Tiziana Life Sciences is making strides in the development of foralumab, a fully human anti-CD3 monoclonal antibody, as a potential treatment for multiple sclerosis (MS) and spinal cord injury (SCI). Recent developments include the expansion of a Phase 2 clinical trial for non-active secondary progressive MS (na-SPMS), the discovery of new immune biomarkers associated with foralumab treatment, and positive preclinical results in SCI models.
Phase 2 Trial Expansion for na-SPMS
Tiziana Life Sciences has broadened its Phase 2 clinical trial evaluating intranasal foralumab for na-SPMS, a condition with no FDA-approved therapeutic options. The trial now includes Yale University, Johns Hopkins University, Cornell University, University at Buffalo, University of Massachusetts, and Thomas Jefferson University. This strategic expansion to the Northeast allows for centralized PET scans at Invicro in New Haven, Connecticut, minimizing scan variability.
Ivor Elrifi, CEO of Tiziana Life Sciences, stated, "We are honored to collaborate with these prestigious institutions as we further expand our clinical trial. This milestone demonstrates our dedication to advancing innovative treatments for patients living with SPMS and underscores the potential of our platform to address complex neurodegenerative diseases."
The Phase 2a trial (NCT06292923) is a randomized, double-blind, placebo-controlled, multicenter, dose-ranging study. It aims to enroll 54 MS patients experiencing continuous disease progression despite available therapies. Participants receive either 50 mcg or 100 mcg of foralumab, or a placebo, administered intranasally in three-week cycles.
Discovery of New Immune Biomarkers
In January 2025, Tiziana Life Sciences announced the discovery of new immune biomarkers in na-SPMS patients treated with nasal foralumab. The study identified gene expression changes detected three months after intranasal dosing, including modulation of:
- FoxP3 T regulatory cells (Tregs)
- CD4+ and CD8+ central memory T cells
- CD14+ and CD14- monocytes
- Naïve B cells
These pathways are associated with antigen presentation, interferon responses, and other regulatory immune mechanisms. Single-cell RNA sequencing (scRNAseq) of peripheral blood samples revealed relevant gene expression changes associated with nasal foralumab, which correlated with a reduction in microglial brain inflammation, as measured by advanced microglial PET scans.
Dr. Tanuja Chitnis, Principal Investigator and Professor of Neurology at Harvard Medical School, commented, "These findings highlight the potential of nasal foralumab in modulating critical immune pathways and offer new insights into its clinical effects. This discovery represents a pivotal step toward personalized treatment strategies for MS."
Positive Preclinical Results in Spinal Cord Injury
Preclinical studies using a nasal anti-CD3 monoclonal antibody, foralumab, in traumatic spinal cord injury (SCI) models have shown promising results. The studies demonstrated that treatment with nasal anti-CD3 led to notable advancements in motor functions. Spinal cord injury is a devastating global health issue, and the inflammatory response mediated by microglia is a critical component in its pathogenesis.
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."
Expanded Access Program
Tiziana Life Sciences has also announced the dosing of additional patients in its Intermediate Size Patient Population Expanded Access (ISPPEA) program for na-SPMS patients who do not qualify for the ongoing Phase 2a study. To date, 14 patients have been enrolled in the expanded access program, with the first 10 patients showing either an improvement or stability of disease within 6 months of starting treatment.
Foralumab, administered intranasally, has shown a favorable safety profile and clinical response in studies to date. It is the only fully human anti-CD3 mAb currently in clinical development.
With these advancements, Tiziana Life Sciences aims to address the unmet medical needs of patients with neuroinflammatory and neurodegenerative disorders, including MS and SCI.
