Tiziana Wins Patent Approval For TZLS-501 Potential Covid-19 Treatment
Biotech Tiziana Life Sciences (TLSA) has 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 recognizes 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 patent (No. 10,759,862) will be published by the USPTO on September 1, 2020. This additional patent on TZLS-501 is significant for the potential treatment of COVID-19 and other pulmonary diseases such as acute respiratory distress syndrome (ARDS), TLSA stated.
“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” commented Dr. Kunwar Shailubhai, CEO & CSO of Tiziana.
“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” he continued.
The major distinguishing feature of TZLS-501 is that it acts via a dual mechanism by not only inhibiting IL-6R signaling 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 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.
As a result, direct inhalation delivery of TZLS-501 to the lungs has the potential to deplete circulating levels of IL-6 and inhibit IL-6R signaling, providing immediate relief to COVID-19 patients, says the company.
Year-to-date the stock has rallied an incredible 260%- and HC Wainwright analyst Ram Selvaraju is bullish on Tiziana’s outlook. He notes that Tiziana has signed a manufacturing agreement for TZLS-501, and is developing an inhalation technology approach 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.
“The proprietary novel technology to administer TZLS-501 directly into the nasal passages or lungs by inhaler or nebulizer has potentially significant clinical advantages for the treatment of COVID-19 patients” Selvaraju told investors.
The analyst recently reiterated a buy rating on the stock with a $10 price target. This indicates shares can surge a further 156% from current levels.
Tiziana initially entered into a world-wide exclusive license from Novimmune, SA for TZLS-501 in 2017, and the license is currently maintained with Bristol Myers Squibb.
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