Tiziana Life Sciences: Advancing at speed
Tiziana (TILS), also listed on NASDAQ (Symbol TLSA), is driving forwards the clinical development plan for its fully-human mAb TZLS-501 for treating COVID-19 respiratory symptoms and has set out the detail of its clinical plan being executed by a group of specialist contract research organisations (CROs). With GMP-grade manufacturing already underway via boutique CRO, STC Biologics, the company has appointed three other CROs to develop and test the handheld nebuliser, to conduct an inhalation safety toxicity study in monkeys, and to initiate a human clinical trial in COVID-19 patients. Having recently announced a US$57mln gross equity offer, subject to imminent closure, TILS looks well set to execute its clinical development strategy both for TZLS-501 and for the full clinical pipeline which includes phase II studies of its proprietary nasal and oral formulations of its lead candidate Foralumab, a fully-human anti-CD3 specific mAb with broad potential to treat inflammatory and autoimmune diseases.
TILS has taken an innovative approach to leverage the potential of TZLS-501 to treat COVID-19, to investigate its promise of helping alleviate life-threatening lung inflammation. To our knowledge TILS is a pioneer in developing anti-IL6R mAbs for administration via a nebuliser or inhaler direct to the lungs and recently filed a patent on the approach in order to target the main site of inflammation directly. To date, trials of anti-IL6R mAbs have as far as we know focused largely on intravenous (IV) or subcutaneous route of administration. The inhaler approach can enable patients to be treated quickly and easily, including potentially outside the hospital setting.
The company is aiming for IND filing/study start in Q1 2021 for TZLS-501 for treating COVID-19 respiratory complications in order to investigate its preclinical anti-inflammatory promise. Repurposing studies of market-leading anti-IL6R mAbs Kevzara (Sanofi/Regeneron) and more recently Actemra (Roche) for COVID treatment have been halted after a lack of efficacy. Preclinical studies of TZLS-501 indicated TZLS-501 showed attractive preclinical anti-inflammatory mechanisms vs Actemra and so this factor and the novel delivery modality and the fact that it is a fully human mAb, are factors that point to clinical and commercial differentiation.
TILS has appointed a set of specialist CROs to execute its clinical development plan including FHI Clinical, a multinational CRO specialising in clinical development of drugs for infectious diseases. Significantly, the company already has experience in running several recent trials in COVID-19 patients and has a large network of clinical sites both inside the US and beyond that can help accelerate clinical trials with TZLS-501. GMP (good manufacturing practice) grade manufacturing of TZLS-501 is ongoing at STC Biologics, which is a specialist CRO that provides full chemistry, manufacturing and control services.
Sciarra Laboratories, an FDA-approved, GMP manufacturer of drug solutions used in nebulisers, inhalers, metered-dose inhalers and nasal sprays, has been appointed to develop and test a hand-held nebuliser alongside GMP manufacturing of the anti-IL6R mAb solution to be used as clinical trial material for the study in COVID-19 patients. ITR Laboratories Canada, a fully accredited and well-established CRO, will be conducting safety and toxicity studies with TZLS-501 delivered by a nebuliser directly into the lungs of cynomolgus monkeys. We await full details on the trial protocol, but successful completion of safety and toxicology studies in monkeys could help to abbreviate the clinical safety testing phase of studies of TZLS-501. Urgent unmet need means that development of TZLS-501 could be accelerated, possibly leading to its widespread supply for investigational use.
TILS is planning to spin off its prognostic test technology
Initiation of phase II studies with Foralumab or a phase I study for TZLS-501 in COVID patients are also likely to be key inflexion points. Furthermore, the company’s application for admission to the standard listing of the UK Official List (and cancellation from AIM) is intended to raise liquidity, access wider investment pools and raise its profile as a global biotech with a growing pipeline.