Tiziana Life Sciences: Transformational potential
Tiziana Life Sciences lead programme Foralumab is notable in that not only is this the only fully human anti-CD3 specific mAb in clinical development, with broad potential for a range of inflammatory and autoimmune diseases, but also due to the novel proprietary formulations being developed by TILS for nasal and oral administration. These ground-breaking approaches can not only reduce the toxicity seen with systemic treatment they may also be more efficacious than standard injected biologics. Broadly, if clinical study outcomes are positive, this can potentially revolutionise treatment in the mAbs market which has a projected value over $130bn by 2025, comprising the best-selling drugs in the world.
The company is also accelerating the development of TZLS-501, a fully human anti-IL6R mAb, towards the clinic for COVID-19 treatment. The innovative delivery route via handheld nebulizer or inhaler to the lung, directly targets the main site of inflammation.
In July TILS filed a patent application on the use of Foralumab, to enhance success of chimeric antigen receptor T cells or CAR-T therapy. The approach covers the use of anti-CD-3 mAbs administered alone or in combination with other therapies to enhance CAR-T treatment, which is a highly promising space being developed for unmet need in cancers and other human diseases and could lead to the wide use of Foralumab if safe and efficacious.
Tiziana’s Phase I clinical study of oral Foralumab in Crohn’s Disease showed its proprietary oral formulation of Foralumab to be well tolerated. Phase II trials are planned in H2 20.Its alternative formulation and safety profile could provide a very attractive alternative to blockbuster IV drugs which registered c $4bn in Crohn’s in 2018. Tiziana recently received the first-ever patent on oral delivery of all anti-CD3 monoclonal antibodies for the treatment of human disease supporting the differentiated approach.
Nasal Treatment with Foralumab for secondary progressive MS was well-tolerated in a Phase I trial and induced positive trends in biomarkers of immunomodulation and anti-inflammation in healthy volunteers. Data from these two Phase I trials with alternative oral and nasal routes of administration indicated that the toxicities that are commonly observed with anti-CD3 IV treatment were not observed. Moreover, data from biomarkers analysis also suggested upregulation of IL-10 and Tregs, which are vital to produce an anti-inflammatory effect and significantly, have the ability to cross the blood-brain barrier. In contrast, the majority of treatment approaches have not succeeded in crossing the barrier, hindering the ability to treat neurodegenerative diseases. The value of the MS treatment market is around $20bn, according to analyst estimates.
TILS is moving the development plan aggressively aiming for IND filing for TZLS-501 for treating COVID-19 respiratory complications in Q1 21. To our knowledge TILS is a pioneer in developing anti-IL-6R mAbs for administration via a nebulizer or inhaler direct to the lungs and has filed a patent on the approach. Also, TZLS-501 showed attractive preclinical anti-inflammatory mechanisms vs market leading anti-IL6R mAb Actemra (Roche), which is being developed for COVID. This could lead to efficacy at lower doses. These factors suggest TZLS-501 can have significant clinical and commercial differentiation. Urgent unmet need means that development of TZLS-501 could be accelerated, possibly leading to its widespread supply for investigational use. the EC recently signed with Roche to supply sufficient quantities of Actemra to the 27 member states for studies.
Quick facts: Tiziana Life Sciences PLC
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