Tiziana develops novel treatment for COVID-19 patients using anti-interleukin-6-receptor mAbs

Company has filed patent application in support of treatment of COVID-19 utilizing anti-il6r via inhaled delivery

Tiziana Life Sciences, a biotechnology company focused on innovative therapeutics for inflammatory and autoimmune diseases, 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 nebuliser.

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 nebuliser 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 utilise a vaccine,” said Gabriele Cerrone, Chair 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), tumour 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 to treat 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.

Excessive production of IL-6 is regarded as a key driver of chronic inflammation and is believed to be associated with the severe lung damage commonly observed with COVID-19 infections and acute respiratory distress syndrome (ARDS).

Tiziana believes TZLS-501 (anti-IL6R) combined with this newly introduced inhalation technology may rapidly inhibit inflammation in lungs and in combination with intravenous administration may deplete circulating levels of IL-6 and potentially halt progression of COVID-19-mediated lung damage and death.

“The filing of this comprehensive provisional patent application covering treatment with our anti-IL-6R mAb, as well as prophylactic intervention with a vaccine candidate, designed from Spike (S) protein of COVID-19, is an important step in finding a solution to the current pandemic."

"We look forward to providing updates on the development of this product candidate and its introduction into clinical trials in a real-world setting,” said Dr Kunwar Shailubhai, CEO & CSO of Tiziana Life Sciences.