- Tiziana Life Sciences and Novimmune S.A. 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.

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