Benzinga | Aug 4, 2020 05:55AM EDT

Tiziana Life Sciences Announces an Expedited Clinical Development Plan for Its Anti-Interleukin-6-Receptor, a Fully Human Monoclonal Antibody, for the Treatment of COVID-19 Patients

Tiziana Life Sciences plc (NASDAQ:TLSA) today announcedt hat it has signed agreements with four CROs 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. The Company intends to initiate the clinical study in Q1 2021 and will work with the following CROs:

FHI Clinical: A subsidiary of FHI 360, FHI Clinical is a multinational CRO specializing in clinical development of drugs for infectious diseases ( https://www.fhiclinical.com). This company has conducted several recent trials in COVID-19 patients and has a large network of clinical sites throughout the US and abroad to expedite clinical trials with COVID-19 patients. In this trial, TZLS-501 will be delivered as an aerosol directly to the lungs using a hand-held nebulizer.STC Biologics: STCBiologics, Inc. is a boutique Good Manufacturing Practice (GMP) CRO that provides full chemistry, manufacturing and control (CMC) services to enable its partners to advance their biologic products from discovery to commercial approval. GMP manufacturing of TZLS-501 is ongoing.Sciarra Labs: Sciarra Laboratories, Inc., is an FDA-approved, current GMP manufacturer of drug solutions used in nebulizers, inhalers, metered dose inhalers ("MDI") and nasal sprays. Tiziana worked with Sciarra Labs to establish clinical supply of nasal sprays of Foralumab used in the recently completed Phase 1. Sciarra Labs will be developing and testing a hand-held nebulizer and GMP manufacturing the anti-IL6R mAb solution to be used as clinical trial 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 is a Canadian Council on Animal Care (CCAC) and American Association for Accreditation of Laboratory Animal Care (AAALAC) CRO and is a fully compliant Good Laboratory Practices (GLP) CRO. ITR will be conducting safety and toxicity studies with TZLS-501 delivered by a nebulizer directly into the lungs of cynomolgus monkeys.Tiziana holds a worldwide exclusive license for TZLS-501 (a.k.a NI-1201) from Bristol Myers Squibb(tm). TZLS-501 is a novel fully human mAb that binds to both the membrane-bound and soluble forms of IL-6R and rapidly depletes circulating levels of IL-6 in the blood (1). Excessive production of IL-6 is regarded as a key driver of cytokine release syndrome (CRS) and chronic inflammation in the lungs of patients with COVID-19 and acute respiratory illness such as Acute Respiratory Distress Syndrome (ARDS). Tiziana's novel and proprietary approach to treatment is to deliver TZLS-501 directly to the lung via inhalation.

Executive Chairman of Tiziana, Gabriele Cerrone, commented: "We have moved quickly to accelerate our clinical development plan for TZLS-501 using our innovative delivery platform, which was developed by Howard Weiner, a world-renowned neurologist and Chairman of our Scientific Advisory Board. I look forward to beginning our human clinical trials in the first quarter of 2021."

Dr. Kunwar Shailubhai, CEO and CSO of Tiziana Life Sciences, commented, "Our proprietary inhalation technology for delivery of TZLS-501 to the lungs in COVID-19 patients is an attractive and most logical approach to deplete excessive levels of IL-6 to provide rapid relief. We are focusing on the development of oral, nasal and inhalation routes of mAb administration for immunotherapy. The common underlying concept in these alternative delivery approaches is to enable local or topical actions to maximize clinical action and minimize undesirable side effects commonly associated with intravenous and subcutaneous administration. Being a fully human anti-IL-6 receptor mAb, TZLS-501 is most suitable for long-term immunotherapies."