Tiziana Life Sciences, a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, announced that it has signed agreements with FHI Clinical and three additional providers to expedite clinical development of TZLS-501, a novel fully human anti-interleukin-6 receptor (anti-IL6R) monoclonal antibody (mAb), for the treatment of COVID-19 (SARS-CoV-2) patients.
Currently, FHI Clinical is collaborating with a team of regulatory and medical experts to help draft a protocol and drug development plan for upcoming pre-IND meetings. FHI Clinical also will provide full CRO services for the clinical study, expected to begin in Q1 2021. In this trial, TZLS-501 will be delivered as an aerosol directly to the lungs using a hand-held nebulizer.
Additional collaborators for this study include:
- STC Biologics: STC Biologics, Inc. is a boutique turn-key contract development and manufacturing organization (CDMO) that provides full Chemistry, Manufacturing and Control (CMC) services and consulting to enable partners advance their biologic products from discovery to commercialization. Good Manufacturing Practice (GMP) manufacturing of TZLS-501 is ongoing.
- Sciarra Labs: Sciarra Laboratories, Inc. is an FDA-approved, current GMP (cGMP) manufacturer of drug solutions used in nebulizers, inhalers, metered dose inhalers (MDI) and nasal sprays. Sciarra Labs will develop and test a hand-held nebulizer and GMP manufacture the anti-IL6R mAb solution to be used as material for the clinical study in COVID-19 patients.
- ITR Laboratories Canada: ITR has been in operation for the last 30 years and is known for its reputation in toxicology testing and other specialized testing services for biotechnology and pharmaceutical industries in North America, Europe and beyond. ITR will conduct safety and toxicity studies with TZLS-501 delivered by a nebulizer.
For more information, visit the Tiziana Life Sciences press release, and download our brochure to learn more about FHI Clinical’s COVID-19 research services.
