Tiziana Life Sciences has announced a new agreement with STC Biologics for manufacturing of its TZLS-501 inhaled anti-IL-6 receptor monoclonal antibody. The company said that it is also working with Sciarra Laboratories to develop a nebulizer for delivery of TZLS-501 for the treatment of COVID-19. In addition, Tiziana said that it had submitted a patent application for the delivery of an inhaled anti-IL6R mAb for the treatment of COVID-19.
According to Tiziana, preclinical studies of TZLS-501 suggest that it could be effective in suppressing cytokine storm and that it “is considerably more potent” than Roche’s Actemra anti-IL-6R mAb. The company says that it acquired rights to TZLS-501 from Novimmune in 2017 and that the drug is “currently in agreement with Bristol Myers Squibb.”
Tiziana Life Sciences CEO and Chief Scientific Officer Kunwar Shailubhai commented, “We are aggressively advancing GMP manufacturing of TZLS-501 concurrently with the development of inhalation technology using a hand-held nebulizer and safety toxicology studies in cynomolgus monkeys. Our objective is to submit an Investigational New Drug (IND) application in the first quarter of 2021 for the treatment of COVID-19 patients.”
STC Biologics President and CEO Magdalena Leszczyniecka said, “The initiation of GMP manufacturing of TZLS-501 with STC is a timely step forward toward expediting development of a potentially innovative treatment for COVID-19 patients. We are very excited and well positioned to accelerate the development of TZLS-501 for COVID-19 patients in such extraordinary times.”
Tiziana is also developing an intranasal formulation of foralumab (TZLS-401), which it licensed from Novimmune in 2014, for the treatment of neurodegenerative diseases. The company said that it is also working with Sciarra Laboratories to manufacture clinical supplies of TZLS-401 for an upcoming Phase 2 trial in progressive multiple sclerosis.
Read the Tiziana Life Sciences press release.
