Tiziana Life Sciences Files New Patent Application for Combination Therapy of anti-CD3 (Foralumab) with GLP-1 Receptor Agonist for Additional Reduction of Obesity - Associated Inflammation

NEW YORK, Jan. 05, 2024 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies, today announced filing of a new patent application relating to composition and methods for combining GLP-1ra and foralumab, a fully human anti-CD3 antibody, to achieve further reductions in systemic and vascular inflammation associated with Type 2 Diabetes (T2D) and also in a separate population of patients with non T2D obesity.

Effectiveness of GLP-1ra non T2D obesity was recently shown in the >17,600 patient SELECT trial by Novo Nordisk (N Engl J Med 2023; 389:2221-2232(NCT03574597). SELECT showed a 20% reduction of major adverse cardiovascular events (MACE) such as heart attack, stroke, and peripheral vascular disease, with semaglutide. The risk of adverse cardiovascular events could be reduced further by the combination of intranasal foralumab and a GLP-1ra. The patent application describes the potential for foralumab to provide additional risk reduction for heart attack, stroke, and peripheral vascular disease. Foralumab given with GLP-1ra may contribute importantly to further risk reduction in this at-risk patient population.

“The GLP-1ra’s have revolutionized the treatment of obesity and type 2 diabetes. Obesity and type 2 diabetes are associated with inflammation in the liver, adipose and vascular tissue. This inflammation contributes to the pathogenesis of stroke,” commented Howard L. Weiner M.D. from Brigham and Women’s Hospital, a founding member of Mass General Brigham Healthcare System and Professor of Neurology. “Although effective, GLP-1ra’s do not completely mitigate the disease process and are associated with various side effects. Intranasal foralumab, a fully human anti-CD3, has shown efficacy in attenuating inflammation in humans with multiple sclerosis and COVID. Because intranasal foralumab induces regulatory T cells in a physiologic fashion, foralumab has novel anti-inflammatory properties that make it applicable to multiple disease conditions. Furthermore, it has had minimal side effects in both human and animal studies. We have now discovered intranasal anti-CD3’s positive effect in models of diet-induced obesity related to mitigating its complications. Intranasal anti-CD3 therapy also dramatically decreases inflammation and metabolic changes. Thus, we believe it has the potential to be an ideal therapy to be given in combination with the class of GLP-1ra approved drugs.”