Neovacs’ second most advanced immunotherapy is an IFNα Kinoid for systemic lupus erythematosus (SLE). SLE is a common and life-threatening chronic autoimmune disease characterized by the breaking of tolerance to nuclear components and profound alterations of the immune system. It is an area of huge unmet medical need and affects as many as 3 million people in the seven largest pharmaceutical markets. No new therapies for lupus have been approved in decades, even though current treatments lack specificity and often cause considerable side effects.

Lupus researchers have studied the role of several cytokines in causing dysregulated activation of immune system cell types and a key role for IFNα has been posited by clinicians as early as 1979, based on findings of elevated levels of IFNα in SLE patients’ serum. Further, corporate interest in this pathway is indicated by the fact that there are 3 monoclonal antibodies to IFNα in clinical development for lupus at large companies.

Neovacs has produced promising preclinical data with the IFNα Kinoid. Neovacs showed that immunization of NZB/W mice with the IFNα Kinoid prevented lupus manifestations, (proteinuria, renal lesions, and death) upon subsequent challenge with an adenovirus vector expressing IFNα. This protection was shown to be dependent on the maintenance of an effective threshold of anti-IFNα antibody in the serum. Of potential importance, the Company has shown that antibodies induced by the IFNα Kinoid neutralize all subtypes of IFNα, which is expected to be difficult for monoclonal-based approaches to achieve.  Further, Neovacs has demonstrated that antibody to the IFNα Kinoid neutralizes IFNα in the serum of lupus patients. These data were presented in a poster at ACR 2009 in Philadelphia.

Neovacs initiated a Phase 1/2 clinical trial in lupus patients with IFNα Kinoid in April 2010. Preliminary results from this study are expected early in 2011.