TILS.L Regulatory News (TILS)

Tiziana Life Sciences PLC

("Tiziana" or the "Company")

Tiziana acquires a unique bio-repository from Shardna SpA and establishes LonGevia Genomics Srl, a Sardinian based subsidiary to further enhance and develop its portfolio 

London, 18 July 2016 - Tiziana Life Sciences plc (AIM:TILS), a clinical stage biotechnology company focused on targeted drugs to treat diseases in oncology and immunology, announces today that it has purchased key assets from Shardna SpA ("Shardna") a biobanking and genomics research company located in Cagliari, Sardinia, for a total value of €258,000. Tiziana has also established an Italian subsidiary in Sardinia, LonGevia Genomics Srl, specifically to develop these assets to identify novel drug targets and diagnostic applications, through integration with its global research network.

Prof. Napoleone Ferrara, a member of Tiziana's Scientific Advisory Board, states that "the acquisition of Shardna represents an opportunity to study a unique collection of DNA samples from a homogeneous and well-characterized population. This could advance our understanding of aging and other key pathophysiological processes and potentially result in diagnostic and therapeutic advances".

"Sardinia is renowned as one of only three regions in the world with an exceptionally high proportion of centenarians," commented Tiziana's Chairman and founder, Gabriele Cerrone, "This transaction provides access to a unique bio-repository, which we can now leverage and combine the massive power and low cost of next generation gene sequencing with the full complement of "-omics" technologies. The opportunity is to generate valuable insights into gene regulatory networks, genotype-phenotype linkage and gene-environment interactions that will feed into and inform our drug discovery and diagnostic programmes. We believe our management team, who have collectively been instrumental in the discovery and development of blockbuster drugs such as Avastin and broadly adopted diagnostics such as the PSA test for prostate cancer, have the capability, expertise and insights to discover new drugs and diagnostics to address important unmet medical needs using this biobank resource."

The Shardna biobank, one of the largest and oldest in the world, includes 230,000 biological samples, from the almost 13,000 fully genealogically linked residents of the Ogliastra region of Sardinia. This genetically homogenous community has certified record data that traces back genealogy over four hundred years and is supplemented with genotyping data and clinical status. This high level of characterisation within the well-maintained records has resulted in a biobank that is a uniquely rich and a potentially valuable source of scientific data.

In recent years a number of biobank assets have been consolidated and vertically integrated with genomics, diagnostic, and pharmaceutical/biotech companies that are vying to control access to samples of value for drug development. For example, deCODE Genetics, the Iceland-based genomics and biobank company was bought by Amgen for approximately $415M.

This Ogliastra region of Sardinia has a prevalence of centenarians almost fifty times that of the US or UK. Indeed inhabitants have the second highest longevity after Okinawa Island, Japan. The longevity "Blue Zone" located in the provinces of Ogliastra and Nuoro in the mountainous region of Sardinia, where villages have been isolated for centuries, shows a value of the Extreme Longevity Index computed for the newborns between 1880 and 1900 that is more than twice as high as that of whole Sardinia. Strikingly the female/male ratio among centenarians in this population is close to one, as 47 male centenarians and 44 female centenarians were found.

Shardna SpA was founded in 2000 and was the first Italian research company in the field of genomics, created initially through a public private partnership. Research at Shardna was aimed at the identification of genetic and environmental factors which carry a predisposition to common multifactorial diseases through the study of the genetically homogeneous population from the isolated communities in the Ogliastra region of Sardinia.

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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.

The Company is focused on its lead compound, 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 completing phase II clinical trials for epithelial thymic carcinoma and/or thymoma in patients previously treated with chemotherapy and has filed an IND to enroll patients in an exploratory trial in Hepatic Cellular Carcinoma (HCC).

The Company is also in clinical development of foralumab. Foralumab is the only fully human engineered anti-human CD3 antibody in clinical development. This phase II compound has potential application in a wide range of autoimmune and inflammatory diseases, such as ulcerative colitis, 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' clinical development teams are working on its Bcl-3 candidate; which 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 and 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. The Company is preparing the IND package with the intention of progressing to clinical trials early 2017.

For more information go to http://www.tizianalifesciences.com