Tiziana Life Sciences has discovered new immune biomarkers in patients with non-active secondary progressive multiple sclerosis (na-SPMS) treated with their lead candidate, intranasal foralumab, a fully human anti-CD3 monoclonal antibody. The biomarkers, identified through single-cell RNA sequencing, indicate modulation of T regulatory cells, central memory T cells, monocytes, and B cells – pathways associated with antigen presentation, interferon responses, and other immune regulatory mechanisms. This discovery stems from Tiziana’s ongoing expanded access program (ISPPEA) and correlates with previously observed reductions in microglial brain inflammation in the same patient group.
This biomarker discovery is crucial for advancing the treatment of na-SPMS. It provides mechanistic insight into the clinical effects observed with nasal foralumab, potentially paving the way for personalized MS treatment strategies. Confirming the drug’s biological activity strengthens its position as a promising therapeutic option in a disease area with significant unmet medical need. This offers hope for patients who have historically had limited treatment choices.
The study involved single-cell RNA sequencing of peripheral blood samples collected before treatment and at three and six-month intervals after nasal foralumab administration. The identified gene expression changes, correlating with reduced brain inflammation, provide concrete evidence of foralumab’s immunomodulatory effects. These findings are being prepared for submission to a peer-reviewed journal. Foralumab is currently being investigated in a Phase 2a trial for na-SPMS and an expanded access program now enrolling up to 30 patients.
This biomarker discovery is a significant step forward for Tiziana and the development of foralumab. It strengthens the scientific rationale behind its clinical development, potentially accelerating its path towards regulatory approval and ultimately providing a much-needed treatment option for na-SPMS patients. It also positions foralumab as a potential therapeutic agent for other autoimmune and neurodegenerative diseases, broadening the company’s pipeline and market opportunities.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
