TNFα Kinoid proves effective in rheumatoid arthritis model tests

Neovacs, a developer of immunotherapies for autoimmune and chronic diseases, has announced that it has demonstrated the efficacy of the TNFα Kinoid in a transgenic mouse model of arthritis.

'The results achieved in this stringent therapeutic model further confirm the potential of the Kinoid active immunotherapy approach in severe autoimmune diseases', said Guy Charles de la Horie, Neovacs" ceo.

'Further, the transient nature of the effect, and the absence of a booster response to TNF alone are both highly encouraging in terms of the practical controllability of the approach and are consistent with our clinical results to date'.

In summary, the research demonstrates that:

In mice with established arthritic disease, treatment with the TNFα Kinoid produces significant therapeutic benefit (when compared with control animals) at Week 27.

The degree of clinical benefit is similar to that provided by infliximab (a passive antibody therapy).

Both the clinical benefit and the presence of anti TNFα antibodies to TNFα induced by administration of TNFα Kinoid are transient.

Administration of a maintenance dose of TNFα Kinoid restores both clinical benefit and antibody levels.

Administration of TNFα alone did not induce any recall immune response to TNF? in Kinoid-immunised mice. This means that endogenous expression of TNFα is not expected to act as a booster for antibody levels, an important consideration in the reversibility and controllability of Kinoid-based active immunotherapy.

Previously published research (PNAS 2006; 103; 51: 19442-47) demonstrated the efficacy of the TNFα Kinoid in preventing disease onset in arthritis-prone mice.

In December 2009, Neovacs announced that it was initiating a Phase II clinical study of TNFα Kinoid in rheumatoid arthritis patients who had failed treatment with a TNFα inhibitor and had antibodies against the failed drug. A Phase I/II study in patients with active Crohn's disease is ongoing.

The company expects to initiate clinical trials of a second product candidate, IFN? Kinoid, an immunotherapy targeting interferon alpha (INFα), in lupus patients in the first quarter of 2010.