Tiziana Life Sciences plc to expedite development of TZLS-501 for COVID-19

New York/London: Tiziana Life Sciences plc, a biotechnology company focused on innovative therapeutics for inflammatory and autoimmune diseases, has announced that it is expediting the development of TZLS-501, a novel, fully human anti-interleukin-6 receptor (anti-IL6R) monoclonal antibody (mAb) for treatment of patients infected with coronavirus COVID-19 (SARS-CoV-2). Tiziana plans to administer TZLS-501 using a proprietary formulation technology. The Company entered into a worldwide license for composition-of-matter of TZLS-501, a fully human mAb targeting IL-6R, with Novimmune, SA, a Swiss biotechnology company in 2017.

Certain patients infected with coronavirus COVID-19 may develop an uncontrolled immune response resulting in severe damage to lung tissue which could lead to respiratory failure. Early clinical studies conducted by doctors in China suggest that anti-IL6R mAbs may be used in clinical practice for the treatment of COVID-19. Consequently, China'sNational Health Commission has recommended the use of Roche's blockbuster drug, Actemra® for treatment of patients infected with COVID-19, with serious lung damage and elevated IL-6 levels. Actemra was first approved by the FDA in 2010 for rheumatoid arthritis. Besides Actemra®, Sanofi and Regeneron are currently exploring Kevzara®, an FDA-approved anti-IL-6 receptor therapy for rheumatoid arthritis, for treatment of severe COVID-19.

Tiziana's anti-IL-6R mAb binds to both the membrane-bound and soluble forms of IL-6R and rapidly depletes circulating levels of IL-6 in the blood. Excessive production of IL-6 is regarded as a key driver of chronic inflammation and is believed to be associated with severe lung damage observed with COVID-19 infections and acute respiratory illness. A recent Chinese study also reported that COVID-19 infection caused clusters of severe respiratory illness such as severe acute respiratory distress syndrome (ARDS).

"We believe that the features of TZLS-501 consisting of its dual mechanism of action to inhibit signalling by the membrane-bound and soluble IL-6 receptors along with rapid depletion of circulating IL-6 cytokine, a major cause of lung damage, provides TZLS-501 with distinct advantages for treatment of COVID-19 over other anti-IL-6R mAbs such as Actemra® and Kevzara® for treatment of COVID-19. The recent decision by researchers in China to add Actemra® to treatment guidelines for coronavirus patients with serious lung damage confirms the utility of anti-IL6R mAb. We are excited to move forward with our clinical development plan to expedite evaluation in patients as soon as possible", said Dr Kunwar Shailubhai, CEO & CSO of Tiziana Life Sciences.

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