TILS.L Regulatory News (TILS)

Tiziana Life Sciences PLC

("Tiziana" or the "Company")

Tiziana Life Sciences in-licenses NI-1201, a fully human anti-IL-6R monoclonal antibody

Exclusive world-wide license expands therapeutic pipeline in key immunological areas

London, 3 January 2017 - Tiziana Life Sciences plc (AIM: TILS, the "Company"), a clinical stage biotechnology company developing targeted drugs for cancer, autoimmune and inflammatory diseases, announced the acquisition of an exclusive world-wide license for NI-1201, a fully human anti-interleukin-6 receptor (IL-6R) monoclonal antibody (mAb), from Novimmune SA. In exchange for the exclusive license from Novimmune the Company agreed to an upfront cash payment, milestone payments, and a royalty on future sales.

Monoclonal antibodies against IL-6R have been explored as potential drugs to treat inflammation in the past. NI-1201's unique mechanism, however, has the potential to considerably increase anti-inflammatory activity as well as complementing the Company's program on foralumab (NI-0401), a fully human oral anti-CD3 mAb.

"We view NI-1201 as a potential game-changer for addressing the high unmet need of autoimmune and inflammatory diseases" commented Gabriele Cerrone, Chairman of Tiziana Life Sciences. "The acquisition of NI-1201 not only strengthens our business strategy of developing novel fully human mAbs to treat life-threatening inflammatory diseases such as non-alcoholic steatohepatitis (NASH) and rheumatoid arthritis, but expands our potential to leverage the pioneering work we are doing with foralumab, the oral anti-CD3 mAb to treat autoimmune and inflammatory diseases."

"The acquisition of NI-1201 is both strategic and very exciting for Tiziana Life Sciences because a fully human anti-IL-6R mAb perfectly complements foralumab, the Company's fully human oral anti-CD3 mAb which is being explored for treatment of NASH and type 2 diabetes," said Professor Howard Weiner, a member of Tiziana Life Sciences' Scientific Advisory Board. "It is known that dampening inflammatory signals driven by IL-6 enhances the induction of the regulatory mechanism induced by anti-CD3 mAb's (Faria AM and Weiner HL. Oral tolerance. Immunol Rev. 2005; 206:232-59)."

About anti-IL6R (NI-1201)

A key driver of chronic inflammation is excessive production of IL-6 and its receptor IL-6R, both of which are responsible for inducing inflammatory responses. NI-1201, a fully human anti-IL-6R mAb, differs from other anti-IL-6R mAb's such as tocilizumab (Actemra, Hoffmann-La Roche), which exerts its pro-inflammatory effects predominantly through binding to membrane-bound IL-6R, in that NI-1201 acts not only on membrane-bound IL-6R, but also on soluble IL-6R, and is also able to deplete circulating levels of IL-6 in blood.

About Professor Weiner

Howard L. Weiner M.D. is the Robert L. Kroc Professor of Neurology at the Harvard Medical School and Director and Founder of the Partners Multiple Sclerosis Center and Co-Director of the Ann Romney Center for Neurologic Diseases at Brigham & Women's Hospital in Boston. He has pioneered immunotherapy in multiple sclerosis, and has investigated immune mechanisms in nervous system diseases including Alzheimer's disease, amyotrophic lateral sclerosis, stroke and brain tumours. He has also pioneered investigation of the mucosal immune system for the treatment of autoimmune and other diseases.

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

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