An intranasal anti-CD3 monoclonal antibody for the treatment of spinal cord injury (SCI) has shown positive results in new studies.
The inflammatory response from spinal cord injury, mediated by microglia, is a critical component in the progression of SCI.
The treatment – called Foralumab – is a fully human, anti-CD3 monoclonal antibody (an immunosuppressive drug) that has been shown to stimulate T regulatory cells when dosed intranasally.
Activated T cells play an important role in the inflammatory process.
Foralumab binds to the T cell receptor and dampens inflammation by modulating T cell function, thereby suppressing effector features in multiple immune cell subsets.
According to Tiziana, which has developed the treatment, this effect has been observed in patients with Covid and with multiple sclerosis, as well as in healthy normal subjects.
The company suggests that immunomodulation by nasal anti-CD3 mAb represents a novel avenue for treatment of neuroinflammatory and neurodegenerative human diseases.
In these studies, the preclinical model was subjected to a spinal cord injury and then was treated with nasal anti-CD3, resulting in notable advancements in motor functions.
“Our pre-clinical findings underscore the pivotal role of nasal anti-CD3 in modulating microglial inflammation associated with spinal cord injury,” said Dr. Howard Weiner, chairman of Tiziana’s Scientific Advisory Board and co-director of the Ann Romney Center for Neurologic Diseases at Brigham and Women’s Hospital.
Dr. Saef Izzy, associate professor of neurology at Harvard Medical School, commented: “Treatment with nasal anti-CD3 not only dampened microglial activation but also led to marked improvements in motor function among the injured models.
“These results hold promise for a transformative therapeutic approach in SCI.”
CEO of Tiziana Life Sciences, Ivor Elrifi, highlighted the strategic implications: “We are swiftly advancing towards expanding our nasal foralumab technology from successful applications in neurologic diseases like secondary progressive multiple sclerosis to now encompass spinal cord injury.
“This underscores our commitment to pioneering treatments that address significant unmet medical needs.”
The treatment is currently being studied in patients with non-active secondary progressive multiple sclerosis in a Phase 2a trial.
