Tiziana Life Sciences, Ltd. (TLSA), a biotechnology company developing immunomodulatory therapies, on Thursday, reported the discovery of new immune biomarkers from its ongoing study of lead investigational product, intranasal Foralumab, in patients with non-active secondary progressive multiple sclerosis or na-SPMS.
The company expects to continue evaluating the data and plans to submit these findings to a peer-reviewed journal.
The study is part of Tiziana's expanded access program or ISPPEA and has identified important gene expression changes in immune pathways after three months of treatment with nasal foralumab.
Key findings include:
-- Modulation of FoxP3 T regulatory cells or Tregs, central memory T cells or CD4+ and CD8+, monocytes or CD14+ and CD14-, and naïve B cells, which are known to be linked to immune regulation and antigen presentation.
-- The biomarker changes correlate with clinical improvements, including stabilization of the disease and reduced microglial brain inflammation as shown by advanced microglial PET scans.
These discoveries provide new insights into the mechanism of action of nasal foralumab and its potential in treating SPMS.
Tiziana Life Sciences remains committed to advancing the development of this novel therapy, which is currently in a Phase 2a trial for na-SPMS.
Foralumab, the first fully human anti-CD3 monoclonal antibody in clinical development, is also being studied for its broader potential in treating neurodegenerative and autoimmune diseases.
TLSA closed Wednesday's (Jan.22 2025) trading at $0.79 up 8.51%. In premarket trading Thursday, the stock is down 5.89% at $0.75.
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