Tiziana joins rheumatoid arthritis race

Tiziana Life Sciences has expanded its pipeline in autoimmune diseases. The company acquired an exclusive world-wide license for Novimmune’s arthritis candidate NI-1201, a human anti-interleukin-6 receptor (IL-6R) monoclonal antibody (mAb). The amount of the upfront cash payment, future milestone payments, and royalties on future sales were not disclosed.  

Novimmune’s preclinical IL-6R antagonist complements the company’s pipeline in autoimmune diseases. While its human anti-CD3 mAb Foralumab will soon enter Phase I trials as treatment for such inflammatory bowel disease, according to Tiziana’s pipeline chart, it is also suitable for autoimmune diseases such as ulcerative colitis, multiple sclerosis, lupus, non-alcoholic steatohepatitis (NASH) and type 1 diabetes. NI1201 targets the multi-billion dollar market of rheumatoid arthritis (RA).  

Currently, only one IL-6R blocker (tocilizumab, Hoffmann-La Roche AG) has entered the market as treatment for RA patients, who are not responsive to TNF blockers. Furthermore, Sanofi’s sarilumab is in Phase III testing as well as a range of IL6 antagonists such as GSK / Janssen Biologics’ sirukumab (CNTO 136) and Bristol Myers Squibb’s IL6 blocker clazakizumab (BMS-945429). However, as tocilizumab predominantly binds to membrane-bound IL-6R, NI-1201 also clears the blood from soluble IL-6R.  

“We view NI-1201 as a potential game-changer for addressing the high unmet need of autoimmune and inflammatory diseases,” said Gabriele Cerrone, Chairman of Tiziana Life Sciences. “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, member of Tiziana’s Advisory Board. “It is known that dampening inflammatory signals driven by IL-6 enhances the induction of the regulatory mechanism induced by anti-CD3 mAbs.”