Tiziana Life Sciences Announces $4-Million Grant to Study Anti-CD3 in Alzheimer’s Disease

Tiziana Life Sciences, Ltd. recently announced the National Institutes of Health (NIH), National Institute on Aging have awarded a $4-million grant to Dr. Howard Weiner as principal investigator at Brigham and Women’s Hospital to be the key research site, to study nasal anti-CD3 for the treatment of Alzheimer’s disease (AD). This significant grant will fund a key research study over the next several years, advancing preclinical and ultimately, clinical studies of intranasal anti-CD3 as a potential treatment for this devastating neurodegenerative condition.

“Alzheimer’s disease is the most common form of dementia, affecting more than 6 million people in the United States alone. Despite extensive research, effective treatments remain limited, and the need for innovative therapeutic approaches is urgent,” said Howard L. Weiner, MD, Principal Investigator, Chairman of Tiziana’s Scientific Advisory Board and co-director of the Ann Romney Center for Neurologic Diseases at Brigham and Women’s Hospital, a founding member of Mass General Brigham healthcare system.

The NIH grant will allow the acceleration of ongoing research efforts, including the advancement of preclinical studies and preparations for clinical trials. Specifically, the research will focus on the potential of anti-CD3 to modulate immune system activity, reduce neuroinflammation, and ultimately slow the progression of Alzheimer’s disease. The company’s proprietary formulation of anti-CD3 is administered intranasally where it binds to the T cell receptor, which then stimulates T regulatory cells for delivery to the central nervous system.

Ivor Elrifi, CEO of Tiziana Life Sciences, added “We are thrilled to be able to progress our pipeline with this prestigious NIH grant, which underscores the potential of our anti-CD3 therapy to address a critical unmet need in Alzheimer’s disease. This funding will enable us to expand our research and move one step closer to developing a new therapeutic option for patients and families impacted by this debilitating condition. At Tiziana, we remain committed to advancing science that could improve the quality of life for patients through groundbreaking immunotherapies.”

The NIH grant represents a major milestone in Tiziana’s development pipeline and is part of the company’s broader strategy to explore the use of anti-CD3 in a range of autoimmune and inflammatory diseases. Tiziana’s team of scientists and clinical researchers are eager to build upon promising preclinical data that suggest anti-CD3 has the potential to alter disease progression in Alzheimer’s by targeting immune pathways involved in neurodegeneration.

The company expects to initiate first-in-human clinical trials in Alzheimer’s Disease patients using its intranasal anti-CD3 monoclonal antibody in the coming months, marking an important step toward regulatory approval and commercialization.

Foralumab, a fully human anti-CD3 monoclonal antibody, is a biological drug candidate that has been shown to stimulate T regulatory cells when dosed intranasally. At present, 10 patients with Non-Active Secondary Progressive Multiple Sclerosis (na-SPMS) have been dosed in an open-label intermediate sized Expanded Access (EA) Program with either an improvement or stability of disease seen within 6 months in all patients. The FDA has recently allowed an additional 20 patients to be enrolled in this EA program. In addition, intranasal foralumab is currently being studied in a Phase 2a, randomized, double-blind, placebo-controlled, multicenter, dose-ranging trial in patients with non-active secondary progressive multiple sclerosis (NCT06292923).

Activated T cells play an important role in the inflammatory process. Foralumab, the only fully human anti-CD3 monoclonal antibody (mAb) currently in clinical development, binds to the T cell receptor and dampens inflammation by modulating T cell function, thereby suppressing effector features in multiple immune cell subsets. This effect has been observed in patients with COVID and with multiple sclerosis, as well as in healthy normal subjects. The non-active SPMS intranasal foralumab Phase 2 trial (NCT06292923) began screening patients in November of 2023. Immunomodulation by nasal anti-CD3 mAb represents a novel avenue for treatment of neuroinflammatory and neurodegenerative human diseases.

Tiziana Life Sciences is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy. Tiziana’s innovative nasal approach has the potential to provide an improvement in efficacy as well as safety and tolerability compared to intravenous (IV) delivery. Tiziana’s lead candidate, intranasal foralumab, which is the only fully human anti-CD3 mAb currently in clinical development, has demonstrated a favorable safety profile and clinical response in patients in studies to date. Tiziana’s technology for alternative routes of immunotherapy has been patented with several applications pending and is expected to allow for broad pipeline applications. For more information, visit www.tizianalifesciences.com.