Tiziana Life Sciences announced it will advance development of TZLS-501, a fully human anti-IL-6 receptor monoclonal antibody, capitalizing on heightened industry activity in the IL-6 pathway space following Novartis' recent $1.4 billion acquisition of Tourmaline Bio. The clinical-stage biopharmaceutical company plans to pursue non-dilutive funding strategies for TZLS-501 while continuing to advance its lead program, intranasal foralumab.
Dual Mechanism Targeting IL-6 Pathway
TZLS-501 represents a fully human anti-IL-6 receptor monoclonal antibody targeting both membrane-bound and soluble forms of IL-6R. This dual mechanism of action blocks IL-6R signaling while simultaneously reducing circulating IL-6 cytokines, which are recognized drivers of inflammation, lung damage, and chronic fibrosis. The antibody was licensed from Novimmune, SA, in Geneva in 2017.
The therapeutic approach addresses IL-6's role as a cytokine that binds to its receptor subunit IL-6Rα on cell membranes, serving as a major determinant in priming pathogenic T cells to produce inflammatory responses. The receptor IL-6Rα can be shed in soluble form (sIL6Rα), which binds to circulating IL-6 cytokine in the blood, with downstream signaling from this complex mediating pro-inflammatory effects underlying inflammatory diseases.
Broad Therapeutic Potential Across Multiple Indications
Excessive IL-6 signaling plays a central role in multiple diseases, including rheumatoid arthritis, acute respiratory distress syndrome, idiopathic pulmonary fibrosis, systemic lupus erythematosus, and various cancers. By reducing both receptor-mediated signaling and circulating cytokine burden, TZLS-501 may offer therapeutic advantages in managing these acute and chronic inflammatory conditions.
Tiziana sees potential to develop TZLS-501 as a monotherapy or in combination with its lead candidate foralumab, as well as with other anti-inflammatory and anti-infective agents. This flexibility positions the antibody as a potentially versatile therapeutic option across multiple inflammatory disease areas.
Strategic Timing Following Market Validation
"Novartis' recent acquisition of Tourmaline demonstrates how IL-6 therapy is increasingly valued in treating systemic inflammation and related diseases," commented Ivor Elrifi, Chief Executive Officer of Tiziana Life Sciences. "While intranasal foralumab remains our lead program and primary focus, we are reviewing development opportunities for TZLS-501 as a complementary asset."
Elrifi emphasized the unique positioning of TZLS-501, stating, "Its unique ability to address both membrane-bound and soluble IL-6 signaling, positions it as a potentially powerful therapy for acute and chronic inflammatory conditions." The company views the recent market developments as creating an opportune time to explore TZLS-501's development potential.
Maintaining Focus on Lead Program
While advancing TZLS-501, Tiziana will not divert resources or focus from ongoing clinical trials with foralumab, its fully human anti-CD3 monoclonal antibody for multiple sclerosis. Foralumab has shown promising results in 14 patients with non-active secondary progressive multiple sclerosis in an open-label Expanded Access Program, with either improvement or stability of disease seen within 6 months in all patients.
The company is currently conducting a Phase 2a, randomized, double-blind, placebo-controlled, multicenter, dose-ranging trial of intranasal foralumab in patients with non-active secondary progressive multiple sclerosis. Foralumab represents the only fully human anti-CD3 monoclonal antibody currently in clinical development, utilizing Tiziana's innovative nasal delivery approach.
