TILS.L Regulatory News (TILS)

Tiziana Life Sciences licences new anti-cancer stem cell technology from Cardiff University

London, 07 May 2015 - Tiziana Life Sciences plc ("Tiziana", AIM: TILS), the clinical stage biotechnology company focused on targeted drugs to treat diseases in oncology and immunology, has exclusively licensed a novel anti-cancer stem cell agent, capable of targeting aggressive tumour forming cells originating from the breast, pancreas, colon and prostate, from Cardiff University scientists.

The novel agent, known as OH14, is an inhibitor of c-FLIP (cellular FLICE (FADD-like IL-1β-converting enzyme)-inhibitory protein), a known suppressor of apoptosis (programmed cell death). c-FLIP acts inside the cell by preventing the instructive cell death that occurs when a signal protein produced by neighbouring cells attaches to the target cell's surface. c-FLIP blocks this death signal from entering the cell. Suppression of apoptosis is a recognised driver of cancer cell proliferation, thus by inhibiting this suppression it should be possible for cell death to occur and proliferation of cancer to be thwarted.

Under the terms of the agreement, Tiziana will fund £50,000 per year for a research project at the University focused on building the structure activity relationships (SARs) around OH14 and to improve the activity of this series of compounds. Additionally, Tiziana will pay to the University milestone payments up to c.£2 million and pay royalties on sales of any licensed products developed as a result of the project. If certain milestones are achieved Tiziana will also pay one per cent of its enterprise value to the University in the event of a trade sale of Tiziana to a third party.

This agreement is Tiziana's second with the University following the Bcl3 licensing agreement in January 2014.

Gabriele Cerrone, Chairman and founder of Tiziana, commented: "We are very excited to help drive forward this project in the promising new field of cancer stem cell therapeutics, and delighted to have extended our relationship with Cardiff University. This agreement further strengthens our portfolio of exciting pre-clinical assets to complement our Phase II assets of milciclib and foralumab. We look forward to working with the University to identify further inhibitors of c-FLIP. We will then seek to develop the most promising of these into novel drugs for cancers, such as those of the breast, where up-regulation of this c-FLIP is believed to be important in cancer cell proliferation."

Dr Richard Clarkson, lead researcher on the c-FLIP project and senior researcher at Cardiff University's European Cancer Stem Cell Research Institute (ECSCRI), said: "Cardiff University is delighted to extend its relationship with Tiziana Life Sciences. OH14 is an example of a new generation of experimental agents designed to selectively target the pernicious stems cells within a tumour, thus improving the long-term prospects of cancer patients."

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About Tiziana Life Sciences

Tiziana Life Sciences plc is a UK biotechnology company that focuses on the discovery and development of novel molecules that treat human disease in oncology and immunology.

In January 2015, the Company entered into an exclusive licence from Nerviano Medical Sciences relating to milciclib, a molecule which blocks the action of specific enzymes called cyclin-dependent kinases (CDK) involved in cell division as well as a number of other protein kinases. Milciclib is currently in phase II clinical trials for thymic carcinoma in patients previously treated with chemotherapy.

The Company also in-licensed another clinical asset in December 2014 from Novimmune. Foralumab is the only fully human engineered anti-human CD3 antibody in clinical development. This phase II asset has potential application in a wide range of autoimmune and inflammatory diseases, 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.

Tiziana Life Sciences' research team has discovered that Bcl-3 has a prominent role in the metastasis of mammary cancers, and has elucidated the mechanism of Bcl-3 action to be a regulator of cancer cell motility. Tiziana has also determined that Bcl-3 inhibition suppresses cell motility in triple-negative, HER-2-positive PR- and ER-positive breast cancer sub-types, suggesting that Bcl-3 may be a master regulator of this metastatic property not only in aggressive breast cancers, but across the clinical spectrum of breast disease.

About Cardiff University

Cardiff University is recognised in independent government assessments as one of Britain's leading teaching and research universities and is a member of the Russell Group of the UK's most research intensive universities. Among its academic staff are two Nobel Laureates, including the winner of the 2007 Nobel Prize for Medicine, University Chancellor Professor Sir Martin Evans. Founded by Royal Charter in 1883, today the University combines impressive modern facilities and a dynamic approach to teaching and research. The University's breadth of expertise encompasses: the College of Arts, Humanities and Social Sciences; the College of Biomedical and Life Sciences; and the College of Physical Sciences and Engineering, along with a longstanding commitment to lifelong learning. Cardiff's four flagship Research Institutes are offering radical new approaches to cancer stem cells, catalysis, neurosciences and mental health and sustainable places.