TILS.L Regulatory News (TILS)

Tiziana Life Sciences plc

("Tiziana" or the "Company")

Development of a Proprietary Oral Formulation of Foralumab, a Fully Human Anti-CD3 mAb, for use in an Upcoming Phase 2a Clinical Trial in NASH

· Successfully developed a novel formulation enabling oral immunotherapy with foralumab for NASH and other autoimmune diseases

· The proprietary technology underlying the oral formulation is a significant advancement in the field of oral immunotherapy with human monoclonal antibodies (mAbs)

London, September 6, 2017 - Tiziana Life Sciences plc (AIM: TILS, the "Company"), the clinical stage biotechnology company developing targeted drugs for cancer and autoimmune diseases, announces development of a novel, proprietary, oral formulation of foralumab, a fully human anti-CD3 monoclonal antibody (mAb), to be used in upcoming clinical studies in patients with non-alcoholic steatohepatitis (NASH) and other inflammatory diseases. This is the first-ever development of an oral formulation suitable for therapy with foralumab (NI-0401).

"Oral immunotherapy with an anti-CD3 mAb is expected to be a preferred approach for targeted immunomodulation without eliciting immunosuppression throughout the body. However until now, oral administration has not been pursued due to the expectation of mAbs being inactivated by the harsh conditions in the gastrointestinal tract," commented Gabriele Cerrone, Chairman of Tiziana Life Sciences. "The development of this proprietary oral formulation is a breakthrough in novel dosing formulation and we believe that this technology may have broad additional therapeutic utility with other mAbs."

"Oral administration with biologics such as mAbs is a potential game changer for immunotherapies, enhancing drug safety while potentiating immunomodulation to provide clinical responses," said Kunwar Shailubhai, CEO and CSO of Tiziana Life Sciences. "Recently we demonstrated, using humanized mice models, that orally administered foralumab is biologically effective to produce immunomodulatory activity1. Thus, successful development of the oral formulation of foralumab is a major milestone, and it opens up a novel avenue for treatment of NASH and other autoimmune diseases."

Cited Reference

1. Oral treatment with foralumab, a fully human anti-CD3 monoclonal antibody, prevents skin xenograft rejection in humanized mice. Ogura M1, Deng S, Preston-Hurlburt P, Ogura H, Shailubhai K, Kuhn C, Weiner HL, Herold KC.Clin Immunol. 2017 Jul 21. pii: S1521-6616(17)30342-X. doi:10.1016/j.clim.2017.07.005. [Epub ahead of print]

About NASH 

Non-alcoholic fatty liver disease (NAFLD) is one of the causes of fatty liver, which occurs when fat is deposited (steatosis) in the liver due not related to alcohol use. It affects 30% of the western world population. Non-alcoholic steatohepatitis (NASH) is a severe type of NAFLD. NASH occurs when the accumulation of liver fat is accompanied by inflammation and cellular damage. The inflammation can lead to fibrosis (scarring) of the liver and eventually progress to cirrhosis, portal hypertension, liver cancer and liver failure. According to a market research report Nonalcoholic Steatohepatitis Treatment Market 2015-2025 published by iHealthcareAnalyst, Inc., the global nonalcoholic steatohepatitis treatment market is estimated to reach USD 19.5 Billion in 2025, expanding at a current annual growth rate of 10.0% from 2016 to 2025. Currently there is no approved therapy for NASH.

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.

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

This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.

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