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Tiziana Announces Publication of a Peer-Reviewed Article on the Intranasal Administration of Foralumab Demonstrating Modulated Effector CD8+ T cell Function and an Induced T Cell Regulatory Response in Human Subjects
Third-party research conducted by leading U.S. academic institutions published in a peer reviewed journal Frontiers in Immunology shows a favorable safety
About this update from Tiziana Life Sciences Ltd
[{"type":"text","content":"Third-party research conducted by leading U.S. academic institutions published in a peer reviewed journal Frontiers in Immunology shows a favorable safety profile for intranasally administered foralumab and immunological activity in humans Finding supports Tiziana’s intranasal foralumab monoclonal antibody platform as a new modality for the treatment of autoimmune and CNS diseasesTiziana’s fully human foralumab is the first anti-CD3 mAb which has not shown an anti-drug antibody (immune reaction) in humans NEW YORK, Nov. 23, 2022 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company enabling breakthrough CNS immunomodulation approaches to enhance the functionality of Treg-based therapies, announces publication of a scientific article in the peer-reviewed journal Frontiers in Immunology entitled “Nasal administration of anti-CD3 monoclonal antibody modulates effector CD8+ T cell function and induces a regulatory response in T cells in human subjects”(1) . The study was completed by researchers at the Brigham and Womens Hospital (BWH) and Harvard Medical School. The goal of the study was to assess safety and the immune effects of an entirely human, previously uncharacterized nasal anti-CD3 mAb (foralumab) in humans and its in vitro stimulatory properties. The findings support Tiziana’s intranasal foralumab platform as a new modality for the treatment of autoimmune and CNS diseases. About the Study The study evaluated 27 healthy volunteers (nine per group) who received either intranasal foralumab at a dose of 10ug, 50ug, or 250ug daily for 5 days or placebo. Safety was assessed and immune parameters were measured on day one (pre-treatment), and days 7, 14, and 30 by Fluorescence-Activated single Cell Sorting (FACS) and by Single-cell RNA sequencings (cRNAseq). No adverse events or safety signals were found when foralumab was dosed at the amounts of 10ug, 50ug and 250ug given for 5 consecutive days. Immunomodulatory effects were predominantly observed at the 50ug dose. At the 50ug dose a reduction of CD8+ effector memory cells, an increase in naive CD8+ and CD4+ T cells, and reduced CD8+ T cell granzyme B and perforin expression were observed. A dose effect with 50ug being more immunomodulatory than 250ug is consistent with previously conducted animal studies of mucosal to...