Tiziana gets US patent for 'TZLS-501' antibody

Biotechnology company Tiziana Life Sciences announced on Monday that the United States Patent and Trademark Office (USPTO) has granted a patent for methods and use of fully human monoclonal antibody ‘TZLS-501’ that recognised 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 AIM-traded firm said it initially entered into a worldwide exclusive licence from Swiss biotechnology company Novimmune in 2017, with the licence currently maintained with Bristol Myers Squibb.

It said the patent, number 10,759,862, would be published by the USPTO on 1 September, and said the grant was of “particular significance” for the potential treatment of Covid-19, as well as other pulmonary diseases such as acute respiratory distress syndrome (ARDS).

The major distinguishing feature of TZLS-501, the company said, was that it acted via a dual mechanism by both inhibiting IL-6R signaling, as well as depleting circulating levels of IL-6.

That feature made it potentially suitable for treatment of Covid-19 and ARDS.

For example, Covid-19 patients often develop an uncontrolled immune response, or ‘cytokine storm’, resulting in severe damage to the lung tissue, which could lead to respiratory failure.

Tiziana said many studies also indicated excessive levels of IL-6 in the lungs and in the blood of those patients, adding that it was believed that the cytokine storm in lungs was primarily due to excessive levels of IL-6.

Thus, direct inhalation delivery of TZLS-501 to the lungs using a hand-held nebuliser had the potential to deplete circulating levels of IL-6, and inhibit IL-6R signaling, providing immediate relief to Covid-19 patients.

“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,” said chief executive and scientific officer, Dr Kunwar Shailubhai.

“We are expediting the clinical development of TZLS-501, GMP manufacturing, simultaneously developing inhalation delivery directly to the lungs using a nebuliser and conducting the inhalation safety toxicology studies in Cynomolgus monkeys.”

Dr Shailubhai said completion of those studies would enable the firm to file an investigational new drug application, and initiate a clinical trial in Covid-19 patients by the first quarter of 2021.

“Subsequently, we plan to use TZLS-501 with the same inhalation delivery technology for the treatment of patients with ARDS.”

At 1223 BST, shares in Tiziana Life Sciences were up 4.29% at 156.44p.