Anti-TNFα therapies have already demonstrated their efficacy across a wide range of inflammatory disorders, in particular RA, juvenile arthritis, spondyloarthropathy, psoriasis and Crohn’s Disease. Sales of these products exceeded $16bn in 2008.

Although powerful, current anti-TNFα therapies also have significant drawbacks, making new treatment approaches sorely needed. The most problematic aspect of mAb therapies is the frequent development of treatment resistance as they are used long-term to treat chronic diseases. Datamonitor estimates that there are over 126,000 patients resistant to current TNFα therapies in rheumatoid arthritis alone. Anti-TNFα treatments also have a cumbersome dosing regimen of frequent IV infusions or SC injections.

Neovacs’ lead product candidate, TNFα Kinoid, should address these issues, and therefore have the potential to be the next treatment revolution in TNF-mediated autoimmune diseases. Neovacs’ active immunization avoids treatment resistance by eliciting a natural immune response through the production of polyclonal antibodies against multiple epitopes of TNFα. Importantly, since the antibodies are elicited from the patient’s immune system itself, they will not generate an immune response themselves, even in patients that have developed resistance to mAb treatments. Furthermore, patients only need 3 or 4 maintenance doses per year, another key benefit for patient compliance and healthcare cost.

TNFα Kinoid is in an ongoing Phase I/II dose escalation study in Crohn’s Disease patients in South Africa and Switzerland. Preliminary results from the trial were presented at GASTRO 2009 in London in November.

In December 2009, Neovacs initiated a Phase 2 clinical study of TNFα Kinoid in rheumatoid arthritis patients who have failed at least one TNFα inhibitor and have antibody to the drug they failed