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Tiziana Life Sciences Ltd. develops intranasal foralumab, a fully human anti-CD3 monoclonal antibody, as a clinical-stage biotechnology company focused on neuroinflammatory and neurodegenerative diseases. News for TLSA centers on clinical and preclinical data for intranasal anti-CD3 therapy, including non-active secondary progressive multiple sclerosis, Multiple System Atrophy, Alzheimer’s disease, ALS, Long COVID-associated neuroinflammation, and age-related cognitive decline.
Company updates also cover biomarker work involving CSF proteomics, TSPO-PET and microglial activation, peer-reviewed publications, scientific conference presentations, expanded-access observations, and financing actions such as registered direct offerings of ordinary shares and warrants.
Tiziana Life Sciences (Nasdaq: TLSA) has submitted an Investigational New Drug (IND) application to the FDA for a phase 2 clinical trial of intranasal foralumab in Amyotrophic Lateral Sclerosis (ALS) patients. The trial, supported by an ALS Association grant through the Hoffman ALS Clinical Trial Awards Program, will evaluate two doses of the company's intranasal foralumab in 20 patients.
Foralumab, a fully human anti-CD3 monoclonal antibody, represents Tiziana's lead development candidate. The company's intranasal foralumab programs now target three neurodegenerative diseases: ALS, Multiple Sclerosis, and Alzheimer's disease.
ALS, also known as Lou Gehrig's disease, is a fatal neurodegenerative condition affecting nerve cells in the brain and spinal cord, leading to muscle weakness and paralysis. Most patients survive less than five years after diagnosis, highlighting the urgent need for new treatment options.
Tiziana Life Sciences (NASDAQ: TLSA) has published a groundbreaking study in Nature Neuroscience demonstrating significant positive results for their nasal anti-CD3 therapy in treating traumatic brain injury (TBI). The study shows that nasal administration of Tiziana's anti-CD3 monoclonal antibody, foralumab, effectively reduced neuroinflammation and improved recovery.
The research, led by Dr. Saef Izzy at Brigham and Women's Hospital, revealed that the therapy induces IL-10 producing regulatory T cells that migrate to the brain and modulate microglia activity. Key improvements observed in the preclinical model included:
- Reduced anxiety
- Less cognitive decline
- Improved motor skills
The study validates the mechanism of action of foralumab and its potential application in treating various neuroinflammatory conditions, including Multiple Sclerosis, Alzheimer's disease, and ALS. This breakthrough is particularly significant as there are currently no effective treatments available for TBI, which remains a major unmet medical need.
Tiziana Life Sciences (Nasdaq: TLSA) announced that a nasal anti-CD3 (foralumab) preclinical study for Long COVID is nearing completion in the second quarter of 2025. Foralumab, a fully human anti-CD3 monoclonal antibody, could offer a novel treatment for Long COVID by reducing microglial activation, which contributes to persistent brain inflammation associated with the condition.
Long COVID affects millions worldwide with symptoms including fatigue, cognitive impairment ("brain fog"), and psychiatric issues like depression. PET imaging studies confirm increased microglial activity in Long COVID patients, highlighting the need for targeted therapies.
Previously, Tiziana conducted a human clinical study where foralumab was nasally administered to COVID-19 patients for 10 consecutive days, showing good tolerability and significant reduction in lung inflammation. The company's nasal anti-CD3 platform has also demonstrated efficacy in reducing microglial activation in models of multiple sclerosis and Alzheimer's Disease.
Tiziana Life Sciences (NASDAQ: TLSA) has announced a product development services agreement with Renaissance Lakewood , a Contract Development and Manufacturing Organization (CDMO) specializing in nasal drug delivery. The collaboration focuses on optimizing the formulation and scaling up production of intranasal foralumab, Tiziana's lead development candidate.
The partnership aims to advance the development of intranasal foralumab, a fully human anti-CD3 monoclonal antibody, for treating neurodegenerative and inflammatory diseases. Renaissance will leverage its expertise in pharmaceutical-nasal product development and manufacturing to ensure compliance with quality and regulatory requirements.
Recent studies have shown that intranasal foralumab can activate regulatory T cells that cross the blood-brain barrier, reducing neuroinflammation in conditions like Alzheimer's disease and multiple sclerosis. This collaboration represents a strategic step toward clinical development and potential commercialization of the treatment.
Tiziana Life Sciences (TLSA) has announced the dosing of four additional patients in its Intermediate Size Patient Population Expanded Access (ISPPEA) program for non-active secondary progressive multiple sclerosis (na-SPMS). The program now includes 14 patients total, with the first 10 patients showing either improvement or disease stability within 6 months of treatment initiation.
The expanded access program utilizes intranasal foralumab, the company's lead development candidate and a fully human, anti-CD3 monoclonal antibody. This program specifically targets patients who don't qualify for the ongoing Phase 2a clinical trial (NCT06292923), providing access to this investigational therapy for those who might not otherwise receive it.
Tiziana Life Sciences (NASDAQ: TLSA) announced a TV feature highlighting their first patient treated with intranasal foralumab for moderate Alzheimer's disease through their expanded access program. The segment showcased Joe and his wife Karen sharing their experience with the treatment.
Foralumab is a fully human anti-CD3 monoclonal antibody administered intranasally, targeting immune system dysregulation in Alzheimer's disease. The treatment aims to reduce inflammation by modulating microglial activation, a critical component in neurodegenerative diseases. The therapy works by inducing Tregs that travel to the brain to modulate neuroinflammation, an approach that has shown efficacy in animal models and MS patients.
This expanded access program allows patients without clinical trial access to receive the treatment through compassionate use. The therapy represents a potential complementary approach to existing anti-amyloid treatments, addressing neuroinflammation in Alzheimer's disease.
Tiziana Life Sciences (NASDAQ: TLSA) announced positive results from studies using nasal anti-CD3 monoclonal antibody in treating traumatic spinal cord injury (SCI). The preclinical model demonstrated notable improvements in motor functions after treatment with nasal anti-CD3.
The research showed the treatment's effectiveness in modulating microglial inflammation associated with SCI and dampening microglial activation. This advancement is significant given that approximately 300,000 individuals live with SCI in the U.S., with over 17,000 new cases annually.
The company is expanding its nasal foralumab technology from applications in neurologic diseases like secondary progressive multiple sclerosis to include spinal cord injury treatment, addressing a significant unmet medical need.
Tiziana Life Sciences (Nasdaq: TLSA) has announced its decision not to engage in capital raising activities in the immediate future. This announcement follows the company's recent discovery of new immune biomarkers in patients with non-active secondary progressive multiple sclerosis (na-SPMS) treated with nasal foralumab, their lead development candidate. Foralumab is a fully human, anti-CD3 monoclonal antibody being developed as an intranasal immunomodulation therapy. The company's management emphasized their commitment to delivering shareholder value and advancing their drug candidates through clinical trials and regulatory processes.
Tiziana Life Sciences (NASDAQ: TLSA) has announced the discovery of new immune biomarkers in patients with non-active secondary progressive multiple sclerosis (na-SPMS) treated with nasal foralumab. The findings were observed in their ongoing ISPPEA expanded access program through single-cell RNA sequencing of blood samples taken before, three, and six months after drug administration.
The study identified key gene expression changes in several immune cell types, including FoxP3 T regulatory cells, CD4+ and CD8+ central memory T cells, CD14+ and CD14- monocytes, and Naïve B cells. These changes were associated with a reduction in microglial brain inflammation, as measured by advanced PET scans.
The company's intranasal foralumab, a fully human anti-CD3 monoclonal antibody, is currently in Phase 2 trials. The biomarker discoveries are expected to help monitor treatment efficacy and patient response in future trials.
Tiziana Life Sciences (Nasdaq: TLSA) has announced promising findings regarding its nasal anti-CD3 monoclonal antibody, which mitigates side effects associated with the discontinuation of GLP-1 agonists. These drugs, used for treating metabolic disorders, often lead to side effects like muscle and bone loss, causing patients to stop treatment and lose the benefits of tissue homeostasis. Tiziana's therapy not only enhances the positive effects of semaglutide, a GLP-1 agonist but also sustains these benefits even after discontinuation.
Dr. Howard Weiner highlighted that nasal anti-CD3 provides a novel and non-toxic method for maintaining tissue homeostasis and improving patient outcomes. Researcher Selma Boulenouar PhD, noted that the therapy sustains tissue homeostasis and mitigates inflammation in key organs, including adipose tissue, liver, kidneys, and brain, even on a high-fat diet. The therapy's efficacy is attributed to its ability to induce regulatory T cells, which reduce tissue inflammation.
CEO Ivor Elrifi emphasized that these findings represent a significant advancement in treating metabolic and age-related diseases by maximizing the therapeutic benefits of GLP-1 drugs while minimizing associated risks.