Tiziana Life Sciences announced that the United States Patent and Trademark Office (USPTO) has granted a patent for methods and use of fully human monoclonal antibody (mAb; TZLS-501) that recognises both IL-6 receptor (IL-6R) and IL-6 receptor complex with IL-6 (IL-6R/IL-6) for prophylactic and therapeutic intervention for human diseases. The Company initially entered into a world-wide exclusive license from Novimmune, a Swiss Biotechnology company in 2017. The license is currently maintained with Bristol Myers Squibb. The patent (No. 10,759,862) will be published by the USPTO on September 1, 2020. The grant of this additional patent on TZLS-501 is of particular significance for the potential treatment of COVID-19 and other pulmonary diseases such as acute respiratory distress syndrome (ARDS).

“TZLS-501 acts via a dual mechanism by not only inhibiting IL-6R signalling but also depleting circulating levels of IL-6. This distinctive feature of TZLS-501, a fully human anti-IL-6R mAb, makes it potentially suitable for the treatment of COVID-19 and ARDS.  For example, COVID-19 patients often develop an uncontrolled immune response (cytokine storm) resulting in severe damage to the lung tissue which could lead to respiratory failure. Many studies have also indicated excessive levels of IL-6 in the lungs and in the blood of these patients, and it is believed that the cytokine storm in lungs is primarily due to excessive levels of IL-6. Hence, direct inhalation delivery of TZLS-501 to the lungs using a hand-held nebulizer has the potential to deplete circulating levels of IL-6 and inhibit IL-6R signalling thus providing immediate relief to COVID-19 patients,” informed the company through a statement.

“The granting of this patent along with our previously filed patent application on inhalation delivery of anti-IL-6 mAbs strengthens our intellectual property for the treatment of lung diseases. We are expediting the clinical development of TZLS-501, GMP manufacturing, simultaneously developing inhalation delivery directly to the lungs using a nebulizer and conducting the inhalation safety toxicology studies in Cynomolgus monkeys. Completion of these studies will enable us to file an IND and initiate a clinical trial in COVID-19 patients by Q1 2021. Subsequently, we plan to use TZLS-501 with the same inhalation delivery technology for the treatment of patients with ARDS”, added Dr Kunwar Shailubhai, CEO & CSO of Tiziana.

The person who arranged for the release of this announcement on behalf of the Company was Dr Kunwar Shailubhai, CEO & CSO of Tiziana.