechnology company, which engages in the research and development of biotechnological and pharmaceutical products. It specializes in developing transformative therapies for neurodegenerative and lung diseases. The company was founded by Gabriele Marco Antonio Cerrone on February 11, 1998 and is headquartered in London, the United Kingdom.
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- Jefferies analysts identify neuroinflammation as one of the most important emerging storylines in Parkinson's disease drug development, with key milestones expected heading into 2027. - The addressable early Parkinson's population across the US and EU is projected to exceed two million patients by 2035, representing a potential disease-modifying therapy market approaching $8 billion. - BioVie's bezisterim reported positive Phase 2 topline data showing improvements in blood-based inflammatory markers and clinical outcomes, with patients having higher baseline inflammation seeing the greatest benefit. - Jefferies contends that Parkinson's is driven by multiple mechanisms—alpha-synuclein, cellular cleanup breakdown, and neuroinflammation—meaning single-pathway drugs alone are unlikely to succeed.
- Tiziana Life Sciences has begun enrollment in a Phase 2 randomized, placebo-controlled trial evaluating intranasal foralumab as both monotherapy and in combination with FDA-approved anti-amyloid therapies for early Alzheimer's disease. - New TSPO-PET imaging evidence demonstrates persistent and widespread microglial activation in an Alzheimer's patient despite treatment with lecanemab, confirming that neuroinflammation remains present even after amyloid plaque reduction. - The trial will test whether intranasal foralumab, a fully human anti-CD3 monoclonal antibody, can reduce microglial activation and slow cognitive decline by targeting the inflammatory component of Alzheimer's disease. - Foralumab has previously shown efficacy in reducing microglial activation in secondary progressive multiple sclerosis patients, with all 14 patients in an expanded access program showing either improvement or stability within 6 months.
- The Sean M. Healey & AMG Center for ALS completed enrollment of 41 participants in its first biomarker-driven MyMatch trial testing repurposed digoxin for ALS treatment. - Tiziana Life Sciences was selected to enter the program with intranasal foralumab, a fully human anti-CD3 monoclonal antibody targeting neuroinflammation in ALS patients. - The ALS MyMatch program uses personalized medicine approaches with genetic and biofluid biomarkers to match patients to optimal experimental treatments in early-phase trials. - The initiative aims to accelerate ALS drug development by generating clear efficacy data and identifying target populations for larger phase 2/3 trials.
- Tiziana Life Sciences announces advancement of TZLS-501, a fully human anti-IL-6 receptor monoclonal antibody targeting both membrane-bound and soluble forms of IL-6R with dual mechanism of action. - The company's decision follows Novartis' recent $1.4 billion acquisition of Tourmaline Bio, validating increased industry interest in IL-6 pathway therapeutics for inflammatory diseases. - TZLS-501 shows potential for treating multiple conditions including rheumatoid arthritis, acute respiratory distress syndrome, idiopathic pulmonary fibrosis, and various cancers by reducing both receptor signaling and circulating cytokine burden. - Tiziana plans to pursue non-dilutive funding strategies for TZLS-501 development while maintaining focus on its lead program, intranasal foralumab for multiple sclerosis.
- Tiziana Life Sciences announces suspension of immediate capital raising activities following breakthrough discovery of new immune biomarkers in non-active secondary progressive multiple sclerosis patients. - The company's lead candidate, intranasal foralumab, represents a novel approach to immunotherapy as the only fully human anti-CD3 monoclonal antibody in clinical development. - Management reaffirms commitment to advancing their innovative drug delivery technologies, focusing on alternative routes of immunotherapy administration for improved efficacy and safety.
- Tiziana Life Sciences has dosed the first patient with moderate Alzheimer's disease with intranasal foralumab at Brigham and Women's Hospital in Boston. - Foralumab, a fully human anti-CD3 monoclonal antibody, aims to reduce brain inflammation by stimulating T regulatory cells, differing from amyloid or tau approaches. - The NIH awarded a $4 million grant to Dr. Howard Weiner to study nasal anti-CD3 for Alzheimer's, supporting preclinical and clinical studies of foralumab. - Foralumab has shown promise in multiple sclerosis, with ongoing trials and expanded access programs, highlighting its potential in neuroinflammatory diseases.
- Tiziana Life Sciences is expanding its Phase 2 trial of intranasal foralumab for non-active secondary progressive multiple sclerosis (na-SPMS) to include more prestigious U.S. medical centers. - The company announced the discovery of new immune biomarkers in patients with na-SPMS treated with nasal foralumab, enhancing understanding of the drug's mechanism. - Preclinical studies show that nasal anti-CD3 treatment, foralumab, led to notable advancements in motor functions in models with spinal cord injury (SCI). - Tiziana Life Sciences has dosed additional patients in its Expanded Access Program for na-SPMS, with early data showing disease stabilization or improvement.
- Tiziana Life Sciences has been awarded a grant from the ALS Association to fund an early-stage clinical trial of intranasal foralumab in patients with amyotrophic lateral sclerosis (ALS). - The trial will assess the safety and efficacy of two different doses of foralumab in 20 ALS patients, building on promising results observed in multiple sclerosis (MS) trials. - Foralumab, an antibody-based therapy, targets CD3 on T-cells to modulate immune activity and reduce neuroinflammation, a key factor in ALS progression. - The study will utilize PET imaging to evaluate the drug's impact on brain inflammation, mirroring successful imaging approaches used in previous MS studies with foralumab.
• Eisai presented Phase 1/2 data on E2814, an anti-tau drug, showing reduced levels of disease biomarkers in participants with mild to moderate genetic Alzheimer’s. • Roche terminated its agreement with UCB for beprenemab, an experimental tau-targeting antibody, after Phase 2 trial results showed it did not slow cognitive decline. • A Phase 2 trial of intranasal insulin and empagliflozin showed that insulin alone was associated with a small improvement in cognitive test performance in early Alzheimer’s patients.
- A study reveals that combining nasal anti-CD3 antibody (foralumab) with semaglutide improves liver homeostasis in diet-induced obesity models. - The combination therapy significantly reduces inflammation markers, addressing a key factor in obesity-related metabolic disorders. - Researchers suggest this novel approach could offer a new way to treat obesity-related inflammation and liver dysfunction. - Tiziana Life Sciences plans to advance these preclinical findings into human clinical trials, aiming for innovative solutions for metabolic diseases.
