NEW YORK: Tiziana Life Sciences plc, a clinical stage biotechnology company, announced the execution of an agreement with STC Biologics Inc. for GMP manufacturing of TZLS-501, an anti-IL-6 receptor monoclonal antibody (mAb) acquired from Novimmune in 2017, 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. 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.

TZLS-501, a unique and best-in-class anti-IL-6R mAb, follows a dual mechanism by not only blocking downstream signaling pathways from membrane-bound and soluble IL-6 receptors, but it also rapidly depletes blood-stream levels of IL-6, the major culprit for cytokine release syndrome (CRS) in lungs of COVID-19 patients. In receptor binding assays, TZLS-501 is considerably more potent than the other anti-IL-6R mAb in this class, such as ActemraÒ (Roche)1,2. These biochemical features, differentiating TZLS-501 from other mAbs in this class, offer potential distinctive clinical advantages in effecting a rapid suppression of the cytokine storm at much lower doses.

The proprietary inhalation technology for direct delivery of mAbs or other small molecule drugs such as Remdesivir® (Roche) to lungs could potentially be a transformational therapy for developing a rapid treatment of COVID-19

“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,” said Kunwar Shailubhai, Ph.D., CEO and CSO of Tiziana Life Sciences.

“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,” added Dr. Magdalena Leszczyniecka, President and CEO of STC Biologics. “Our state-of-the-art single use production facility, highly cross-trained experienced personnel, and nimble decision-making has provided unprecedented speed to clinic in prior GMP campaigns. Together with a strong track record of pharmaceutical, regulatory and process development know-how, we are uniquely positioned to advance TZLS-501 to the clinic.”

Sciarra Laboratories, Inc., has been developing and manufacturing pharmaceutical aerosol products for over 25 years. Previously, Sciarra worked with Tiziana to successfully manufacture clinical supplies for the nasal administration of Foralumab, a fully human anti-CD3 mAb, for the recently completed Phase 1 trial3, and the company is currently working with Tiziana to manufacture Foralumab for nasal administration using a medical device, which will also be used for the upcoming Phase 2 trial in progressive multiple sclerosis. This phase 2 trial will commence shortly at the Brigham and Women’s Hospital, Harvard Medical School, Boston, MA.