Tiziana Life Sciences announced that the U.S. Department of Defense (DoD) has awarded a research grant to study the use of intranasal anti-CD3 therapy in traumatic spinal cord injury (SCI). This funding builds on Tiziana’s strategy to expand the therapeutic potential of its intranasal anti-CD3 platform beyond autoimmune and neuroinflammatory diseases into large, underserved neurological indications.
The DoD award will support a three-year study of intranasal anti-CD3 in the acute phase of SCI, aimed at patients who present to the hospital immediately following injury. Complementing this, a two-year Stepping Strong Breakthrough Award will expand research into the chronic phase, focusing on patients living with persistent neurological deficits.
Traumatic SCI is a major unmet medical need, with nearly 300,000 Americans living with permanent disability and more than 17,000 new injuries annually. Current standard of care remains supportive, with no approved therapies that improve neurological recovery or prevent the chronic complications caused by persistent spinal cord inflammation. The Company believes this represents a significant commercial opportunity in a market with high disease burden and no disease-modifying treatments.
Researchers in the Immunology of CNS Injury Program at Brigham and Women’s Hospital, a founding member of Mass General Brigham, have previously reported promising preclinical results using intranasal anti-CD3 demonstrating benefits in motor outcomes, suggesting potential to improve independence and quality of life. This non-invasive therapy, delivered through the nose—avoiding surgery or infusions, is designed to rebalance the immune system, reduce microglial-driven inflammation in the injured spinal cord, and support functional recovery. The same mechanism may be relevant in other acute CNS injuries.
“SCI is not a one-time event—it is a chronic inflammatory disease. Our findings suggest that intranasal anti-CD3 could change the trajectory of injury by addressing the immune cascade that continues to damage the spinal cord long after the initial trauma,” commented Saef Izzy, MD, FNCS, FAAN, Critical Care Neurologist at Mass General Brigham, and head of the program. “With support from the Department of Defense and Stepping Strong, we are moving from discovery to translation. Our goal is to build the data needed to bring a safe, practical therapy to people living with spinal cord injury.”
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