SOURCE: Tiziana Life Sciences PLC

May 19, 2016 02:00 ET

Immunotherapy Journal Review of Anti - CD3 Monoclonal Antibodies Highlights Therapeutic Potential of Tiziana's Foralumab

LONDON, UNITED KINGDOM--(Marketwired - May 19, 2016) - Tiziana Life Sciences plc (AIM: TILS)

Tiziana Life Sciences PLC

("Tiziana" or the "Company")

Immunotherapy journal review of anti - CD3 monoclonal antibodies highlights therapeutic potential of Tiziana's foralumab

foralumab is the only fully human anti-CD3 monoclonal antibody currently in development for the modulation of autoimmune disease

May 19, 2016 - Tiziana Life Sciences plc (AIM: TILS), a clinical stage biotechnology company focused on targeted drugs to treat diseases in oncology and immunology, today announced that foralumab, was featured in a review article entitled, "Therapeutic anti-CD3 monoclonal antibodies: from bench to bedside" published online ahead of print in peer-reviewed journal, Immunotherapy (see This follows the announcement made by the Company on 11 January 2016 that outlined Tiziana's plans to initially evaluate foralumab in two clinical indications; namely, graft vs host disease, and ulcerative colitis, an inflammatory bowel disease.

Investigations over the last 20 years have shown that anti-CD3 monoclonal antibodies (mAbs) effectively treat autoimmune disease in animal models and have also shown promise in clinical trials. Growing industry focus on clinical applications of immunotherapy has also stimulated greatly increased interest in modulation of immune tolerance.

The review article, authored by Dr. Howard Weiner, who joined Tiziana's Scientific Advisory Board earlier this year, and Dr. Chantal Kuhn of Harvard Medical School, highlights unique attributes of foralumab that differentiate it from the other anti-CD3 monoclonal antibodies (mAbs) evaluated in the past. In particular, it was noted that foralumab is currently the only fully human anti-CD3 mAb in development and that this should potentially translate into reduced side effects and improve the overall safety profile of foralumab compared to other anti-CD3 mAbs in development, potentially translating to reduce side effects and an improved overall safety profile as compared with murine and other non - human mAbs.

The article also summarized studies demonstrating that the oral or nasal administration of an anti-CD3 mAb has significant potential as a novel approach to treat autoimmune and inflammatory diseases such as Non-alcoholic Steatohepatitis (NASH), inflammatory bowel diseases (IBD) and type 1 diabetes.

Tiziana Life Sciences is implementing Dr. Weiner's breakthrough research for clinical development of foralumab.

Dr. Howard Weiner is the Robert L. Kroc Professor of Neurology at the Harvard Medical School, Director and Founder of the Partners Multiple Sclerosis (MS) Center and Co-Director of the Ann Romney Center for Neurologic Diseases at Brigham & Women's Hospital in Boston. He pioneered the investigation of the mucosal immune system for the treatment of autoimmune and other diseases.


Tiziana Life Sciences plc
Gabriele Cerrone, Chairman and founder
+44 (0)20 7493 2853
Cairn Financial Advisers LLP (Nominated adviser)
Liam Murray
+44 (0)20 7148 7900
Beaufort Securities Limited (Broker)
Saif Janjua
+44 (0)20 7382 8300
FTI Consulting
Simon Conway / Natalie Garland-Collins
+44 (0)20 3727 1000

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 thymic carcinoma in patients previously treated with chemotherapy and preparing and 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 this year.

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