Tiziana Lifesciences Develops Novel Investigational Treatment For Patients Infected with COVID-19 Utilizing Direct Delivery of Anti-Interlukin-6-Receptor Monoclonal Antibodies

Company Has Filed Patent Application in Support of Treatment of COVID-19 Utilizing Anti-IL6R Via Inhaled Delivery

NEW YORK and LONDON, April 09, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company focused on innovative therapeutics for inflammatory and autoimmune diseases, announced today that it has developed investigational new technology to treat COVID-19 infections, which consists of direct delivery of anti-IL-6 receptor (anti-IL-6R) monoclonal antibodies (mAbs) into the lungs using a handheld inhaler or nebulizer. Development of this novel technology is a step forward toward expediting  development of  TZLS-501, a fully-human anti-interleukin-6 receptor (anti-IL6R) monoclonal antibody (mAb) for treatment of patients infected with COVID-19 (SARS-CoV-2) coronavirus.  The Company believes the technology could also be applicable for use with other FDA approved mAbs and drugs.  The Company has submitted a provisional patent application for the delivery technology.

“Direct delivery of anti-IL-6R mAb to the lungs using a portable handheld inhaler or nebulizer is a rapid and immediate therapy for children and adults infected with COVID-19.  Importantly, this treatment with our fully human anti-IL-6R mAb (TZLS-501) has the potential to be a long-term therapy to halt progression and reduce mortality in patients with COVID-19, as a portion of the population may not opt to utilize a vaccine,” said Gabriele Cerrone, Chairman of Tiziana Lifesciences.  

Patients infected with COVID-19 are known to develop an uncontrolled immune response (“cytokine storm”), which results in excessive production of pro-inflammatory cytokines and other proteins such as interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-a) and Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF), which in turn causes severe damage to lung tissue resulting in respiratory failure and eventually death. Among these cytokines, IL-6 seems to be one of the major culprits underlying coronavirus-mediated respiratory failure. Early clinical studies conducted by doctors in China suggest that anti-IL6R mAbs may be used in clinical practice for treatment of COVID-19.  Consequently, China’s National Health Commission has recommended the use of Roche’s blockbuster drug, Actemra and Sanofi’s Kevzera for treatment of patients infected with COVID-19.