Biotechnology company Tiziana Life Sciences has announced that it will present pre-clinical data on the effects of intranasal anti-CD3 monoclonal antibody in an animal model of intracerebral hemorrhage (hemorrhagic stroke) at the Annual American Academy of Neurology (AAN) conference in Boston, Massachusetts. Dr. Saef Izzy, neurocritical care faculty at Brigham and Women’s Hospital and a founding member of Mass General Brigham healthcare system, will present the data on April 23, 2023.
The data shows that intranasal foralumab, the first-ever fully human anti-CD3 monoclonal antibody, has the potential to treat intracerebral hemorrhage, a condition where the vast majority of patients do not fully recover. One-month behavioral outcomes improved in the model of intracerebral hemorrhage, suggesting that anti-CD3 neuroimmunomodulation effects Tregs which may lead to positive motor and cognitive outcomes. The modulation of neuroinflammation by inducing FoxP3 Tregs appears to have a beneficial effect in intracerebral hemorrhage.
Intranasal foralumab is expected to start Phase 2 trials in the third quarter of 2023 in patients with non-active SPMS. The drug binds to the T cell receptor and dampens inflammation by modulating T cell function, suppressing effector features in multiple immune cell subsets. This effect has been demonstrated in patients with COVID and with multiple sclerosis, as well as in healthy normal subjects.
Dr. Izzy’s research also demonstrated that nasal anti-CD3 increased FoxP3 Tregs and IL-10-producing FoxP3 Tregs in the brain. This finding aligns with Tiziana’s previous work in other inflammatory neurological diseases such as multiple sclerosis. Howard L. Weiner, Co-Director of the Ann Romney Center for Neurologic Diseases at Brigham and Women’s Hospital and Chairman of Tiziana’s Scientific Advisory Board, said that Dr. Izzy’s research shows the importance of inducing regulatory T cells in decreasing microglia activation, modulating neuroinflammatory response in the brain, and improving neurological recovery.
Matthew W. Davis, Chief Medical Officer of Tiziana, said that based on Dr. Izzy’s research, the company plans to explore further studies to develop intranasal foralumab for this devastating condition. The drug’s technology for alternative routes of immunotherapy has been patented with several applications pending and is expected to allow for broad pipeline applications.
The AAN conference is a prestigious event, and Dr. Izzy’s abstract has been assigned the number 010. The presentation will be webcast until May 14, 2023, and the link can be found on the AAN’s website. Inquiries about Tiziana Life Sciences can be made to the company’s business development and investor relations manager, Paul Spencer. Investors may also contact Irina Koffler of LifeSci Advisors.
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