TILS.L Regulatory News (TILS)

Tiziana Life Sciences plc

("Tiziana", AIM: TILS) today announces that it has entered into an agreement with Novimmune S.A.. The full text of the joint announcement follows:

Tiziana Life Sciences licenses foralumab from Novimmune SA

Fully human anti-CD3 mAb has shown encouraging results in phase I/II trials in GVHD and Crohn's Disease

Tiziana to evaluate drug's potential in a number of inflammatory diseases

London, Geneva 22 December 2014 - Tiziana Life Sciences plc ("Tiziana", AIM: TILS), the clinical stage biotechnology company focused on targeted, drugs to treat diseases in oncology and immunology, and Novimmune S.A., a company focused on the discovery and development of antibody-based drugs to benefit patients with inflammatory, auto-immune disorders, and cancer, today announce that they have entered into an agreement under which Novimmune grants Tiziana an exclusive license for the clinical development and commercialisation of foralumab, a fully human antihuman CD3 receptor monoclonal antibody (CD3 mAb).

Targeting the CD3 receptor is a well-validated approach to modulating T-cell response and achieving immunosuppression. Foralumab is a phase II asset with 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. Evidence suggests that in rheumatoid arthritis, anti CD3 antibodies, when used in conjunction with anti-TNF antibodies such as Humira, Remicade and Enbrel - which represent a multi-billion dollar market - may exhibit a synergistic effect. In the coming months, Tiziana will be evaluating and prioritising such potential therapeutic applications of foralumab. Tiziana will continue to focus strongly in the field of oncology, advancing its pre-clinical breast cancer research programmes in Bcl-3 and "Top 20", and now has a clinical stage asset to complement its pre-clinical portfolio.

Tiziana will pay an upfront fee of $1.25 million for the license to Novimmune within 60 days after signing the agreement and will make further payments to Novimmune totalling $750,000 by February 2018. Tiziana will also pay a royalty on sales or a share of sub-licence revenues to Novimmune, subject to the deduction of certain costs.

Gabriele Cerrone, Chairman of Tiziana, commented: "This is a transformational deal for Tiziana that broadens our pipeline, immediately converting us to a clinical stage company. Foralumab, our new lead pipeline asset, has broad potential applications in a number of important multi-billion dollar markets. We look forward to updating the market in the coming months as we evaluate how we wish to progress this exciting molecule."

Jack Barbut, CEO of Novimmune, added: "Novimmune is delighted that this promising experimental medicine will be developed further by Tiziana and that Novimmune retains a share in any future value created."

Contacts:

About foralumab

Foralumab targets the CD3 epsilon (CD3ε) receptor and was developed using Medarex's (now a subsidiary of Bristol-Myers Squibb) UltiMab® technology to engineer fully human antibodies to targets of interest. The antibody was also engineered to minimize unwanted cytokine release by deliberately modifying the Fc-receptor region of the antibody. The drug is suitable for both IV infusion and subcutaneous administration. Anti-CD3 antibodies are a clinically proven therapeutic option for achieving immunosuppression. Orthoclone OKT3®) (Janssen-Cilag) was the first therapeutic monoclonal antibody (mAb) directed against part of the CD3-TCR complex expressed on mature T-cells to be approved by the FDA for the treatment of solid-organ transplantation in 1986. However, OKT3® is a mouse antibody and provokes side effects.

In pre-clinical and clinical studies to date, foralumab has shown encouraging signs of efficacy and an acceptable safety profile. A phase IIa clinical trial in Crohn's disease, and a phase I/II open-label study in graft versus host disease (GVHD) following kidney transplantation have been completed. Tiziana intends to explore other indications for foralumab.

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's lead asset is foralumab, 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 Novimmune

Novimmune SA is a leading drug discovery and development company focused on creation of antibody-based drugs for patients with inflammatory, auto-immune and other disorders. To date, Novimmune has advanced seven drug candidates to treat a range of conditions. Novimmune has a diverse clinical pipeline including NI-0501, NI-0101 and NI-1401.

NI-0501 is an anti-interferon g monoclonal antibody currently in a Phase II study for treatment of the orphan disease haemophagocytic lymphohistiocytosis, a potentially lethal inflammatory syndrome.

NI-0101 is a first-in-class anti-TLR4 monoclonal antibody. TLR4 is a receptor in the pathway leading to activation of the innate immune system, and has been implicated as a target for conditions including rheumatoid arthritis, lung disease, diabetes, and kidney disease. NI-0101 has successfully completed a phase I clinical trial and Novimmune intends to progress it as potentially the first personalized medicine for rheumatoid arthritis.

NI-1401 is a differentiated anti IL-17 monoclonal antibody that binds the three forms of IL-17 A and F. It was licensed to Genentech in 2010. Genentech is responsible for development and is expected to announce initiation of a phase II clinical program in early 2015.

Novimmune has also developed a proprietary bi-specific antibody platform to expand its pipeline. In addition to pursuing additional drug discovery, development and commercialization partnerships, Novimmune plans to bring selected drugs to market for orphan drug applications.