TZLS-501 / Light Chain Biosci, Tiziana Life Sci - LARVOL DELTA

Tiziana Life Sciences plc - Interim Results for the Six Months Ended 30 June 2021 (GlobeNewswire) - "Working with Sciarra Laboratories to evaluate two hand-held nebulizer devices for use in the study and characterizing physical/performance characteristics. Once a device has been selected, a few candidate formulations of anti-IL6R mAb, from formulation development studies at STC Biologics, will be manufactured at small scale and evaluated using the devices; Engaged ITR Laboratories in Canada to complete inhalation safety toxicology studies in Cynomolgous monkeys using the purified, characterized anti-IL6R mAb test item. Results from the study will be used to establish dosing for a Phase 1 study in healthy volunteers. Additional parenteral administration safety toxicology studies are in progress at ITR Laboratories to support clinical studies for treatment of autoimmune and inflammatory diseases."

Preclinical • Immunology

Tiziana Granted a Patent on Methods and Use of Anti-IL-6/IL-6 receptor Monoclonal Antibodies as Prophylactic and Therapeutic Interventions for COVID-19 and other pulmonary diseases (Finanznachrichten.de) - "'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..."

Media quote

Tiziana Life Sciences Announces Agreement with STC Biologics for GMP Manufacturing of an anti-Interleukin-6-Receptor Monoclonal Antibody for Clinical Studies in Patients with COVID-19 (GlobeNewswire) - "Tiziana Life Sciences plc...today announces the execution of an agreement with STC Biologics, Inc. ('STC') for GMP manufacturing of TZLS-501...currently in agreement with Bristol Myers Squibb (BMS). Tiziana is simultaneously developing an inhalation technology, in collaboration with Sciarra Laboratories, for the direct delivery of TZLS-501 into the lungs using a handheld inhaler or nebulizer for treatment of patients with COVID-19....'Our objective is to submit an Investigational New Drug (IND) Application in the first quarter of 2021 for the treatment of COVID-19 patients,' said Kunwar Shailubhai, Ph.D..."

Commercial • Cytokine storm • IND • Licensing / partnership • Media quote • Infectious Disease • Novel Coronavirus Disease

Tiziana Lifesciences develops novel investigational treatment for patients infected with Covid-19 utilizing direct delivery of anti-interlukin-6-receptor monoclonal antibodies (GlobeNewswire) - "Tiziana Life Sciences plc...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 has submitted a provisional patent application for the delivery technology."

Patent

Tiziana Life Sciences CEO explains how its potential coronavirus fighting antibody is unique (Proactiveinvestors) - "Dr Shailubhai says dual mechanism of action to inhibit signalling by the membrane-bound and soluble IL-6 receptors along with the rapid depletion of circulating IL-6 cytokine make its antibody unique. The company recently raised gross proceeds of approximately $10 million to help fund development efforts."

Video

Tiziana announces closing of offering and resulting total voting rights (Yahoo Finance) - "Tiziana intends to use the net proceeds received from this Offering (i) to advance the clinical development of Foralumab, (ii) to expedite clinical development of TZLS-501 for coronavirus COVID-19, and (iii) for working capital and other general corporate purposes."

Financing

Tiziana Life Sciences developing TZLS-501 as a potential treatment for coronavirus patients (PRNewswire) - "Tiziana Life Sciences plc...today announced that its TZLS-501 treatment could be a potential treatment for patients infected with coronavirus (COVID-19) who are at risk of respiratory failure....Tiziana plans to administer TZLS-501 using a proprietary formulation technology....'We are excited to move forward with our clinical development plan to expedite evaluation in patients as soon as possible'."

Clinical