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Highlights
- Tiziana Life Sciences identifies new immune biomarkers in MS patients treated with foralumab.
- The discovery paves the way for monitoring patient response to the novel therapy.
- New findings boost investor confidence, resulting in a 19% after-hours spike.
Tiziana Life Sciences Ltd (NASDAQ:TLSA) has made significant strides in the field of multiple sclerosis (MS) treatment, revealing the discovery of new immune biomarkers in patients with non-active secondary progressive multiple sclerosis (na-SPMS). These patients were treated with Tiziana’s novel therapy, nasal foralumab. The findings are part of an ongoing Expanded Access Program (ISPPEA), in which patients have shown promise in their responses to the intranasal treatment. This discovery could mark a critical milestone in monitoring and understanding how foralumab works in the body.
The breakthrough comes from an analysis that observed changes in gene expression three months after patients were administered intranasal foralumab. Among the key immune biomarkers discovered were the modulation of FoxP3 T regulatory cells, central memory T cells, and monocytes. These biomarkers are tied to immune processes that play a central role in regulating antigen presentation and interferon responses. Essentially, they offer deep insights into how the body’s immune system reacts to the treatment, further demonstrating the drug’s potential in targeting key immune mechanisms in MS.
Employing advanced technologies like single-cell RNA sequencing, Tiziana's research team tracked the gene expression changes occurring after three and six months of treatment. This process closely correlated with observable improvements in the patients’ conditions, including reduced brain inflammation. Such positive results were confirmed through microglial PET scans, which highlight reduced brain activity typically linked to inflammation. These biomarkers not only indicate that the therapy is making a biological impact but may also serve as a foundation for future clinical trials and clinical monitoring of patients receiving foralumab.
Dr. Howard Weiner, Chairman of Tiziana’s Scientific Advisory Board, highlighted the findings’ importance in understanding foralumab’s biological effects and enhancing treatment monitoring. "This discovery offers new ways to track a patient’s response to the treatment, strengthening the overall evidence supporting its clinical effects," he stated.
Tiziana Life Sciences CEO, Ivor Elrifi, also expressed confidence in the data, emphasizing that the promising findings offer further validation of foralumab’s potential as an innovative immunomodulatory therapy. As the first fully human anti-CD3 monoclonal antibody, foralumab continues to show promise not only in MS but in a range of other autoimmune and neurodegenerative diseases.
These new biomarker discoveries resonated positively with investors, as shares of Tiziana Life Sciences soared as much as 19% after the announcement. This provides a substantial boost to the company's prospects as it moves forward with its clinical exploration.
