Tiziana Life Sciences, Ltd. has been awarded a $4 million grant from the National Institutes of Health (NIH) to investigate intranasal foralumab (anti-CD3) as a potential treatment for Alzheimer's disease (AD). The grant, awarded by the National Institute on Aging, will support research led by Dr. Howard Weiner at Brigham and Women’s Hospital.
Targeting Neuroinflammation in Alzheimer's
The NIH grant will facilitate the acceleration of ongoing research efforts, including preclinical studies and preparations for clinical trials. The research will focus on the potential of anti-CD3 to modulate immune system activity and reduce neuroinflammation, ultimately aiming to slow the progression of Alzheimer's disease. Tiziana’s anti-CD3 formulation is administered intranasally, binding to the T cell receptor and stimulating T regulatory cells for delivery to the central nervous system.
Expert Commentary
"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," commented Howard L. Weiner, M.D., 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.
Clinical Development Plans
Tiziana anticipates initiating first-in-human clinical trials in Alzheimer’s disease patients using its intranasal anti-CD3 monoclonal antibody in the coming months. This marks a significant step toward potential regulatory approval and commercialization.
Foralumab's Mechanism of Action
Foralumab, a fully human anti-CD3 monoclonal antibody, stimulates T regulatory cells when administered intranasally. In an open-label Expanded Access (EA) Programme, 10 patients with Non-Active Secondary Progressive Multiple Sclerosis (na-SPMS) showed either improvement or disease stabilization within 6 months. The FDA has recently approved enrollment of an additional 20 patients in this EA program. Furthermore, intranasal foralumab is being evaluated in a phase 2a, randomized, double-blind, placebo-controlled, multicenter, dose-ranging trial in patients with non-active secondary progressive multiple sclerosis (NCT06292923).
Broader Implications
Tiziana Life Sciences is exploring the use of anti-CD3 in various autoimmune and inflammatory diseases, building on preclinical data suggesting its potential to alter disease progression in Alzheimer’s by targeting immune pathways involved in neurodegeneration. The company is committed to advancing science to improve the quality of life for patients through immunotherapies.
