The following information is provided by Tiziana Life Sciences plc (the "Company") in accordance with Rule 26 of the AIM Rules. Until 23rd April 2014 the company’s name was Alexander David Investments Plc.
Tiziana Life Sciences plc (“Company”) is a biotechnology company that focuses on the discovery and development of novel molecules that treat human disease in oncology and immunology.
On 24 April 2014 the Company acquired Tiziana Pharma Limited (“TPL”) via a reverse takeover (as defined in the AIM Rules). TPL was formed in November 2013 as a vehicle to acquire and exploit certain intellectual property in biotechnology.
On 22 December 2014, the Company in-licensed the molecule foralumab, the only fully human engineered anti-human CD3 antibody in clinical development, from Novimmune SA. Foralumab targets the CD3 epsilon (CD3ε) receptor, which is a recognised approach for modulating T-Cell response and achieving immunosuppression. Foralumab is a phase II asset with potential application in a wide range of autoimmune and inflammatory disease, such as multiple sclerosis, type-1 diabetes (T1D), inflammatory bowel disease (IBD), psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable.
On 20 January 2015, the Company in-licensed milciclib from Nerviano Medical Sciences. The compound milciclib blocks the action of a specific set of enzymes known as cyclin-dependent kinases (CDKs), which are involved in the process of cell division, as well as a number of other protein kinases. Milciclib has an unusual kinase inhibitory profile making it active against other receptors such as, tyrosine kinase, src family and splicing kinases. Milciclib is currently in phase II clinical trials for thymic carcinoma in patients previously treated with chemotherapy. Milciclib has demonstrated that is well tolerated in over 263 patients in phase I and II clinical trials and has been granted orphan designation by the European Commission and by the US Food and Drug Administration (FDA) for the treatment of malignant thymoma / thymic epithelial tumours. Nerviano has demonstrated, in preclinical studies, that milciclib has potential in other cancer indications, specifically liver and breast cancer.
In March 2020 Tiziana announced that it is expediting development of TZLS-501, a novel, fully human anti-interleukin-6 receptor (anti-IL6R) monoclonal antibody (mAb) for treatment of inflammation and lung damage in patients infected with coronavirus COVID-19 (SARS-CoV-2). Tiziana plans to administer TZLS-501 as an aerosol directly to the site of inflammation using a nebulizer or metered inhaler. The Company entered into a world-wide license for composition-of-matter of TZLS-501, a fully human mAb targeting IL-6R, with Novimmune, SA, a Swiss biotechnology company in 2017
In April 2020 Tiziana Life Sciences acquired all intellectual property relating to a nanoparticle-based formulation of Actinomycin D (Act D; a.k.a. Dactinomycin), from Rasna Therapeutics, Inc. ("Rasna") to expand its pipeline.
Act D, an antibiotic drug, approved initially for infectious diseases in the United States in 1964. Subsequently, this antibiotic was shown to exhibit anti-cancer activity in 1974. Since then the drug has been used to treat various types of cancer. Since Act D is a potent inhibitor of RNA synthesis, may have potential for treatment of COVID-19 patients either alone or in combination with TZLS-501 inhalation treatment.
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